Q3 2022 Nabriva Therapeutics PLC Earnings Call

November 10, 2022

[music].

Welcome to the new breed of Therapeutics third quarter 2020.

<unk> financial results call and corporate update.

All participants will be in listen.

Should you need assistance, please signal our conference.

Excellent.

Right.

After todays presentation, there will be an all.

Tough question.

That's a good question.

Then one on your telephone keypad.

Let me draw your question. Please press Star then two.

Please note this event is being recorded.

I would now like to turn the conference over to Mr. Dan Donlan CFO . Please go ahead.

Thank you and good afternoon, everyone welcome to <unk> conference call and webcast, where we will be discussing the third quarter 2022 earnings and providing a business update the.

The slides for today's presentation are posted on the Companys web site, Www dot and Abreva dot com and can be found under the investors tab in the events and presentations section.

We recommend that you refer to the presentation as we will be using the slides for today's discussion.

Before we begin on slide two I would like to remind everyone that this conference call and webcast will contain forward looking statements about the company. These statements are subject to risks and uncertainties that could cause actual results to differ. Please note that these forward looking statements reflect our opinions only as of the date of this call. We will undertake no obligation to <unk>.

<unk> or publicly release the results of any revisions to these forward looking statements in light of new information or future events factors that could cause actual results or outcomes to differ materially from those expressed in or implied by such forward looking statements are discussed in greater detail in our most recent filings on Form 10-K, and our other periodic report.

On forms 10-Q, and 8-K filed with the SEC.

Turning to slide three let's briefly run through this afternoons agenda, Ted Schroeder and debris. The CEO will start with a business update and presented an overview of the commercial highlights from the quarter. I will then provide a brief financial review before we Ted comes back with some final commentary and leads our Q&A session I.

I will now turn the call over to <unk>, Chief Executive Officer, Ted Schroeder.

Thank you Dan and thank you to everyone joining our call. This afternoon.

We turn to slide five I'd like to take some time to update you on our outlook regarding the current position of the business against the backdrop of the broader macro environment.

Like many of our peers. The breeder has faced headwinds in the macro environment as it relates to investor sentiment for the biotech and more specifically the anti infective space. As a result, we believe our portfolio of assets are significantly undervalued by the market.

Given that we are currently trading at approximately 40% of cash with revenue generating assets, it's clear to say that the sum of the parts valuation is worth more than we're currently getting credit for in the market.

With access to capital limited in the current market environment, our ability to raise capital efficiently and effectively continues to be a challenge.

Given these challenges we have shifted efforts to focus primarily on <unk> grow by building upon our commercial success as we believe this is the most efficient and effective way to extend our cash runway and preserve optionality and value for our shareholders. Additionally.

Following a broader assessment of potential options, we have engaged to raise capital to help advise us on a range of strategic options to maximize the value of the underlying business.

Starting with <unk>.

We have a revenue generating asset, which fully funds our commercial infrastructure and has generated net sales of approximately $24 million year to date through September 2022.

Second we have an approved product in the U S for cat within letter developers, both IV and oral monotherapy with a novel mechanism of action and a well tolerated option for patients with cat.

This is an asset with 11 years of patent life remaining and has.

Has the potential to deliver more value in the future with an increase in investments to drive awareness of the attributes and benefits of Zen letter.

With the appropriate resourcing behind the brand. We believe there is significant untapped potential for Zen letter in the U S.

The letter also has three separate and distinct royalty opportunities outside the U S with income generating potential in Canada with our partner Sanofi on in Eastern Europe , with our partner <unk> and with the potential approval in China with our partner Sumitomo.

Additionally, we have another potential lifecycle management opportunity with them with the letter in the treatment of patients with cystic fibrosis that could generate up to 100 million in incremental peak sales.

Given the small concentrated patient population, we remain optimistic about the potential isn't let it in cystic fibrosis and look forward to having top line data before the end of this year.

