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Sera Prognostics, Inc. (SERA) Q3 2021 Earnings Call Transcript

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SERA earnings call for the period ending September 30, 2021.

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Sera Prognostics, Inc. (SERA -1.96%)
Q3 2021 Earnings Call
Nov 09, 2021, 5:00 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:


Operator

Good afternoon, and welcome to the Sera Prognostics conference call to review the third quarter results for fiscal year 2021. [Operator instructions] As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Peter DeNardo of CapComm Partners for a few introductory comments.

Peter DeNardo -- Investor Relations

Thank you, Danielle. Good afternoon, everyone. Welcome to Sera Prognostics' third quarter '21 earnings conference call. At the close of the market's date, Sera Prognostics released its financial results for the quarter ended September 30, 2021.

Presenting for the company today will be Greg Critchfield, chairman, president, and CEO; and Jay Moyes, our CFO. During the call, we will review the financial results we released today, after which we will host a question-and-answer session. If you not had a chance to review our quarterly earnings release, it could be found at our website at seraprognostics.com. This call can be heard live via webcast at seraprognostics.com, and a recording will be archived in the Investors section of our website.

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Please note that some of the information presented today may contain projections or other forward-looking statements about events and circumstances that have not yet occurred, including plans or projections for our business, future financial results, and market trends, and opportunities. These statements are based on management's current expectations and the actual events or results may differ materially and adversely from these expectations for a variety of reasons. We refer you to the documents the company files from time to time with the Securities and Exchange Commission, specifically the company's annual report on Form 10-K, its quarterly reports Form 10-Q, and its current reports on Form 8-K. These documents identify important risk factors that could cause the actual results to differ materially from those contained in our projections or forward-looking statements.

I will now turn the call over to Greg, Sera Prognostics' chairman, president, and CEO. Greg.

Greg Critchfield -- Chairman and Chief Executive Officer

Thank you, Peter, and good afternoon, everyone. Today, I will provide an overview of key business highlights during the quarter and our expected developments over the near term. Sera is a company that is moving at this point in time from a clinical development stage into a commercial-stage enterprise. We are very pleased with our progress during the third quarter and excited by the opportunity ahead of us to grow the company and to achieve our vision of improved healthcare for mothers and babies.

To achieve this, we are deploying our capital judiciously to build the capabilities to engage in full commercialization that we believe will generate significant revenue growth in the future. We are engaged in ongoing publication of Sera's science and technology to extend our leadership in pregnancy. We are building an effective commercial organization, and we are collaborating with key individuals and organizations as we move forward to achieve our goals. Let me start by discussing further validation of our PreTRM testing technology and the significant positive impacts that Sera's testing can have on healthcare costs while bettering maternal and neonatal care.

I'll then discuss a new key collaboration and the buildout of our company with additional staff and advisors. During Q3, we announced the publication of a detailed health economic analysis in the peer-reviewed journal, ClinicoEconomics and Outcomes Research. This publication illustrates the clinical benefit of combining our PreTRM testing with evidence-based interventions to improve neonatal health and reduce total healthcare costs. This work adds to the growing body of evidence supporting the effectiveness of Sera's test and treat strategy in identifying women at risk for spontaneous preterm birth and providing more proactive care in those pregnancies.

Proactive care in more pregnancies that are truly at higher risk of premature birth has the ability to reduce complications of preterm birth, decrease cost of the length of stay, and save healthcare expenses. The recently published health economic analysis was conducted by Sera working in partnership with Anthem's analytics subsidiary, HealthCorp, using actual claims data of more than 40,000 pregnant women and infants. The analysis evaluated the application of the PreTRM test and treat strategy by modeling testing to be conducted during weeks 19 or 20 of pregnancy and assess the benefits across the population by providing proactive interventions in the higher PreTRM test risk cases. Note that the effective compliance model in the study was very conservative with only 60 percent of eligible candidates assume to receive proactive interventions.

