Letter From The Driver’s Seat Of PrISUm’s Penumbra Car

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Penumbra, Inc. (NYSE:PEN) Q1 2016 Earnings Conference Call May 9, 2016 4:30 PM ET

Executives

Sara Thompson - Director, Corporate Initiatives

Adam Elsesser - Chairman & CEO

Sri Kosaraju - CFO

Analysts

Robbie Marcus - JPMorgan

Larry Biegelsen - Wells Fargo

Bob Hopkins - Bank of America Merrill Lynch

Jason Mills - Canaccord Genuity

Operator

Good afternoon. My name is Connor and I'll be your conference operator today. At this time, I'd like to welcome everyone to the Penumbra Incorporated First Quarter 2016 Conference Call. [Operator Instructions]. Thank you. I would like to introduce Ms. Sara Thompson, Director of Corporate Initiatives for Penumbra. Ms.Thompson, you may begin your conference.

Sara Thompson

Thank you, operator and thank you all for joining us on today's call to discuss Penumbra's earnings release for the first quarter of 2016. A copy of the press release and financial tables which include GAAP to non-GAAP reconciliation can be viewed on our Investor Relations website. During the course of this conference call, the Company will make forward-looking statements pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding our financial performance, commercialization, clinical trials, regulatory status, quality, compliance and business trends.

Actual results could differ materially from those stated or implied by our forward-looking statements due to certain risks and uncertainties including those described in our 10-K dated March 8, 2016, filed with the SEC. As a result, we caution you against placing undue reliance on these forward-looking statements and we encourage you to review our periodic filings with the SEC including the annual report previously mentioned for a more complete discussion of these factors and other risks that may affect our future results or the market price of our stock. Penumbra disclaims any duty to update or revise our forward-looking statements as a result of new information, future events, developments or otherwise.

Thank you very much and, with that, I would like to turn the call over to Adam Elsesser, Penumbra's Chairman and CEO.

Adam Elsesser

Thank you, Sara. I'd like to welcome everyone to Penumbra's first quarter 2016 conference call. I'm joined today by Daniel Davis, President of North America and Sri Kosaraju, Chief Financial Officer and Head of Strategy. I will start today's call with key business updates for the quarter and then I'll turn it over to Sri to cover further financial details. Our total revenues for the first quarter of 2016 were $57.9 million, compared to $39 million for the first quarter of 2015, an increase of 48.7% as reported and 51% in constant currency. We achieved net income in the quarter of $0.8 million, compared to $2.5 million in net income for the same period last year. Similar to last quarter, we saw strength in all our main product families, in both neuro and peripheral vascular.

Many of the key themes across our businesses are consistent with what we have discussed in the past. And I'll now provide some specific highlights on what we observed in the quarter. We're very pleased with the strong growth in our neuro business. Within ischemic stroke, the focus remains on the market development efforts, to ensure that patients that can be treated with mechanical thrombectomy get to the right hospital in the time to be treated. As a leader in the field, Penumbra is focused on leveraging our relationships and resources to help support both small and large market-development initiatives. This success of these efforts will have the most significant long term impact for ischemic stroke patients and for our stroke franchise.

Over the past quarter, we continued to observe Neuro intervention was favoring direct aspiration as a foundational mechanism in mechanical thrombectomy. The trend towards direct aspiration continues to be validated in the academic literature as leaders continue to discuss and refine modern mechanical thrombectomy technique. Though we're the only company with an aspiration system, we do see and continue to expect to see, the trialing of guide catheters for use in stroke procedures. We have anticipated this happening for some time and we have had a strategy in place that we believe ensures our long term leadership in ischemic stroke. Furthermore this strategy also supports the growth of our broader neuro business. To that end, we're very excited about the neuro growth opportunities beyond ischemic stroke. This quarter, within neurovascular embolization, we went to a broader number of physicians to introduce our smart coil. The feedback from introductory cases has been very favorable. While this is encouraging, we still have a challenging process ahead in getting smart on the shelf at these centers.

