BioCryst Pharmaceuticals Inc (BCRX) 2018 Q1 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the BioCryst First Quarter 2018 Earnings Conference Call.

(Operator Instructions) As a reminder, this call is being recorded.

I would now like to turn the conference over to Tom Staab, Chief Financial Officer.

Please begin.

Thank you, Latoya.

Good morning, and welcome to BioCryst's first quarter 2018 corporate update and financial results conference call.

Today's press release and accompanying slides are available on our website.

Participating on the call with me today are Jon Stonehouse, Chief Executive Officer; and Dr. Bill Sheridan, Chief Medical Officer.

Following our formal remarks, we will answer your questions.

Before we begin, I want to direct your attention to Slide 2, which discusses our use of forward-looking statements and potential risk factors regarding an investment in BioCryst.

As detailed on the Slide, today's conference call will contain forward-looking statements, including those statements regarding future results, unaudited and forward-looking financial information as well as the company's standalone future performance and/or achievements.

These statements are subject to known and unknown risks and uncertainties, which may cause our actual results, performance or achievements to be materially different from any future results or performance expressed or implied in this presentation.

You should not place undue reliance on these forward-looking statements.

For additional information, including a detailed discussion of risk factors, please refer to the company's documents filed with the Securities and Exchange Commission, which can be accessed on our website.

I'd now like to turn the call over to Jon.

Thank you, Tom.

Good morning, and thanks for joining us today.

We got off to a strong start to 2018, implementing our plan, advancing our programs and announcing the strategy for optimizing long-term value.

The most advanced of our programs is BCX7353, a late-stage program testing the first once-a-day oral medicine for the prevention of hereditary angioedema attacks or HAE.

The pivotal trial for that program APeX-2 is up and running and enrolling rapidly, which is good for the clinical trial, and is also a good indicator for the demand of this one capsule once-a-day treatment.

Most of the planned APeX-2 sites in the U.S. are now up and screening patients.

In addition, we recently held our investigator meeting in Europe and expect to be screening patients at European sites in the coming weeks.

So we remain on track to report efficacy and safety results from the first 24 weeks of this trial in the first half of next year.

Our strategy for the pivotal prophylaxis program is to prioritize enrollment of APeX-2 first and utilize U.S. sites for this trial only until Part 1, the first 24 weeks, is completed.

Our next priority is the open label safety trial for 7353, called APeX-S.

Enrollment for APeX-S is focused outside the U.S., initially in Europe, and is also now running and enrolling.

Like our previous EU trials, this trial has a slower ramp-up due to longer site startup time.

Safety data from this trial is an important component of the NDA filing.

Our target for filing in the second half of 2019 remains on track.

In addition to HAE prophylaxis, we are also studying 7353 for treatment of acute attacks.

ZENITH-1, our Phase II clinical trial for acute treatment of HAE attacks with an oral liquid formulation of 7353 is also advancing well.

ZENITH-1 enrollment is wrapping up with over 80% of patients enrolled.

We are now on to the third cohort and enrolling patients at the 250-milligram dose.

We remain on track to report the results from the 750-milligram dose cohort in the third quarter of this year.

Our recently announced early programs are also proceeding on schedule.

Both BCX9250 and BCX9499 are ALK2 inhibitors for the treatment of fibrodysplasia ossificans progressiva or FOP are entering toxicology studies.

In addition, BCX9930, a molecule for a different rare disease, is entering toxicology studies as well.

We remain on track to enter Phase I clinical trials for each of these programs in the first half of next year.

While these programs are early, having a new wave of molecules discovered in-house to refill our pipeline is important in creating sustainable value.

Wrapping up, the program update we announced last week, an additional approval of our single-dose IV infusion antiviral, peramivir, for the treatment of acute uncomplicated influenza by the EMA.

Alpivab is the brand name in Europe.

