Q4 2021 SCYNEXIS Inc Earnings Call
Greetings and welcome to <unk> fourth quarter, and full year 2021 earnings conference call.
At this time all participants are in a listen only mode.
Question and answer session will follow the formal presentation.
If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.
As a reminder, this conference is being recorded.
I would now like to turn the conference over to your host Debbie Atkinson Executive Director of Communications and Investor Relations. Please go ahead.
Hello, everyone and welcome to today's conference call to discuss our fourth quarter and full year 2021 financial results and corporate update.
Before we start let me remind you that today's call will include forward looking statements based on current expectations, including statements concerning our financial outlook for the future leadership as expectations for our future financial and operational performance as well as our business strategy because such statements are subject to risks and uncertainties actual results may.
They differ materially from those expressed or implied by such forward looking statements. Please refer to our filings with the Securities and Exchange Commission, including our most recent annual report on Form 10-K , and quarterly report on Form 10-Q , including in each case under the caption risk factors and in other documents subsequently filed with or furnished to the SEC.
All forward looking statements speak only as of today March 29, 2022, <unk> undertakes no obligation to update such statements to reflect events that occur or circumstances that exist. After the date on which they were made the information on today's call is not intended for promotional purposes and not sufficient for prescribing.
Decisions.
Joining us on today's call are <unk>, President and CEO , Dr. Marco tackling Eddy Chief Commercial Officer, Christine Cohen Chief.
Chief Medical Officer, Dr. David Angulo, and interim Chief Financial Officer, Larry Hoffman following our prepared remarks, we'll open the call to questions now I will turn the call over to Dr. Mark <unk>, President and CEO .
Thank you Debbie good morning, everyone on one Jonathan Thank you for joining us today for our fourth quarter and full year 2021 earnings Investor call.
We are excited to share with you updates on the progress of the launch of breakfast sandwich.
And outline our vision for the future of the IBEX Hudson jokes franchise.
But as we get ready for 2022 pivotal year for sudden access let me briefly summarize key accomplishments of 2021.
On the R&D front, we obtain approval all day breakfast one just for the treatment of PBC the.
First new antifungal class.
'twenty, yes.
Following the positive phase three results of the Campbell study announced in February we plan to expand by end of the year. The labeling of Brexit Sam to include the prevention of recurrent BBC and as a result of our agreements with FDA. We are expanding the <unk> program with the module trial that may allow us.
An approval in invasive candidiasis in 2024.
We have an answer on Brexit.
<unk> had a historic transformation in 2021, becoming a fully integrated company.
At the end of 2021, Brexit plan was covered by commercial insurance for more than 40% of lives in the U S and we achieved about 4600 prescriptions and $1 1 million in net revenues.
On the corporate side, we close 2021 with more than $100 million in cash and the runway into the second quarter of 2020. We also continue to look for business development deals like the one we did with the hassle for greater China and for other non dilutive ways to strengthen our.
<unk>.
Yeah.
But the most important point to bring home today.
Our vision to make <unk> a.
A successful sustainable and profitable antifungal franchise is becoming a reality with the Brexit now approved the launch for the treatment of BDC also known as vaginal yeast infections, we plan to expand its labeling by end of this year to the provincial number accordingly, we see an indication for which nothing easier.
Moreover, we expect to get <unk> approved for a skin infections, namely in basic candidiasis in 2024 all of these indications when taken together will create the franchise with the potential to generate $700 million to $800 million a year in net sales.
In the U S alone.
So what are our key goals for 2022, well one is expanding Brexit fam labeling and advancing biological program and these are the key objective for our team.
David will talk more about these programs.
As Dan will discuss how we plan to grow but extra from adoption and how to expand insurance coverage.
Larry our interim Chief Financial Officer will provide more details on our expenses and cash balance.
Then we will open the floor for a Q&A session.
Now I would like to turn the call over to our Chief commercial officer lithium coin Christine.
Thank you Marcel and good morning last quarter I shared with you our prescribers enthusiasm about Brexit then as you may recall, we reviewed our plans to target clinicians, who treat a great deal of vaginal yeast infection.
Since our early days of launch in August we encountered exactly what we expected a well ingrained physician habits to continue using the same old ASR products, yet following a discussion with our representatives healthcare providers confirmed their desire to treat patients with vaginal yeast infections with the new product beyond the common Lee.
As days off.
