Q4 2019 Earnings Call

Good afternoon, everyone and welcome to he loves Pharmaceuticals fourth quarter and full year 2019 earnings webcast and conference call. Today's call is being recorded at this time it would like to turn the call over time.

Barbara Ryan you Lux Investor Relations. Please begin.

Thank you Gigi welcome and thank you for joining US. This afternoon for a review of he likes pharmaceuticals fourth quarter and full year 2019 financial result, and business update joining me. This afternoon are Dr., Greg Williams, Chief Executive Officer, Neil fell off Chief operating officer in General Counsel.

So Tom Havard Dr., Tom Haverty, our Chief Medical Officer, Dr. math, you get there our VP of research and Steven Mcdonald, Our Vice President Finance and accounting.

Before we begin I would like to remind you that any statements made during this call that are not historical are considered to be forward looking statements within the meaning of the private Securities Litigation Reform Act up 1995 actual results may differ materially from those indicated by these statements as a result of various important factors, including those.

The stuff and the risk factor section in our most recent annual report on form 10-K filed with the Securities and Exchange Commission and our other reports filed with the FCC.

Any forward looking statements represent our views as of today March 5th Twentytwenty only a replay of this call will be available on the company's website Www Dot you lock pharma dotcom. Following this call. It. It's now my pleasure to turn call over to Dr., Greg Williams Chief Executive.

Officer.

Thank you Barbara and welcome to he walks is fourth quarter and for your 2019 earnings webcast and conference call.

2020 will be a very important here for you logs as we continue to advance our clinical and scientific programs for LCR as she library and report fees to talk one concept data from our cystic fibrosis clinical trial program, which we believe will be a substantial value inflection point for the company.

Last week, we announced the leadership and organizational realignment to ensure that the company has a cash one wave two years with sufficient capital to run through the end of 2021.

These actions strengthen our commitment to cystic fibrosis for ensuring that we have the right resources and the strategic flexibility to accomplish our key priority, which is to deliver tough one phase two proof of concept theater free alike. So too in cystic fibrosis in the first half of 20 Twond.

We will also continue with enabling work in water, so dominant polycystic kidney disease for E. D. P D and inherited retinal disorders.

We continue to be focused on delivering value to shareholders well fulfilling our mission to provide treatment options to patients with high unmet medical needs in the most safe an expeditious manner.

In a plan succession I've been appointed Chief Executive Officer, and I'm thrilled to have the opportunity to lead the company at this critical time as we advance the phase two development program for elixir too in cystic fibrosis.

Her well, we're continuing to develop other compounds for Merrell Youre as she library.

With me and inherited retinal diseases.

He assured that we have a strong an experienced team with expertise in clinical drug development basic research and regulatory affairs.

I'm highly confident that we have the capabilities and the resources needed to deliver on hurdles.

Personally led the development of multiple drugs. The most recent of which is close which is now the number one prescribed anabolic postmenopausal osteoporosis.

I'd like to express the company's in my personal gratitude to Bob Ward and the other departing employees, who have enabled the company to advance to this stage.

In cystic fibrosis, we were committed to ensuring full enrollment or they used to see of clinical trials and reporting tough one proof of concept theater in first half of this year.

We're extremely pleased that we're conducting these trials the top see of clinical trial sites.

In fact, the express level of interest and support for our cystic fibrosis program from top investigators trial sites and patient advocacy groups has been tremendous.

A recent discussion with members of our CFO programmed advisory group, we had the opportunity to share the positive results of the completed first cohort of our phase two clinical trial for ILEC, So to endeavor Patrick Cystinosis.

They view the safety and efficacy data is very exciting for Cystinosis patients. We're pleased that we met the primary safety endpoints.

Together with the support of pharmacokinetics and this trial. These data further de risk our phase to see a program.

We expect that there'll be a steady cadence of additional data scientific presentations and publications as we move through this year.

We will be presenting data from our inherited retinal disorders program and our ROE me third through the settlement. We're pleased that our scientific presentations on our phase two clinical trial for helix. So too has been accepted for presentation at the European Cystic fibrosis conference in early June it will be part of a workshop titled beyond launch.

Leaders approaches involving gene editing and alternative channels.

We also plan to present data for you know look so two in cystic fibrosis up in North American cystic fibrosis Cofunds in late October.