We also noted in our press release that we are in dispute with our partner, Seqirus, that encompasses a number of topics, including a contested payment of a $5 million milestone for approval in Europe.

Lastly, we have received presolicitation notice for the procurement of additional RAPIVAB by the CDC for the replenishment of the U.S. government stockpile.

We expect to have procurement discussions completed by the end of the government's fiscal year at the end of September.

That's it for the program update.

I will now turn it over to Tom, who will go through the first quarter financials.

Tom?

Thanks, Jon.

I'm pleased to discuss the details of our first quarter 2018 financial results.

My comments are focused on BioCryst as a standalone company and do not reflect the proposed impact of a BioCryst-Idera combination from our pending merger.

The exception to the statement, of course, relates the BioCryst incurred merger expenses that have been reported thus far.

We closed the quarter with approximately $138 million in cash and investments.

This capital is expected to provide liquidity for us through September 2019, and importantly, beyond the reporting of ZENITH-1 and APeX-2 clinical trial results.

We are pleased with our progress in these studies thus far and are thankful that we have a cash runway extending beyond these very important data points.

Turning to Slide 12.

Our revenue for the first quarter of 2018 decreased to $4 million from $9.4 million recorded in the first quarter of 2017.

The decrease was primarily due to $6.1 million of revenue derived from 2017 events that are somewhat infrequent, that is, events we do not expect to normally recur on a quarterly basis and did not recur in 2018.

Those events were a $2 million milestone payment related to RAPIVAB's Canadian approval as well as $4.1 million of royalties derived from Japanese government stockpiling.

While we do expect the Japanese government and other governments to stockpile RAPIVAB because of its unique product profile, the timing and amount of these transactions is difficult to predict due to the relevant governments' appropriations and stockpiling processes.

First quarter 2018, R&D expenses increased to $18.4 million from $16.8 million incurred in the first quarter of 2017.

The increase resulted primarily from additions in R&D personnel to support the evolution of all of our programs as well as increased spending on HAE surrounding the ongoing APeX-2, APeX-S and ZENITH-1 clinical trials and increased levels of development on our preclinical programs.

These expenses were partially offset by a decrease in peramivir and galidesivir expenses due to lower activity in 2018 as compared to 2017.

General and administrative expenses of $7.6 million increased for the first quarter of 2018 as compared to $3.1 million for the first quarter of 2017.

The increase was largely the result of $4.7 million of merger-related costs that were incurred in 2018 associated with our pending merger with Idera.

Moving below the operating line.

We incurred $2.2 million of interest expense in the first quarter of 2018, which is in line with the $2.1 million incurred in the first quarter of 2017.

In addition, we recognized a $1.8 million mark-to-market loss in the first quarter of 2018 as compared to a $1.5 million mark-to-market loss in the first quarter of 2017.

These losses result from periodic changes in the U.S. dollar-Japanese yen exchange rate and the related mark-to-market valuation of our underlying hedge agreement.

As mentioned in previous quarters, these losses have no underlying cash outflow.

Our net loss from the first quarter of 2018 was $25.8 million or $0.26 per share as compared to $14.2 million loss or $0.19 per share in the first quarter of 2017.

Moving on to Slide 13.

Our cash balance was approximately $138 million at March 31, 2018, and our cash utilization for the first quarter of 2018 was $22.9 million.

In regards to 2018 guidance, we continue to expect our cash utilization to be in the range of $67 million to $90 million, and our operating expenses in the range of $85 million to $110 million.

With merger-related costs and the aggressive advancement of our programs, we are currently trending to the upper end of both guided ranges.

Consistent with previous quarters, our operating expense guidance excludes equity-based compensation due to the difficulty and reliably projecting this expense as it is impacted by the volatility and price of our stock as well as by the vesting of the company's outstanding performance-based stock options.

Now I'd like to turn the call back over to Jon for his closing remarks.

Thank you, Tom.

I'd like to conclude by providing a brief update of our previously announced proposed merger with Idera.