And so our plan to ensure awareness and understanding of Brexit.
You increased so secure vaginal yeast infections remains our number one focus each day.
<unk> is the first and only oral fungicide on therapy that treats vaginal yeast infections, providing symptom relief with complete resolution. It has activity against a broad range of candida species, including those that are resistant to fluconazole.
These key clinical benefits coupled with the ease of a one day oral dosing are of great importance to health care providers and continue to motivate prescribing.
In August our sales team began to meet with their key health care provider customers. As you may recall, there is a wide and deep swap of Obgyns and other physicians, who treat women with BBC and our focus is on the top PBC prescribers, our sales team work to generate awareness of.
Brexit them, while at the same time, helping to physicians clearly understand the utility of a non is all fungicide all treatment for vaginal yeast infections.
Based on their work we have built a strong early base of Brexit than prescribers.
Our intention is to grow that base of prescribers and continue to expand prescribing.
In quarter, four 2021 alone more than 1600 physicians prescribed Brexit them. This progress is positive and these are the early indicators of Brexit them adopt.
Now.
Let's discuss the early results of our marketing and sales effort.
First and foremost it isn't portion for me to convey to you that breakfast than has been received positively by our health care provider customers, we have been able to educate prescribers on the benefits of Brexit them.
As with all launches convincing decision makers to do something different after a two decade habit is quite a task.
We have been able to effectively begin the conversation with these prescribers and help them to identify appropriate patients and to trial Brexit that.
We generated 3674 prescriptions in quarter, four 2021, which represents solid growth over quarter three 2021.
The majority of the growth in Q4 came from what I discussed earlier, which is expanding our prescriber base and generating more trial of Brexit them with new writers.
Okay.
In November we administered what is called an attitude trial and usage report or <unk>.
We learned that the same prescribers are reporting that they expect to expand their usage of Brexit them over the next three months.
What is important here is that our message Brexit them is an effective one day treatment that kills east is both meaningful and motivating to them.
And now these prescribers are having good outcomes with their patients and they are expanding their use.
These are all good indicators.
Now as for quarter, one 2022, our field teams continue calling on their health care providers, where they are evil, giving some given some office closures due to COVID-19 .
In some instances we have we have had to pivot like other companies to call on health care providers, who are more accessible the inability to get into some of these offices accounted for softness in January .
However, as things began opening back up in February you can see our ability to access these physicians and continue to drive their use of Brexit them once again.
As we continue to build demand for Brexit them. We also continue our work with insurers and payers.
As I've mentioned in our last call our National account directors are very seasoned and tenured with long standing relationships with their payer customers.
Based on this they have been able to secure important Brexit then review meetings since early 2021.
By the end of quarter four 2021, we successfully garnered coverage of and access to breakfast for more than $81 million commercially insured lives, which represents more than 48% of commercial lives.
This is not just a testament to the efforts of our national account team, but to the payers recognizing the high unmet need and clinical value of the first non azole therapy to treat Canada.
This coverage is not easily secured and I am pleased that we are tracking ahead of our expectations at this time.
Our launch to date has been highly focused on generating awareness trial and usage with our health care provider customers, while gaining access to Brexit them with payers. It is working.
As we all know well launches are a critical phase of our products commercial lifecycle and thats without a pandemic I am pleased with the efforts of our field teams despite difficult external stress factors in the environment. They have endured the challenges of the pandemic, both personally and professionally and niche soldier on.
And remain motivated and enthusiastic to keep that keep growing the brand.
It is rewarding to bring such an important therapy as Brexit them to health care providers and to patients. The feedback from physicians has been highly encouraging and hearing their experience with Brexit continues to fuel our efforts.
Thank you and I will now turn the call over to Dr. David Angulo, Our Chief Medical Officer, David <unk>.
Thank you Christine.
We continue to make significant progress in the development of <unk> for both community and hospital settings.
As recently announced we successfully completed our people those phase III study candle and reported positive results.
This study evaluated the efficacy of <unk> in preventing recurrences, so political vaginal <unk> in patients with recurrent BBC.
<unk> was given 300 milligrams PIV 1 billion loans for six months and what's comparing against the matching placebo.
In the study 65, 4% of patients receiving <unk> achieved clinical success, which was defined as not having any recurrence at all either culture proven presume or suspected through the week 24, compared to 53, 1% of placebo treated patients.
This difference was statistically significant.
