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BioTime (BTX) Q1 2019 Earnings Call Transcript

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BTX earnings call for the period ending March 31, 2019.

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BioTime (AMEX: BTX)
Q1 2019 Earnings Call
May 09, 2019, 4:30 p.m. ET


  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:


Welcome to the BioTime, Inc. first-quarter 2019 earnings conference call. [Operator instructions] An audio webcast of this call is available on investor section of BioTime's website at This call is subject to copyright property of BioTime, Inc.

and recordings, reproduction or transmission of this call without the expressed written consent of BioTime is strictly prohibited. As a reminder, today's call is being recorded.I would now like to introduce your host for today , Ms. Ioana Hone, director of investor relations at BioTime. Ms.

Hone, you may begin.

Ioana Hone -- Director of Investor Relations

Thank you, Nova. Good afternoon, and thank you for joining us. A press release reporting our first-quarter 2019 financial results was issued earlier today, May 9, 2019, and can be found on the investors section of our website. Please note that today's conference call and webcast will contain forward-looking statements within the meaning of federal securities laws, including statements regarding our strategy, goals, product candidates and clinical trials, expected synergies and benefits of the Asterias acquisition and financing matters.

Such statements are subject to significant risks and uncertainties, including those described in our press release issued on May 9, 2019 and our SEC filings on Form 8-K, Form 10-K and Form 10-Q. Actual results or performance may differ materially from the expectations indicated by our forward-looking statements due to those risks and uncertainties. We caution you not to place undue reliance on any of the forward-looking statements, which speak only as of today. Joining us today are our chief executive officer, Brian Culley; our chief financial officer, Brandi Roberts; our chief medical officer, Ed Wirth; and our senior vice president of clinical and medical affairs, Gary Hogge.

The executives will provide prepared remarks, then take questions from analysts and institutional holders.With that, I'd like to turn the call over to Brian Culley, our CEO.

Brian Culley -- Chief Executive Officer

Thank you, Ioana. Good afternoon, everyone and thank you for joining today's call. We have continued to pave the way toward our objective of becoming the leading cell therapy company. With the successful close of the Asterias acquisition, we now have three clinical stage cell therapy assets in our pipeline, which means 2019 will be an important year in terms of completing our open trials and planning for our next ones.

I'll now highlight some recent developments with OpRegen, OPC1 and Renevia before asking Brandi to review our updated financials. Beginning with OpRegen, last week one of our study investigators presented updated results from our ongoing open label Phase I/IIa clinical study of OpRegen for the treatment of dry-AMD with geographic atrophy. This work was presented at the 2019 Association for research in Vision and Ophthalmology annual meeting, also known as ARVO. And we're pleased to report that treatment with OpRegen continues to be well tolerated, and in some patients signs of structural improvement in the treated areas of the retina have been observed.

Importantly, the initial data from the better vision Cohort 4 patients, those who have less advanced dry-AMD and smaller areas of GA, remain encouraging with indications of the continued presence of the transplanted OpRegen cells and some improvements in visual acuity. The updated and detailed data from this ongoing study is available at the events and presentation section of our website. There, you can see evidence of rapid healing of the injection site, details on the systemic and ocular safety of OpRegen and walk through a number of case studies, which collectively give us confidence that we're on the right track as we continue to enroll better vision patients for Cohort 4. Our next step with OpRegen is to deploy an improved delivery system in at least the next six patients.

We believe more precise delivery of cells to the back of the eye will lead to a reproducible safer and ultimately, an overall superior procedure with an increased likelihood of positive clinical outcomes. And as you'll recall, in January, we entered into an exclusive agreement with Orbit Biomedical to use their sub-retinal delivery system for more precise administration of OpRegen cells to the eye. I'd like to highlight that Orbit is a specialty medical device company founded through the acquisition of the leading surgical platform for sub-retinal delivery and the transfer of key individuals from the Janssen Biotech unit of Johnson & Johnson to the Orbit team. The Orbit sub-retinal delivery system received FDA 5 10-K clearance in November of 2018, and we announced that we had entered into an agreement with them in January of 2019.