Key findings of this comprehensive and conservative analysis include 20 percent reduction in preterm birth less than 37 weeks of pregnancy, 33 percent reduction in very early premature births less than 32 weeks of pregnancy, 10 percent reduction in neonatal intensive care admissions, seven percent reduction in overall hospital length of stay $863 net savings, one -- that's $1,608 gross savings per pregnancy that was evidenced by the $54 million reduction in total costs in the population that was studied. Based on the $863 net savings, the authors of this conservative analysis estimate that more than $850 million could be saved annually in US individual- and employer-sponsored health plans. We believe this work provides a compelling economic rationale that is appealing to payers, and it should help foster widespread adoption of our PreTRM test and treat strategy by health insurance payers. On the scientific front, last week, we announced a rigorous peer-reviewed PreTRM test validation of a risk threshold that stratifies pregnancies into higher or lower risk categories for preterm birth.

This work was published in the Journal of Clinical Medicine. This threshold enabled more proactive interventions to help address higher risk of premature delivery in women whose preterm risk results are at or above twice the average population risk for spontaneous preterm birth. In a pregnancy where the risk is at or above that 15 percent threshold, the doctor and patient can decide to more proactively address that risk with intervention designed to help the mother and baby. This PreTRM test risk threshold underpins the published data, demonstrate the performance of value of Sera's PreTRM test and treat strategy in published validation studies on prematurity prediction and published health economic models, demonstrating its impact in population and in intervention studies where clinical benefits of the strategy are assessed.

Note that the 15 percent risk threshold is also employed to interpret an individual mother's risk result as higher or lower when she receives Sera's PreTRM testing commercially. In the recent threshold analysis publication, it was demonstrated that patients at or above 15 percent or twice the intended use population risk had significantly higher risk of spontaneous preterm birth and that they had a higher frequency of adverse clinical outcomes. Publication of this work adds to the growing body of evidence supporting the clinical validity and utility of our PreTRM test in identifying women at risk. This additional validated data for physicians, employers, and payers further demonstrates Sera's ongoing efforts to improve pregnancy outcomes and reduce healthcare costs through studies and collaborations with respected independent parties and individuals.

These efforts highlight Sera's vision to provide actionable insights to benefit mothers the newborns and to save on healthcare costs by improving patient outcomes. Sera has always been interested in addressing prematurity, both in the US and abroad. In the early days of the company, we worked on building predictors that could benefit underserved population that are disproportionately affected by prematurity, particularly in Asia, in Africa, and in the US. Our earliest studies overrepresented underserved populations as we discovered and further validated our PreTRM test to make sure that our test would work well for them.

Since 2015, Sera has conducted work in cooperation with the Gates Foundation efforts, and we anticipate upcoming publication of work in non-US geographies that further demonstrate the power of our technology to assess prematurity risks in low, middle -- and middle-income populations. Finally, our preterm prospective -- or excuse me, our PRIME prospective intervention study being conducted across the US includes underserved populations where prematurity risks are very high. We have maintained a constant focus to ensure that our predictors work well where they are needed the most. We have just announced an important key collaboration to further help underserved US communities address healthcare disparities by partnering with PreemieWorld, GLO Preemies, and the Alliance for Black NICU Families.

Leading organizations all geared to empowering and supporting families impacted by preterm birth. The long-term goal of this collaboration is to help educate and stimulate conversations between patients, their families, and their physicians to improve individualized assessment for preterm birth risk. According to a study published in 2020, African American women in the US are 15 percent more likely to deliver prematurely when compared to Caucasian women. And we believe that education and access to information is essential to changing this unacceptable statistic.

We are proud to join with these leading organizations in a united effort to effect change and improve healthcare outcomes in this underserved segment of the patient population. A word about people. Sera works internally and externally with very talented and dedicated people that are essential in building our company for success. We were pleased to announce last week the engagement of Dr.

Woodrow Myers as an advisor to the company on public and political affairs. Dr. Myers is a nationally recognized leader in developing medical quality initiatives, and he has extensive experience and leadership in addressing health equity and disparities. We are honored to have him join our team and lead on a multidisciplinary effort to execute a national- and state-specific political and public affairs strategy to help address healthcare disparities that disproportionately affect underserved communities.

