Q1 2020 Earnings Call

The first quarter Twentytwenty financial results conference call.

At this time all participants are in listen only mode. Later, we'll conduct a question and answer session and instructions will follow at that time.

If anyone should require assistance during the conference. Please press Star then see room on you touched on telephone as a reminder, this conference maybe recorded I would now like to turn the conference over to your host Jackie Kaufman of Tresiba. Please go ahead ma'am.

Thank you Patricia good afternoon, and thank you for joining the Tracy to first quarter Twentytwenty financial results conference call in today's call Garrett cleaner, our founder CEO and President will discuss business progress and Jeff Parker. Our CFO will then discuss our financial results for the first quarter.

Please note that in today's call, we will be making very statements that include forward looking statements as defined under the applicable securities laws forward. Looking statements include the potential timing for approval, our commercial launch of a bear armor anticipated activities related to our NDA filing, including the assigned PDUFA goal date and the scheduling of an advisory.

The meeting the potential approvability of Aviram or through the accelerated approval program, our hiring plan, our medical affairs commercial and manage market activities. The conduct of our valor CKD confirmatory post marketing trial, the potential impact of Cobot 19 financial guidance and other statements that are not historical facts.

Management's assumptions expectations and opinions reflected in these forward looking statements are subject to risks and uncertainties that may cause actual results to differ materially from any future results performance or achievements discussed in our implied by such forward looking statements.

I see that can give no assurance that these statements will prove to be correct and we do not intend and take undertake no duty to update. These statements. We also urge you to read the risks and uncertainties associated with our business that are described in our filings with the Securities and Exchange Commission.

For a copy of our press release that was issued prior to this call. Please go to www dot try ceded dotcom and follow the linked to our Investor Relations page at this time I'd like to turn the call over to Garrett.

Thank you Jack and thank you all for joining on the call today.

Covance 19 pandemic has affected us all.

Sincerely grateful to the healthcare providers and other online essential workers will continue to work tirelessly to serve our communities and of those in need.

I also want to acknowledge our employees, who have made a remarkably smooth transition to working virtually.

Working as a team I believe remain as productive as out I'm also proud of our implies some supported those affected by in the call with 19 pandemic in several ways.

Donating mass to local hospitals to contributing generously covert 19 million, a charities, which have unmatched 100% by choice either.

Before I share that he doesn't have a commercial launch preparations let me provide a brief update at all and you from Vera and our ongoing volatility confirmatory post marketing trial.

The variety is on the review by the FDA somebody accelerated approval program for the PDUFA goal date of August 22nd 2020 for the potential problem to market the very much in the United States.

At this time, we do not believe to covert 19 pandemic has affected overdue for goal date of August 22nd we continue to work cooperatively with the FDA review management Nantong hadn't yet.

You know a day 74 that on the FDA indicated that a plan to hold an advisory committee meeting or outcome to discuss the application and all these type a meeting with the FDA held in May 2020, the FDA indicated attorney does not plan to hold an outcome to discuss the verma due in part of logistical challenges posed by call. It nine team.

And all in fact, a meeting with FDA and we took the opportunity to address outstanding review issues.

Was that our data and rationale as to why we think we're very much satisfies the requirements for initial approval I'm really excited to pull that program, including the magnitude and durability of the treatment effect on asserted markups and bicarbonate demonstrated in that he is the athree or whatever you want a trough on an initial approval we have to ensure that U.S. patients who would be per square.

Very much clinically significant benefit that outweighs the risk of treatment of all while the idea continues its review we remain confident that our submission meets a standard for approval who they occur it if we were pulled out.

It's an investigator site every three months, which provides for a significant scheduling flexibility. In addition, we've implemented a study wide covert 19 contingency guidance, which is in line with corresponding FDN you may guidance on conduct of clinical trials. During this endemic to ensure a patient safety and well being and to preserve the try.

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This guidance allows the conduct of remote assessments of subject safety and the delivery of study drug directly to subject homes were allowed to ensure continuity of treatment regarding the pace of enrollment slowdown has occurred as a result of the covert 19 pandemic as such we have monetizing our screening and enrollment progress and hope to bring on woman back to cities.

Dave as the pandemic subsides at this time and if he has to do a complete enrollment in the volatility trial in the first half of 2021.

