MASI
#Hello, everyone.
Joining me today are Chairman and CEO, <UNK> <UNK>; and Executive Vice President of Finance and CFO, <UNK> de <UNK>.
This call will contain forward-looking statements which reflect Masimo's current judgment, including certain of our expectations regarding fiscal 2016 financial performance.
However, they are subject to risks and uncertainties that could cause actual results to differ materially.
Risk factors that could cause our actual results to differ materially from our projections and forecasts are discussed in detail in our SEC filings, including our most recent Form 10-K and Form 10-Q.
You will find these in the Investors section of our website.
I'll now pass the call to <UNK> <UNK>.
Thank you, <UNK>.
Good afternoon, and thank you for joining us for Masimo's second quarter 2016 earnings call.
We're happy to again report results that surpassed our projections.
As in the first quarter, we continued to see strong worldwide adhesive sensor growth, which we believe was attributable both to increase in hospital sensors and our growing base of new customers as evidenced by the prior two quarters' growth and another strong quarter of driver shipments as we shipped 45,300 additional SET and rainbow SET oximeters in Q2, excluding our handheld and Finger Pulse oximeters.
Here are some other highlights from our second quarter.
Our product sales grew by nearly 12%.
Our second quarter 2016 GAAP earnings per share was $0.55, including an $0.08 per share gain related to the new accounting rules for gains realized on stock option exercises and an approximate $0.04 FX benefit.
This is a 57% increase from our GAAP earnings a year ago.
Important new clinical studies were published during Q2 continuing to validate the growing list of Masimo technologies and products that are reducing cost and improving patient care.
And we received two important FDA clearances, which will expand our domestic product portfolio, and on which I will discuss later in today's call.
We're encouraged that our 10-year plan to achieve strong earnings growth, built on a solid foundation of breakthrough products and strong and broad service has continued to become more visible and consistent over the last two years.
Encouragingly, our results for the first half of 2016 have exceeded our original projections and as a result, we are very happy to be able to once again increase our financial guidance for the rest of 2016.
Next, <UNK> will review our second quarter financial results in more detail and also provide you with our new 2016 financial guidance.
I will then discuss some additional second quarter business, product and clinical highlights.
<UNK>.
Thank you, <UNK>, and good afternoon, everybody.
Our second quarter 2016 total revenues were $172.6 million, which was up 10.9% from $155.7 million in the prior year period.
Total product revenues rose by 11.5% or 11.1% on a constant currency basis versus the second quarter of 2015.
Product revenues for Q2 exceeded our expectations too, as <UNK> noted, to both continued strength in attracting new customers, notably in some of our key OUS regions as well as an increase in US hospital sensors.
Rainbow product revenues for Q2 totaled $14.9 million, which was up 10.6% from $13.5 million in the prior year period.
This increase is consistent with our projected total annual rainbow growth of approximately 10%.
Our Q2 SpHb revenues declined to $3.6 million from $4.4 million in the prior year period.
This decline was due primarily to a difficult comparison involving two large license orders last year, as well as a slight delay in the shipment of an OUS order, which will now be realized in Q3.
Our worldwide end-user or direct business, which includes sales through just-in-time distributors, grew 12.7% in the second quarter to $140.9 million versus $125.1 million in the year ago period.
Our direct business represented approximately 86% of total product revenue in the quarter versus 85% in the prior year period.
OEM sales comprised the remaining 14% and rose by 5.1% versus the prior year period to $23.7 million.
By geography, total US product revenue increased by 10.2% to $117 million compared to $106.2 million in the same quarter of 2015.
Our total OUS product revenues of $47.6 million rose by 15% versus $41.4 million in the same prior year period and were up 13.6% on a constant currency basis.
OUS revenues represented approximately 29% of total Q2 product revenues, up from 28% in the prior year quarter.
Our second quarter 2016 GAAP product gross margin was 65.1%, up by 90 basis points from the previous year's 64.2%.
This improvement is attributable to a number of factors including a more favorable product mix, the continuing benefits from our value engineering efforts and other manufacturing cost initiatives, as well as favorable FX movements, including the year-over-year decline in the value of the Mexican peso versus the US dollar.
