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F2Q13 Earnings Call

November 1, 2012 8:00 a.m. ET


Susan Lisa - IR

Mike Minogue - Chairman, President, and CEO

Bob Bowen - VP and CFO


Brooks West - Piper Jaffray

Greg Simpson - Wunderlich Securities

Charles [Crawson] - Sidoti & Company

Anthony Petrone - Jefferies

Steve Beuchaw - Morgan Stanley


Good day, ladies and gentlemen and welcome to the Abiomed Inc. second quarter 2013 earnings conference call. [Operator Instructions] I would now like to turn the call over to your host, Susan Lisa. Please go ahead.

Susie Lisa

Thank you. This is Susie Lisa. I’m the senior director for investor relations and corporate development at Abiomed, and I have with me here this morning Mike Minogue, our chairman, CEO and president, and Bob Bowen, our CFO.

I hope everyone made it safely through the storm, and appreciate your flexibility with our rescheduled date here this morning. The format for today's call will be as follows. First, Mike will discuss strategic highlights for the quarter and then turn to our key operational and strategic objectives for the year, with particular emphasis upon our clinical and regulatory processes and progress. Bob will then review the financial results for the quarter and provide an update on our corporate goal of operational excellence. We will then open the call to your questions.

Before turning the call over to Mike, I want to remind you that during the course of today's conference call and the question-and-answer session that follows, we may make projections or other forward looking statements that are subject to the Safe Harbor provisions of the securities laws regarding future events or the financial performance of the company.

We caution you that these statements are only predictions and that actual results may differ materially. We also alert you to the risks contained in the documents we filed with the Securities and Exchange Commission, such as our annual and quarterly reports on Form 10-K and 10-Q. We do not undertake any obligation to update or correct any forward looking statements.

And now I’ll turn the call over to Mike.

Mike Minogue

Good morning everyone. We’re pleased to report the most profitable quarter in company history, with 27% growth in total revenue at $37.4 million. We believe our sustained year over year Impella growth curve of greater than 30% for more than three years indicates Impella is emerging as a critical device for patients requiring percutaneous circulatory support.

In addition, we continued to execute our plan and achieve significant milestones this quarter, with our Impella CP 510(k) clearance, publication of PROTECT II in circulation, announcement of new Impella CPT codes, and progress on our Symphony technology.

We are positioned for another record year, and maintain our place as one of the fastest-growing, profitable medical device companies. Congratulations to the entire team for your results and efforts.

On another note, as noted in the press release, Abiomed recently received a HIPAA administrative subpoena from the U.S. Attorney’s office. The subpoena seeks documents related to the Impella 2.5.

We understand the investigation to be focused on marketing and labeling. Abiomed is in the process of responding to the subpoena, and intends to cooperate fully. The request for information does not prohibit our ability to support our customers and help them achieve the best possible outcomes for their patients. As is standard legal practice, it is not appropriate for us to comment further on this matter at this time.

So today I will focus on our third corporate goal for fiscal ’13, executing on our clinical and regulatory processes, and Bob will cover the rest. So, for the clinical and regulatory processes, first I will explain our strategic plan for FDA regulatory approvals on Impella. Second, I will discuss the 515 program initiative, and last highlight our existing recent Symphony progress.

For some regulatory history, Abiomed received the Impella 2.5 510(k) clearance in June 2008, and the submission included data on 129 patients. The existing Impella 2.5 510(k) clearance is for “partial circulatory support, using an extracorporeal bypass control unit for periods of up to six hours. It is also intended to be used to provide partial circulatory support for periods of up to six hours, during procedures not requiring cardiopulmonary bypass. The Impella RECOVER 2.5 percutaneous cardiac support system also provides pressure measurements which are useful in determining intravascular pressure.”

The Impella CP was 510(k) cleared this September with the same indications as the Impella 2.5, and represents greater than 30% higher flow with the same access site for percutaneous support. This is what many physicians have been waiting for, and the customer demand is evident, which was confirmed at TCT.

While not always mentioned, the new Impella AIC console, with autoflow features, is also impacting the ease of use and learning curve for the technologists. Abiomed is committed to supporting clinical studies and research that may help future regulatory approvals for expanded uses for the Impella line of products. Abiomed has conducted and published three FDA studies, PROTECT I, RECOVER I, and PROTECT II, and created an ongoing IRB approved Impella registry on real-world clinical usage, published under Europella and USpella in 2010 and 2011 respectively.