Lastly, with can tipo for the U S. We have a product with a novel mechanism of action patent exclusivity now extended through 2038, and a proven track record of outside the U S for over 40 years trading multi drug resistant organisms across various indications.

With over 3 million patients in the U S with M D R's and Tipo provides an attractive alternative for treatment of this growing issue in the United States.

To summarize we have multiple assets currently generating or on the verge of potentially generating revenue in the near future.

With this backdrop, we believe the most efficient path forward is to attempt to maximize value from these assets in the near term, while extending our cash runway and maintaining the optionality as we look to realize the full value of our assets for both the patients they treat and our shareholders.

Moving to slide six.

Like to highlight some of the efforts we've made to optimize our cash position our.

Our strategy includes suspending all noncore R&D projects and implementing a 40% reduction in our global workforce by reorganizing functions and streamlining back office support.

As a result, we have reduced operating expenses created efficiencies within the business and extended our cash runway into the first quarter of 2023.

These efforts will remove approximately 20% of operating expenses from our based operating plan by the end of 2023, our near term focus is to optimize our cash position maximize value from individual assets within our portfolio and efficiently enhance shareholder value while building upon.

Our commercial execution we.

We believe this provides us time to adequately assess a broader range of value, creating options across the business by controlling what we can control within our existing business.

Moving to slide seven we continue to be encouraged by our operational execution in the business on the commercial side. We saw continued momentum in the acceleration of <unk>, we had a 16% quarter on quarter pure X demand growth and continue to focus on the sales force execute.

<unk> with some external.

Capitalizing on the significant acceleration in demand.

I'm thrilled that we have achieved our goal of hitting the peak historical sales run rate in the middle of 2022 in line with our previous guidance.

As I mentioned, we have implemented a strategic restructuring plan to reduce cash burn and refocus our efforts on near term value drivers and we continue to see improvements in our operating cash burn compared to the prior year.

We continue to challenge ourselves to be disciplined with spending to further accelerate the operating leverage driven by the continued growth of <unk>.

On the clinical side, we now expect topline data from the phase one cystic fibrosis study in Q4 2022. This is an acceleration from our previous guidance of Q1 2023.

This is a credit to the team as we have demonstrated the ability to execute operationally and the clinical side of the business.

We have talked previously about the possibilities that then let it in this patient population and I won't reiterate these points later in the presentation.

Lastly, the Los Angeles, China NDA decision remains on track with an expected regulatory approval in the second half of 2023.

As you will recall this has the potential to generate low double digit royalties and up to $86 million in incremental sales and regulatory milestones.

Another significant value creation opportunity within the portfolio over the next 12 months.

You can see on slide eight if extra posted its third consecutive quarter of double digit prescription demand growth was 16% for prescription demand growth in Q3, 22 versus Q3 dollars 21, an 18% year to date prescription demand growth compared to the same nine months.

Period of 2021.

During the recent quarter, we saw yet another high end retail prescription demand since we restarted promotion of the brands generating 1148 retail prescriptions.

On the back of this retail prescription demand, we have achieved our guidance of getting back to peak historical sales run rate of extra by the middle of 2022. This is another example of our ability to deliver operationally on our goals and objectives with our commercial footprint.

Continued momentum with the <unk> promotion reaffirms our confidence in the realignment efforts that were implemented in April of this year, we remain confident in our ability to continue the growth of extra and view this as a solid foundational asset in the portfolio.

As we move on to slide nine we are encouraged to see that our target call reach for <unk> has more than doubled in the third quarter of 2022 compared to the first quarter of 2022 following the realignment in April of this year. Additionally.

Additionally, since the re alignment we have converted 225, new sort of extra writers.

<unk> accounting for 40% of those new prescriptions written this is encouraging given the promotional sensitive nature of the brand and the opportunity to continue to expanse of extra juice within this key segment of prescribers.

Expect to read.

Yes, we expect to continue to expand.

Combining the increased reach and frequency with the established promotional sensitive nature of extra though we believe it sets up for continued momentum as we move forward with this commercial strategy and focus around the brand.

