NEWS -- Edited Transcript of CYTX earnings conference call or presentation 1-Apr-19 12:30pm GMT
Thomson Reuters StreetEvents•April 7, 2019
Q4 2018 Cytori Therapeutics Inc Earnings Call
San Diego Apr 7, 2019 (Thomson StreetEvents) -- Edited Transcript of Cytori Therapeutics Inc earnings conference call or presentation Monday, April 1, 2019 at 12:30:00pm GMT
TEXT version of Transcript
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Corporate Participants
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* Gary S. Titus
Cytori Therapeutics, Inc. - CFO
* Marc H. Hedrick
Cytori Therapeutics, Inc. - CEO, President & Director
* Tiago M. Girão
Cytori Therapeutics, Inc. - Former CFO, Senior VP of Operations & Secretary
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Conference Call Participants
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* I-Eh Jen
Laidlaw & Company (UK) Ltd., Research Division - MD of Healthcare Research & Senior Biotechnology Analyst
* Jason Wesly McCarthy
Maxim Group LLC, Research Division - Senior MD
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Presentation
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Operator [1]
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Good afternoon, ladies and gentlemen. Welcome to the Cytori Therapeutics Fourth Quarter and Full Year 2018 Earnings Results Call. (Operator Instructions)
Before we begin, we want to advise you that over the course of the call and question-and-answer session, forward-looking statements will be made regarding events, trends, business prospects and financial performance, which may affect Cytori's future operating results and financial position.
All such statements are subject to risks and uncertainties, including the risks and uncertainties described under the Risk Factors section included in Cytori's annual results on Form 10-K and quarterly results on Form 10-Q filed with the Securities and Exchange Commission from time to time.
Cytori advises you to review these risk factors in considering such statements. Cytori assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.
It is my pleasure to turn the floor over to Dr. Marc Hedrick, Cytori's President and Chief Executive Officer. Sir, you may begin.
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Marc H. Hedrick, Cytori Therapeutics, Inc. - CEO, President & Director [2]
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Good morning, everyone. Thank you, Stephanie. Welcome to our fourth quarter and year-end 2018 earnings call. My name is Marc Hedrick, President and CEO of Cytori. And joining me on today's call is our incoming Chief Financial Officer, Gary Titus; and also here is our outgoing Chief Financial Officer, Tiago Girão.
On the call today, I'm pleased to be able to explain the corporate asset sale that was just reported this morning, the rationale for that particular transaction and the importance of the transaction to our ongoing pivot to become a leading clinical-stage oncology company. Thereafter, I'll provide an update on the progress of the company's clinical programs. Then Tiago and Gary will then update on the financial and commercial performance. After which, I'll update on forthcoming milestones, and then we'll have time for Q&A.
First of all, and most importantly, as I mentioned, the Cell Therapy asset sale reported this morning is an important next step in our goal to build a leading clinical-stage oncology company. The pivot really began based on our 2017 acquisition of then Azaya Therapeutics.
To briefly summarize the transaction, we divested a portion of the company's adipose Cell Therapy assets for $4 million upfront to one of the company's existing partners, Lorem Vascular, which is based in Melbourne, Australia. The asset sale included much of the Cell Therapy assets, intellectual property and know-how.
However, the transaction excludes all rights in the company's most valuable market, which is Japan. Also, the deal excludes rights to the existing BARDA contract, and Cytori will continue to maintain both of these key aspects of the business.
The company also retains substantial inventory to supply these 2 portions of the business, but then in the future, we'll obtain product via supply agreement executed with Lorem Vascular. The transaction is anticipated to close over the next month, following completion of the requisite closing conditions.
Now let me update you on our clinical program. We've made considerable progress in the last quarter in advancing our oncology pipeline. Since our last call, ATI-0918, our generic pegylated liposomal doxorubicin hydrochloride, has received its official invented name, which will be Doxorubicin Hydrochloride Cytori or let me use DHC for short. The intended use of DHC is for late-stage breast and ovarian cancer as well as Kaposi's sarcoma and multiple myeloma. Our initial target market is in Europe, with an estimated market opportunity of approximately $120 million annually.