Vintage of IDEXX of Homegoods over placebo was sustained over the three month follow up period.
<unk> remain a statistically significance.
With these results we are now on target for submission of a supplemental NDA in the United States in the second quarter of this year and we anticipate receiving approval by the end of the year.
These results reinforce the broad clinical utility of our novel antifungal in BBC and position <unk> as a much needed treatment option for patients suffering from the economies.
Additionally, the catalyst study provided some exciting news on the activity of the one the <unk> treatment in patients who failed three base of clinical data.
More than 70% of these fluconazole failure patients successfully achieved a significant reduction or elimination of signs and symptoms. After the one day course of IDEXX of Volcker.
We also continue making progress on the development programs for invasive fungal diseases and the following is a brief summary of the status of each.
The initiation of activities for our module study ever.
<unk> stepped on therapy in patients with invasive can be the yes. These are on track for having the first patient enrolled in Q2.
The innovative design of this study has triggered significant interest from investigators and we are currently evaluating a large pool of potential sites globally.
We will be enrolling approximately 220 subjects and we anticipate completion of these are studying early 2024 with potential approval late that year.
The significance of the unmet medical meeting and basically the <unk> and the potential for <unk> to offer a clinical benefit in these indications is highlighted by the orphan designation that <unk> received in the past year from the European Medicines Agency. The same designation was previously granted.
The U S FDA.
We continue to enroll well in our fueling candle study in <unk> studies.
As you May recall visa studies focused on patients with severe few million fungal infections, including candied alleys.
That are refractory.
People agents or in patients that cannot eliminate all that up before we.
We will be sharing the latest interim look at all the data for the visa studies in Q2.
But he used analysis of interim data from these studies clearly indicated the significant potential of hydraulics up let us establish that up the option for these very difficult to treat severe fungal infection.
Our senior just phase II study evaluating diabetics, if I'm getting combination with Vodafone are solid for the treatment of invasive aspergillosis remains active.
Also enrolling the most impacted by the Covid pandemic, we remain confident that enrollment will improve this year, allowing us to reach meaningful conclusions by you at the.
The results from this study will guide decisions regarding potential next steps for development of diabetics are from there for the treatment of invasive pull monovisc.
In Q4.
The intravenous formulation of hybrid except when they're successfully completed single and multiple ascending doses in a phase one study.
We were very pleased to see that the lippo Soma formulation of <unk> was well tolerated and the target expulsion was reached.
While we disclosed an extra step so for IV development program with regulators, we added scaling up manufacturing to enable subsequent clinical phases of development.
And as previously mentioned, we have completed our registration trial for the recurring BBC indication and we are on track to file next quarter on our.
Approval of the recurrent BBC indication will result in a very broad VDC label with the opportunity to help patients across a broader spectrum of the disease, including those suffering from incidental BBC episodes to those with Rakuten BDC that are often seeing their lives significantly affected by this chronic condition.
Uh huh.
I also want to mention that last year, we had a significant preclinical discovery when we reported that <unk> showed at GDT and synergistic efficacy with amphotericin B in a mouse model of newco to Mycosis <unk>.
Alternative treatment options for this devastating disease with very high mortality rates at this out of this but we need it.
In this heavily but significant development Dido source evaluating the potential clinical utility of <unk> in these conditions, which we had a need to do within our <unk> study.
And now let me turn the call over to Larry Hoffman or interim Chief Financial Officer.
Thank you David for the fourth quarter of 2021, Brexit from generated $600000 in net revenues was the first full quarter of sales for <unk> since its approval by the FDA in June of 2021.
As a reminder, we are recording revenue upon the sale of inventory to the wholesaler.
The net revenue amount represents sales none of all discounts to insurers also includes any discounts from patient assistant programs like our co pay card.
We expect our net selling price to improve over the course of the year.
Our cost of product revenue was $200000 for the fourth quarter of 2021 R&D expense for the fourth quarter of 2021 decreased.
The $7 7 million from $10 2 million versus the comparable prior year quarter.
SG&A expense for the fourth quarter of 2021 increased to $15 million from $5 2 million versus the fourth quarter of 2020.
The increase of $9 $8 million was driven by a $7 2 million increase in commercial expenses.
Relating to the ongoing commercialization of Brexit vote.
Total other expense was $6 9 million for the fourth quarter of 2021.
Versus total other expense of $27 4 million for the fourth quarter of 2020.