Another meaningful neuro update for us in the quarter was receiving an expanded indication for Apollo, our neurosurgical tool. Apollo is now indicated for both the cerebrum and ventricular systems which increases the number of patients who may be treated with this technology to include those with both intracerebral and intraventricular hemorrhage. The expanded indication has been part of our longer term strategy and is an important milestone for the development of this product. It, however, does not alter the timeline for our overall efforts as we undertake the process of dramatically changing the treatment paradigm for patients suffering from hemorrhages.

In our peripheral vascular business, we continue to see strong growth and progress. Just a few weeks ago Penumbra attended the Society of Interventional Radiology or SIR conference in Vancouver. This was just the third time we attended the conference and it reminded us of the rapid progress we have made in a short time. Similar to last quarter, we continue to see strong pull through of our embolization portfolio. In the quarter, we launched our lantern micro catheter which is a high flow, low-profile micro catheter designed to assist in the delivery of our embolization products. In January, we also introduced the POD packing coil which is a complementary a device uniquely designed to pack densely behind Ruby and POD to include peripheral arteries and veins. Both lantern and the POD patent coil represent internally developed additions to our peripheral vascular portfolio. In peripheral thrombectomy, our Indigo system continues to be met with broad enthusiasm from physicians and it has had significant impact.

At SIR we presented the final results of our prism study which showed very high revascularization rates in a subset of patients that are candidates for peripheral thrombectomy. As we had previously commented, this is a transformational therapy. While many leaders in the field have adopted and now utilized the Indigo system, we continue to believe there will be a long process and a broader adoption of Indigo as physicians continue to become experts in its use. The level of excitement that we saw around this paradigm changing technology at the SIR meeting was very encouraging. I would like to end my remarks by sharing a conversation I had last week with a retired fire Captain from Redding California, Darren Duval. He shared with me that several weeks ago he had great difficulty breathing, so he went to the emergency room at his local hospital. Initially he was treated with a drug for a pulmonary embolism.

The next morning his symptoms had not improved and his physician, Doctor Bay, was concerned that he might die. Using our Indigo system which is indicated to remove fresh plaque from the peripheral arteries and veins, Doctor Bay was able to remove large burdens of plaque to save Darren's life. It is hard to express how profound our conversation was and how motivating Mr. Duval's story is to the entire team at Penumbra. I'll now turn the call over to Sri for more specific details on the quarter.

Sri Kosaraju

Thank you, Adam. For the first quarter ended March 31, 2016, our total revenues were $57.9 million, an increase of 48.7% reported, compared to the first quarter of 2015 or 51% in constant currency. Our geographic mix of sales in the quarter were 68% U.S. and 32% international. Neuro and Peripheral Vascular represented 71.3% and 28.7% of sales respectively. Revenue from our neuro business grew to $41.3 million in the first quarter of 2016, from $31.7 million in the same period a year ago, an increase of 30.4% reported or 32.8% in constant currency. Our neuro growth was driven by sales of our Penumbra system which includes ACE and ACE64. As previously discussed, we continue to believe that year-over-year comparisons will transition as the market heads into the second leg of growth and also as we head into comparative periods post the stroke trials.

Revenue from our Peripheral Vascular business grew to $16.6 million in the first quarter of 2016, from $7.3 million in the same period a year ago, an increase of 127.9% reported or 130% in constant currency. In the quarter, we continued to see an exceedingly strong pull-through from our peripheral embolization products, as we had expected. While our year-over-year growth in peripheral thrombectomy was strong, our sequential growth was behind that of the fourth quarter. As a reminder, the prior quarters have included the effect of initial sales in the U.S. and Europe respectively.

We continue to believe that there will be meaningful time and effort involved before we see consistent ongoing usage by new and existing centers. Our gross profit in the quarter was $39.9 million or 68.9% of revenues compared to $26.7 million or 68.6% of revenues for the same quarter last year. Now moving to operating expense, total operating expense for the quarter was $38.1 million or 65.7% of revenue, compared to $22.7 million or 58.4% of revenue for the same quarter a year ago. Our research and development expenses were $5 million for Q1 2016 compared to $3.2 million in Q1 2015.