Shifting our focus to an update of our phase one trial of <unk> and let it in patients with cystic fibrosis slide 10 lays out our rationale for exploring and letter as a treatment option for CF patients with chronic staph aureus <unk>.

Infections.

CF Foundation has stated that one of their key areas of focus is to identify effective treatments against methicillin resistant Staphylococcus aureus.

And MRSA.

This supports the supports our thesis when evaluating then let it in CF patients that staff for US remains an unmet medical need in patients with cystic fibrosis.

Then let it is available on both an oral and IV formulation has demonstrated potent anti MRSA activity.

<unk> lung penetration potent anti inflammatory activity and is well tolerated. We continue to believe that may provide an attractive treatment option for this difficult to treat population.

If completed enrollment in the phase <unk> cystic fibrosis study in partnership with the CF Foundation and now expect top line data in Q4 2022 accelerating our prior guidance of Q1 2023, we look forward to sharing these important data in this patient population.

Then later in the weeks and months ahead.

We believe that positive data in this trial could create another potential revenue catalyst was the potential peak incremental market opportunity of $100 million.

I'd now like to turn the presentation over to Dan for a brief update on the financials for the current core for the third quarter.

Thank you Ted.

Turning to slide 12, you will see a summary of our key financial metrics for the three months ended September 32022 versus the same period of 2021 total revenue in the quarter grew 3% versus the third quarter of 2021% to $9 $2 million, consisting primarily of some extra net sales.

Net sales of $8 $6 million grew 10% year on year versus the third quarter of 2021.

Other revenue decreased due to recognition of onetime payments in 2021 related to milestones we received for <unk> in China.

R&D expense grew in the quarter as we wrapped up our phase one trial for <unk> in patients with cystic fibrosis.

Balance of our R&D spend consist primarily of regulatory requirements around both send letter and can people.

SG&A expenses decreased 3% versus Q3 of 2021 as we continued to control spending in these areas with a disciplined approach while also absorbing inflation.

The growth in net sales and a decrease in SG&A continued to improve our operating leverage and have a positive impact on our operating cash burn.

Operating cash burn improved significantly in the quarter with a 50% reduction compared to the same period from the prior year.

We also continued to pay down our debt facility with Hercules paying down approximately $1 million of the debt in the current quarter.

We exited the third quarter with cash and cash equivalents of $14 $8 million and as a result of our restructuring efforts, we have extended our runway into the first quarter of 2023 I'd like to turn the presentation back over to Ted for some closing remarks.

Okay.

Sorry about that.

Given the pressures in the macro environment impacting our ability to efficiently raise capital and significantly undervaluing our portfolio. We believe our current initiatives to extend our cash runway and focus on maximizing the value of the products in our portfolio is the most efficient way to preserve optionality and value.

For our shareholders. We have continued to drive growth and so that drove advanced our lifecycle management opportunities with <unk> in cystic fibrosis and expanded the global presence of <unk> with our partners to unlock royalty revenue streams in the near future we have executed operationally throughout 2022.

And we will continue to pursue options to maintain that progress over time to continue to bring these important antibiotic options to the patients who desperately need them.

With that I would now like to turn the call back over to the operator, so that we can open the line for the Q&A session operator.

We will now begin the question and answer session.

You asked a question you May press.

Hello, Thank you Pat.

Thank you.

Please pickup your handset that ballpark.

Your question please.

Okay.

At this time last call Gladman, Charlie with MLS.

Got it.

Okay.

Your first question comes from Carl Byrnes from Northland Capital market. Please go ahead.

Thanks for the question.

With respect to the 40%.

<unk> head count reduction in the anticipated, 20% Opex savings.

That hit the third quarter and the fourth quarter, given where you are right now with those initiatives.

Dan you want to take that question.

Sure.

Carl for the question yes.

We weren't expecting too much of the savings into Q3 and Q4, given some of the separation agreements will start to realize some of those savings as we turn the calendar year into 2020.

Okay.