Now I'd like to its got the significant work that we've done to understand the impact of the covert 19 pandemic at all potential launch up with that.

I'll start by saying that'd be a data driven organization and it's certainly applies to approach to a large activities.

We have evaluated multiple third party surveys conducted our own surveys spoken to numerous contact biotechnology companies are launching products in this environment and carefully considered the scope and timing of our plans to launch November.

First and it's clear that the covert 19 pandemic strains of health care system, and if I take a it has changed the way physicians and patients are currently able to attack.

The use of telemedicine to supplement office visits and additional personal protective equipment elements of the patient duct expands the likely here to stay.

But our research also indicates that many of the most significant disruption should be temporary and their strong interest from physicians and payers for news therapies that provide health benefits to patients and address large unmet medical needs.

And our research indicates this is particularly true and then nephrology community as an example at the end of April was fairly 50 to fall just something around the country that typically see about 100 patients per week. They reported that the pandemic has negatively affected the activity in the fact is is that an estimated 60% reduction weekly patient visits to the offices in April.

Relative to its typical week earlier this year. However, the server is all the other shows that it was 65% of these in the fall just a stepped up to learning more about new products, even in the current environment with increased to 94% vendor Pandemics upsides.

More specifically when shown very much target product profile, 80% doesn't fall just said they would consider prescribing or definitely would prescribe the verma via telemedicine and 95% indicated they would consider prescribing are definitely would prescribe for them and the office.

We are encouraged at the very methodical if I listen to this type of enthusiasm from the fall just either in a virtual or in person setting.

When that information, but this information in hand, along with a multitude of other data points I would like to share with you today, our ongoing successful prelaunch activities and why we continued to be excited for the launch of Verma, if approved to treat metabolic absent those isn't there was slow the progression of chronic kidney disease.

Let me start with our extensive medical Affairs campaign, we launched a team of 10 medical science liaisons. After the end cap spring clinical meeting in March but response of seven presentations, a poster session and his CMU symposium on interventions from metabolic us on those and filling CKD progression.

All of these presentations and events were held virtually and well attended giving us increased confidence as we head into the second half of two to 2020 that both in person and virtual activities around disease indication as a very much can be effective.

Oh I Miss out on gauging within Caf meeting participants and I've already virtually reached out to about 750 nephrologist.

The reception in interest has been exceptional and that's not a surprise given the important findings from our reason the father server that indicated at nearly 70% of the fall just find publications or journal articles to be one of the best sources of medical information.

Recall that we supported often 14 posters and publications in 2019 in early 2020. These publications like about Amazon with many important scientific publications to facilitate the appropriate scientific exchange business fall just about a wide range of topics related to metabolic overdoses. These include a recent special Arctic on Jason on the mechanism of <unk>.

Metabolic absent those induced kidney injury and security as well as a systematic review and made analysis of the effects of treatment, but about cousin doses and see Jason.

Presentations at major in the Fogey Congress and presented new data on the significant clinical consequences of my back of the doses to bone muscle and getting them and of course, if the question arises about November on without would be able to discuss the very much via one or two on the trial is out there were published in back to back issues of the Lance.

Another key area of focus on medical Affairs team, which was the subject of presentations at both ends and kidney week, an end to have spring meanings has been the current I'm the treatment of metabolic acidosis based on multiple analyses only 3% to 15% of patients with men at minimal I got the doses and seek idea currently taking over the coming out well alkali.

Supplement in an attempt to manage and metabolic acidosis.

This dramatic on the treatment is likely due to the simple fact that the current over the coming option upswing bicarbonate. Because then significant challenges first as regardless of the sodium bicarbonate to live as excess sodium to the patient and for patients with seek idea would do sodium died as recommended to avoid exasperating common commodities, such as hypertension heart failure and edema.

Second and supported by peer reviewed publications excess sodium load has been shown to reduce efficacy of aces and arbs hypertensive medications, which a cornerstone for the treatment regimen for CKD patients due to the ability to slow CKD progression and third and the recently published by Cup study out of the UK. So in.

I call. It was not demonstrated to be safe and efficacious, which is considered a typically prescribed daily dose at 1.5 to three grams per day.

As you May recall the bike of study is one of the only large multicenter double blind placebo controlled randomized trials that investigated the use of typically those are sort of bike after treatment of all kinds of doses and abroad patient population over two year period.