Data and analytical capabilities are a cornerstone of our business when it comes to extensively analyzing information to validate what we're doing to provide healthcare insight to patients, physicians, and payers, and to lead to new and improved products. At quarter-end, we were very pleased to announce the appointment of Dr. Paul Kearny as chief data officer. His extensive data science, bioinformatics, and proteomics experience help us to foster further innovation for Sera.

I'm also very pleased to report that we have begun our buildout of the commercial team to robustly scale PreTRM testing. We have now hired a talented sales force comprised of 26 representatives, concentrated regions where we begin selling our test with a good initial basis of third-party payment. We have sales representatives hired on both coasts, western Midwest, southern Mid-Atlantic, and northeastern territories. By the end of this quarter, we anticipate having 30 active sales territories, covering approximately 12 percent of all US pregnancies.

These sales representatives call on physician offices, educating them about PreTRM testing, and how to incorporate testing into their clinical practices. We also have an experienced team of market access personnel who are in discussions with payers as we emphasize the health and economic benefits of our test and treat strategy and work to secure reimbursement contracts. From these states' deployment, we expect to extend our testing ultimately throughout the US. Note that we are receiving payment from major payers in the United States as we are initially rolling out our PreTRM testing.

We are building and deploying digital marketing programs to engage women who are the ultimate important customer for whom our testing has been created. We believe that the coordinated efforts to address the three key customers we have, doctors, patients, and payers will help us to grow revenues as our commercial team executes on our vision. And finally, to expand our talented pool of advisors, we are pleased to have just appointed Zhenya Lindgardt to Sera Prognostics board of directors. Zhenya possesses significant expertise and deep understanding of both healthcare and consumer technologies that are important enablers of our strategy and can help drive adoption among patients, physicians, and payers through her profound knowledge of consumer-centric approaches.

She currently serves as CEO of the Commons Projects Foundation, a global nonprofit focused on enabling trust ecosystems for individuals' data. And prior to that, served as vice president of Platform And Customer Engagement on the executive team at Uber. She's also served with the Boston Consulting Group and has served on the board of directors of City Harvest, a New York City hunger charity. She shares our passion and vision to create better lives for women and newborns globally, and we welcome her aboard.

Looking forward, we see a robust opportunity to potentially ramp the adoption of our PreTRM test and treat strategy to address prematurity. While the COVID pandemic has somewhat impaired our initial scale-up in Q3 and going into Q4, we believe that this problem is something we can successfully move through and look ahead to the time it will recede in the rearview mirror. Looking forward, we expect to announce upcoming contracts with payer, employer, and physician network groups who adopt our testing. A growing revenue ramp is expected to follow the signing and implementation of testing within these groups.

We foresee additional clinical and economic data readouts and publications occurring in the future as well. We are very encouraged by our execution thus far in 2021, giving us confidence as we move into year-end and into an exciting 2022. I'll now turn the call over to Jay for a brief review of our third quarter financial results and some color on our expectations through year-end. Jay?

Jay Moyes -- Chief Financial Officer

Thanks, Greg, and good afternoon, everyone. We are pleased with our execution to date and our positioning from a commercial perspective as we approach year-end and the new year in which we expect to see additional commercial developments occur. Today, I'll briefly review our financial results for the third quarter and then provide some color on our outlook for the near term. For the third quarter of 2021, we reported revenue of $23,000, compared to $5,000 in the same period of 2020.

Total operating expenses of $9.5 million were up significantly from $4.6 million for the third quarter of 2020. The increase is primarily due to the scale-up of operations to address the significant opportunities we see ahead for our PreTRM test. Research and development expenses for the third quarter of 2021 were $2.7 million, compared to $1.9 million for the prior-year period due primarily to increased laboratory operations and clinical study costs. Selling, general, and administrative expenses for the third quarter of 2021 were $6.7 million, up from $2.8 million in the prior year.