Yes.

Just to be clear most of that reduction about half of the half of the reduction came from.

Anna.

Got it.

Yeah.

And then turning to persisting.

For cystic fibrosis with the phase one open label PK study reading out in the fourth quarter and given.

As the press release comments on early stage development.

What would be your next steps there with respect to advancing.

The CF program whats been laid up.

Yes, so we do have several other as we noted on the slide several other non clinical.

Data that will be published as well so.

Penetration in the.

<unk> in CF patients.

CF model, which is a standard model that prescribers are familiar with.

And some of the other drug drug interaction work that's important for folks. So that there is a package of data that will be presented also because we've partnered with the CF Foundation they will.

Disseminate those data as they are published to their their treating physicians. So it's really moving forward there and then we'll assess.

Down the road, whether a registrational program as appropriate.

But for now I think we're just publishing the data and so physicians can.

Make a decision as to what may be best for their patients.

Does it may have resistant staph infections.

Got it great and then just one final question.

Can you comment on.

The funds raised via the ATM, obviously, it looks like there is some activity with respect to the team may be around.

A couple of hundred thousand shares raising.

Great.

Racing.

Okay.

Maybe $4 million to $5 million.

Wherever you can provide there would be great.

Sure Yes, thanks, Karl we did have some activity in the quarter around the ATM.

There's a few million dollars in the quarter, we still have some capacity, but it hasnt been that active theres a couple of days, where we leveraged it for for some funding.

Got it thanks.

Thanks Carl.

Okay.

Mike.

Yes.

One question.

Question.

Thank you.

Alright, Ted and Dan Thanks for taking my questions.

First I wanted to start by asking you as you.

As you focus primarily on sort of extra.

And look at strategic options.

Essentially for the rest of your pipeline I'm wondering if you could be specific on.

On both in the letter.

Both cap and CF as well as can people.

And are those both open to those options.

What are you looking for.

The near term.

Yeah. So.

<unk> review process and the mandate with PRA is really to look at all the all the strategic options. So I think we're open minded.

About how that how it would evolve forward into.

A variety of different options, which could include.

It could include wire all the brands or some combination.

Okay.

And then.

The current sales of <unk>.

In the quarter.

Eight.

Six.

Fell just shy of the $8 seven last quarter.

Given that you're essentially.

Flat growth.

Wondering.

If you could.

Share with us some more thoughts about how you think about the growth prospects for the brand and what Youre doing to Reenergize.

The growth.

Dan you want to talk about the net sales calculation.

Sure Yes.

Thanks, Ed.

Net sales I think.

Underlying demand has grown what we saw this quarter versus same quarter. Prior year was a little bit of inventory movement from the wholesalers, it's kind of a normal normal kind of level setting and if you recall, we launched our own in D. C back in April of 'twenty. One so I think last year there was some buying.

As we kind of reestablish the brand and there was a benefit of some stocking in the third quarter of last year versus kind of more normal level buy ins in the third quarter of this year, but I think the more important part and Ted can build on that is to look at the underlying <unk> retail demand has continued to grow and going forward I think thats what will be be the driver.

Yes.

I totally agree with that with Dan we did see some shift last year from.

Wholesale ordering that would sort of wind up into the second quarter, but build into the third quarter and this year. It was kind of the opposite.

And so it's really somewhat of a timing issue, but the important point is as Dan highlighted is that total prescriptions are growing.

And growing at a nice clip and eventually wholesaler demand over the years period of time will catch up and were well ahead of last year and continuing to grow.

The fourth quarter I think we will.

We will show that.

Growth in <unk> driven by demand is.

Stained and.

So we're actually very bullish on the upside potential for <unk> and the trajectory that it's on.

Okay.

One last follow up if I may.

Just wondering with the phase one data from <unk> and <unk>.

<unk> expected.

And the next few weeks.

Sure.

Do you plan to include in that readout any exploratory efficacy endpoints.

That perhaps could help with any strategic review.

Yes.