Furthermore, in this past quarter, we've submitted an intent to file notification to the EMA, also European Medicines Agency, that we plan to file a marketing authorization application in approximately 7 months. Furthermore, beginning in Q1 2019 at our oncology manufacturing plant in Texas, we began producing the first registration lots, which continues to go on in that facility. So assuming our marketing authorization for Doxorubicin, or DHC, is approved on schedule, we have a target launch planned for late 2020, potentially in conjunction with a commercial partnership.
Now let me talk about the second drug for a moment. That drug is ATI-1123, which is a Phase II-ready, albumin-stabilized, pegylated liposomal docetaxel. As I mentioned on the last call, the protein stabilization enhances both the integration of the lipophilic API, which is docetaxel, and improves the stability of the liposome. Polyethylene glycol on the liposome surface extends the blood circulation time while reducing macrophage system uptake.
Cytori's developing ATI-1123 to provide key enhancements to existing formulations of docetaxel alone or docetaxel plus another entity. Specifically, we intend ATI-1123 to improve safety by removing the need for solvents, reduce the morbidity by eliminating requirement for standard pretreatment medications, provide better patient and provider convenience and comfort and also it requires or should require less patient time spent in the treatment center, which results in lower cost of therapy. Ultimately, we hope that enhanced systemic docetaxel exposure through ATI-1123 may have efficacy benefits as well.
Now previously, the company obtained Orphan Drug Designation from the FDA for small cell lung cancer. And currently, the company is working with Camargo, a regulatory consultant, which is a firm that specializes in 505(b)(2) application to update our active IND and seek the 505(b)(2) status and accelerated approval.
Beyond small cell lung cancer, the company intends to target additional indications as well with ATI-1123. We estimate providing further information on the 505(b)(2) applicability and the anticipated clinical program thereafter sometime in mid-2019, and our current plan is to move aggressively to develop this drug.
Now in terms of our Cell Therapy program and the leftover assets that stick with Cytori. First of all, in Japan, ADRESU, the pivotal stress urinary incontinence trial, should readout in Q2 of 2019. All patients have been treated, and the Last Patient Last Visit has been attained.
In our BARDA-funded Phase I thermal burn trial, the U.S. FDA allowed us to expand the enrollment criteria, which was received in Q1, that will enable us to better recruit patients to support enrollment. Those changes in concert should increase the relative patient population in this trial by three- to five-fold. In addition, the trial has been amended to evaluate the impact of treatment on the graft donor sites as well. And 7 sites are anticipated to be recruiting by the end of April.
So before I turn the call over to our new CFO, Gary Titus, I would like to take a moment to publicly acknowledge the contributions, hard work and dedication of our outgoing CFO, Tiago Girão. Tiago, thank you very much.
Now to Gary. Gary started officially as CFO today and already has a deal completed. Way to go, Gary. For the past 15-plus years, Gary has been CFO for mostly public biotechnology and health care companies. Most recently, he led the successful U.S. initial public offering on the NASDAQ exchange for UroGen.
Gary, welcome aboard.
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Gary S. Titus, Cytori Therapeutics, Inc. - CFO [3]
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Thanks, Marc. I'm pleased to be joining the Cytori team at a pivotal time for the company. It will be exciting times as we aggressively execute on our corporate goals in 2019. Our experience with development -- my experience with development stage, commercial stage and particularly, oncology-focused public companies has me well positioned to lead Cytori to the next level and beyond. We have a lot to accomplish this year, and I'm glad to have the opportunity to help Marc and the board during these challenging but exciting times. Finally, I would also like to reiterate Mark's comments on Tiago's contribution to the company, a truly outstanding effort.
Now for a final time, Tiago, please take us through the financials.
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Tiago M. Girão, Cytori Therapeutics, Inc. - Former CFO, Senior VP of Operations & Secretary [4]
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Thank you, Gary and Marc. Good morning, everyone.
Getting right to the numbers. Consistent with our guidance, 2018's operating cash burn was approximately $12 million compared to $18.1 million in 2017. Operating cash burn in Q4 totaled $2.5 million compared to $4.2 million in Q4 of 2017. The reduction in annual cash burn was mostly related to reductions in operating expenses.
Net losses totaled $2.2 million in Q4 2018 and includes a $600,000 credit related to the change in fair value of our warrant liabilities. This compares to $4.3 million net loss in the fourth quarter of 2017.