This was due primarily to increased headcount as the company scales commercial operations and general corporate infrastructure, as well as increased costs related to operating as a public company following our initial public offering this past July. Net loss for the third quarter of 2021 was $9.9 million, compared to $5.1 million for the same quarter a year ago. As of September 30, 2021, the company had cash and cash equivalents of approximately $82.5 million and an additional $67.5 million of available-for-sale securities. We believe that significant cash position is sufficient to enable us to successfully scale testing for revenue on our anticipated timeline and meet our profitability objectives.

Turning now to our expectations for the remainder of the year. As Greg mentioned and as numerous companies have noted recently, we experienced some challenges during the quarter from COVID-19 that impacted our testing revenue for the third quarter. We anticipate these challenges will impact testing revenue through the fourth quarter as well. And with that, we'll open the line for questions.

Operator?

Questions & Answers:


Operator

[Operator instructions] The first question comes from Patrick Donnelly of Citi. Please go ahead.

Patrick Donnelly -- Citi -- Analyst

Hey, guys. Thanks for taking the questions. Maybe one on the sales reps. You know, it's encouraging to hear you guys at 26 out there already going to 30.

How should we think about that ramp continuing over the next, you know, 12, 24 months, particularly as you get more payors onboard. You know, how many do you envision, you know, a critical mass a few years out and what's -- what that look like over the next year or so?

Greg Critchfield -- Chairman and Chief Executive Officer

Yeah. Great question, Patrick. We believe that we currently have a very good-sized footprint to begin testing. And as I said before, we're focusing on areas where there is payments by insurance companies.

And what you do is you expand out over time as more data become available, as more contracts are secured. That allows you to grow the company in a much more profitable manner. We believe that to cover the entire US, a sales force of about 250 sales representatives is required to address the OB-GYN channel. This is the same size that Jay and I built the sales force to be at Myriad when we -- that was the second of the specialty sales forces that we built there.

So, that's what we see happening. We believe it can be done in a planful way, in a way that does not waste effort and money. And we are clearly looking at growing over time as the sales force moves forward.

Patrick Donnelly -- Citi -- Analyst

That's helpful. And then just on the payer ramp. You know, what's the right way to think about some of these other large national payers coming on board in terms of the timeline. I mean, is it waiting on, you know, some of the bigger data reveals? Is it kind of seeing a little more health economics? You know, what are those conversations like? And again, what should we think about in terms of timing for some of those catalysts?

Greg Critchfield -- Chairman and Chief Executive Officer

What I can tell you, Patrick is that right now, we are in conversation with regional payers, with self-insured employer groups, and national payers. Those conversations are ongoing. We share data, we discuss where things are going. And what will happen over time, we believe that the smaller payers will come first and then larger ones later.

And that's what we see happening. We anticipate the ability before the year -- before year-end to be able to announce one or more of these collaborations with payor groups and look forward -- you should look forward to that. And in the future, of course, there will be many more announcements as we grow our footprint and our payer coverage map.

Patrick Donnelly -- Citi -- Analyst

OK. Great. And then maybe last one if I can. Just in terms of practice accessibility, again, as you build out the sales force.

What are you seeing in terms of, you know, whatever metrics you guys have in terms of what practices are -- your sales reps can actually get into, kind of the efficiency of some of their calls in person if they're able to get in-person with the COVID impact? Just wondering, you know, how you're seeing that ramp, and again, how you're expecting that to trend over the next few quarters as, hopefully, we turn the corner on this.

Greg Critchfield -- Chairman and Chief Executive Officer

Yeah. That's great. So, the -- as I said before, part -- some of our discussions are with physician groups. That's an efficient way of doing things.

Some are with integrated health networks, some are with large practices that are just different geographies. Our salespeople are looking based on data. They target -- they have a target list of high-potential candidates, and those are the ones that we go to first. We believe that doing that in a way where the OB-GYN and MFM to whom they refer difficult cases, working together to establish protocols is a way to systematize the testing that's done in any geography.

And that's part of the discussion that takes place.

Patrick Donnelly -- Citi -- Analyst

All right. Thanks a lot, Greg.

Greg Critchfield -- Chairman and Chief Executive Officer

You bet.

Operator

The next question comes from Brian Weinstein of William Blair. Please go ahead.