During the fourth quarters of 2021 and 2020. So next just recognized non cash losses of $5 million and $21 $3 million respectively.
On the fair value adjustment of warrant liabilities, the net cash losses of $600004 4 million, respectively on a fair value adjustment of derivative liabilities.
The net loss for the fourth quarter of 2021 was $29 2 million.
Or a $1 five a share compared to a net loss of $42 7 million or $3 43 per share.
For the comparable prior year quarter.
Our full year 2021 financial results are as follows Brexit and generated net product revenue of $1 1 million for 2021.
Earlier in 2021, we recognized $12 1 million in licensing revenue from Hans So pharma for similar to our exclusive license agreement for a Brexit fund jump in the greater China region.
Our cost of product revenue was 300000 for 2021.
R&D expense for 2021 decreased to $23 8 million from $36 5 million.
Versus the comparable prior year the.
The decrease of $12 7 million or 34, 9% was primarily driven by decreases of $5 5 million in CMC costs.
$5 2 million in clinical development expense.
$900000 in preclinical over expense.
$500000 in the regulatory and $500000 in other R&D related programs.
SG&A expense for 2021 increased to $49 9 million.
From $14 $6 million versus the comparable prior year period.
The increase was driven by increases in commercial expense to support the ongoing commercialization of Brexit.
As well as well as business development expense associated with our licensing agreement with handsome.
Which we entered into in February of 2021.
Yes.
Total other income was $24 9 million for 2021.
<unk> total other expense of $7 2 million for the comparable prior year.
During 2021, and 2020 <unk> recognized a noncash gain of $30 4 million.
And a noncash loss of $5 2 million risk.
Respectively on a fair value adjustment of its warrant liabilities and non cash gains of $1 2 million and $2 3 billion, respectively on the fair value adjustment of its derivative liabilities.
The net loss for 2021 was $32 9 million.
Or $1 25 per share.
<unk> to a net loss of $55 2 million or $5 15 per share for the comparable prior year.
As Marco mentioned at the start of the call we have a strong cash runway into the second quarter of 2023.
We have cash and cash equivalents of $104 5 million.
As of December 31, 2021, with an additional $9 7 million raised in Q1 of 2022.
The sale of New Jersey, net operating losses were $4 7 million and the drawdown of $5 million from the Hercules SPV debt facility.
Yeah.
Our partnership with hands, so provides us with the potential of $112 million.
And the future long term development and commercial milestones and the strength of our patent protection and our ongoing business development efforts provides us with additional opportunities internationally.
Thank you and before we begin the Q&A I'll turn the call back over to Marco. Thank you, Larry and before we close the call for Q&A I want to reiterate a few key points first <unk> is an innovative product for the treatment of ABC and we are making great strides with hcp's.
And patients. Moreover, we anticipate expanding the labeling to include.
Sanction of recorded to D. C by end of this year second our R&D pipeline for hospital indication is extremely robust and we expect to enroll the first patient in our module trial in the second.
Second quarter, the objective of the amount of the trial is to obtain the indication of invasive candidiasis for robotics iPhone, Joe and third we are in a very strong financial position with a cash balance of over $100 million.
And one way into the second quarter of 2024.
Operator, please open the floor for questions.
Okay.
Thank you at this time, we'll be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad.
A confirmation tone will indicate your line is in the question queue.
You May press Star two if you would like to remove your question from the queue.
For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
Our first question today is from Louise Chen of Cantor. Please proceed with your question.
Hi, Good morning, everyone. This is kirby onto Louise Thank you for taking our questions. So you put it you were at 40% of commercial insurers why we're interested in here more of a strategy increasing the coverage also what is your goal in coverage by the end of this year.
Questions also on the commercial appears to number of scripts per healthcare provider has more than $2 three scripts.
Each HCP on average for Q4.
3700, the bar by 1600, how does this compare to other antifungal treatments in the start of the product lifecycle.
Will it be the typical rate in PVC and how do you expect the script activity to improve over time. Thank you So Michigan.
Well, that's a lot of questions.
So let's start with the coverage coverage for US is first of all we are good at what we achieve and certainly our Christina and her team are putting into a positive withstand it sustained.
Any comments on our strategy to continue to get.
More coverage while we.