As of this quarter, over 150 peer-reviewed papers have been published on Impella. In the recent months, Abiomed, in coordination with the FDA, has taken extensive actions to correct our noted compliance issues identified in our annual report. Abiomed has conducted an internal compliance audit of marketing materials and recertified the field team and management on our Impella labels.

Abiomed was also audited by the FDA at our headquarters this summer, and there were no observations of quality issues related to our operations. Our corrective action plan on our compliance issues appears to be moving forward, and Abiomed is committed to a positive working relationship with the FDA.

Additionally, the company is taking actions to gain additional regulatory approvals for our devices, utilizing existing and new clinical data. For example, number one, we will pursue the humanitarian device exemption, or HDE, approval for smaller, specific patient populations of up to 4,000 patients per year. These submissions will include prior Impella studies and may require small future studies.

Number two, the Impella RP study submission, with extended duration of support, is on track, and we anticipate conditional IDE approval next quarter. There is a clear critical need for this device for patients suffering acute right heart failure. Outside the U.S., our physicians have told us that this product has already saved lives.

And three, and finally, for cardiogenic shock patients requiring extended circulatory support, Abiomed attempted the FDA study called RECOVER II. This was a randomized Impella versus intra-aortic balloon pump, cardiogenic shock study that was difficult to enroll patients for multiple reasons, including protocol consent and ethical challenges.

With the recent intra-aortic balloon pump SHOCK II study in Europe, showing no benefit of the intra-aortic balloon pump in cardiogenic shock patients, it has become even more difficult to justify a randomized trial compared to Impella today. However, Abiomed has recently met with the FDA to discuss new concepts for clinical studies of Impella in cardiogenic shock patients, including a bridge to recovery study on the Impella family of devices.

BTR, or bridge to recovery, refers to our existing FDA approval for myocardial recovery on Abiomed’s legacy surgical products, BVS and AV5000. Our proposed BTR study would compare Impella clinical outcomes for cardiogenic shock patients to performance goals based on our approved BVS and AV5000 results. This concept is similar to the HeartMate II to HeartMate I BTT approval. We will also continue to explore with the FDA multiple ways of establishing the clinical value of Impella for cardiogenic shock patients.

Now I’d like to discuss the 515 program initiative. Since 2009, the 515 process has been implemented industry wide, and at that time, Abiomed submitted data for Impella. Abiomed believes - but this is subject to change - that the call for the 515 panel related to the Impella technology will occur in early December, and include both the intra-aortic balloon and the non-roller type cardiopulmonary bypass blood pump, which includes Impella, TandemHeart, CentriMag, and all heart-lung machines.

If a product or indication is deemed class 2, it will remain 510(k), as compared to class 3 designation, which would require a future submission of a PMA after a grace period of time to complete the necessary clinical trials. The overall process will take time, possibly years, before the issuance of the final rule that determines a device or indication’s classification. In the meantime, all categories remain on the market under their current indications.

Now turning to new products, we are excited to report that our second Symphony patient was recently discharged home after a 28-day course of therapy. To remind everyone, Symphony is not approved for sale or use in the United States and is in a clinical trial in Canada.

Our second patient, a 67-year-old, had a long history of ischemic heart failure, six heart attacks in the last 10 years, and he had deteriorated to a New York Heart Association class four. In addition, his ejection fraction had deteriorated to just 15%. He had exhausted all other surgical and medical options for treatment of his heart failure before being admitted to the Royal Victoria Hospital in Montreal, Canada, for treatment with Symphony.

The patient was on Symphony support as planned for 28 days, during which he experienced an immediate improvement in hemodynamics and displayed improvement in his color and warmth of his extremities. While on the device, he also made clinically significant improvements in his ability to ambulate and perform activities of daily living. And his frequent walks through the halls of the hospital earned him the title, “the mayor of the unit.”

It was amazing to see first-hand the transformation and impact to this patient’s energy after such a minimally invasive procedure. The patient is now at home with his family and continues his cardiac rehabilitation. He and his family are very grateful for the Symphony therapy, and currently there are three centers in Canada and we recently received approval to start a clinical trial in France.