Our CFO phase two program consists of two open label trial, one for clinical investigators enrolling patients that sites in Europe in Israel. The second phase two trial focuses on sites in the United States.

The expansion of our CFO program to the U.S. has been made possible in part by funding provided by the cystic fibrosis Foundation and the door Smith of our protocol by the therapeutic development network in Europe or protocols that endorsed by the European Cystic fibrosis Society clinical trial network.

Neuropathic Cystinosis.

We reported positive phase two top line data for election to from the completed first cohort of study E Mail 003.

This study met the primary safety endpoints and the reductions in white blood cell assisting provide a clear indication of biologic activity in these patients at nominal doses greater than 0.5 milligrams per kilogram per day.

The pharmacokinetics if you look so to administered were consistent with those expected based on the prior said, Matt and real studies.

The emerging profiles imports continue development in this dose range.

In this study it looks or two was generally well tolerated with no debts for toxicity, odder toxicity or serious adverse events potentially related ilecs of too.

Following completion of the first cohort the independent Safety Review Committee met to review, the pharmacokinetic and safety results and approved progressing to the second cohort that would enable enrolling patients ages 12 and older.

We believed that the clear indication biologic activity provides human proof of concept for Elixa to India risks other clinical applications of our ERP as cheese library.

However, due to study design limitations patients across all drugs groups had elevated and uncontrolled pre treatment white blood cells is teaming levels, which made it difficult to fully evaluate ILEC so to mediated white blood cell 15 reductions.

Therefore, we have discontinued the study that will not proceed with the second cohort as contemplated in the original protocol.

We are continuing to review these data with appealed scientific and clinical experts to determine appropriate modifications for possible New study design.

Last quarter, you Lux team presented new positive scientific data during the American Society of Nephrology kidney week from our completed renal impairment study, which supports the expansion of our research in the kidney beyond never pelvic cystinosis into other areas such as 80 PK do.

The data also provides modeling necessary for dose adjustments based on renal function.

Our screening programs continue to evaluate opportunities to dance helix into for new indications or other novel molecules from FBR as Chief Library.

We continue to advance our work in ophthalmology and our team achieved an important proof of concept milestone demonstrating that our ers GE compounds can restore protein production, India I wouldnt injected intravitreal leap in animal model.

We will build on this milestone with our ongoing formulation efforts to sustain compound exposure across longer treatment periods.

We are evaluating washer syndrome, and other disorders of the photo receptors or RP recently, demonstrating read through of the most common nonsense Elliot for the Sep 290, Mio Seveneight NPD six be genes.

We believe that the encouraging results from our ongoing Cystinosis study support expanding our research and that could be into diseases, such as 80, PKD, where there's a high prevalence of nonsense mutation patients.

We are the most advanced company tackling the great challenge of developing new potential therapies for nonsense mutations there was a high level of interest and enthusiasm in the scientific and clinical community for programs as well as in the business community.

We remain actively engaged in pursuing strategic business relationships to expand our therapeutic footprint and accelerate our progress.

We ended 2019 with 56.3 million cash and cash equivalents.

The realignment of our resources, we've extended our cash runway to two years, which will take us through the end of 2021.

We are well funded to advance our clinical programs to deliver top line data for electro two in cystic fibrosis into events, the preclinical activities free elixir too and our library of molecules in additional indications.

I'd now like to introduce Dr., Tom Haverty, our Chief Medical Officer, who will provide you with a further updates on our phase two programs and discuss the advances in our work in genetic kidney disease.

Thank you Greg as you know our CFO phase two program. Currently consists of two trials one in Europe in Israel and the second in the U.S., There's a high level of interest and support for these trials both in the U.S. and globally.

Professor eight Concord M. M D headed their vision of Pediatrics Children's Hospital adopts a medical center in Israel is a global lead investigator our phase two protocol have been given a high priority ranking by the European Cystic fibrosis Society clinical trial network in the U.S. Dr. Ahmet EULAR director of the adult fist.

Rick Fibrosis program at the Boston Children's Hospital, Brigham and Women's CF Center is the lead investigator.

We're very pleased with the high quality of the clinical sites, we are working with and appreciate the CF, providing financial support for a portion of this trial. These are open label studies and we expect to report topline phase two proof of concept data in the first half of this year, we expect to present data for Ilecs.