We will continue doing what we've done we have had a lot of success there Michael as you know the national account guys know their customers, while they work with the medical science liaisons to bring the clinical data to the payers and the payers themselves have seen the need for another option on non azole option and so that right. There has been really important to our payers.
We will continue doing all the things we have been getting which has had these pharmacy and therapeutic Committee review meetings will continue going through the clinical data and even market as some of these payers themselves are looking at their own claims data to see what's happening in their patient membership when they don't have an option to ease off and so that's <unk>.
A very important thing for us because these payers need something else win in Haynesville doesn't work.
That helps and we look at it will be second question of it is.
Christine.
Further elaborated with I would like just to remind that there is very.
Very.
Lethal previous experience because the last time with <unk> was applauding DTC was more than 25 years ago. So there is maybe not so much we can compare too and so.
We are certainly entering the field, where we need to break some habits casino was measured.
Please yes, absolutely and it takes time right.
Any category and I've done this in multiple different categories you have to.
Meet your calls to the physicians that matter the physicians, who are treating these conditions and in this case. These EDC traders, but you can't just do it once you have to do it multiple times. It takes multiple times to change a habit explain and remind that in what Brexit vendors. So looking at the.
The rate of 2627 at this moment in time to six to seven <unk> per prescriber at this moment in time, that's pretty good because that means to me what I'm, saying is that we have convincing Lee stated that <unk> is a treatment for these prescribers that's a neutral.
They started to try it that's what the trial is and then they found other patients I mean, they continue to find other patients. So it is straight math, but it is a rate we will look at how many patients how many prescriptions per prescriber as we go but it's super early Mark up, but that's a pretty good rate.
Thank you.
And that's why I get so much congrats on the quarter.
Thank you.
The next question is from Michael Higgins of Ladenburg Thalmann. Please proceed with your question.
Thanks, Congrats guys on the successes in 2021 really a transformational year for you guys.
Just a couple of questions on.
On the marketing approaches you touched upon some of these.
Comments in here in Q, Q&A, so far as well but.
Any potential changes to the marketing strategy in the back half of the question is.
When you take a look at the prescribers in the back half of 2021, it seems to be that there were some early adopters is that who you were targeting is that maybe just some folks and understood.
On the product maybe you had some some patient interaction that got them going so just trying to get a sense for that.
We saw over the winter months are seem to be sort of a plateau. So.
I believe crown had some impact there as well so just trying to get a sense for the.
The efficiency of the targeting so far thanks, Yeah, Hi, Michael its Christine Thank you for the question.
I mean, you always want to take a look at your targeting right, but and we have looked at it the targeting is really really strong it definitely is.
You used a good phrase early adopters that's that that was part of the criteria that we looked at for these call targets right and it absolutely was right. So you can get to you.
You get to trial and adoption quicker with those types of targets for sure.
In the January timeframe framed yes, absolutely some of those offices were closed and those are the most productive offices. So you definitely see some softening there, but absolutely tracks with windows offices start to open and our reps are able to get back in you absolutely see the bounce back there so no change in.
The approach except to say always make sure we hit our high decile call targets, because they matter and Thats exactly who we have with us in that strong base and they are continuing to expand their own prescribing because they are having good outcomes. So you always want to make sure you stick with your base of these types of coal tar.
<unk> early adopters does that does that makes sense, it's Michael.
Yes that makes a lot of sense.
And Michael if I can add to talking about strategy. What are you when something is Cristina was mentioning before something that clearly has been very very important.
We're expecting for the Doctor is one of the attributes of a bunch of them are <unk>. The fact that this is really a different philosophy in haynesville and basically brings.
And I attribute that just never unfortunately, cardiome for PVC so overseas.
<unk> was confirmed.
But we get from the field. So we think we are on the right strategy and we will continue to pursue it.
Thanks, Mark appreciate that one follow up for you Marco.
There are discussions going with potential European partners.
What stage would you say your outreach and discussions are at this stage. Thanks.
Okay.
I think I've been mentioning recently after the approval.
And so I know, we have a product which has been at least.
In terms of.
From a regulatory aspect clearly b type of conversation and interaction that we had in different regions have been intensifying.
Three major regions for us.
Critical <unk> Europe , one is Japan and the other is Latin America. These are putting major regions and of course the discussion.
So just the tune.
Clearly the fact that we were able to last year or two.
The.
Partnership with <unk> for greater China, we are a company that canceled.
A very.
Very favorable deal.
That means.