For the fiscal year 2018, net losses totaled $12.6 million and includes a $2.2 million credit related to the change in fair value of warrant liabilities. This compares to a net loss of $22.6 million for the same period in 2017. Note that net losses in 2017 include a noncash charge of $1.7 million recorded associated with new process R&D, part of the oncology asset acquisition.
On research and development expenses in Q4, our R&D expenses, excluding share-based compensation, were $2.3 million as compared to $2.4 million in fourth quarter of 2017. For fiscal 2018, R&D expenses were $8.6 million compared to $11.5 million in the same period in 2017. The decrease in R&D spending during both periods are attributed primarily due to the completion of the STAR clinical trial activities and efficiency improvements. While these reductions were partially offset by our investments in ATI-0918 manufacturing activities in San Antonio plant as well as our investments in the BARDA and RELIEF clinical trial.
Now on our sales and marketing. Our sales and marketing activities related expenses decreased this quarter to approximately $400,000 as compared to approximately $500,000 in Q4 2017. On the same basis, for the full fiscal 2018, our sales and marketing expenses were $1.9 million as compared to $3.5 million in expense in 2017. The decrease in sales and marketing expenses relates to a lower salary -- salary benefits as well as lower professional services associated with our HABEO precommercial activities in the U.S.
G&A expense, excluding share-based compensation, was $1.1 million in the fourth quarter of 2018 as compared to $1.5 million in Q4 '17. For fiscal '18, G&A expenses were $6.1 million as compared to $7.1 million in 2017, another great year of a double-digit decrease in G&A expense. The continuing tightening of G&A expenses was related principally to reductions in salaries and benefits resulting from our September 2017 restructuring as well as discretionary spend.
Now with respect to our revenues. Q4 total revenues were $2.1 million as compared to $1.5 million in Q4 a year ago. For fiscal 2018, total revenues were $6.7 million as compared to $6.4 million in 2017. Q4 and full year 2018 total revenues included a $1 million milestone received from our partner, Bimini, related to the achievement of certain gross profit levels of Puregraft sales.
Turning quickly to the balance sheet. At December 31, we had $5.3 million of cash and $13 million of debt. In December of 2018, we amended our debt with Oxford, providing additional flexibility by pushing out our interest-only period to today.
Now turning the call back to our new CFO and our continuing CEO, Marc Hedrick.
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Marc H. Hedrick, Cytori Therapeutics, Inc. - CEO, President & Director [5]
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Thank you, Tiago. Let me update you on our forthcoming milestones for the near future, and then we'll have time for Q&A.
So in terms of milestones. Number one, completion and filing of the company's first marketing authorization application with the EMA for DHC, Doxorubicin Hydrochloride Cytori; followed by then an anticipated commercialization time frame of approximately 2020 late in that year.
We intend to receive 505(b)(2) pathway feedback from the U.S. FDA for ATI-1123, anticipated in the first half of 2019. And then later in 2019, we intend to provide a clinical development road map, budget and time line for the drug. And then furthermore, we intend to reinitiate clinical trials soon thereafter. In Q2 2019, we also anticipate receiving a clinical data readout for our ADRESU pivotal SUI trial.
So thank you, and Stephanie, I'll turn the call back over to you for Q&A.
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Questions and Answers
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Operator [1]
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(Operator Instructions) Our first question comes from the line of Jason McCarthy with Maxim Group.
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Jason Wesly McCarthy, Maxim Group LLC, Research Division - Senior MD [2]
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So first, I'd just like to see if you could discuss what you see as the major growth drivers for the Celution System. Particularly, what factors could drive increased consumables utilization? And then also, have you seen any impact from the Class III Medical Device Designation you announced earlier this year? Or is that more of a 2019 going-forward story?