Oh two in cystic fibrosis later this year at the European Cystic fibrosis conference in June and the North American Cystic fibrosis conference in late October.

And never perfect Cystinosis as Greg described the first cohort of our phase two study met its primary safety endpoint and provided proof of biologic activity along with the anticipated pharmacokinetic results.

These positive results along with the results of our renal impairment study provide a basis for expansion to studies of additional kidney diseases caused by nonsense mutations one such genetic kidney disease is 80, PKD, which is a relatively common inherited genetic kidney disease.

Occurring in between one in 401 in a thousand patients affecting 300000 to 600000 individual patients in the U.S. alone as a fourth leading cause of end stage renal disease in the United States.

Over 25% of the primary genetic changes that caused 80, PKD, our nonsense mutations where premature stop code on in the gene leads to it truncated often unstable protein.

I would like now to turn the call over to Dr., Matt Good Doris who will provide updates on our ongoing work and 80 PKD and additional development program.

Thank you Tom.

Our preclinical efforts in Reno and Okcular continue to advance our team focuses on applying our understanding of read through to the unique genetics of each disease and evaluating efficacy with a focus on protein function using assays versatile enough to enable our personalized medicine approach.

As described by the to hit hypothesis. Most individuals with 80 PKD are born with a single defective copy of either PKD, one or the PKD to gene.

For the disease. This is the primary genetic mutation or hit.

In the kidney sporadic second hit will trigger CES formation throughout life, leading ATP, Katy and potentially end stage renal disease.

We are focused on those individuals whose primary hit is a nonsense o'neil.

Using a reporter assay, we have already observed dose dependent read through with our ers cheese across the most common PKD one the wheels and an expanded our studies to include PKD too.

We are now applying this information to our functional model effort in order to confirm that the read through we observed has the and impact on CES formation and growth.

Our cystic fibrosis platform has highlighted utility of organizing technology to assess function in a translational model.

Similarly for 80, PK D., we're going to avoid stride from patient cells or induced pluripotent stem cells can be differentiated in a manner that recapitulates the cellular diversity of the kidney and generates the CES characteristic of the disease state.

As part of this effort we are excited to be working with Dr. Benjamin Friedman of the University of Washington, pioneering 80, PKD organization technology on this program.

We intend to evaluate additional cellular and or animal models of 80, Piquet D and with positive results advance toward dine de submission.

We're pleased to report on the advances of the hit CF program in Europe.

Last year, we joined the hits yet.

Hits CF consortium to support the collection of cystic fibrosis patient derived organization and the initiative to conduct a prospective clinical trial to confirm the translational potential of the organization model.

It's CF recently announced completion of the first phase of the effort collection of organizations from patients at 47 of the biggest CF centers in 16 countries throughout Europe.

This collection included Oregon to lights from over 100 individuals bearing rare nonsense mutations in the CF TR gene.

Hit CF is now testing the organizations for elect so Q responsiveness in the laboratory.

The first dataset evaluating he'll ekso too in 31 patient derived organovo examples demonstrate activity in a majority of the nonsense organization.

The intend to the program is to use these positive results to enroll those individuals with responsive organization in a prospective clinical trial with elect so too.

We believe this program will continue to expand the application of organ only technology from drug discovery through drug approval.

Indeed, Eddie locks, we continue to use the technology to identify the most responsible deals for inclusion in future clinical trials recently identifying a nonce until the deal in which elect so to increase the CF TR function in Oregon lights to levels over two fold greater than that observed for some of the most responsible deals such as.

Oh Gee five four culex.

We are committed to progress elect so two down the development path to provide potential treatment options to the CF population with unmet medical need.

Turning to inherited retinal disorders as we previously reported library compounds have demonstrated dose dependent read through using our in vitro as a platform acceptable intravitreal tolerability and achieved an important preclinical milestones demonstrating restored protein production in an animal model.

Ers G intravitreal injection.

We conducted studies in a mouse model with a naturally occurring nonsense mutation in the.

Two team.

Which results in a form of albinism, president and human type two akio Kid cutaneous albinism.

In this model the our 262 X mutation results in a lack of CA to channel protein, which is needed to establish the ph in the organelle that produces pigment.

In the Lannett, though.

Some of these results will.

He presented at ARVO dismay.