The increase was primarily due to greater compensation expense resulting from increased headcount to support our continued investment in our products. SG&A expenses were $33.1 million for Q1 2016, compared to $19.5 million for Q1 2015. Our spending increased primarily due to increases in headcount and related compensation expense as well as increases associated with our operating as a public Company. We had net income of $0.8 million in Q1 2016, compared to net income of $2.5 million in Q1 2015.

Moving to our balance sheet, we ended the quarter with $144.4 million in cash and cash equivalents. We continue to expect increases in our working capital needs in order to support ongoing product introductions and we also expect modest uses of cash to support construction efforts relating to several new buildings on our campus which we plan to expand into this year.

As a final comment, while we're not formerly changing our revenue guidance this early in the year, we do feel comfortable towards the top end of our previously stated 2016 revenue range of $230 million to $235 million.

And now, I would like to turn the call back to Adam for closing remarks.

Adam Elsesser

Thank you, Sri. We're starting 2016 with strong momentum at Penumbra. What is more important is that while we're focused on driving revenue growth, we're doing it with the same fiscal discipline that has been a cornerstone of our Company for the past decade. We're in a very exciting time at Penumbra. We have the opportunity to positively impact a great number of people. However, it is critical that I stress that the work ahead of us is significant. It is not easy and in certain cases, it has not been done before. I can assure you, however, that the amazing people at Penumbra relish this challenge. Stories like the one I shared about our products helping one of our country's first responders help keep us focused and dedicated to do this significant work.

Thank you. Operator, we can now open the call to questions.

Question-and-Answer Session

Operator

[Operator Instructions]. Your first question comes from the line of Mike Weinstein with JPMorgan.

Robbie Marcus

This is Robbie Marcus in for Mike. So maybe just to start off, once again your Neuro number was very strong came in above our thinking. And this was the first time it annualized since a lot of the data sets were presented last year. We still saw very strong growth not just from you but also Stryker as well so it appears that it's the market that's expanding. So maybe you could just give us a little more detail on exactly what trends in the market you're seeing, how much work is being done by the hospitals and the ambulances to coordinate and improve care and then how we should be thinking about that growth for the rest of the year.

Adam Elsesser

Well, Robbie, it's Adam. I will touch sort of on some of the specific things we're seeing out in the field and then Sri can talk about the trend as we go forward. There's no question your accurate. We're feeling very good about the business as it's across all of our lines in Neuro, not just in ischemic stroke. But we're seeing work being done as we've sort of talked about the second leg of work and a lot of the early work is at a local level. Hospital by hospital, County by County, where folks have gotten together and put in place programs and educational work so that patients are getting to the right place in certain places. But it's certainly not across every County and in every emergency service yet in this country. And that's where, I think, the next phase of work that's done sometimes at a state level, sometimes at a national level, will come into play and that's in the U.S. and of course that has to happen throughout the world as well. So that’s the work that's ahead of us, but there's no doubt that some of the passion at work that the companies as well as the local stroke providers are putting in are starting to see a benefit for the patient's.

Sri Kosaraju

Yes. And Robbie, on the market growth rate, question that you had asked, I think this is what we had expected on anniversarying the stroke trials and it wasn't one particular day or one particular event, it was a couple of them that occurred through the fall in the beginning of the year last year so we're going through that. I think we're all collectively, as a group us and our peers going through those changing comps together so you'll see that and I think the second leg phenomenon that we raised in our last quarter is absolutely something that we're seeing through Q1 and we're going to continue to expect to see the same way that we had thought.

Robbie Marcus

All right. And maybe shifting a bit to your stent retriever. Were you able to go through any of the data sense? Or have you heard an update from the trial or anything else you can share on that.