So, in summary, we are executing our plan and expanding our portfolio of products. The Impella CP product, and the Impella RP, when FDA approved, will provide a new level of support options that can be administered percutaneously, a first in the history of heart pumps. The early clinical results from the Symphony patients are encouraging, and hold the promise of improving hemodynamics with a pacemaker-like implant, with the hope to remodel the heart.

And, our clinical and economic evidence continues to build. The company has never been in such a position of financial strength, with no debt, as we approach $100 million in cash. And finally, we feel the momentum, especially after TCT, and believe customer demand has never been higher.

This is the most significant time in company history. Thank you to all our stakeholders for your support.

I will now turn the call over to Bob Bowen, our CFO.

Bob Bowen

Thank you Mike, and good morning everyone. Before I get started, I would like to refer you to the Safe Harbor language noted at the outset of the call, as well as the risks and uncertainties noted in our SEC filings, particularly our most recently filed 10-K. I would also like to bring to your attention the GAAP non-GAAP reconciliation that we have provided in the earnings press release, which is intended to aid investor understanding of our financial results.

With respect to our first corporate goal, revenue growth, as noted in our earnings release, fiscal 2013 second quarter revenue of $37.4 million was up 27% from last year, which was above the guided revenue growth rate for the year of 23-24%.

As anticipated, we did see lower activity levels in the cath lab during the summer months. Worldwide Impella revenue of $32.8 million was up 32% from the prior year, and was consistent with previously guided Impella annual growth of 30%-plus for the year. Worldwide Impella revenue has grown in excess of 30% for 12 straight quarters.

U.S. Impella revenue in the quarter, at $30.8 million, was up 33%, and Impella revenue outside the U.S. of $2.1 million was up 24%. The breakdown for reported usage was 50% for prophylactic, 38% for combined emergency support, and 12% for all other applications. All grew double digit year over year.

On a year to date basis, worldwide revenue totaled $76.2 million, up 34% from $56.8 million in the prior year and Impella revenue of $67.5 million was up 44% from $47 million in the prior year.

With regard to customer owned inventory levels of the Impella 2.5, which I have reported on during past calls, the average Impella 2.5 inventory level at hospitals in the U.S. was essentially unchanged from the last quarter at approximately 2.2 catheters per site.

As for our fourth corporate goal, operational excellence, gross margin rate for the quarter was 80.8% and was slightly below the year ago period. In addition to average selling prices, which have been very stable, gross margin rates are influenced by a number of factors, including unit product volumes, which have been somewhat higher in the past couple of quarters due to planned increases in safety stock levels; the number of consoles placed at new and existing sites; the addition of new operators to support capacity increases, as there is a 4-6 month training requirement; and yields.

Our safety stock levels are now about where we want them. We are comfortable with capacity levels and yields have been stable. We placed 114 consoles worldwide this quarter, compared to 97 in the prior year, and we opened 30 new Impella 2.5 sites in the U.S. compared to 22 in the prior year and 34 in the prior quarter. As of the end of the quarter, approximately 44% of U.S. Impella 2.5 sites have received the new AIC console, which is required to operate the Impella CP.

Total operating expense in the fiscal second quarter was $24.3 million, as compared to $23.1 million in the prior year, or up 5% on a 27% revenue increase, which reflects the strong leverage of our business model. On a year to date basis, operating expense is up 6% on a 34% increase in revenue.

In fiscal 2Q, income from operations totaled $5.6 million, or 15.8% of revenue, compared to $0.8 million, or 2.7% of revenue in the prior year. Clearly in this quarter, we were well above our previously guided annual operating margin range of 8-10%, and you may recall we previously indicated that in any given quarter we could fall outside the annual targeted range.

We do plan to see an increase in second half expense levels compared to the first half, including continued efforts around new product development and expansion of our commercial organization.

GAAP net income was $5.5 million, or $0.13 per diluted share, a nine fold increase compared to GAAP net income of $0.6 million, or $0.02 per diluted share in the prior year. This is the first quarter where the year over year comparison of GAAP net income has actually been net income in both quarterly periods, and we now have had five straight quarters of GAAP profits.