Orbit's focus is to transform the accuracy, safety and consistency of delivering therapeutics to the sub-retinal space of patients suffering from sight threatening diseases, and we believe there is no comparable device available to deliver cells in the precise and careful way which Orbit provides. We have already submitted a protocol amendment to the FDA to add the Orbit device to our protocol. And pending the 30-day waiting period, we expect to begin dosing subjects with the Orbit device this quarter. We also plan to introduce our new thaw-and-inject formulation, which should be much easier to use and eliminate the need for extensive dose preparation.

Consequently, we expect to be in a position to provide important updated data on the OpRegen Orbit treated patients and our new formulation no later than at the American Academy of Ophthalmology annual meeting in October. Moving to our second program, OPC1, which I'll just remind everyone, is the delivery of oligodendrocyte for progenitor cells to treat spinal cord injury. Just a few days ago, we announced the issuance of the patent from the U.S. Patent and Trademark Office for a method of reducing spinal cord injury-induced parenchymal cavitation.

Cavitation is a destructive process that occurs within the spinal cord following injuries and typically leads to permanent loss of motor and sensory function. A key finding from our Phase I/IIa study of OPC1 was that 95% of subjects showed evidence by MRI scans that OPC1 cells engrafted at the injury site and helped to prevent cavitation. We think preventing cavitation is one of the key mechanisms by which OPC1 can help improve outcomes in SCI patients. And notably, the recently issued patent would have a term that expires no earlier than 2036 and further solidifies our competitive advantage in this space.

Also pertaining to our OPC1 program, last month our chief medical officer, Dr. Edward, presented additional findings from our SCI clinical trial at the 26th Annual Conference of the American Society for Neural Therapy and Repair. The primary goals of the study were met and they included: observing the safety of OPC1 in cervical SCI patients, metrics related to the optimal timing of the OPC1 injection, the tolerability of the immunosuppression regimen, the engraftment of OPC1 cells and rates of motor recovery among different study subpopulations. These data provide us with the information needed to design the next clinical study.

For example, we observed that among the 25 subjects treated in the study, the two worst performing subjects both also had postoperative cord compression. We do not think that this is a coincidental finding and it highlights the kind of situation that we will seek to mitigate in the next trial through careful protocol design and patient selection criteria.If you like to review these encouraging results for yourself, we've provided some patient-level data on our website in the events and presentation section just as we did for the interim data from the OpRegen study. Although, we do still have a number of additional analysis to do on the OPC1 trial, and we must meet with the FDA to propose our next steps. We do expect our next study to be randomized and to be designed to provide evidence that our OPC1 cells provide a clinically meaningful benefit to SCI patients.

Lastly, we appreciate the generous support of the California Institute for Regenerative Medicine or CIRM, whose grant funding has helped not only to advance the clinical development of our OPC1 program but also to generate these encouraging clinical results, and from whom we intend to request additional support for the OPC1 program later this year. Turning next to Renevia, our medical aesthetics program for HIV lipoatrophy. We submitted our CE Mark application for Renevia last year and its review is still ongoing. We previously estimated that we would receive a response during the second half of this year.

But based on recent information from our regulatory contacts in Europe, we believe we now are in the final stages of the review process, and we currently estimate that we will receive a response this quarter. Although, a successful CE Mark registration reflects well upon this organization's ability to obtain marketing authorizations, I've explained previously that Renevia itself does not fit strategically into our new focus on cell therapy treatments. So if and when our application is approved, we intend to seek an external partner for the commercialization of Renevia in Europe. So to sum up, we remain focused on setting up BioTime for long-term success.

Key actions we've taken toward this goal includes spinning off our early stage assets into AgeX, gaining two new clinical programs via the Asterias acquisition and hiring a brand-new management team including a CEO, CFO and new general counsel, who starts later this month. Importantly, we are now solely focused on making clinical progress with our three cell therapy programs. We also intend to establish a new brand in corporate image, which will highlight our commitment to cell therapy, so you can expect to hear about those updates in the coming months. Overall, we're pleased to report on another successful quarter featuring clinical data updates, accelerated guidance and additional steps, which we believe will position the company for durable success.

I now will hand things over to Brandi to review our financials and discuss some additional plans for this year.

Brandi Roberts -- Chief Financial Officer

Thank you, Brian. Let me start the financial discussion with some balance sheet highlights. At March 31, 2019, BioTime's cash, cash equivalents and marketable securities totaled $27.1 million. Our investment in OncoCyte was valued at $58 million as of March 31, 2019.