This was strictly a PK and safety study and so theres not an ethics.

Readout in.

In that study so.

Strictly PK.

But the design of the studies.

So and how we and what we believe it will show is that the PK in CF patients is similar to the PK in non CF patients.

That's an important finding because.

Does it speaks a lot to dose that would mean that the current marketed dose would be the appropriate dose.

And.

But given the chronic nature of the infection, you would probably see.

It potentially see more.

Doses per patient so.

Right.

It's not quite an efficacy study, but I think I've checked some of the boxes for penetration and getting to the organisms in getting to the site of infection that are important.

Testing, which antibiotics might be appropriate in this patient population.

Thanks, so much.

You bet.

Okay. Thank you have a question please correct Scott.

Scott.

We look towards amendments.

Final question correct itself.

This concludes our question and answer session I would now like to turn the conference back over.

No closing remarks.

Thank you and thanks to each of you for joining our call. This afternoon I. Appreciate your interest and we look forward to updating you in the weeks weeks ahead, and we especially look forward to reporting the results of the phase <unk> cystic fibrosis pay.

Patients before the end of the year. Thanks, everyone have a good rest of the day.

The conference has now concluded. Thank you for attending today's presentation you may now.

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[music].

Welcome to the Liberty the Therapeutics third quarter 2015 financial results and corporate update.

All participants will be in listen only mode.

Need assistance, please signal our conference specialist.

By pressing star followed.

Ill advised me right.

After todays presentation, there will be an opportunity to ask questions.

To ask a question you May press Star then one on your telephone keypad.

Let me draw your question Scott.

Scott.

Please note this event is being recorded.

I would now like to turn the conference over to Mr. Dan Donlan.

Please go ahead. Thank you and good afternoon, everyone welcome to <unk> conference call and webcast, where we will be discussing the third quarter 2022 earnings and providing a business update.

The slides for today's presentation are posted on the Companys website, www dot <unk> dot com and can be found under the investors tab in the events and presentations section.

We recommend that you refer to the presentation as we will be using the slides for today's discussion.

On forms 10-Q, and 8-K filed with the SEC.

Turning to slide three let's briefly run through this afternoons agenda, Ted Schroeder and debris. The CEO will start with a business update and present, an overview of the commercial highlights from the quarter. I will then provide a brief financial review before we Ted comes back with some final commentary and leads our Q&A session.

I will now turn the call over to <unk>, Chief Executive Officer, Ted Schroeder.

Thank you Dan and thank you to everyone joining our call. This afternoon.

We turn to slide five I'd like to take some time to update you on our outlook regarding the current position of the business against the backdrop of the broader macro environment.

Like many of our peers. The brita has faced headwinds in the macro environment as it relates to investor sentiment for the biotech and more specifically the anti infective space. As a result, we believe our portfolio of assets are significantly undervalued by the market.

With access to capital limited in the current market environment, our ability to raise capital efficiently and effectively continues to be a challenge.

And following a broader assessment of potential options, we have engaged to raise capital to help advise us on a range of strategic options to maximize the value of the underlying business.

Starting with <unk>.

We have a revenue generating asset, which fully funds our commercial infrastructure and has generated net sales of approximately $24 million year to date through September 2022.

Second we have an approved product in the U S for cat with them letter that offers both IV and oral monotherapy with a novel mechanism of action and a well tolerated option for patients with cap. This is an asset with 11 years of patent life remaining and has the potential to deliver more value in the future.

With an increase in investments to drive awareness of the attributes and benefits of Zen letter.

With the appropriate resourcing behind the brand. We believe there is significant untapped potential for Zen letter in the U S.

Then led to also has three separate and distinct royalty opportunities outside the U S with income generating potential in Canada with our partner Sanofi on in Eastern Europe , with our partner <unk> and with the potential approval in China with our partner Sumitomo.

Additionally, we have another potential lifecycle management opportunity with them.

Then later in the treatment of patients with cystic fibrosis that could generate up to 100 million in incremental peak sales.