As a reminder, at the start of the year, we had a U.S. federal net operating loss carry-forward of approximately $191 million, which is fully reserved for accounting purposes. These federal NOLs begin to expire in 2018, and span to 2031. Our effective tax rate in fiscal Q2 was 8%.

Looking at the balance sheet, accounts receivable of $18.3 million equated to 50% of quarterly revenue, or 46 days sales outstanding, compared to 53% of quarterly revenue, or DSO of 48 days in the prior year.

Inventory of $14.5 million equated to 39% of quarterly revenue, and turned at 2.4 turns compared to 2.9 turns in the prior year. Impella disposable and console inventory levels have increased with the addition of Impella CV, as well as the planned effort to increase safety stock levels and maintain safety stocks at both our Aachen, Germany and Danvers, Massachusetts facilities.

During the quarter, cash and short term marketable securities increased $7.8 million to $89 million. Notably, $6.8 million of the $7.8 million generated in fiscal Q2 was generated from operations. For the first six months, cash provided by operations net of capital expenditures totaled $9.5 million. We have generated increasing amounts of cash from operations and increasing amounts of free cash flow for five straight quarters, and as a reminder, we have no debt.

Turning to guidance, we were very pleased with our first half performance, and in line, or slightly ahead, of our internal targets. But in light of the recent receipt of the U.S. Attorney’s Office subpoena, we are maintaining our full year revenue guidance for fiscal year 2013 in the range of $155 million to $157 million, representing expected annual growth rate of 23-24%.

We also continue to expect to see annual Impella growth of greater than 30%, driven by increased utilization along with the launch of the Impella CT.

We will now open up the call for questions. Operator, would you please open up the line for questions?

Question-and-Answer Session


[Operator instructions.] Our final question comes from Brooks West from Piper Jaffray. Your line is open.

Brooks West - Piper Jaffray

Just a couple points of clarification on the investigation. You say that the Attorney’s office is looking at marketing and labeling of Impella 2.5, and I’m wondering if you could just expand on where the concerns might be on the labeling. And then secondly, I’m a little surprised that the subpoena came from HIPAA. And is there a potential patient information problem here as well?

Mike Minogue

On the second part of that, we don’t believe it has anything to do with patient confidentiality. It’s more of the umbrella of the department of HHS. But as far as what we’ve stated, this is the investigation. We don’t have any more color on marketing and labeling. That’s what we understand it to be. And we will comply. We’ll provide the information, we will be completely transparent, but at this point we’re not able to comment further on any of the other details.

Brooks West - Piper Jaffray

And then on the 515, again, you just expect to receive some kind of notification from FDA, and then you respond from there? There’s not an actual panel meeting, right?

Mike Minogue

Yes, this is not a panel meeting for Abiomed or Impella. This is a panel meeting for the 515 process, which we believe will incorporate the intra-aortic balloon pump as well as the non-roller blood type, which that includes a laundry list of products, which includes Impella, TandemHeart, CentriMag, and all the prior heart-lung machines.

Brooks West - Piper Jaffray

You mentioned going for an HD approval on a device. Which device are you looking at for them?

Mike Minogue

It’s a collection of products. It could be the 25, 50 or both. So to give you an example for that is a patient population that might require more than six hours, where the physicians feel that it’s an emergency necessity. So, for example, the pediatric device, which we’ve submitted. We actually have an HUD for that, and we’re collecting data. And there’s other subsets like that, which could be based on some of our prior studies, like the RECOVER I study that was low-output syndrome.


Our next question comes from Greg Simpson from Wunderlich Securities. Your line is open.

Greg Simpson - Wunderlich Securities

Brooks hit on my obvious first question, and I was specifically wondering about the HIPAA part of it, so you’ve addressed that, and obviously can’t say a lot. Let me turn then to the next thing, at TCT it was seemingly clear to me that the interest level in the CP device was extremely high. Can I get maybe just some anecdotal comments coming out of TCT about that? And then more specifically, can you maybe give us a sense of how many centers now have the new console, and now have the CP and are using it?

Mike Minogue

TCT was an exciting week for us. I think we discussed that there were 25 presentations on Impella. I think that’s the most ever in the history of the company being at TCT. Relative to the CP, we’ve done now over 60 patients, in the United States and Europe. It is a controlled rollout, so that we can really focus and prioritize good training and the best outcomes possible. And as far as the AIC, that’s important because only sites with the new console can run the Impella CP, and in future the Impella RP. So we’re about 40-45% on our way through the entire installed base with the new console.