We have spent the last several weeks engaging with shareholders on the strategic and financial merits of the transaction, which will create a new company to be called [Valencion] .

We continue to be very excited opportunities for growth and stockholder value creation from this combination as well as its many compelling benefits that can be delivered on behalf of the patients and employees of both companies.

Together, we will create a more competitive company focused on rare diseases with many more strategic opportunities to enhance stockholder value.

Among other things, the combined company will be able to integrate and capitalize on both BioCryst and Idera's separate and complementary talents and expertise to successfully commercialize late-stage development candidates and expand the number of rare disease targets that can be advanced into development.

Valencion will have a more robust product pipeline led by 2 Phase III programs, 2 Phase II rare disease programs and a variety of early-stage programs and supporting assets giving us more shots on goal and diversifying risk by combining synergistic discovery engines with enhanced development opportunities.

This means we'll have the ability to leverage both structure-guided small molecule design and nucleic acid oligonucleotide chemistry within 1 organization.

We believe the combination of small molecule and oligo chemistry may create more effective and potentially unique treatments for rare diseases, ultimately allowing us to expand the number of rare disease targets that can be advanced into development.

For example, oligonucleotide chemistry primarily targets the kidney and the liver.

However, by combining BioCryst's small molecules with Idera's oligos, we may be able to deliver oligos to other target organs in the body.

We believe this potential creates an exciting growth opportunity by establishing a unique and broader platform to pursue.

In other words, more opportunities for success that are differentiated.

Lastly, the combined company will have increased financial strength and flexibility, making it well positioned to fund internal clinical development, discovery research and commercial launch preparation efforts.

As you know, the transaction is subject to approval by the stockholders of both companies.

We invite all stockholders of record as of May 28, 2018, to join us at our special meeting to vote on the proposed merger on July 10, 2018, at 10:00 a.m.

Eastern.

We continue to work toward completing the transaction so that we can deliver the benefits of the combination to employees, patients and stockholders.

We're also looking forward to the new clinical data on Idera's IMO-2125 program, which will be presented at the American Society of Clinical Oncology meeting in Chicago on June 4th.

We remain as confident as ever about the financial and strategic benefits this combination will deliver, and we'll continue to keep you updated on our progress.

That's it for our prepared remarks.

We will now open it up for your questions.

(Operator Instructions) The first question is from Brian Abrahams of RBC Capital Markets.

A question on the HAE program and then a couple on the proposed merger.

I guess on the -- starting with the 7353, on the ZENITH study with enrollment there wrapping up, is there anything you could say about maybe what you're observing on a blinded basis in terms of attack rate and safety that gives you confidence that this study will be able to show -- clearly show benefit for 7353 as well as confidence in the GI tolerability at the high dose?

This is Bill.

Brian, thanks for the question.

The oversight of the study, of course, is blinded as you pointed out.

We have looked into the operational compliance aspects from both the investigator and patient perspective.

And just as a reminder, the events in this study are treated at home and that's the modern era of self-administered care for the treatment of acute attacks in hereditary angioedema.

So that the patient's attacks need to be qualified for the experimental treatment.

That's done over the telephone with site investigator, and that's going well.

The patients need to fill out a diary.

That's going well.

So the -- from the point of view of gathering the data we need to analyze and come to a conclusion about whether the drug is effective, I think we feel pretty confident that the operational aspects of the study are delivering exactly what we will need.

So that's going well.

We haven't had any safety issues.

Great.

And then on the proposed merger, Bill, you noted that you are expecting operating expenses to be in the higher end of the range in part due to merger-related costs.

Can you talk a little bit more specifically about that?

Maybe quantify that to some degree, and what we should be looking for going forward if the merger were to go through in terms of those costs potentially washing out as well, as kind of the latest updates on potential synergies from a financial standpoint and the cash needs of combined company versus BioCryst as a standalone?

Sure, Brian.