Reported second quarter 2016 total operating expenses were $78.7 million, an increase of $3.6 million or 4.9% versus $75.1 million in the prior year period.
Our SG&A expenses were $63.9 million, an increase of $2.2 million or 3.6%, while our R&D spending was $14.8 million, an increase of 10.6% versus the year ago period.
The increase in R&D expenses related to additional engineering resources to support both ongoing Masimo new product development efforts as well as additional staffing related to our commitment to reinvest the medical device tax savings.
Second quarter 2016 operating income was $36.4 million compared to $27.8 million in the prior year period.
This significant increase in year-over-year operating income is the result of a combination of factors, including strong product revenue growth, improved product gross margins and continued operating expense control.
Encouragingly, for the third quarter in a row, our operating income margin has exceeded 21% and in fact, was up over 300 basis points above the same prior-year quarter.
Q2 2016 non-operating income was approximately $500,000 compared to non-operating expense of $1.1 million in the prior year period.
The $500,000 in Q2 non-operating income includes approximately $1 million in net interest expense related to borrowings under our line of credit less other interest income.
This interest expense was more than offset by approximately $1.5 million in favorable foreign exchange translation gains resulting from changes in foreign exchange rates from April 2, 2016 to July 2, 2016 on our OUS local currency denominated balance sheets.
Our second quarter 2016 effective tax rate fell to 18.6%, down from 30% in the same period last year and well below our expected rate of approximately 30%.
This lower than expected Q2 effective tax rate was due to a $4.1 million benefit we recognized related to our adoption of ASU 2016-09, the new accounting rule regarding the reporting of tax benefits resulting from the exercise of stock options.
As you'll recall, the new accounting rules require that the tax benefit related to the exercise of stock options reported as a discrete benefit to the current quarter effective tax rate as part of the profit and loss statements.
In the past, these tax benefits were recorded directly to equity.
Without this discrete item, our adjusted Q2 effective tax rate would have been 29.7%, very close to our 30% projection.
As a result of this new accounting rule, our Q2 2016 fully diluted EPS was increased by $0.08 per diluted share, following a $0.02 increase in Q1 2016.
Our average shares outstanding for Q2 were 52.7 million, down from 53.7 million in the year ago period, but up from 51.9 million in Q1, 2016.
During Q2 quarter, we repurchased an additional 400,000 shares, increasing our year-to-date purchases to 1.5 million shares.
The sequential increase in our Q2 weighted share count was primarily due to the impact that a higher stock price has on the diluted value of stock options outstanding under the treasury stock method.
Second quarter GAAP net income increased by approximately 55% to $30 million or $0.57 per diluted share including the $0.08 per diluted share benefit related to the discrete Q2 accounting change and the 4% benefit from movements in foreign exchange rates.
As of July 2, 2016, our DSO was 47 days compared to 52 days as of April 2, 2016 and compared to 46 days as of January 2, 2016.
Our inventory turns remained at 3.7, consistent with the April 2, 2016 level and were down from 4.2 as of January 2, 2016.
Total cash and cash equivalents as of July 2, 2016 were $116.1 million compared to $132.3 million as of January 2, 2016.
During the first six months of the year, we have generated approximately $56.7 million in cash from operations and $19 million from the exercise of stock options.
These funds were used in part to repurchase 1.5 million shares at a cost of approximately $63.4 million and to repay approximately $10 million in our line of credit borrowings and to fund our operations.
During the most recent second quarter alone, in addition to the repurchase of approximately 400,000 shares at a cost of approximately $20.5 million, we also repaid $50 million on our line of credit, lowering our total borrowings outstanding from $225 million at the end of Q1 to $175 million at the end of Q2.
Now I'd like to take just a moment to update our fiscal 2016 financial guidance, which is based on the best information we have available to us.
We are now projecting that our total fiscal 2016 GAAP revenues will be approximately $689 million, including $658 million in product revenues, up from our prior estimate of $647 million, which was (inaudible) from our original fiscal 2016 guidance of $640 million in product revenues.
We now expect our annual GAAP 2016 product gross profit margins to be approximately 65%, up from our prior guidance of 64.7%.
We now also expect our fiscal 2016 operating expenses to be approximately $314 million, which is up slightly from our prior guidance of approximately $312 million.