Given the small concentrated patient population, we remain optimistic about the potential isn't letter in cystic fibrosis and look forward to having top line data before the end of this year.

Lastly, with compete though for the U S. We have a product with a novel mechanism of action patent exclusivity now extended through 2038, and a proven track record of outside the U S for over 40 years trading multi drug resistant organisms across various indications.

With over 3 million patients in the U S with MD ours, and Tipo provides an attractive alternative for treatment of this growing issue in the United States.

To summarize we have multiple assets currently generating or on the verge of potentially generating revenue in the near future.

Moving to slide six.

I'd like to highlight some of the efforts we've made to optimize our cash position our.

Our strategy includes suspending all non core R&D projects and implementing a 40% reduction in our global workforce by reorganizing functions and streamlining back office support.

As a result, we have reduced operating expenses created efficiencies within the business and extended our cash runway into the first quarter of 2023.

Our commercial execution we.

We believe this provides us time to adequately assess a broader range of value, creating options across the business by controlling what we can control within our existing business.

Moving to slide seven we continue to be encouraged by our operational execution in the business on the commercial side. We saw continued momentum in the acceleration of some extra we had a 16% quarter on quarter pure X demand growth and continue to focus on the sales force execution.

<unk> with external.

Capitalizing on the significant acceleration in demand.

I'm thrilled that we have achieved our goal of hitting the peak historical sales run rate in the middle of 2022 in line with our previous guidance.

We continue to challenge ourselves to be disciplined with spending to further accelerate the operating leverage driven by the continued growth of <unk>.

On the clinical side, we now expect top line data from the phase <unk> cystic fibrosis study in Q4 2022. This is an acceleration from our previous guidance of Q1 2028.

This is a credit to the team as we have demonstrated the ability to execute operationally and the clinical side of the business.

We have talked previously about the possibilities that then let it in this patient population and I will reiterate these points later in the presentation.

Lastly, the Los Angeles, China NDA decision remains on track with an expected regulatory approval in the second half of 2023.

As you will recall this has the potential to generate low double digit royalties and up to $86 million in incremental sales and regulatory milestones.

Another significant value creation opportunity within the portfolio over the next 12 months.

Period of 2021.

During the recent quarter, we saw yet another high end retail prescription demand since we restarted promotion of the brands generating 1148 retail prescriptions.

Continued momentum with <unk> promotion reaffirms our confidence in the realignment efforts that were implemented in April of this year, we remain confident in our ability to continue to growth of extra and view this as a solid foundational asset in the portfolio.

Additionally, since the re alignment we had converted 225, new sort of extra writers.

<unk> accounting for 40% of those new prescriptions written this is encouraging given the promotional a sensitive nature of the brand and the opportunity to continue to expanse of extra juice within this key segment of prescribers.

Expect to REIT.

Yes, we expect to continue to expand.

Combining the increased reach and frequency with the established promotional expenses nature of the vaccine trial. We believe it sets up for continued momentum as we move forward with this commercial strategy and focus around the brand.

Shifting our focus to an update of our phase one trial of <unk> in patients with cystic fibrosis slide 10 lays out our rationale for exploring <unk> as a treatment option for CF patients with chronic staph aureus <unk>.

Infections.

CF Foundation that stated that one of their key areas of focus is to identify effective treatments against methicillin resistant Staphylococcus aureus.

And MRSA.

This supports the supports our thesis when evaluating Zen letter in CF patients that step for us remains an unmet medical need in patients with cystic fibrosis.

Cause them, let it is available on both an oral and IV formulation has demonstrated potent anti MRSA activity.

<unk> lung penetration potent anti inflammatory activity and is well tolerated. We continue to believe that may provide an attractive treatment option for this difficult to treat population.

If completed enrollment in the phase <unk> cystic fibrosis study in partnership with the CF Foundation and now expect top line data in Q4 2022 accelerating our prior guidance of Q1 2020, we look forward to sharing these important data in this patient population.

Then later in the weeks and months ahead.