Clearly a perception that these brokers significant valuable truck cycle.
So stay tuned we I can assure you we are working working hard on this on these aspects of business and government.
I appreciate it thanks guys.
Thank you thank you Michael.
As a reminder, if you would like to ask a question. Please press star one on your telephone keypad.
Our next question is from Oren <unk> of H C. Wainwright. Please proceed with your question.
Thanks, guys.
A couple.
If I could just maybe follow up on the first question I was talking about prescribed.
Prescriber prescriptions per rider.
To dig for that.
Two and a half per Doc as an average obviously you know are you seeing practices are several practices where.
They are writing a much higher volume and maybe for a meaningful percentage of their BBC patients already and if so what factors are driving that is it just a matter of experience or is it more about access in their particular region to region, our patient base or.
Or something else and how are you leveraging that youre seeing it or how do you leverage that across.
Other targets, maybe speaker programs et cetera, and I have a couple follow ups. Thanks.
Okay. Thank you earn its christine thanks for the question.
Yeah, it's a bunch of all of that stuff. So we absolutely have prescribers that are writing well above the two five <unk> per.
Prescriber that like we said that was straight math you absolutely do have higher writers there. It comes at the criteria I would say our physicians, we got too really early they already had some information and knowledge from the medical side publications all of that going into our launch in August and then I would say to you cheekily promotion work.
Right. So when a rep show up and they show up consistently and they may convincing.
Arguments that Brexit then into neutral that you should use for this or that patient. It always you see that or and you see that you apply that promotion and it actually.
Comes back in a very reciprocal way.
From that time utilization on the prescribers parts. So it's a confluence of a lot of those things.
I don't know what each and every prescribers denominate denominator out there our BDC patients patient load, our but we absolutely have prescribers that are writing above the two five and the idea there to your point it to share best practices. So whatever's working if it's the promotion or is it.
Seeing certain phenotype of a doctor and talking to them in a certain way we share that across the whole of the sales force in what's called best practice sharing and then to your point there are other tactics like speaker programs, we will bring some of that information in and show how our speaker will get out there.
And talk about what they see and how they see breakfast I'm working in there.
Patient population.
It is a bunch of factors orin.
Okay.
Who are the patients do you think that are getting <unk>.
Brexit firm in this stage of the launch I mean, obviously it is not yet approved formally for prevention of recurrent PVC, but should I assume that it's being used mostly in refractory or repeat customers so to speak.
Or are we already seeing to the best.
You have your understanding.
First line or de Novo patients getting it.
Well as you can imagine with sort of the low hanging fruit for us.
At the beginning of the launch a boost patients better.
<unk> been experiencing in the past.
PVC and maybe we have not yet been fully satisfied with fluconazole in with it.
When just Patrick.
So.
So these are the type of patients that certainly we.
We may have.
More and more traction on the beginning because that'd be one where <unk> can really benefit of something different of a new mechanism of action and if when you decided on the mechanism of action.
I would actually you said it well there Michael we really stick with what what makes sense to the doctors when we talk to them is the fact that this is a non as all its different fungicide all activity. It kills right one day dosing and the last piece or and that really gets traction when we're talking to doctors is complete resolution of.
Signs and symptoms and that's almost like a patient type.
Message right and so when you put these pieces together and you talk to the Doctor They actually think about the patient their trading and they come up with it. So it's not necessarily I know, we as commercial people think about it the first second and third line, we actually paint the patient picture Moscow, and Thats really where we get the traction that does that.
Oren.
And just if I could be greedy I apologize just lastly, I think on the <unk> call you talked about maybe rolling out some quote unquote, DTC, which can mean a lot of different things. Obviously in early 2022, I'm wondering if that has happened or is happening.
Yes. So we are so funny DTC, so I would change it to D. T P. As in patients right. So what we will do is we have a really nice program campaign that we will launch in the summer timeframe coordinated with our summer kickoff of bomb.
The poa this.
And it will have some really strong and memorable campaign and messages for these patients that were learning about every single day and it'll be in the doctor's offices arent theirs.
Theres televisions in doctors' offices, there's labor behind material will put content up everywhere there as well as we will do a really strong digital push banner ads content integration and stuff like that so that will be summer timeframe you didn't miss it.
Okay. Thank you and thank you Ron.
The next question comes from Steve Brozak of WB. Please proceed with your question.
Okay.
Yes.