When this tissue exposure data is coupled with our ongoing sustained release formulation efforts and the read through potential we observe against nonsense mutations in disease causative jeans, such as us to a mile seven a set to 90 NTT east fixed fee. We are encouraged that the intravitreal ers.

Gee approach could provide restoration of critical protein to preserve or restore visual function across nonsense related inherited retinal disorders.

I would now like to ask Steve Mcdonald, our VP of finance and accounting to provide a review of our full year financial results for 2019.

Thanks, Matt.

As of December 31, 2019, the company reported total cash, including cash equivalents and marketable securities a $56.3 million, which we believe will fund the company's operations through topline data in cystic fibrosis and through the end of 2021.

For the quarter ended December 31, the company incurred a net loss of 11.6 million or 29 cents per share as compared to a net loss of $14 million or 40 cents per share for the same period in 2018.

As we have shared one of our key accomplishments in the third quarter of last year was entering into our agreement with the cystic fibrosis Foundation, who will provide up to 1.6 million in funding contributing towards our U.S phase two cystic fibrosis study.

In Q4, we received the first payment of 400000 and in Q1 of 2020, we received the second 400000.

In the fourth quarter noncash stock compensation expense totaled $2.7 million.

With 2.2 million allocated to Ginny and point 5 million to R&D.

Fourth quarter 2019, R&D expense totaled 5.7 million compared to 6.5 million for the same period in 2018.

The quarter to quarter R&D expense decrease was driven by the timing of significant activities in our phase two clinical trials, along with preclinical on CMC costs and lower noncash stock compensation.

DNA expense for the fourth quarter of 2019.

It was $5.8 million a decrease from 7.6 million for the same period in 2018.

Moving to the full year numbers.

The company incurred a net loss of 50.9 million or $1.34 cents per share as compared to a net loss of 47.2 million or $1.45 cents per share for 2018.

The 3.7 million increase in net loss was driven primarily by higher R&D expenses, while DNA expenses declined.

Noncash stock compensation expense for the full year 2019 was 11.3 million with 8.9 million per quarter to DNA and 2.5 million to R&D.

Full year R&D expenses totaled 25.8 million compared to 20.5 million for 2018, an increase of 5.3 million.

The year over year, R&D increase was driven primarily by increases in salaries and other personnel costs.

And in expenses related to our phase two clinical trials, along with expanded preclinical operations.

Full year DNA expense totaled 24.7 million compared to 26.5 million for 2018, a decrease of 1.8 million.

The decrease was primarily related to lower noncash stock based compensation and a decrease in infrastructure related costs, partly offset by increases in salaries and other personnel related costs.

Given the realignment announced last week, we would like to provide you with some guidance for our cash burn in 2020 and 2021 to assist you as you were requires revised remodels.

We are taking a onetime charge in Q1 of 2020 estimated at 1.7 million primarily for severance costs.

We expect that our quarterly cash burn will decline sequentially as we move through the year to reflect the company's reduced head count elimination of non priority program spending and targeted efficiencies.

Therefore, while the majority of cost savings will fall in DNA, there will be some reduction in our R&D spending.

We expect that our cash burn rate will reach any deer in the fourth quarter of 2020 and remain fairly stable throughout 2021.

Also for your modeling purposes, our total shares of common stock outstanding as of December 31, 2019 were 40.031 million.

This concludes the fourth quarter and full year financial comments and I'll turn the call back to Greg.

Thank you Steve.

2020 will be an important year free logs as we expect to report topline data from our phase two proof of concept clinical trials in cystic fibrosis in the first half of this year, which we believe will be a major value inflection point for the company.

I'm extremely excited to be leaving the company at this time is highly confident that we have the right team with the necessary experience as well as these strategic flexibility to achieve our goals.

Beyond cystic fibrosis, we continue to advance our portfolio of no RSP molecules. We believed several of these compounds demonstrates encouraging levels of read through activity and preliminary tolerability data supporting their potential therapeutic development.

We expect to report scientific data on our inherited retinal disorders program at our vote in early may in an abstract on the ILEC. So too has been accepted for presentation at the European Cystic fibrosis Conference in June. We also expect to report data on ILEC, So to the North American cystic fibrosis conference in late October.

We thank you for joining us on our fourth quarter and full year 2019 earnings call and we look forward to continuing to update you on our progress. Thank you very much.