Adam Elsesser

Yes. We have not made any -- and are not making any additional announcements from what we made on the last call.

Robbie Marcus

Okay. And I'll sneak one last one in. On Indigo, I just want to make sure I'm interpreting your comments correctly and that you expect growth from this point on for the rest of the year but more moderated growth than what we've may be seen in the past few quarters. Is that a fair way to be thinking about it?

Sri Kosaraju

So I think we touched on this on the Q4 call. Related to the Q4 results that we saw in Indigo. And I think we think about this broader peripheral that a lot of that incremental growth from the fourth quarter, we had suggested what happened in the back half of the year, of this year and we continue to believe that.

Operator

Your next question comes from the line of Larry Biegelsen with Wells Fargo. Your line is open.

Larry Biegelsen

Sri, just maybe if you could talk about your philosophy with setting guidance, you did 51% constant currency growth. I believe this quarter and the guidance at the high end of the range implies of about 20% growth for the remaining three quarters and so could you just talk a little bit about is there something specifically in the business that you see that is giving you pause? Or is it just early in the year? And I had some follow-ups. Thanks.

Sri Kosaraju

Yes it's more the latter in the year, -- the latter comment that you made about early in the year. We're just getting out of the gate in Q1. There are a lot of positive trends and again as I think we had touched on in our comments in the call a lot of them are consistent than trends and dynamics that we have seen last quarter for that matter the last few quarters so everything's pretty consistent and moving along the way that we had expected but just as a philosophical matter, it's pretty early in the year for us to be recalibrating the guidance we gave just recently in our fourth quarter call.

Larry Biegelsen

So let me add a follow-up on the 3-D trial, Adam I heard your comments about that you're not making any additional announcements but can you tell us if you know at this point in time why the trial was halted? First, second, when are we going to see the results publicly? And do you still expect approval of the 3D stint retriever by year-end 2016?

Adam Elsesser

Well, there's a couple of questions in there. We'll start with the last one. I believe that I stated that we will be submitting it by the end of the year. I just want to make sure I reiterate the difference between getting clearance and submitted. Second, we have not yet announced but we do expect to present the data publicly sometime this year, at a major medical meeting and I absolutely promise you will now when that happens. But we have not yet announced the specific timing as it relates to that. But my guessing -- or mine surmising that I did on the last call -- there is nothing that I know that would change that at all.

Larry Biegelsen

And then, lastly for me, guys, you talked about some competition in the aspiration market with guide catheter use and your strategy to combat that. Can you give us a little bit more color on what you're seeing in the market maybe what you think your share is at this point and again and share with us your strategy to maintain your leadership position there and I'll drop. Thank you.

Adam Elsesser

Sure. I think it's a great question. Listen, interventionalists always like to make sure that they are using the best tools and certainly like to try things. We understand that and have always expected that. We feel very, very confident moving forward that our technology will continue to differentiate us and be in the primary seat as it relates to aspiration. And as I've said, I think all of this discussion and -- has only continued to bring light to the fact that aspiration is playing such an important foundational role in this field going forward and that to be very honest, is really the exciting part about it.

Operator

Your next question comes from the line of Bob Hopkins with Bank of America. Your line is open.

Bob Hopkins

I'm in a car so I apologize for any background noise. So congrats on a great start to the year I just had a couple of things I wanted to follow up on. First was just on the neuro growth I was wondering if you could, whatever you're willing to disclose just maybe give us a little more color for the drivers in the quarter, so specifically, when you look at the year-over-year growth in kind of Q1 versus Q4, could you guys see accelerating growth in your stroke business? Maybe talk a little bit about smart and how much that might have contributed, just wanted to get a flavor for some of the moving pieces.