We believe that positive data in this trial could create another potential revenue catalyst was the potential peak incremental market opportunity of $100 million.

I'd now like to turn the presentation over to Dan for a brief update on the financials for the current quarter for the third quarter.

Thank you Ted.

Net sales of $8 $6 million grew 10% year on year versus the third quarter of 2021.

Other revenue decreased due to recognition of onetime payments in 2021 related to milestones we received for <unk> in China.

R&D expense grew in the quarter as we wrapped up our phase one trial for <unk> in patients with cystic fibrosis.

Balance of our R&D spend consist primarily of regulatory requirements around both send letter and can depot.

SG&A expenses decreased 3% versus Q3 of 2021 as we continued to control spending in these areas with a disciplined approach while also absorbing inflation.

The growth in net sales and a decrease in SG&A continued to improve our operating leverage and have a positive impact on our operating cash burn.

Operating cash burn improved significantly in the quarter with a 50% reduction compared to the same period from the prior year.

We also continue to pay down our debt facility with Hercules paying down approximately $1 million of the debt in the current quarter.

We exited the third quarter with cash and cash equivalents of $14 8 million and as a result of our restructuring efforts, we have extended our runway into the first quarter of 2023 I'd like to turn the presentation back over to Ted for some closing remarks, given the pressures in the macro environment impacting our ability to efficiently raise capital and <unk>.

<unk> undervaluing, our portfolio, we believe our current initiatives to extend our cash runway and focused on maximizing the value of the products in our portfolio is the most efficient way to preserve optionality and value for our shareholders. We have continued to drive growth and so backstroke advanced our lifecycle.

Management opportunities with them, let it in cystic fibrosis and expanded the global presence of them, let it with our partners to unlock royalty revenue streams in the near future.

Executed operationally throughout 2022, and we will continue to pursue options to maintain that progress over time to continue to bring these important antibiotic options to the patients who desperately need them.

With that I would now like to turn the call back over to the operator, so that we can open the line for the Q&A session operator.

Thank you we will now begin the question and answer session.

To ask a question you May press Star 91 telephone keypad.

If youre using a speakerphone please pick up your handset that ballpark.

Your question. Please press Star then two.

At this time, we'll pause momentarily to assemble our stuff.

Comes from Carl Byrnes Northland capital market.

Please go ahead.

Thanks for the question with respect to the 40%.

<unk> head count reduction in the anticipated, 20% Opex savings.

How might that hit the third quarter and the fourth quarter, given where you are right now with those initiatives.

Dan you want to take that question.

Sure. Thanks, Karl for the question yes.

We weren't expecting too much of the savings into Q3 and Q4, given some of the separation agreements will start to realize some of those savings as we turn the calendar year and into 2020.

Okay.

Yes.

Just to be clear most of that reduction.

Half of the half of the reduction came from.

Anna.

Got it.

Yeah.

And then turning to the letter.

The Pacific fibrosis with the Phase one open label PK study reading out in the fourth quarter and given.

The press release comments on early stage development, what would be your next steps with respect to advancing.

The CF program whats been laid up.

Yes, so we do have several other as we noted on the slide several other non clinical.

Data that will be published as well so.

Penetration in the <unk>.

Viewed in CF patients Theres, a mouth CF model, which is a standard model that prescribers are familiar with.

And some of the other drug drug interaction work that's important for folks. So that there is a package of data that will be presented also because we've partnered with the CF Foundation they will.

Disseminate those data as they are published to their their treating physicians. So it's really moving forward there and then we'll assess.

Down the road, whether a registrational program as appropriate.

But for now I think we're just publishing the data and so physicians can now.

Make a decision as to what may be best for their patients.

Does it may have resistant staph infections.

Got it great and then just one final question.

Can you comment on.

The funds raised via the ATM, obviously, it looks like there is some activity with respect the team may be around.

Couple of hundred thousand shares raising.

Racing.

Maybe $4 million to $5 million anywhere wherever you can provide there would be great.