And then one last thing, on the console itself, is that’s the one we probably haven’t promoted enough, but for those that saw it at TCT, and for our customers that are coming in, it really is more intuitive, the technologists like to work with it, and it’s basically the latest and greatest in computer technology platform, which gives us some more capability in the future for measuring hemodynamics and potentially having other technologies incorporated into the platform.

Greg Simpson - Wunderlich Securities

And again, the plan, you’ll go to full launch again with the caveat that it will be the centers, obviously, with the AIC. You’ll go full launch essentially as of January 1?

Mike Minogue

Correct. So the full launch of the Impella CP in the United States will be in our fourth quarter, which starts in January.


Our next question comes from Charles [Crawson] from Sidoti & Company. Your line is open.

Charles [Crawson] - Sidoti & Company

On the expenses for the quarter, definitely coming in a little under what we expected, and it seems like the Street as well. You mentioned that they were going to be up for the second half. Can you kind of tease a little bit more on what that might look like compared to this quarter?

Bob Bowen

The quarter coming into is probably going to look more like the first quarter, or possibility a little bit higher. We are trying to, as rapidly as possible, expand our commercial organization. And we also had some deferral of expenses related to product development efforts in the first half that are now going to be second half expenses.

Charles [Crawson] - Sidoti & Company

And then Mike, I remember you mentioning the internal compliance review. Can you just add a little bit of color on what you guys might have found there? Was there anything that you needed to adjust severely or anything like that?

Mike Minogue

Yeah, I think any time you get a warning letter from the FDA, you need to really recertify and reestablish your process and your rigor around the controls. And so those were outlined back in 2011 and we’re continuing to work on the basic things that have to do with, specifically, how we promote the product, what our label is.

And from an operational perspective, this is the first time we disclosed that we went through that audit this summer, and there were no observations of quality issues. So for those that have been in that area, this is a great win for the company, and we want to make sure that we’re having a positive working relationship with the FDA. We have ongoing interaction with them. And we’re even providing them, in advance, some of our marketing material. For example, at TCT we shared in advance our material, our presentations that would be in our booth, and anything else we thought would be of interest to them.


Our next question comes from Anthony Petrone from Jefferies Group. Your line is open.

Anthony Petrone - Jefferies

Mike, just going to go back to marketing and labeling real quick. I’m wondering if we go back to the July 2011 letter, and in that letter they also referenced January 2010, the initial letter, when they were looking at promotional activities. Is it the use of comparative language [unintelligible] intra-aortic balloon pump that they’re once again zoning in on here?

Mike Minogue

That issue, for example, was comparing the hemodynamic support, so that was comparing the two. And we’re no longer comparing the two side by side, from a hemodynamic perspective, with the exception of where it is in clinical studies and in publications.

Anthony Petrone - Jefferies

And is there any timing as to - I know it’s early days here - but if you could provide any color on what is the next step from Abiomed with the FDA in terms of interacting with them and complying. Are there any dates we should be looking at in the next few months?

Mike Minogue

We’re having constant interaction with the FDA, because as we went through we have a lot of submissions in place, and we have some future submissions pending. So we have constant calls with them, meetings with them, because we have lots of products, lots of new products, lots of submissions. RP is very active right now. We will be submitting for some more studies as outlined, and we just have the normal routine communication from our prior products.

Anthony Petrone - Jefferies

I’m going to jump over to CP for a moment. One of the concerns that came up when that approval for CP, or the instructions for use, do you view that in any way as a gating factor to adoption once you have full-scale launch in the fourth quarter? Was there any feedback from TCT related to the instructions for use?

Mike Minogue

I think the one thing to be clear, is the indication for the Impella 2.5 is the same as the indication for the Impella CP 510(k) clearance. It’s in the instructions for use that we added language given to us by the FDA and the Impella CP we did not provide any clinical data. It was a supplement off of the Impella 2.5. So we’ll move forward, and continue to collect data and focus on just getting the best patient outcomes.