We continue to expect that our tax rate for the remaining six months of fiscal 2016 will be approximately 30%.
We are projecting that our average quarterly weighted shares outstanding for the rest of fiscal 2016 to be between 53 million and 54 million.
And as a result of these changes, we are now expecting our 2016 GAAP EPS to be approximately $2.01, up from our prior estimate of $1.83 per diluted share and our original projection at the start of the year of $1.69 per diluted share.
And with that, I'll turn the call back to <UNK>.
Thank you, <UNK>.
I want to congratulate our team for our performance through the first half of the year.
We intend to continue to achieve results that exemplify our greater growth potential, stemming from our breakthrough technologies that have had a profound impact on patient care and cost of care.
As <UNK> just described, we have once again boosted our full-year forecast to incorporate a more positive outlook for 2016.
We are realizing higher revenues through drivers across our installed base as utilization has risen.
In addition, steady growth for Rainbow and recent regulatory clearances for important new products provide us with greater confidence that we'll exceed our prior target set at the beginning of this year.
We're consistently winning new hospital conversions for Masimo SET and Rainbow SET oximeters.
During Q2, we received two noteworthy product clearances from the FDA.
First, we received FDA clearance for our O3 Regional Oximetry monitor, enabling us to participate in an estimated $125 million market that is growing by 10% annually.
Given the accuracy and ease of use of O3 compared to competitive monitors in the field, we hope to capture meaningful share in this market in the next few years.
In fact, one of the world's leading centers for cardiovascular medicine and transplantation, DHZB, the German Heart Center in Berlin, has adopted our O3 Regional Oximetry and SedLine Brain Function monitoring technologies to monitor their patients in the operating room and intensive care unit.
DHZB is a specialized hospital dedicated to the diagnosis and treatment of cardiovascular and thoracic diseases, implantation of mechanical circulatory support systems and heart and lung transplantations and treats more than 7,200 in-patients and 24,000 outpatients annually.
The second notable FDA clearance we received in Q2 was for our wearable tetherless Radius-7 monitor with Rainbow measurement capabilities.
The Rainbow version of Radius-7 allows for patient mobility within the hospital and includes continuous hemoglobin measurement as an option, which may be useful for detecting post-operative internal hemorrhage.
We also recently initiated the launches of next-generation SedLine and next-generation SpHb products in Europe, both of which incorporate substantially improved technology that increases their clinical utility.
On a related note, we are happy to report that the rollout of Rainbow parameters within both low acuity and high acuity monitors made by Philips has commenced.
GE is also now selling Rainbow in its low acuity monitor line.
Unfortunately, we've recently learned that GE's rollout of Rainbow in their high acuity monitors would likely be delayed by two years to three years.
On the clinical front, two papers are recently published that support the clinical utility of Masimo's innovative technologies.
In a study utilized ---+ using the first generation Pronto Pulse CO-Oximeter to non-invasively measure total hemoglobin in 114 patients.
SpHb was successfully measured 89% of the time.
With mean lab-based hemoglobin values of 12.6 grams per deciliter plus and minus 1.9 grams per deciliter and mean noninvasive SpHb values of 12.3 grams per deciliter plus or minus 1.6 grams per deciliter.
The authors, Dr.
Ryan and colleagues, at the University of Tennessee Health Science Center, the Le Bonheur Children's Hospital found that non-invasive and invasive measurement correlated well and that the rapid availability of results and the lack of requirement of the venipuncture non-invasive hemoglobin monitoring maybe a valuable adjunct into initial valuation and monitoring of pediatric trauma patients.
They also noted that non-invasive SpHb testing may be most effective in determining when invasive testing of hemoglobin is warranted.
A paper just published in transplantation proceeding, authored by Dr.
Lee and colleagues at Chang Gung Memorial Hospital in Taiwan investigated the utility of PVI and concluded that PVI may serve as a reliable estimate of cardiac preload status in patients undergoing or topic liver transportation as higher PVI values correlated with lower right ventricular end-diastolic volume [values] so that an increase in ventricular preload status could be inferred from a decrease in PVI during OLT.