Sure Yes, thanks, Karl we did have some activity on the ATM.

$2 million in the quarter, we still have some capacity, but haven't been that active theres a couple of days, where we leveraged it for for some funding.

Got it thanks.

Thanks Carl.

Hi, Ken.

Okay.

One.

Question.

Hum.

Please go ahead.

Alright, Ted and Dan Thanks for taking my questions first I wanted to start by.

Ask you as you.

As you focus primarily on sort of extra and look at strategic options.

Essentially for the rest of your pipeline I'm wondering if you could be specific on.

On both of them later.

And both cap and CF as well as can people.

And are those both open to those options.

What are you looking for.

In the near term.

Yeah. So.

<unk> review process and the mandate with PRA is really to look at all the all the strategic options. So I think we're open minded.

About how that how it would evolve forward into.

A variety of different options, which could include.

It could include one or all the brands or some combination.

Okay.

And then.

The current sales of <unk>.

In the quarter.

Eight.

Six.

Fell just shy of the $8 seven last quarter.

Given that you're essentially.

Flat growth.

Wondering if if.

You could share with us some more thoughts about how you think about the growth prospects for the brand and what Youre doing to Reenergize.

The growth.

And you want to talk about the net sales calculation.

Sure.

Thanks, Ed.

Net sales I think the underlying demand has grown what we saw this quarter versus same quarter. Prior year was a little bit of inventory movement from the wholesalers, it's kind of a normal normal kind of level setting and if you recall, we launched our own NBC back in April of 'twenty one so.

Last year, there was some buy in as we kind of reestablish the brand and there was a benefit of some stocking in the third quarter of last year versus kind of more normal level buy ins in the third quarter of this year, but I think the more important part and Ted can build on that is to look at the underlying <unk> retail demand has continued to grow and going forward I think that's what it'll be.

<unk> be the driver.

Yes.

I totally agree with that with that and we did see some shift last year from.

Wholesale ordering that would sort of wind up into the second quarter, but build into the third quarter and this year. It was.

Kind of the opposite.

And so it's really somewhat of a timing issue, but the important point is as Dan highlighted is that total prescriptions are growing and growing at a nice clip and eventually wholesaler demand over the years period of time will catch up and were well ahead of last year and continuing to grow.

The fourth quarter I think we will.

We will show that.

Growth in <unk> driven by demand is sustained.

We're actually very bullish on the upside potential for <unk> and the trajectory that it's on.

Okay.

One last follow up if I may.

Just wondering with the phase one data from <unk> in later than expected.

In the next few weeks.

Yes.

Do you plan to include in that readout any exploratory efficacy endpoints.

That perhaps could help with any strategic review.

Yes.

This was strictly a PK and safety study and so theres not an ethics.

Readout in.

In that study. So this is strictly PK.

But the design of the studies.

So and how we and what we believe it will show is that the PK in CF patients.

Similar to the PK in non CF patients and that the.

That's an important finding because it speaks a lot to dose that would mean that the current marketed dose would be the appropriate dose.

And.

But given the chronic nature of the infection, you would probably see.

It potentially see more.

Doses per patient so.

Alright.

It's not quite an efficacy study, but I think as check some of the boxes for penetration and getting to the organisms in getting to the site of infection.

That are important.

Assessing which antibiotics might be appropriate in this patient population.

Thanks, so much.

You bet. Thank you. Okay. Thank you have a question please press star.

Anyone.

Those amendments.

Final question. This concludes our question and answer session I would now like to turn the conference back over for any closing remarks.

Thank you and thanks to each of you for joining our call. This afternoon. Appreciate your interest and we look forward to updating you in the weeks weeks ahead, and we especially look forward to reporting the results of the phase <unk> cystic fibrosis.

Patients before the end of the year. Thanks, everyone have a good rest of the day. The conference has now concluded thank.

Thank you for attending today's presentation you may now disconnect.

Q3 2022 Nabriva Therapeutics PLC Earnings Call

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