It's Tom.

So first of all, the merger-related costs were just under $5 million, $4.7 million.

And in regards to being in the upper end of our operating expense ranges, there are 2 factors that really contribute to that.

One, is the aggressive advancement of predominantly our HAE program but also some of our preclinical programs.

So that's moving as quick or quicker than what we anticipated in our budget.

And obviously when we did our budget, we didn't anticipate any due diligence and merger-related costs.

And so between those 2 factors, it pushes you into the upper end of our forecasted ranges.

In regards to the cash runway for both organizations, I think -- obviously, I can speak for BioCryst, but I have also heard my counterpart at Idera and both the organizations have cash through September of 2019 as of the most recent public reporting.

And they've also mentioned that they expect $20 million in synergies in year 2 and a total of $30 million in year 3. So I think it would be inappropriate to discuss what the combined entity would look like because we're still going through the integration procedures.

And I'm sure that, that will take some time after the deal was closed to come out with some public information.

So let me just add, Brian.

In my prepared remarks, I talked about some of the financial flexibility that the new company will have.

And that comes in the form of stuff that Tom and I would characterize as more likely in the short term and then some stuff that's a bit further off, that's a bit more substantial.

So in the bucket of more likely on the Idera side there's an opportunity that they've gotten from the sale of warrants that they brought in additional capital.

We got the opportunity with this procurement contract to bringing in additional capital.

There is ability to refinance the mid-cap debt because we're assuming in that runway of the combined company that we would have to pay that back.

And so refinancing that is something that we're relatively confident that we'll be able to do.

And then there are a couple of other things that Idera is working on, that could bring in additional capital.

All together, that's somewhere in the $50 million to $60 million range roughly.

And then the longer term is what we've talked about before, where it's really clear that 2125 to really be able to take advantage of using it in a number of different tumor types requires the financial strength of a much bigger player.

And so there is an interest level from strategic players in this space, and we remain confident that there could be a license deal that could bring in both an upfront payment and milestones that we think could be substantial in helping fund the future of the company.

And then we've also talked about the ability to out-license 7353 in Japan.

And Bill this month will be heading to hopefully finalize the development plan for Japan with PMDA and we'll be working shortly after that to start our conversations with partners in Japan.

So those things are bigger chunks that we think can really make a difference in funding the launch of 7353, funding clinical development of other programs as they advance and funding the research.

That's really helpful.

Jon and Tom, sorry, I misspoke.

I meant those questions -- that question for you.

But I do have one more question for Bill, if I may.

I guess what are the key things that I guess, what we should be looking for coming out of the 2125 data at ASCO that might influence, I guess, the rationale as -- and consideration of the merits of the risk profile, the potential scientific synergies of the merger?

And I'll hop back into queue.

Sure.

My understanding is that there will be an update of the 2125 plus ipilimumab of their ongoing Phase II experiment in melanoma.

And they had an impressive response rate.

So an update on the response rate and the durability of responses are the key items.

I think that our review, we were pretty satisfied that the safety profile of the combination is similar to the safety profile of ipilimumab alone.

And that progress on that study is going to be a really interesting to see.

I think in the market research that Lynne and their team independently at the time that we did our diligence, the oncology community feedback was very clear that a response rate in people who have failed already a checkpoint inhibitor of about double the response rate you would get alone, which is (inaudible) would be very impressive.

And we value the asset, taking that into account, with an overall response rate of 30%, which is a lot lower than they initially saw in the original presentation.

So I think they're the main things that we'll be looking forward to seeing an update on.

And you go from 10 patients to 21 patients.

So much larger data set.

That gives you more confidence that what you're seeing is real.

So we're looking forward to the data coming out on June 4.

The next question is from Liisa Bayko of JMP Securities.

Congratulations on getting the kind of Phase III design up and going and looking forward to the merger completing.

Just a question about the Phase III actually.