We also noted that right ventricular end-diastolic volume was better correlated with PVI than with other static filling pressures, such as central venous pressure or pulmonary artery occlusion pressure, therefore giving a safer, faster and better estimate of fluid responsiveness.
These two papers are just the latest examples of the high clinical value that our technologies provide to clinicians as they strive to improve patient care.
In fact, we estimate that the use of SET Pulse Oximeter, Rainbow SpHb and PVI will save an average hospital $1.3 million a year.
In the age of both the Affordable Care Act and the expansion of ACOs, technologies that help clinicians get it right the first time are what hospitals want.
In closing, our focus on delivering on our 10-year plan is based on our guiding principles of remaining faithful to our promises and responsibilities.
We are encouraged that our first half of 2016 financial performance has exceeded our original [2016] guidance, and in doing so, has allowed us to once again increase our financial guidance for the year.
We are looking forward to what will be a record year in 2016 as we head into the final stretch of our 10-year plan in 2017.
As always, we remain focused on our mission to improve patient outcomes and reduce the cost of care by taking non-invasive monitoring to new sites and applications with our breakthrough non-invasive monitoring technologies.
With that, we'll open the call to questions.
Operator.
Certainly.
Certainly value engineering work that we've been doing the last few years is resulting in some of those gains.
Our value-based pricing with our customers and our discipline with that along with the expansion of the new products, obviously, we've been talking about rainbow for a while, but we're seeing excellent growth with SedLine, excellent growth with capnography, and now O3.
So adding SET, Rainbow and now Root, which has these new modalities together, along with the open connectivity and creating the connected ---+ for the hospital, we think will help us drive strong revenue gains as we manage our expenses to what we believe are sustainable given the initial investment we made in the first 60%, 70% period of this 10-year plan.
Well, not to get too much into the minutia, all I can say, had we had that order in Q2, our revenues for hemoglobin would have grown 10% instead of being in decline, also given some of the factors of the last ---+ same quarter period ago.
But what I can tell you on the Middle East, we're working really well with them.
The run rate of sales have been excellent.
We did regain the tender that we had won last year, and in fact hospitals' run rate for that was probably 2 times, 3 times of what we did last year with them.
However, there is pressure from the Finance Minister for these hospitals to not automatic, get what they ask for, so they will be working towards getting what they want, but instead of it being pre-approved for the whole year, they'll have to seek it on a regular basis.
So while all of that will mean not much for this year for us, because we've already projected worst case anyway, and we're more than happy to meet that with the new projections we gave you, we'll have to track what really happens on the street in Q3 and Q4 and then hopefully in Q1 of next year, we can tell you what to expect for the rest of the year based on the historical usage patterns, because unfortunately we can't rely on the tender request and tender win that we had given the way the Finance Minister has, I guess reined in that freedom from the hospitals and we'll request additional demands on a regular basis.
We haven't reached any new agreement, but we still remain optimistic that royalties will continue till October 2018, given that we won the IPR on two of the patents that they went to try to eliminate.
The one that we won goes till October 2018, the one that we partially lost expires next month.
So that ---+ obviously the royalty haven't changed.
So we think things will remain till October 2018 and if we can do something more with Medtronic, we'll be announcing it as soon as we have it.
Yes, directionally it's exactly right.
Working (multiple speakers) we had in the second quarter made us confident enough to take up our projected revenue guidance for both Q3 and Q4 in the range of about $2 million.
We also though, because of the higher amount of weighted shares, ended up essentially, you could say effectively, losing $0.01 because of the impact of the now projected higher share number for Q3 and Q4.
So the combination of that, the higher revenue of about $2 million each quarter offset by slightly higher weighted share numbers resulted in a net increase of about $0.01 for both Q3 and Q4.
Correct.
Yes, we actually can't because of the discrete nature of those.
We can't even include those in any kind of forward guidance, number one, because it's very difficult, of course, to project what kind of stock option exercises might occur.
And secondly, because it's simply isn't allowed as part of your forward effective tax rate guidance.
Sure.
On the GE, given that, of course, we are in possession of confidential information that I cannot disclose, all I can tell you is this delay had nothing to do with us.
It's something that is an internal issue for them, but with their permission, we wanted to share with you where they are.