In summarizing was unsuccessful study the author concluded that our results suggest that at least for patients aged six you know about the CKD categories, four and five 1.5 to three grams per day of or bike opted not to produce any health benefits and maybe associated with net harms.

This is an important milestone in the history of freedom at about government doses as it provides clear evidence that in the well controlled study. These daily doses of sodium bicarbonate proven to be safe and efficacious a cost effective.

It is also interesting to note at the office of the bike up paper referenced the Verma as a potential new therapy from end of August the doses in particular, they noted at the very much novel mechanism of action the binding and removing asset could avoid the sodium related liabilities of neutralizing assets. The sodium bicarbonate. They also highlighted the various clinical trial results and its ability to success.

That's really increase and bicarbonate and to improve physical function with the quality of life using both patient reported an objective measures.

We were pleased to see this recognition up a very much from these external investing yes.

In addition in supporting Cama programs enable HCP to obtain professional educational credits by competing causes a minute bug after doses and that serious complications at the end care virtual meeting we supported our first symposium titled evidence based interventions for me slowing CKD progression more than three in 25 people participated in the livestream Ovenden more.

And we'll be able to see the program. Once it is posted on the N. Caf website. We supported two additional accredited programs in March they've already garnered more than 2300 participant given effect of these CMH events, we will be supporting additional courses later this year with a goal of reaching over 4000 HCP at least the credit education programs by the.

End of 2020.

And now turning to our disease awareness campaign that Keith rust and our disease awareness efforts has been to emphasize the urgency to treatment of all kinds of those over the past year, we've made significant progress and emphasizing the understanding off and urgency to treat metabolic after those.

As we've discussed at length for you in the past an overwhelming understanding among the father nephrologists that metabolic out the doses is linked to the progression of CKD as was worsening bone and muscle health.

The current lack of urgency to treat as attributed primarily to the simple fact that physicians have not had a proven safe and efficacious FDA approved treatment to describe to their CKD patients with chronic metabolic after those clearly we believe that the verma has the potential to address this significant unmet medical need.

To do live our disease awareness message, we've utilized multiple digital communication channels. We've generated about approximately 3 million use impressions for three distinct internet platforms paid into that search display media and target email. This has resulted in a 96% increase and visits to I'm at a bug acidosis insights dot com website from Q4 to those 90.

Into Q1, two and funny and puts us well in a way to our goal of approximately 10 million user impressions by the time of Verma launch.

And we're already seeing positive is all going to forge a community from these disease awareness efforts I proprietary survey of 15 to fall just let me just completed in April showed that 82%. The father surveyed believes metabolic acidosis associated with an increased risk of CKD progression and mortality 76 believe it as an independent and modify Lewis.

Factor for CKD progression.

And 76% belief also that negatively impacts helping patients FIA and function.

These are encouraging levels of agreement that emphasize understanding of the urgent need to treat m-. They also recently conducted to Berkshire advisory boards with practicing fall just from around the United States in March and April and do exceptionally pleased and encouraged by the focus and interest that our advisory boards in the fall just exhibited in these sessions together. These two advisory board.

And grew 24 prominent into fathers and over four session. They provide feedback on both our disease awareness materials and the verma as a potential treatment from at a Buck I suppose it's come away from these interactions with even greater confidence and the significant potential value that the verma may deliver for CKD patients with metabolic I suppose.

Also we've received great interest them over 40 in the fall just do a key opinion leaders in various geographic regions of the rest of surface because no a peer to peer programs that would be plan throughout the rest of this year.

In addition to our disease education efforts. We also have made significant progress educating pass on the health and economic implications of untreated them at a Buck I wasn't doses and have obtained good feedback on coverage for potential first and only treatment from at about got to those.

Team has not met with over 85 unique pairs, who collectively represent over 290 million insured lives. That's up from the 51 payer meetings that we reported in our last call and be a wild always toward our goal of engaging that at least 100 peers panto anticipated approval.

Also in March we also the managed markets Advisory Board meeting spending a full David 10 passive represent approximately 100 million life.

Our advisory Board participants represented all major categories of ensures including commercial medical Medicare advantage and managed Medicaid that.

The individually pair meetings have been very productive and Mira many of the opinions on the outboard participant but focused today on the highlights of the outboard me.