What kind of patients are you going to be targeting for the Phase III in terms of sort of background rate of (inaudible) ?

Liisa, thanks for the question.

So because the study is a lot longer than APeX-1, we've been able to liberalize the eligibility criteria on attack rates, so around about one a month or sort.

In other respects, the eligibility criteria are typical of the clinical trial.

People have to be in otherwise good health and be able to comply with study requirements, the study visits, taking an oral medication, filling out diaries.

All of that is actually critically important to running the study.

So not every patient with hereditary angioedema is able to do those things in various circumstances.

But in general, it's a broad in the U.S. adult and adolescent population of the sort I described.

I would add to that Bill and his team have learned a lot from previous trials that we run.

And so the screening process and just making sure that we know that these people have HAE ,#1, and understand their overall condition and we're knocking out people that don't qualify and keeping people that do, I think we're getting much better at that.

We were good at it before.

But I think we're getting better and that is critical when you're in Phase III study.

And do you have patients that have maybe been on some of the other prophylactic medications, in some sort of washout period, how does that work?

Sure.

I think the individual patient choices about their medical care with their physician, we don't influence and we don't try to influence.

We can't -- for obvious reasons, we can't have other prophylactic medicines given during the study.

Also for obvious reasons, we have all of our studies and will continue to allow and insist on the availability of acute medicine to treat attacks, one or other of acute model medicines that are specifically targeted for HAE acute attack treatment.

So there will be a whole range of diversity of experience with prior therapies.

And we've seen that in our other studies.

We expect to see it again here with people who have had experience with many of the prophylactic therapies already that are on the market.

And she had a question about washout?

Yes.

The washout is determined based on the half-life of the drug.

So for example, if people had been on antigens before that takes a while to wash out.

So there is an adequate washout period designed for each of the prophylactic agents.

And during the process, they can't -- there is a prospective screening element here as well.

They don't come straight into the randomized part of the study.

So during the prospective screening portion, they can't be on any prophylaxis either.

Okay.

That's helpful.

That makes sense.

Could you give us -- kind of run through your assumptions in terms of like from here to approval in terms of timing, and so on and so forth?

Sure.

I think we haven't changed our guidance on that.

So our planning takes into account our best estimates of how long it will take to recruit and run the study and also how long it will take to recruit and run the APeX-S safety program because both of those combined are important.

There's also a maturing rat carcinogenicity study that will read out in the middle of next year.

So all of those things combined, as Jon said before, will lead to an NDA timeline in the second half of next year.

I think the -- from the point of view of when we would get a readout for the 24-week efficacy and safety analysis of APeX-2, we anticipate that before the middle of next year.

Your next question is from Maury Raycroft of Jefferies.

To serve for ZENITH, if you can talk about the baseline screening and how much history you have on patients coming into the study?

If you can provide any general perspective on the heterogeneity and the baseline attack rates between patients?

Interesting question.

Thanks, Maury.

I think for ZENITH, it's a very special study because; a, it's not prophylaxis and; b, what we're doing is seeing whether an intervention with an oral kallikrein inhibitor kind of accelerate the recovery back to normal once you have an attack.

So there's still some things we're measuring things like visual analogue scales, the severity and the symptoms during the attack and how quickly they resolve.

For that study, clearly, if you've got to swallow an oral medicine to treat the attack, the type of attack is important.

And if you're vomiting then can't swallow an oral medicine, for example.

So as I mentioned before, each attack has to get qualified.

There will be a whole range of heterogeneity in terms of historical attack frequency.

It's pretty liberal again.

It is taking time for people to go through a total of 3 qualified attacks on study.

For example, if the physician is not available or it's 2:00 in the morning and they don't want to call the physician in that particular attack, won't get treated with an experimental medicine, that's probably the commonest reason and should have not a suitable time to do it.

So that's factored into the estimate that Jon mentioned before.

We're very confident we'll be able to report out the Part 1 results in the third quarter.