Our investment in OncoCyte grew by more than $35 million in the first quarter due to significant stock appreciation based on positive data OncoCyte announced in January 2019. OncoCyte continues to do well and accordingly, our investment in OncoCyte was worth approximately $66 million as of yesterday. Our promissory note due to us from Juvenescence had an outstanding balance principle plus accrued interest of $22.5 million as of March 31, 2019. If Juvenescence completes an IPO with proceeds of at least $50 million prior to our note maturity, then the note will convert into Juvenescence stock.

The conversion is subject to an upward adjustment if the 20 day VWAP of AgeX stock is above $3. Based on yesterday's closing price, the 20-day VWAP of AgeX is $4.57. If the conversion were to take place now, the number of shares to be issued would be adjusted upward by roughly 52% and the shares at the time of issuance would be worth more than $32 million based on yesterday's closing price. If the promissory note is converted, our Juvenescence stock will be a marketable security that we may use to supplement our liquidity needs.

If the promissory note is not converted, it is payable in cash plus accrued interest at 7% per year, which will be about $24.6 million at maturity in August of 2020. We believe that Juvenescence is a creditworthy debtor, and we'll be able to service this payment. We also added new intangible assets to our balance sheet in the first quarter of 2019 due to the Asterias merger. The fair values of OPC1 and VAC2 were recorded as $31.7 million and $14.8 million respectively.

As I get ready to highlight the statement of operations, I'd like to remind everyone that beginning on August 30, 2018, BioTime's ceased recognizing revenues and expenses related to AgeX and its subsidiaries due to the AgeX deconsolidation on that date. Total revenues for the three months ended March 31, 2019, were $900,000, an increase of $200,000 compared to $700,000 for the same period in 2018. The increase was primarily related to a $400,000 increase in grant revenues, offset by a $200,000 reduction in subscription and advertisement revenues attributable to the AgeX deconsolidation in 2018. Total operating expenses, which comprised of research and development expenses and G&A expenses for the three-month ended March 31, 2019, were $13.6 million as reported and $7.9 million as adjusted.

In addition to stock-based compensation and depreciation in the amortization expense, there were also $3.5 million of Asterias merger transaction related costs that were excluded from total operating expenses as adjusted. The full reconciliation between GAAP and non-GAAP operating expenses by entity is provided in the financial tables included with our earnings release. Research and development expenses for the three months ended March 31, 2019, were $5 million, a decrease of $900,000 compared to $5.9 million for the same period in 2018. The decrease was primarily related to a $1.6 million decrease from the AgeX deconsolidation and the absence of AgeX research and development expenses incurred after August 30, 2018, offset by a net increase of $600,000 in BioTime programs, primarily related to an increase of $800,000 in OpRegen related expenses, an increase of $600,000 in OPC1 and VAC2 expenses, and a reduction of $800,000 in Renevia and Hystem expenses.

General and administrative expenses for the three months ended March 31, 2019, were $8.7 million, an increase of $2.7 million compared to $6 million for the same period in 2018. The increase was primarily attributable to increases of $3.5 million in severance, legal and related costs related to the Asterias merger and $500,000 in noncash stock-based compensation expense due to additional equity award grants. These increases were partially offset by a decrease of $1.3 million from the AgeX deconsolidation and the absence of AgeX general and administrative expenses incurred after August 30, 2018. Other income were expense nets for the three months ended March 31, 2019, reflected other income net of $47.7 million compared to other expense net of $51.5 million for the same period in 2018.

The increase was primarily related to changes in the value of equity investments in OncoCyte and Asterias for the applicable periods. The net income attributable to BioTime for the three months ended March 31, 2019, was $39.3 million or $0.30 per share, basic and diluted, compared to a net loss attributable to BioTime of $63.5 million or $0.50 per share, basic and diluted, for the same period in 2018. As we mentioned on our last earnings call in March, due to our extensive redundancy across our existing GMP facility in Jerusalem, and our recently acquired GMP facility in Fremont, we plan on realizing significant synergies from the Asterias merger. We are still in the process of transitioning manufacturing activities from Fremont to Jerusalem but the integration is going well and according to our timeline.

By June 30, we expect to complete our transfer of activities and a reduction of force of more than 85% of the Asterias employees as their roles and tasks are transferred to others at BioTime in the U.S. and Israel. In terms of guidance, we anticipate that our cash burn for 2019 will be in the range of $32 million to $34 million. We believe that our 2019 net expense budget will be in the range of $36 million to $38 million, excluding noncash items.