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Marc H. Hedrick, Cytori Therapeutics, Inc. - CEO, President & Director [3]
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Jason, it's Marc. Thank you. On the consumables, okay, going back to the Regenerative Medicine approval of late 2015, if you look at quarter-over-quarter consumable utilization, we see steady double-digit annual growth, almost quarter-over-quarter with some lumpiness but essentially, quarter-over-quarter. So that's been driven by nonapproved, nonreimbursed sales. So there's not specific indication, except through the current Regenerative Medicine Law. So the thing that particularly will likely drive growth is, hopefully, the clinical trial called ADRESU, the SUI trial is positive, hits its primarily endpoints. That should potentially be a reimbursable indication. And so I think that will be the next near-term growth driver. And as I mentioned, that trial readout is Q2, Jason, our current time line. On the Class III approval, so we've been negotiating with the Japanese government for some time as to the proper regulatory path. Prior to this, it was as a Class I device. So they simply up-classified this to be more on the same plane as dialysis units that have a higher degree of oversight regulation. So what it doesn't do is really drive the market, but it puts us in a premium position in the market. It says that this device operates in a plane consistent with dialysis machines and so forth and, really tends not to only help us, but it tends to make it more difficult for competitors to come into the market.
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Tiago M. Girão, Cytori Therapeutics, Inc. - Former CFO, Senior VP of Operations & Secretary [4]
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Just to clarify one point, Jason, that Marc indicated, we -- our sales in Japan, they are approved initially through a Class I device process. Then, after that, with the new Regenerative Medicine Law, and what I think what Marc is or was trying to indicate, was that they are nonreimbursed. As you well know, the true drivers of sales in Japan are on the aesthetics as well as the OA field, both of which the clinic that treat patients are fully approved under the new Regenerative Medicine Law. I just wanted to make that specific clarification for the record.
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Jason Wesly McCarthy, Maxim Group LLC, Research Division - Senior MD [5]
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And then I just have another one on the docetaxel in the U.S. So are there any areas where you could see liposomal docetaxel having a particular advantage? Or is it more of an improvement across the board? And then, when you're seeking approval, would approval be indication-specific with additional trials to expand the label? Or would it be more of a blanket approval and pretty much anywhere where you can use docetaxel?
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Marc H. Hedrick, Cytori Therapeutics, Inc. - CEO, President & Director [6]
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So Jason, on the question of the ATI-1123, the liposomal docetaxel. So the best data we have is the Phase I trial, and it shows particular efficacy or tumor reduction in patients that have pancreatic cancer and lung cancer. And as we've just recently completed an exhaustive analysis of the market opportunity for this indication, and we believe that small -- second-line therapy for small cell lung cancer is a niche that could provide potentially accelerated development. But we also think, potentially, as a first-line therapy for small cell as well as pancreatic cancer and several other oncology opportunities are possible clinical targets for that drug. So as I mentioned, I don't want to get out there prematurely with what our clinical development plans because there are other inputs to that. But those are -- those indications I just mentioned are consistent with what we saw in the Phase I and consistent with where we think the market opportunities are. And to your basic question, we think that there are a number of indications where an approved version of docetaxel can make an impact in the market.
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Jason Wesly McCarthy, Maxim Group LLC, Research Division - Senior MD [7]
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And for Gary, congratulations, and for Tiago, best of luck with everything going forward.
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Gary S. Titus, Cytori Therapeutics, Inc. - CFO [8]
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Thank you.
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Tiago M. Girão, Cytori Therapeutics, Inc. - Former CFO, Senior VP of Operations & Secretary [9]
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Thanks.
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Operator [10]
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(Operator Instructions) Our next question comes from the line of I-Eh Jen with Laidlaw & Company.
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I-Eh Jen, Laidlaw & Company (UK) Ltd., Research Division - MD of Healthcare Research & Senior Biotechnology Analyst [11]
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First, Tiago, great job. And second, for Gary, congrats for joining the team, a great team. Just a few couple of quick questions here. The first one is for the divestiture to Lorem. Could you be a little bit more specific in terms of what assets to be sold to them versus the things you will retain? I know there's the things in Japan that you'll retain, but any more specific in other geographic areas? Or any colors on that?
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Marc H. Hedrick, Cytori Therapeutics, Inc. - CEO, President & Director [12]
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Yale, yes, it's Marc. I'll take a crack at that, and Tiago can come in and correct me afterwards if I miss something. So it's easier to back into that than it is to hit it head on. So well, from a Cell Therapy perspective, what was not included were all of the capabilities to operate the business in Japan. And by that, I mean IP, trademarks, hard assets, leases, inventory, technology transfer rights, manufacturing rights, regulatory and clinical data. So that was excluded from this asset sale, all the things that Japan needs. The other thing that was excluded is the BARDA contract. So everything needed to operate and maintain that BARDA contract, the appropriate rights, supply of product and so forth, all are retained by the now Cytori. So then kind of flip that, Lorem Vascular receives the rights in those territories that they don't already have, that are not represented by BARDA and by Japan. It includes hard assets with raw materials, IP, trademark, access and leases to 2 facilities. So they have everything they need to bring manufacturing to their existing territories but also to serve the market fully in the U.S., Europe and other markets that they license as part of the transaction. Does that help clarify things for you, Yale?