The good news is Philips has fully rolled out, Drager has been out there for a while with Rainbow technology, Welch Allyn, ZOLL and many other OEMs.
So we're anxious to get GE out there, but I know they're doing everything they can.
But unfortunately things like this sometimes happen in the product development cycle.
As far as our litigation with Philips, as you know, it's been broken up in four phases.
We won phase 1 for $467 million verdict, which was not finalized, which actually may end up being a good thing because Supreme Court recently changed the standards for willful infringement.
We think we have a great willful infringement case against Philips, which will be ---+ now we'll bring it up on the phase 2 coming up in January, but we'll seek to bring back on the phase 1 victory as well, where they have admitted that they infringed our technology before even the trial began.
For us, the phase 3, that'll be the antitrust suit and patents use case against us, that will happen in March of next year and then phase 4 is some additional patents we have against them along with our antitrust suit against them and that has not been scheduled yet.
So in summary, if I was going to tell you what I think will happen, I think hopefully ---+ assuming we win the antitrust and patents use in March, probably about 18 months after that, I'm sure Philips will appeal to the Court of Appeals, Federal Circuit Court of Appeals, which we expect we should win.
And so we think sometime in about two years from now, we'll have our first check from Philips.
And maybe with the pre-judgment interest, post-judgment interest, if there is willfulness found (inaudible) that could be much bigger than the $467 million that we secured in the phase 1 trial and post-judgment rulings by Judge Stark.
We don't really know what our market share is, those are difficult to assess.
We do believe we are growing 2 times to 3 times the rate of growth in the pulse oximetry market given that we're now ---+ we've been growing for almost two years at above 10% rate.
So unfortunately, that's all I have for you.
I know there's surveys that are done by independent surveying companies, I don't know how much I can trust those.
So therefore, I don't want to state what they say because I know there are ways of guessing that those numbers as not as scientific as how sometimes they're truly done when economists get involved in big case trials and so forth.
Sure, <UNK>.
I think as we've been articulating for the past couple of years now actually, we changed really our direction towards planning our future level of total investment in operating expenses and we changed it from a perspective of identifying various targeted opportunities and ways to expand the business and essentially determining whether to fund those kind of expenses.
It's one in which we just simply said, there is a fixed amount of operating expense that we're willing to invest each year and then we work very, very diligently internally to prioritize all of the various spending initiatives that we have.
But at the end of the day, we're limiting ourselves to X amount of dollars outstanding growth.
So because of that approach, obviously there is a tremendous amount of control in terms of our ability to dictate essentially what level of spending we're going to be at and that's something we started at the end of 2014, it's continued all the way through 2015 and it's obviously continuing through this year and as we look forward for the next couple of years, there is no intention to change that type of forced prioritization of investments in order to hit a fixed amount of aggregate spending dollars increase.
Well, I don't think anything has changed on pricing.
We see Medtronic do the same thing that Covidien was doing pricing wise.
Given that we ---+ from clinical studies have data that shows (inaudible) save an average hospital of 250 beds about $1.3 million a year, we, not to mention the lifesaving impact of our technology, the [eye] damage reduction and (inaudible) of our technology, we believe our pricing is just right.
And that's not too low, but consistent to wanting to help our customers reduce cost of care.
We always calculate that into our pricing strategy.
So the good news is, customers are willing to give us a small premium for the value that our technology brings to them that both save them money, big money, not small pennies but also help them take better care of the patients.
Thank you so much, <UNK>.
And I want to just add one thing, the reason we can grow our expenses the way that <UNK> mentioned, in a very disciplined fashion, is because we had grown, as you know, our infrastructure a little bit ahead of plan, normal times, the way we would do things, given the royalties we're gaining from Covidien, Medtronic and that has allowed us now ---+ and I guess the last part of our 10-year plan to not have to grow our expenses, yet not be choking the Company when it comes to both product that saves lives and helps people as well as the number of people we need from an infrastructure perspective to treat our customers as they're accustomed to.
So we're really happy that the 10-year plan is working.
We're happy that our investors have stuck by us and now are seeing the stock working, so we knew this commitment to you and look forward to our next quarter results.
And if you must, thank you all for joining us.