The difference of $4 million between our cash burn and the net expense budget is related to $2 million of net cash that was obtained from Asterias in the merger,as well as another $2 million collected from OncoCyte for prior-year shared services in February 2019. Our projected 2019 net expenses of $36 million to $38 million, despite absorbing one-time charges of more than $8 million related to the Asterias acquisition and the license of the Orbit device, are significantly less than the 2018 expenses of approximately $45 million for the combined companies. This extensive savings is attributable to the sale and distribution of our preclinical assets pertaining to AgeX, the consolidation of manufacturing efforts in Jerusalem and the new management team's commitment to substantial oversight of costs. In coordination with completing our integration of Asterias into BioTime, we are also evaluating the best course of action for bringing in additional capital to the company.

We are committed to making BioTime a premier cell therapy company and to improving our chances of success by ensuring it is well-funded. We currently have multiple funding options available to us. We can seek to leverage our investments in OncoCyte or AgeX. We can seek to leverage the promissory note due to us from Juvenescence.

As of March 31, 2019, the value of our cash, marketable securities, equity positions in our affiliate companies and the balance of the promissory note due to us in August of 2020 was worth more than $100 million. We understand that we need additional capital to progress our clinical stage programs, and we will seek to make the best move or combination of moves at the opportune time. With the changes made in the last eight months, we believe that we have stabilized the company's cost structure and are poised to capitalize on the three clinical stage assets that we are currently developing. We will also continue to evaluate funding and strategic alliance opportunities through our existing and future potential partners.

With that, I will turn the call back over to Brian.

Brian Culley -- Chief Executive Officer

All right, thanks Brandi. As you've seen, we have been rapidly transforming BioTime into a leading cell therapy company through strategic transactions on the Corporate Development, clinical and operational fronts, and we have no plans to slow our pace of progress. We will remain focused on advancing our clinical stage programs in a thoughtful and cost effective manner throughout 2019, and we'll update our investors on our timelines, achievements and regulatory plans. Some milestones to look forward to this year include the initiation of dosing with the Orbit device and a new thaw and inject formulation in our ongoing clinical study of OpRegen, which is expected this quarter.

A decision on BioTime's CE Mark application for Renevia, which is now expected also this quarter. Continuing the clinical advancement of the OPC1 program; including manufacturing improvements and our plans to meet with the FDA to discuss next steps in the clinical development of that program. Strengthening partnerships with CIRM and Cancer Research U.K. for the ongoing support of the OPC1 and VAC2 programs.

Additional milestones include completion of patient enrollment in our Phase I/IIa clinical study of OpRegen, which is anticipated by the end of this year. Evaluating the development of OPC1 as a candidate for multiple sclerosis and ischemic stroke through some ongoing research collaborations we have with major universities. And lastly, an increased presence and engagement with the patient, physician and advocacy communities. So to conclude, we believe that BioTime is heading in an exciting new direction and our goal is to build awareness and support for a reinvigorated and repositioned company.

This management team's priority and focus in 2019 will be to deliver on our stated milestones and continue to increase our visibility in the investment community through continuous communication and engagement. With that, operator, the team here is ready for questions.

Questions & Answers:


[Operator instructions] Our first question comes from the line of Kevin DeGeeter from Oppenheimer.

Kevin DeGeeter -- Oppenheimer and Company Inc. -- Analyst

With regard to the gating factors to enroll the next six patients for OpRegen, I mean, appreciate the granularity of calling out the protocol amendment for the Orbit device and thaw and inject, which of those is, sort of, appears to be the gating timeline factor to initiate them? And against that backdrop, can you kind of also provide us an updated thinking in terms of your expectation of whether DSMB would maybe comfortable allowing you to roll patients concurrently? Or will continue to seek full safety follow-up on these patients before enrolling the next patient?

Brian Culley -- Chief Executive Officer

Yes. Kevin, I think it's a good question for Gary Hogge, who runs that program. So if Gary, please.

Gary Hogge -- Senior Vice President of Clinical and Medical Affairs

Thanks, Kevin for the question. So the independent Data Safety Monitoring Board has already given approval to proceed with the protocol as it was submitted to the agency. Basically, that would involve a gating on the first two subjects, provided that goes well the DSMB is going to reconsider simultaneous open enrollment at that point provided things go well. And the FDA, we're waiting for the period of comment, no comment to expire.