But it does take time for people to get through 3 attacks and go through the process of calling their site investigator, having it qualified and taking the medicine.

The operation now, as I mentioned, all of that is working.

It's just taking some time.

Very helpful.

And for the 3Q update for ZENITH, will that be top line data in a press release?

Or should we expect that at a medical conference?

You should expect that in a company announcement.

And in the past, we have done that in a fair amount of detail each time that we've had top line results coming out of one of other important studies.

Got it.

Okay.

And then for the safety study, has the FDA or EMA prespecified when you should do analyses for the safety study and when you will disclose -- if you'll disclose the results from those analyses?

So the safety study is an open label study, so there is no blinding involved.

Each subject is treated with active agent and we accumulate safety data for the entire duration of the study, which by the way will continue after we file the NDA.

We'll keep patients on the drug until it's commercially available and continue to get additional safety data.

The timing of the analysis is that once we've seen the efficacy data we'll firm up our timelines for the NDA submission and then do [ACUPs] of the safety study to put into the NDA.

Then there is traditionally a safety update, 60 days, 90 days after the NDA submission.

So there is nothing in particular that the regulatory agency has guided about that.

That is just a standard way of doing business.

And the next question is from Serge Belanger of Needham & Company.

Couple of questions on 7353.

You talked that the APeX-2 will most -- initial recruitment will take place in the U.S. while APeX-S will recruit from the EU.

Just wanted your thoughts on that strategy and what kind of makeup between U.S. and EU patients do you expect in the final enrollment numbers of the APeX-2 study?

Yes.

So let me just clarify, Serge, this is Jon, on what we said in terms of priority.

So priority is getting the first half of APeX-2 fully enrolled.

And so what we've said is that the U.S. sites will only be used for that until that is completed.

Then those patients, of course, will be rolling over into the second 24 weeks, which qualifies for additional data for the safety study.

And once we've completed patients in the first 21 weeks, we will open up APeX-S to the U.S. as well.

We are starting APeX-S -- as a result of that, we're starting APeX-S in Europe and that works out nicely because we can't reuse patients from either APeX-1 or ZENITH in APeX-2.

And so -- but we can roll them over to APeX-S.

So that's largely where that enrollment is coming from currently.

And then we will expand -- in addition to the U.S. when the first 24 weeks is completed, we'll also expand over the coming quarters other regions beyond Europe.

If you fast forward to the applications for marketing in the U.S. and Europe, our anticipation is that both studies will have patients represented -- representations from both regions.

Okay.

And on ZENITH-1, you expect a 750-mg cohort to report in the second half of '18.

We updated that actually to the third quarter.

Okay.

Given your experience with that cohort and the smaller numbers of the 2 additional cohorts, what do you think is the cadence for the other cohorts to report in terms of timing?

Our plan is to do a final analysis when the study is finished, and that will be next year.

We're not going to do it part-by-part.

So it will be first part with the 36 patients in the 750-milligram cohort and then a final analysis of all 3 cohorts.

And like I said, we're 80% enrolled.

We're already randomizing in the last cohort the 250-milligram dose, so things are moving along at a good pace.

But the only tricky part is that you got to have patients have 3 attacks, following them for 3 attacks.

And our experience thus far is that, that takes about 4 months.

On average.

On average.

Yes.

If you remember when the study started, it was about middle of last year.

So I think very confident that we will report the final study results next year.

And one last question on RAPIVAB.

Do you expect any government stockpiling from the -- this recent EU approval?

And can you just give us, I guess, a quick history of the U.S. government's stockpiling history of -- with RAPIVAB?

I think there was an order in 2009 or 2010?

Yes.

So let me take that.

So with regard to Europe, I don't think it hurts to have European approval.

So -- but it's hard for me to predict anything around European stockpiling.

But we'll see how that plays out.

With regard to the U.S. stockpiling, you're correct.