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I-Eh Jen, Laidlaw & Company (UK) Ltd., Research Division - MD of Healthcare Research & Senior Biotechnology Analyst [13]
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Yes, that's very helpful. I appreciate that. And the next question is for the docetaxel in the U.S. I appreciate that you mentioned some of the things that you want to do before you provide more color to The Street. But what's the sort of market potential you think that realistically represents for the U.S. market?
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Marc H. Hedrick, Cytori Therapeutics, Inc. - CEO, President & Director [14]
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Well, I think as we've said before and we still believe, that there's a very acceptable niche market for the second-line drug for small cell lung cancer. Topotecan has a number of drawbacks, which is the only approved second-line therapeutic for that indication in the U.S. That's about a $75 million a year market, and we think there's an opportunity to take a sizable share of that market. It potentially is a first-line therapy. There's kind of a similar but, potentially, greater opportunity. And in pancreatic cancer, as you know, is a significant unmet medical need, it's where we saw a lot of potential efficacy signals and the Phase I trial in an area where we think pricing and adoption could be favorable if the drug is safe and effective. So there are a number of other small and niche opportunities for this drug. We're going to be very cautious about which indications we go forward first. And our plan at this point is to do one trial, get on the market and then expand the indications going forward. And the 505(b)(2) pathway with accelerated approval allows us to potentially do that.
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I-Eh Jen, Laidlaw & Company (UK) Ltd., Research Division - MD of Healthcare Research & Senior Biotechnology Analyst [15]
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Okay, great. That's very helpful. And maybe the last question here is for the doxorubicin labels for the doxorubicin in Europe. You mentioned that you're going to do potentially file in late '19 or early 2020. I would just like to know what are the sort of gating factors at this point or things to do before you get to the filing? Was there any specifically related to stability or other aspects?
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Marc H. Hedrick, Cytori Therapeutics, Inc. - CEO, President & Director [16]
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Yale, yes, so just for -- so everyone is on the same page, so we're talking about what we call DHC, which is Doxorubicin Hydrochloride Cytori, which is a liposomal version of doxorubicin that's already completed its bioequivalency trial against Caelyx in Europe. So a key milestone for us was announced a few weeks ago, which is submitting our intent to file with the EMA. So for generics or biosimilars like this is, once you're thinking about 7 months away from applying with your MAA, you need to warn the EMA that you're going to draw this over [to transfer.] So that was a key milestone because we felt like we were able to manufacture the drug, that it is likely to be nonclinically equivalent to Caelyx and that we're ready to begin manufacturing stability lots, which is where we are right now. So as you mentioned and as you asked about what's required going forward, stability lot manufacturer, putting those on the shelf and getting 6 months of stability testing, that's hopefully positive. We have some in vitro comparability testing against Caelyx as well as some cleanup, preclinical work under GCP to basically confirm what's already been done but put it in an appropriate format for an EMA MAA. So those are all things that will be going on in this approximately 7-month window between intent to file and actually filing. And then finally, once we file, we'll have a pretty good idea at that point whether we think we're approvable, then we likely will need another 6 months of stability testing, then to submit with that, that file to ultimately obtain approval.
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Operator [17]
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There are no additional questions at this time. I would like to turn it back over to Dr. Hedrick for closing remarks.
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Marc H. Hedrick, Cytori Therapeutics, Inc. - CEO, President & Director [18]
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Thanks a lot, Stephanie. It's obviously an exciting, challenging time for the company as we complete this key pivot with the goal of becoming a leading clinical-stage oncology company. We're trying to best leverage both our current oncology assets, even as we assess potential new additions to our pipeline.
As always, I just want to thank the employees, the doctors that continue to work with us, our customers, our partners, such as BARDA, and thank you for participating in this call. Please have a good day.
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Operator [19]
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Thank you. This does conclude today's conference call. Please disconnect your lines at this time, and have a wonderful day.