Kevin DeGeeter -- Oppenheimer and Company Inc. -- Analyst

Great. And with regard to the amendment pertaining to the device versus thaw and inject, which -- how should we think about the steps or sort of each one of those to permit you to reinitiate dosing?

Brian Culley -- Chief Executive Officer

So the thaw and inject formulation has already been gone through the CMC amendment back in January timeframe to the FDA, and they had no objections to it at that time. So it's essentially, we've just added that to the Orbit device which again is 510 cleared already. So we don't anticipate, and again it's the same target population as was previously involved with the prior amendments and method of delivery. So it is our expectation that we shouldn't receive any objection.

Kevin DeGeeter -- Oppenheimer and Company Inc. -- Analyst

And one more question, if I may then I'll get back into queue and that pertains to OPC1. Appreciate the granularity in terms of how to think about a potential upcoming meeting with FDA. But I think you specifically called out endpoints in future studies that may confer or allow clear evaluation of clinical benefit in these patients. Can you expand on kind of your current thinking as to, which endpoint or what sort of general series of endpoints do you think ultimately are the most clinically actionable for these patients in quite limited current treatment options?

Brian Culley -- Chief Executive Officer

Yes. As you know there is no regulatory presence, there's no approved agent. So let that address the-Dr. Wirth, our CMO, will address the current state of affairs with respect to endpoints in spinal cord injury.

Edward Wirth -- Chief Medical Officer

Yes, thanks, Kevin, this is a great -- good question. So this is an area of very active research and development within the SCI community. Just within the past couple of years, there have been some important new outcome measures that we think will be potentially useful for demonstrating clinically meaningful function improvement with OPC1. So just to call it a couple, for example, one, is a new outcome measure that was published called the Capability of Upper Extremity Test, which allows functional assessment of the entire arm and hand, which would -- that would complement the motor recovery that we've been looking at previously.

Another one is a patient reported outcome that's been validated and published called the Spinal Cord Injury functional index, and again as a patient reported outcome by definition, we believe that that's a clinically meaningful improvement, if you see improvement on that as well. So these are a couple of things that would be incorporated into the protocol and the design of the next randomized study. So we're feeling pretty good about where the field is moving in this regard, and we will look at how those relapses occur in next study.


Our next question comes from the line of Jason McCarthy from Maxim Group.

Jason McCarthy -- Maxim Group -- Analyst

I'm going to stick with OPC -- the OPC1 program. First question is, you had mentioned that the two, I guess, worst performing patients in the Phase I/IIa study had postoperative compression. Is that something that you would look to possibly screen out in the next study -- in the next randomized study? Or could these patients potentially benefit from a higher dose of cell? And my next question is related to the OPC1 manufacturing. Now that you've brought everything in-house from Asterias, do you expect it to be a pretty seamless transition to the site -- manufacturing site in Israel?

Brian Culley -- Chief Executive Officer

Ed, why don't you do Part A, I can do part B.

Edward Wirth -- Chief Medical Officer

OK, thanks Brian, sounds good. Yes, with regard to the cord compression, it's almost certainly due, and again based on the MRI scans, to fluid that's commonly is found outside the spinal cord but under the skin after surgical procedures. This is common in virtually every surgical procedure. And the surgeons tend to manage it very differently and in talking with all of our surgeons, it's -- they almost unanimously agree that something like this could be pretty easily preventable in future trials, simply by requiring that all the surgeons insert a drain tube overnight after surgery to pull off that fluid that tends to accumulate soon afterward.

And in some cases that we've seen can potentially compress the spinal cord. So we think that that's a very straightforward and easily addressable issue in the future studies.

Brian Culley -- Chief Executive Officer

And then Jason, with respect to manufacturing, in fact, although, I would argue that tech transfer is never a simple process, the benefit, and one of the reasons that we did this acquisition, is that we have a highly skilled CM-cell therapy manufacturing team at our GMP facility in Israel. They have successfully demonstrated things such as moving from 2 dimensional growth on plates of plastic to growing cells reproducibly in multi-liter bioreactors. So those are the kinds of features and improvements and enhancements that we want to do with the OPC1 process as it stood when we got it from Asterias, and we want to get into the hands of our accomplished team, and introduce some of those, what I call pre-commercial attributes and then introduce that -- those improvements into an ongoing clinical trial.