Adam Elsesser

I think from the comments we made, the strength was really across neuro, right? We saw growth and strong growth across all our products, obviously stroke is the biggest driver and the biggest contributor to neuro and we saw growth there and I think we were pleased with what we saw from a market perspective and from our own perspective with our position customers. Smart, we're in the early innings of that and again consistent with our commentary around smart, we're seeing some positive initial feedback out of cases, mind you, these are sort of evaluation or initial cases so we're not on the shelf yet with customers on a sort of a more repeated basis, so our comments on that would be consistent around our expectations that's going to take most of the year for us to get on the shelf and to be driving more ongoing revenue access continued to be strong.

And we made some comments about on the clinical side of Apollo so it's not really a commercial driver for us albeit an important project for us down the road. So I think we characterize it as pretty broad-based strength across nine -- neuro and right down the middle as it relates to moving around our strategy and expectations.

Bob Hopkins

And no worries if you're not going to disclose this but I'm just curious to see if were still at a part of the curve where the stroke business from a year-over-year growth perspective is still -- is it -- I'm just curious if that accelerated in Q1 from Q4 levels and again no worries if you're not going to disclose it but I just thought I'd ask just again trying to get a sense more specifically for how things are going.

Adam Elsesser

Yes. So we're not going to sort of talk about it at that level on this call but I think the comments around the comps I think are valid and whether you pick up on it this quarter or next, I mean, those are definitely very real dynamics that I think as you look at comparisons year-over-year that you are going to start to see.

Bob Hopkins

So also just wanted to get a sense on the purple side, you guys talked about some additional products and some pull through with [indiscernible] maybe you could just talk a little bit more about potentially quantifying those opportunities, how should we be thinking about those products in portfolio and the pull through potential given its success of Indigo and then lastly Sri I just wanted to get a comment on gross margin I mean you're doing really well on the gross margin side is there something that's driving that's sustainable or is it just a particularly big quarter that's all I've got. Thanks so much.

Sri Kosaraju

Yes. Maybe I'll start on the gross margin, Bob and then Adam will touch on the peripheral question but yes, absolutely. A strong quarter as it relates to margins. There's a lot in there. We're introducing products and you would've expected maybe some pressure on the margin line but we're still ramping up smart and some of our other products that we touched on so I think it's a little too early to declare any sort of sustained movements on the margins just now. We're encouraged by it and there's a lot of efficiencies that are being driven on that level to drive future gross margin improvement. But at least at this point I don't think we're ready to declare that as a new point.

Adam Elsesser

And then, Bob, to address your question around peripheral embolization, one of the -- we talk about it as pull through for I think, the very clear reason that selling coils or embolization tools is hard work in the peripheral. There is a lot of competition and it isn't always easy to get physicians attention around the differentiated aspect of our larger and very soft coil. I think what we're seeing is the impact of being in the lab, talking about Indigo which is so transformational, has allowed us to have some of those conversations that we weren't always able to have when it was just talking about the coil as an independent product and I think that's what we're alluding to or talking about and so we'll see how that plays out but we're very encouraged about the reaction to the coil when people try it for the first time.

Bob Hopkins

Okay. So we just thinking of Indigo as kind of the lead product, the biggest potential incremental market opportunity within peripheral.

Adam Elsesser

It certainly is the most transformational product, that is true.

Operator

Your next question comes from the line of Jason Mills with Canaccord Genuity. Your line is open.

Jason Mills

Adam, let me start with ischemic stroke and perhaps if Sri wants to jump in, with respect to the components of the model, we've often talked about the growth in the number of procedures and therapy mix as well as share shift within aspiration is kind of the three drivers there. You clearly did better than everyone at model so I guess within those three things which one was most definitively better than where people had modeled?

Sri Kosaraju

Jason, it's Sri so on that -- trying to decouple this in a model on what's driving the growth over what you might have, I think you touched on what that key variables are, market growth, the penetration of those that who can be treated and then the mechanism or the technique if you will that physicians are using. It's extremely difficult on a sort of quarter by quarter basis to really assess and understand the market aspect of this.