In 2009, we sold to the government 10,000 5-day courses that were purchased, I think, in the November-ish timeframe at $22.5 million.

Those will expire next year.

And so that's why this presolicitation for procurement process has begun to basically replenish what's currently in the stockpile.

(Operator Instructions) The next question will be from Gena Wang of Barclays.

I think most of my questions have already been answered.

Just quick, the APeX-S, just wondering, will you collect any attack data from this safety trial?

Thanks for the question.

Yes, absolutely.

We'll collect attack data during the study.

It's not an efficacy study.

But it will be of interest to see the pattern of attacks and relate that to patient's prior experiences and we'll monitor that during the study.

And an important piece of information, Gena, too is that the way the protocol was designed, we are initially enrolling patients at the 150-milligram dose.

And we put forward an agreement and patients will be randomized for one arm or the other with the 110.

I see.

So how frequent will you collecting the attack data?

And then at what point will you share that data with investors?

So the plan for analysis is what I mentioned before, is that we'll analyze the study when it's time to start compiling the NDA.

So there is the -- the way the data is collected is using a patient diary.

So that will accumulate during the study, and we'll analyze that when the timing is clear on how we need to compile the NDA.

And we'll know that after we've got the 24-week efficacy analysis from APeX-2.

Yes, because it is part of the pivotal program and a part of the filing, we don't want to jump the gun on anything.

And so as Bill says, we will report that data once we've done the cut and submitted.

Okay.

And then one question regarding ZENITH-1.

So the top line data, we will expect the second half this year.

What will be your definition of a successful outcome?

It's a really interesting question because it's very worthwhile to look at how the prior studies of acute attack treatments were designed and reported.

And people forget that there's a placebo response here.

And that -- if you don't treat attacks of hereditary angioedema, they resolve spontaneously over time.

So they reach a maximum and then they go away.

And in every study, there is a placebo treatment effect size.

The difference between the active and the placebo at 4 hours, for example, is generally -- has generally been in the range of 30% to 40%.

So I don't want to predict what we'll see because I don't know what we'll see.

I can predict on the basis of the response to the prior question on this call that we will be able to figure out what's going on because the quality of the information is going to be very high.

So I think that what we're looking for here is clinical benefit from an oral medicine.

That's a big deal when you talk to patients.

And if they can avoid injecting themselves when they have an acute attack, that would be important.

There are going to be some attacks that won't be suitable for oral medicine.

Like I said before, if you're vomiting, then you can rule that out.

If you're having a rapidly progressive laryngeal attack where you can't swallow, you're much better off with an injection under those circumstances.

So I think that having an oral treatment for an acute attack will give patients choice.

And most attacks are not in the categories that I just talked about.

The vast majority are in peripheral or not associated with vomiting or not associated with impaired breathing or impaired swallowing or constriction in the throat.

So the majority of the attacks, if you could treat it with a simple oral liquid, for example, that would be a big deal.

So I think the bottom line here is I don't think there is a prespecified success criteria.

We would like to see a treatment benefit.

We would like to see it that is clearly different from the placebo effect, and we should be able to make a judgment in collaboration with our expert advisers about -- and with the patient advocates about whether that's important.

And I think it's close to that 30% to 40% that Bill talked about with an oral treatment, I think we have a real advantage.

Because what we hear from patients is the injectable burns and sometimes there is a breakthrough attack.

So having an oral that lasts a long time, I think, is going to give us a really big advantage even if we can't treat all attacks.

There are no further questions at this time.

I will turn the call back over to Jon Stonehouse for closing remarks.

So as always, we appreciate your interest in our company.

The main messages here are the trains are moving on time, the programs are advancing as planned, and we continue to push forward as we believe that the merger with Idera makes sense for shareholders, patients and employees.

So thanks for your interest, and have a great day.

Thank you.

Ladies and gentlemen, this concludes today's conference.

You may now disconnect.

Good day, everyone.