Dustin Scaringe -- William Blair and Company -- Analyst

Yes. Hi, this is Dustin on for Brian. We know it's kind of early on but I'm just wondering how we should think about the trajectory and volume expansion here and whether you guys can give us some idea of how you're thinking about that over the next few months.

Greg Critchfield -- Chairman and Chief Executive Officer

Yeah. I lost one word in your question. Could you repeat that? What expansion are you talking about?

Dustin Scaringe -- William Blair and Company -- Analyst

That's volume expansion.

Greg Critchfield -- Chairman and Chief Executive Officer

Yeah. Jay, do you want to start, and I'll finish that up?

Jay Moyes -- Chief Financial Officer

Well, I think the, you know, the volume is expanding. It's early days, and the sales force has been in place since really the beginning of July this past year. And it takes a certain amount of time for the sales force to get up to full efficiency. And I don't know maybe, Greg, you can add some additional color to that.

Greg Critchfield -- Chairman and Chief Executive Officer

You bet. Yeah. So, we were effectively not doing material commercialization before July. This July, we've hired the sales team that I've mentioned, where now we have 26 active reps that are there.

And it's really a combination of things that you want to pay attention to. You want to reduce the burden on patients that's paying for the testing themselves. You do that by going to places where there -- where you have a good basis of insurance coverage first. You also -- you work with payers that do not have -- the payers that are not in the initial group of peers paying for testing and you work to secure contracts with them.

Those things are happening in real time. You need to -- at the end of the day, it's the doctor that orders the tests. And so, one of the key things is making sure that we arm the doctor with information, tools, and practical ways of identifying patients in their practice that are candidates for testing and give -- and actually initiate the testing within their practice. Those activities take time.

If you look at traditional numbers, it takes six to nine months for a sales rep to come up to speed to begin paying for him or herself. That's what's the industry standard among oncology. And it's -- you -- we think of it similarly in our space now.

Jay Moyes -- Chief Financial Officer

And I might add, too, Greg, that we have been seeing encouraging order volume toward the end of Q3. I think that's important to note.

Greg Critchfield -- Chairman and Chief Executive Officer

Yeah. Yes, and the orders we're getting -- our patients, they're both Anthem and non-Anthem patients that are -- where orders are being generated.

Dustin Scaringe -- William Blair and Company -- Analyst

Great. Thank you. And then specifically wondering what's happening with Anthem. What are you guys hearing from them? How are they promoting doctors to use products? And overall, just how are they assisting on the commercialization efforts and what kind of feedback are you getting on the field on -- 

Greg Critchfield -- Chairman and Chief Executive Officer

The people -- 

Dustin Scaringe -- William Blair and Company -- Analyst

In terms how effective that is. So ...

Greg Critchfield -- Chairman and Chief Executive Officer

We're having many discussions about specialized programs to go after the question of how do you roll out the testing within the large insurance network. Those things are happening. We -- our sales reps are in the field educating doctors, and the strategy is a very simple one. The sales rep talks to a doctor, educates him about the need for better identification for preterm birth, the testing.

And once they have understood that, then the idea is to encourage them to offer the testing to all patients in their practice. And then for those patients that are covered by insurers -- insurance companies that don't -- they're not yet paying for things. We begin discussions with them, and I could tell you that we're already seeing revenues from the -- from those kinds of payers now.

Operator

[Operator instructions] The next question comes from Dan Brennan of Cowen. Please go ahead.

Dan Brennan -- Cowen and Company -- Analyst

Hey, guys. Thanks for taking the questions. Maybe the first one. Just going back to volumes, obviously where the, you know, first pitch the first inning here.

But I'm wondering we -- can you guys kind of provide any guidance as we get to the fourth quarter about 2022 volumes, or just kind of -- what can we expect in terms of visibility?

Greg Critchfield -- Chairman and Chief Executive Officer

Yeah. At this early stage, we're not prepared to give guidance at this point in time. We -- we're very early in the game. We are just beginning our commercialization efforts to gain -- to yield orders.