It's our sense from just our conversations in the fields that the market continues to be moving the right direction. We talk about all the market development efforts and we see all that happening and the opportunities that lie ahead on that but it's very hard on a -- going three months at a time to tell you how much more incremental patients that translated to but our sense is that cutting the right direction but consistent with where our thoughts are and maybe I'll just get to your next point which was the movement perhaps and the treatment techniques and that's again another hard one to define numerically, but I think if, as you are, paying attention at all the medical meetings, paying attention to what physicians are talking about, it's our sense as it is, I think, yours and you've written about this, that the movement to adapt or direct aspiration is underway and that's a very real trend and I think we've talked about the validation of that of other folks trying to become involved in that sort of technique as well so our sense is there is movement on that but it's extremely tough to quantify for you and all of the components how much of it was the move to adapt, how much of it was market, it's some combination of the both of those.

Jason Mills

Adam, you talked about strategies to keep Penumbra, at the cutting edge of the competitive sphere here. Is there anything more specific you can give is there? I presume you'd only give us specifics if you started to deploy some of those strategies and if not perhaps how that plays out over the near and medium term.

Adam Elsesser

Yes. I will simply say, you’re accurate. I would want to tell you things that we've already started. I will tell you the following. I think that best defines it for me and that is we've built of the entire business of Penumbra based on really outstanding and unique technology that has really helped drive this field forward. And we feel very confident that we can continue to do that, particularly in stroke and with that said, that is how I think we will continue to stay a leader in the stroke field.

Jason Mills

Just one more on ischemic stroke and then a follow-up on peripheral and then I'll get back in the queue. Sri, one thing I didn't ask about is U.S., O-U.S. whether there were any differences in the pace or trends in the market, internal trends in the market in Europe as what you commented on, the U.S. or where your comments were generally for both geographies and that I will just a follow-up with a peripheral [indiscernible] question and then get back in the queue after that.

Adam Elsesser

Yes. I think our comments were more global rather than specific and very similar trends as it relates to the market side of things as well as of the treatment technique side of things, I think apply to both.

Jason Mills

And then, [indiscernible] Adam and saw the [indiscernible] results and more importantly the reaction clinicians had to those results which was quite good it seemed to us. What has been the most striking manifestation, the early following those results or just in general, as you continue to roll Indigo out and size the different sizes out, to divisions in the United States, can you give us any more color about how those results data or your marketing effort manifests itself in the market and what we should expect going forward and then I guess, lastly and there was a separate question about Apollo because I have throughout every quarter -- it might be helpful just to give us a perspective on that target addressable market -- it seems sizable although longer term and yet you are investing in the invest trial this year, actually can you give us an update on when that starts enrolling and so forth. I'll get back in the queue. Thanks, guys.

Adam Elsesser

All right. Will let me address, first the prism and the reaction and so on. Just again, to reiterate what I said on my comments, that was -- the prism data was data that was collected before the larger sizes so it was definitely a subset of the larger patient population and it was done on the arterial side. That being said, what I think the reaction was is consistent with what people are experiencing and that is real pleasure, real excitement that there is a tool that can so very easily and in a fairly high degree of likelihood or success remove blood clot in an acute setting. And that's what I think has been the reaction. Is that it's relatively new phenomenon that they have growing confidence that they can go after acute clot in parts of the body and just remove it right away. So that impression is growing.

And obviously, stories like the one I shared of the fire captain are growing where they are really having just a fairly dramatic impact. And that's what so encouraging. And that's what's so exciting about that whole area that we're able to do stuff, something that's never been done before. To switch gears to Apollo, we had, as I think you know from past questions, always intended to expand to sort of the full range of hemorrhages that we -- that are available to have an impact on and if you look at just in the U.S., the numbers, there's anywhere from 60,000 to 80,000 patients that have a hemorrhage that's either intracerebral or intraventricular and those are our addressable market. Those are the patients that we're ultimately gearing this product for and again, remain very, very excited and focused on that opportunity as it unfolds for us.

Operator

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

Sara Thompson

And with that on behalf of our management, thank you again for joining us today and for your interest in Penumbra we look forward to updating you on our next call.

Operator

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

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