Anthony Petrone - Jefferies

And last one from me is just on Sandy. We had a call yesterday with a hospital supply company, and they threw out some 29 of 1,000 hospitals that they service were actually down on power here. I think when you look at this, it could be anywhere from 2 to 10 fewer selling days to a group of hospitals. So out of the 695 are there any hospitals that are heavy users of Impella that are now down, where you could potentially see an impact?

Mike Minogue

That’s a good question, and as somebody whose parents and family is in New Jersey, and I’m from New Jersey, it’s been a devastating storm there. And to the credit, to the heroes of Abiomed that are out in the field. They’re still supporting patients, they’re still calling at the hospitals, because they’re dedicated, even with the storm and power, to do everything they can. So our folks are working overtime, not only trying to take care of their own personal situation, but also continue to support the hospitals.


Our next question comes from David Lewis from Morgan Stanley. Your line is open.

Steve Beuchaw - Morgan Stanley

It’s Steve Beuchaw here for David. I wanted to ask a couple of questions, just clarifications, really. Number one is, on the investigation process, do you have any sense for whether it’s tied more so to high risk PTI or AMI?

Mike Minogue

We don’t have any other clarity on this. Again, there’s questions, it’s an investigation. We’re going to provide everything that we have, and we’ll cooperate fully. So we don’t have any other information other than that.

Steve Beuchaw - Morgan Stanley

And then on the 515, just to be clear, two things. So, it would be, very simply, should the device be class 1, 2, or 3, is there anything else outside of that question you would expect the panel to address?

Mike Minogue

That’s one of the questions. The other is it’s possible that certain indications can have different classifications. So they may look at that as well. So is an indication a class 2 or class 3? And if it’s class 2, everything stays as it is with the 510(k). If it’s class 3, there’s a call for more data, after a grace period, to provide some time to do a clinical study.

We do believe we have quite a significant position and have built a portfolio of clinical data. So we think we’re in a good spot here to use the 515 almost as a positive catalyst for the company. Also combined with all the new studies that we’re already in the process of doing to expand or label across the portfolio.

Steve Beuchaw - Morgan Stanley

And can you elaborate on that point, specifically on the grace period that you’re referencing?

Mike Minogue

One example is the intra-aortic balloon pump has not done an FDA study, and the most recent study that came out called the intra-aortic balloon pump SHOCK II showed no benefit of the balloon pump versus no support. And when we’ve had Impella in the past, we’ve tried to a randomized study to the balloon pump. That was the RECOVER II, which had some ethical and protocol challenges.

Now that the balloon pump has been shown not only to have no benefit in SHOCK versus no support for mortality, or whether you put it in before or after the PCI, probably even more surprising to some folks is that it did not even show an improvement in the hemodynamics in the study itself.

So we’re going to continue to study the SHOCK patients with Impella, and the other technology that likely will be going through this review is the ECMO subset. And again, the ECMO subset is under a 510(k), but actually hasn’t ever done an FDA study either. So we’re confident in what we have, and we’re confident that the new studies will help us expand our regulatory approvals.

Steve Beuchaw - Morgan Stanley

And the grace period, can you just elaborate on what the FDA has communicated. Do you have a sense for how much time you might have, and whether there might be any reviews? Or perhaps it’s a reexamination of existing data that the FDA has on hand?

Mike Minogue

We’re trying to give our investors complete transparency and a heads up that this panel could happen. With the way the government is, they haven’t formally put out anything. This is based on verbal discussions. They are subject to change. There are challenges with their budgetary process, as everyone knows, at the end of the year, which can affect any and all panel meetings.

And so we want to prepare everyone. But relative to the grace period, and to the discussion, none of this is specific to any one company. A lot of this is still in the second step of five steps for the 26 categories that are there, which incorporate hundreds of products.

And what they’ve stated on a high level, in the process, not specific to any one company, is either an extended period of time or a grace period. We’ve not had any specific discussions with them, because they haven’t proceeded yet to even have a panel meeting on our category, our classification.

So more of this is just really an early heads up to let you know we’re prepared for it, if and when it happens, and we look forward to the process, to use it as a way to maybe expand our duration or just incorporate our existing studies in the future.


And I’m showing no further questions. I will now turn the call back over to management for closing remarks.

Mike Minogue

Great. Thank you everyone for your time today. If there’s any follow up questions, we will be available and thank you for your support.

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