And as -- over time, we are going to have a much better understanding of things. So, we do not, at this time, plan on giving guidance now. So, that's where we are currently.

Dan Brennan -- Cowen and Company -- Analyst

In terms of harm upcoming data that we should be aware of, obviously, there's a bunch of, you know, studies still ongoing. Can you just kind of remind us what's coming up in 2022 from a data standpoint?

Greg Critchfield -- Chairman and Chief Executive Officer

Sure.

Dan Brennan -- Cowen and Company -- Analyst

And related to that in terms of key publications, any key publications either that are in the works right now or you think the forthcoming 2022, that could be important?

Greg Critchfield -- Chairman and Chief Executive Officer

Yeah. From this point and into next year, we see publications -- additional publications of validations of our prediction in non-US populations as I mentioned, we see additional economic modeling that will talk about the benefit, the economics of the test and treat strategy using our validated thresholds. And then we also anticipate upcoming clinical readouts by the -- by year-end or into the beginning of next year. We anticipate having enough deliveries having occurred in the PRIME study.

This is a large multicenter study within Anthem where the interim look will be read out. And occurs after 2,800 deliveries have incurred.

Dan Brennan -- Cowen and Company -- Analyst

Got it. And maybe from the health economics, can you just give us a sense on the Anthem study goal that savings -- or savings of, I think, in the most recent maybe cost-benefit peer review. I think, you know, there's also a savings, maybe it wasn't as great as Anthem, So, just how do we think about health economics? What, you know, what are the right numbers that are justifying or, you know, persuading payers to, you know, adopt, you know, your test?

Greg Critchfield -- Chairman and Chief Executive Officer

Yeah. What I can tell you is that we -- when we share a spreadsheet model with payers and have them put their own numbers into the model, one of the things that -- in the publication that was quite evident is no matter what numbers you put in, there is a way to save money. And because of that's termed a dominant strategy, and that's the way the authors characterized the strategy. When we show this to payers, the savings are enormous.

If anything, the publication was conservative in its views and we hear some payers telling us we believe these savings are even higher. They're quite impressed with the amount -- with the savings that are [audio gap] Remember, the great majority of preterm deliveries cannot be detected by today's current clinical practice. About one in six are -- those are pregnancies of -- in women carrying a single fetus where the pregnancy is at risk and who will deliver prematurely. Only about one in six are identified by current methods.

Using our test with current methods, it increases the detection by fourfold. That's a significant increase. And being able to intervene early, as the Anthem data show and as our perspective intervention trial -- the present PTB trials show there is benefit in finding those pregnancy and being more proactive in individualized care you can give to those pregnancies who truly are at risk.

Dan Brennan -- Cowen and Company -- Analyst

Great. OK. Thanks, guys.

Greg Critchfield -- Chairman and Chief Executive Officer

You bet.

Operator

[Operator instructions] I'm showing no further questions. I would like to turn the conference back over to Mr. Critchfield for closing remarks.

Greg Critchfield -- Chairman and Chief Executive Officer

OK. We'd like to thank everyone for attending our call today. We are very excited to see the progress as we achieve our vision of improving the health of mothers and newborns and thereby, saving healthcare costs. We're pleased with the efforts of our internal team in the work performed with a number of external collaborators as we seek to improve pregnancy outcomes.

Although these are early days, we believe that the stronger alignment with science, economics, and commercial execution will enable Sera to more rapidly generate revenues over time. And finally, we look forward to sharing our progress with you as we complete 2021 and move into next year. Thanks again for your attention and interest. As a reminder, a webcast of this call will be available on the Investors section of our website.

This concludes the call, and we look forward to providing the next update on our progress following the close of 2021. Thank you, and good afternoon, everyone.

Operator

[Operator signoff]

Duration: 37 minutes

Call participants:

Peter DeNardo -- Investor Relations

Greg Critchfield -- Chairman and Chief Executive Officer

Jay Moyes -- Chief Financial Officer

Patrick Donnelly -- Citi -- Analyst

Dustin Scaringe -- William Blair and Company -- Analyst

Dan Brennan -- Cowen and Company -- Analyst

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