Operator, you May now open up the call for questions.

As a reminder to ask a question you will need to press star one on your telephone to withdraw your question press the pound key please standby well, we compiled the Q and a roster.

Our first question comes from the line Joel Beatty from Citi. Your line is now fan.

Hi, Thanks for taking the questions.

First one is could you compare and contrast.

For charity and cystic fibrosis.

This is cystinosis and help explain the confidence and moving ahead in cystic fibrosis, while it seems that assisting us with this program as discontinued.

Sure Joel so thank you for the call.

This is Greg.

There's a much larger commercial opportunity for cystic fibrosis, I'm not going to give you. The the all the numbers, but no up to about 10% of CF patients have disease due to nonsense mutations and we would potentially be integrate position to be able to help those patients income.

Stress there was a comparatively small number of patients with cystinosis due to nonsense mutations.

That number isn't the range of maybe 30 patients in North America. So it's a comparatively small group is much smaller than CF. Our interest in Cystinosis is certainly in terms of trying to help those patients.

And.

We also thought that by working Cystinosis it would be it would be.

A great path to get us to proof of concept the issues with the Cystinosis trial related to study design and in those patients as we discussed during the call.

There was a significant reduction in the second treatment group and White blood cell 16, we did meet the primary safety endpoint, but because of the design to the trial. There was some drift in their baseline white blood cells cystine results, where the numbers were really quite high and they were quite uneven.

Prior to treatment and it made difficult to fully interpret those results in contrast, with cystic fibrosis. The baseline levels for sweat chloride are pretty consistent overtime in the absence of treatment. There is no variation up.

Down we don't expect the same kind of issue with cystic fibrosis.

The great news about the Cystinosis trial is that we did see clear signs of biologic activity and this helps us to know that we were on the right range. When we were evaluating a similar dose range and similar concentrations for cystic fibrosis.

Great. Thanks for the explanation maybe another question on the organize data for cystic fibrosis.

Sorry, just a few fantastic growing collection of organized it's Tom could you could you talk about how the data and organize to look for the patients who carry that mutation that you're sitting in your trial that was shot if I remember right as the Gi side for two expectation and compare that with how the data looks and.

Other organize that our other nonsense mutation. So we're just other mutations, causing cystic fibrosis.

This is Matt Kundera US great question, so for cheap by 40 wax, which is the most common nonsense mutation cystic fibrosis youre going to way to response has been.

Fairly high so compared to.

Organized responses of approved drugs and known genotypes. We've got a response that we think is equivalent to that and should.

Provide us with translational data to the study results were really encouraged by those results.

But the question about what about other nonsense allow wills and testing it wasn't organized we see a range of responses. So some are organization with a nonsense O'neil.

Have.

Lets response and that of GE by four two x. and we've encountered a fuel deals that are actually greater than that of GE Pipework qx. What we do it is take that data in helping us prioritize those deals that we can go to after this initial study of GBP 40 wax.

Great and then one last question.

Tell us about what.

I'm, sorry that you'll be assessing and phase two trial with a data reading out in the first half of this year end and what you'd like to see to assess your decision to whether to move forward.

Right. So for the cystic fibrosis trials. The primary endpoint is safety, we will also be evaluating pharmacokinetics and the primary pharmacodynamic marker that we'll be looking at is reduction in sweat chloride we would.

If we had.

Our response of a reduction of maybe 10 it would be in the range of showing some biologic activity. If we showed a reduction in the range of 50 or 60 being much more dramatic response that would be something that would be.

More consistent with some of the vertex compounds somewhere in between would also be a favorable response relative to what those patients have available today. So those would be the key endpoints, we'd be looking for all different aspects of safety.

It would be looking at pharmacokinetics, we'd be looking at.

Sweat chloride as an indicator of pharmacodynamics and its well known that while we bloods excuse me while sweat chloride.

Doesn't correlate with patients on a one to one basis for VB, one as a population of correlates very well and that would give us pretty good confidence of going forward into a phase three trial.

Great. Thank you.

Welcome.

Thank you. Our next question comes from the line of Michelle Gilson from Canaccord. Your line is now open.

Hi. Thank you this is lean I hear from Michelle.

So maybe you can just remind us about that trial design and since this trial is if theres any difference between the two trials and how should the trial design cannot clearly demonstrate effect for XL too.