Good morning, sorry, I wasn't sure if I was on mute.
We very much appreciate the importance of the drug and that's what I'd like to focus on have you gotten any direct feedback from the clinicians as to patients who have been these refractory women who have literally.
<unk> a complete change in terms of their signs and symptoms and how how do you incorporate that into our future messaging and what would you expect going forward on these types of this type of feedback and I've got a follow up after that thank you.
Thank you well. Thank you Steve for the question. So let me make first of all something very clear with this.
We want to give you see or patients.
The final set of quarters DTC is not.
<unk> and approved indications therefore, we neither promote in this report.
The commercialization of <unk> in this indication we expect based on our phase III trial is actually to file to file a.
Supplemental NDA this coming quarter and getting an approved then we will be in a position really to go out and to promote to promote.
<unk> indication.
And of course, we.
What we have seen.
Some interesting results in our <unk> study.
As David was mentioning because there has been some patients.
Who received three doses of Fluconazole and these are patients with <unk>.
Part of the study and very affordable metric definition over according PUC.
Three doses of Fluconazole, which is three times.
Approved dose actually and steel.
DTC was not resolved and Solvay entered in this open label study, where they were getting one day treatment with.
Brexit.
And the results were very very promising more than 70% of them actually had a significant improvement or cleared their symptoms. So.
We really feel that these are important data and probably you may expect with probably some of the doctors out there when they are treating patients who may have experienced multiple episodes in their lifetime, we may see the same benefit.
Okay.
Let me swap over to because obviously this is one of those items, where science can drive. This in the results can drive this on the Gamal paper that came out a couple of weeks ago when.
He was reporting about the strength of a Brexit, especially.
Activity around Canada.
<unk>.
Would you expect that as clinicians, especially those who are on the leading edge two to start two to start to see the advantages would you expect more of these types of publications and more of these types of commentary is talking about.
The critical importance of this next generation product and I'll hop back into queue. Thank you.
Thank you Steve This is David Thank you and thank you for the question, Yes, certainly one of the key attributes of hydraulics of hunger is really the activity against the non aggregates candida species, including drilling <unk>.
And we know that one.
One of the cases that are not responding to the coordinated sourcing may be because this business is not susceptible to be sold in Canada is one of the ones, who often have very high.
Levels of <unk>. So we do expect that more and more information is going to come as we expand the use of <unk> in these patients about the response rates, but particularly non albicant candidates species and so that is one of the one of the key attributes that we've found that was fascinating for me.
These put all looking BDC because also <unk>.
<unk> gone unsold may work toward most of let's say majority of Canada, because you really need to drill down to know if this infection east caused by cutting out because we're in the majority in the.
<unk> setting they don't even know what the infections caused by so they don't even know the species, having a drug like <unk> homegoods breathing has goods at least in vitro activity over Candida albicans global AD that cruise Ci, which 100% nonresponsive components. So that just gives you the opportunity the ease of mind to know what.
<unk> has the greatest chances to be successful. So we believe that these types of obligations that you mentioned that you're going to continue pumping up and certainly we are we are.
Investigating those features as well, but thank you for mentioning that.
Two if I can also add to that.
Megaloblast I'll kind of quasi public are important not only in the BDC, but also for hospital infection in fact, Steve and thank you for the question, but it gives me the opportunity to remind everyone that the BDC is just part.
Of the larger franchise in larger antifungal franchise, where we will have.
The BDC with vaginal yeast infections treatment every quarter.
<unk>, which is a very very important program. Because this is also a program where we can bring a product that can really save lives in hospital infection invasive fungal infection. So that is actually the attractiveness and.
Of these <unk>.
Thats helpful. Josef these ability to call that a very broad range of indications and of course now a lot of the focus on some DTC because we are launching visa and of course that is.
I appreciate that this is a very important but.
It's good to remember and to remind everyone that this product is a much broader potential also beyond the PVC.
Steve.
Again, thank you and obviously good luck in the prosecution of the.
Sales. Thank you again.
Thank you thank you Steve.
The next question comes from Kumar <unk> of Brookline Capital markets. Please proceed with your question.
Thanks for taking my questions and congratulations on all the progress.
So with regard to recurrent we see what are your plans with regard to educating physicians.
As you walk through getting the F&B approved.
What medical meetings, how are you planning to present, those and do you have any plans to hire a lot of education on the win for them.