Jason McCarthy -- Maxim Group -- Analyst

Last question. I know strategic focus is not Renevia, once you get the CE Mark, you mentioned that you would seek a partnership for commercialization in Europe, would you do that while retaining right to the U.S.? Or would U.S. rights go to a potential European partner as well?

Brian Culley -- Chief Executive Officer

The correct answer is, it depends. If there is an entity, which is interested in global rights and there's a fair price for that, then we're delighted to do that. If there's an entity that is only interested in regional -- limited regional rights such as Europe and the price is right, and we're open to that. I think what we would intend to do is take a very broad approach, a broad business development campaign and figure out what's out there for us and then try and choose the best deal for the company.


Our next question comes from the line of Reni Benjamin with Raymond James.

Reni Benjamin -- Raymond James -- Analyst

Maybe just on the thaw and inject formulation, can you talk a little bit about what sort of comparability tests were done? And have they -- have the cells been modified in any way to kind of make sure that what the data that we've seen so far and what we're going to get with this new formulation are going to be global?

Brian Culley -- Chief Executive Officer

Reni, I'll get back to Dr. Wirth.

Edward Wirth -- Chief Medical Officer

Yes, Reni, so the OpRegen is OpRegen. Essentially, thaw and inject simply means that the media in which it is frozen in, and it's an FDA-approved product using other cell therapy procedures that we're on clinical trials to date and we did extensive compatibility testing to show that it performs, as well as the previous version of OpRegen, which again the cells are unchanged, simply the way they are frozen down. And we've also completed all those compatibility tests with the Orbit device. Previously we administered them through -- called the torque.

So we're quite confident that the OpRegen is the same, it's simply the way it's frozen down and able to be delivered to the sites.

Reni Benjamin -- Raymond James -- Analyst

And just a follow-up regarding the Orbit device, is there any specific training or special training that needs to occur? Is that also a gating factor, not just to starting but then also to continue expand in those patients?

Edward Wirth -- Chief Medical Officer

Right. So the surgeons involved in the clinical study have all been trained, specifically by an Orbit training facility. So we're good to go from that perspective. We don't intend to involve additional sites at this time.

We think that the sites that are involved will complete the study within the timelines outlined. So we're good to go from that perspective. But yes, additional training is required but it is simply a one-day training that is relatively routine and the surgeons come out very enthusiastic about the use in which the cells are delivered.

Reni Benjamin -- Raymond James -- Analyst

And just one final question for me regarding Renevia and seeking potential external partnerships, have there been any discussions to date? Have there been any interest? And I guess if you could kind of characterize a what's likely, I'm imagining, could be a distribution type deal, what does the ideal deal look like?

Brian Culley -- Chief Executive Officer

I would, of course, want to do some form of an auction situation so we want to bring multiple parties to the table. It doesn't lend itself to a simple answer because it's going to be heavily dependent on the label. If it is a device that's limited to HIV lipoatrophy, it's got to very different look and feel than if it's more of a broad label. And we'll be interested in knowing what sort of capabilities and commitments to further studies that a potential partner would bring to the table.

So the process here, Ren, is to engage a European- based business development group or individual, have them do, I would call, a conventional process, bring opportunities to the table and let the organization negotiate those and try and find a deal that works well for them.


Thank you. And at this time this completes our Q&A session. And I would now like to turn the conference back over to Brian Colley, your CEO. Sir.

Brian Culley -- Chief Executive Officer

Great. Thanks I appreciate everyone joining us this afternoon. I'm obviously excited about our plans hope we'll keep this positive momentum going for a long time. Thank you and have a great afternoon/evening.


[Operator signoff]

Duration: 36 minutes

Call participants:

Ioana Hone -- Director of Investor Relations

Brian Culley -- Chief Executive Officer

Brandi Roberts -- Chief Financial Officer

Kevin DeGeeter -- Oppenheimer and Company Inc. -- Analyst

Gary Hogge -- Senior Vice President of Clinical and Medical Affairs

Edward Wirth -- Chief Medical Officer

Jason McCarthy -- Maxim Group -- Analyst

Reni Benjamin -- Raymond James -- Analyst

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