I think cleanliness good to talk with you again, so the phase two trials in the U.S. as well as in Europe in Israel.

I have four different treatment groups.

The first treatment group starts at 0.3 milligrams per kilogram per day, the top dose the maximum dose would be three milligrams per kilogram per day. The first doses for one week. The second doses for one week. The third dose is for one week and then the final top dose would be two weeks of exposure.

The trials are identical in terms of dose duration end points and key evaluations. There's some small differences relating to the different regions in which the trials are being conducted but the just the trials were designed so that the data could be fully integrated and ultimately will end up with it.

Lee dataset that comprises both.

Both sets of patients both in Europe and Israel.

And in the U.S.

Once again.

As we discussed with Joel.

Key endpoint the primary endpoint to safety, but we're also looking at pharmacokinetics and we're also looking at.

At the reduction in sweat chloride as the key pharmacodynamic marker as an indicator of efficacy.

Got it thank you and congrats on the corridor.

Thank you.

Our next question comes from the Lions, Ted Tenthoff from Piper Sandler airline is now open.

Great. Thank you come a trivial, but I'm really looking forward to data. This year you had one quick question.

This is Stuart touched her cargos quick.

We cyclical peak.

Since were recruited to get more see if youre.

Sure the curve so purpose membrane.

Even though traditionally these patients would not be amenable to a potentiator is or potential use co. Two in combination with competitors or is that something that can be explore via the order noise and then potentially crude.

Got it thanks somewhat score.

Considering that.

Thank you Ted that is a great question and yes.

With any available CF TR, it's possible that.

Additive therapy with a potentiator could make a big difference we've actually looked at this in a number of different models, including humor brought at the fuel cells as well as we're going to once we've seen increased responses when those compounds are used together.

Not a surprise at all is something that could be evaluated down the road, yes, it could be.

That said, we think it's really important to get our phase two data, where we can really understands the potential benefits and safety profile. If you spoke to in these patients.

And then depending upon what we see.

There may be no need for any concurrent medication.

Or we might want to think about some other combination therapy.

That makes a lot of sense.

So something as considering it.

And whats called exit looking forward to more data thanks much.

Okay.

Thank you. Our next question comes from the line of Hong from Janney. Your line is now open.

Hi, Thanks for taking questions. So the first one is a follow up question about the design of the.

Cystic fibrosis study.

Are those different dose.

Separated by was help herein.

Thank you Jim Yes.

Yes, there is a wash out there was a wash out between doses and during that period, we are assisting assessing safety.

We're collecting pharmacokinetic data and then there is a safety review committee that we'll evaluate did a prior to enabling patients to escalate to the next steps.

Okay and then.

So are you want to share any information regarding your plan after the topline data readouts, assuming the data is positive supporting continued development for the program.

Well sure after after we get our phase two data. The next step would be for us to talk with health authorities to gain alignment on what the next steps would be going forwards and then we would start to plan our phase three program.

Does the cash guidance and.

Include that activity.

Im sorry, one more time please.

Sorry does the guidance on operating expenses for 2020 and 2021 include your plan activity for the program.

So the organizational realignment has extended our cash runway through the end of 2021, which is well beyond the completion of our phase two proof of concept trials.

Once again, when we have the phase two data will meet with health authorities to getting alignment on next steps then in 2021, we expect to complete the close out of the phase two trials complete our regulatory interactions and begin ramping up for phase three trials. We've also previously guided that upon completion of our phase to stay.

Ladies we would consider other opportunities potentially for financing. So the short answer is yes, we have those key activities in the model today, and we'll certainly be opportunistic as we go forward.

The final question as to the prospective study.

Would that be funded by the hit CF on the consortium or would that be funded by the company.

The hit study is being funded through M&A I believe as part of that hit program.

Including the prospective clinical study then.

Yes, Brian.

That's correct.

Right.

Thank you very much.

Thank you at this time I'm showing no further questions I would like to turn the call back over to Dr., Greg Williams, Chief Executive Officer for closing remarks.

Well. Thank you everybody really appreciate your attention today and your interest in the Lux. This is going to be a great year for Realex. We're looking forward to completing enrollment to reporting or topline data in the first half of this year and we look forward to talk with you again soon.

Ladies and gentlemen.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.

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