Yes, I can add on this that this is David Thank you come out for the question Stefan Yes. The medical affairs team is really putting all the older plants together to really support a very strong educational campaign in anticipation for an approval and launch for the product for that particular indication the team the medical affairs in them.
<unk> team has been extraordinarily active these past really attending most of the key relevant not only national but also regional.
Meetings in the way that we have been able to really make connections to the people, who typically drive opinions or drive simplification. So what we call the opinion leaders in that sense, but at the same time really providing information to the practices and payers as Christine mentioned. So this has been intensified let's.
Now in a way to to really enable the launch of the approval and the launch of the recall and BBC indication. So you could expect that similar to what happened prior to the launch of the BDC acute BDC treatment that we will have.
CME programs and that we will have as well a very strong presence in this regular meetings that are happening in terms of the in terms of the obgyn space that also in the nurse practitioner space that we found a very good source as well.
Potential prescribers that are eager to receive information from us. Unfortunately, I don't have in front of me right now the schedule of all these events I apologize for that but I can tell you that.
The regional weakness in the national meetings like <unk> Kogan said that they are all going to be Papa.
Populated with our team that are really right now eager and eager to disseminate information that we have on hand for sure.
And the population the obligation for the RBC data and it is going to be as soon as you could see we have already published very extensively or data in the coming from the acute BDC studies and we just have multiple obligations around and with subgroup population. So.
We have been very successful in putting all that information in the public domain and we will do as well with this with this with these days.
Okay. Thank you and you talked a little bit about.
Geographic expansion with potentially with partners Europe , Japan, and Latin America.
What kind of regulatory interactions ongoing bad at all but is that something that could potentially partner with barstool.
Well certainly as we have disclosed many thanks.
With regards to Europe , all our programs have been always discussed with the European Medical agency and incorporating suggestions coming from the European Medical agency to make sure of it.
Our final package.
Was.
Let's see.
Mission submission already before the European Medical agency.
And that really is the European authorities, but we have been discussing.
Most.
And with regard to Japan, and Latin America.
Well that is it.
As you May know that we have.
Yes.
Very.
Especially for Japan special requirements.
But we need to have some bridging activities and that will be something that will be carried out by the potential partner.
Yes.
Thank you so much.
Thank you. Thank you Kumar.
The next question is from Michael Higgins of Ladenburg Thalmann. Please proceed with your question.
Thanks a.
A couple of follow ups, if I could here in the time remaining.
You know I'll leave you alone on these these are more so for Dave and a Marco just some clinical questions.
Give us first off.
Your outlook for timing and design of any IV lysosomal formulation second questions on synergy.
The back half of 'twenty, two that are reasonable and then third question being an equal mycosis have you seen any ah patients enrolling into jewelry. Thanks guys.
And Michael This is David Thank you for the question. So the first one is regarding the IV formulation and timing.
Just make sure that overall demand.
So we are right now, yes, sorry, yes, yes, sorry, yeah, nothing can Michael so for the IV formulation as I mentioned, we were extraordinarily pleased to really see that.
Termination seem to have addressed previously.
This concerns regarding infusion tolerability shifts in now.
Inflation that we feel very confident can be really thrilled, but I think that development.
We are.
We are really aiming to find kind of a.
Abitibi region, abbreviated bridging strategy. That's what we are trying to and that's what we are really focusing in discussing with regulatory agencies to find what is the right. The right approach to really try to integrate these particular intravenous formulation within our development programs to maximize all of the information that we obtain from me.
At the same time to really try to get them up and running in the later stages of development as soon as possible.
Have not is steel.
Determining what are the specific timeline for that but I can tell you that both or objective is as I have mentioned in the past is ready to progress this into phase II accelerated phase III very rapidly and we are in the process of having those conversations to try to really find what is the right alternative in the REIT.
Option within within the regulatory environment at the same time, we are.
The and very optimistic that this will move forward very fast and we are.
So we are progressing on the manufacturing floor to be at for the IV formulation to enable those clinical studies as soon as we reached some let alone.
Endeavour.
This time, we have not guided specifically for timelines because we want to make sure that we have all the all the elements to be able to really plan appropriately and to be able to guide.
Timelines that you know we like to meet when we typically got for guidance, we want to make sure that we can do that so that's why we ask for the IV.
For the senior just your question was related we feel confident about about releasing data towards the second quarter of this year.
And I must say that that particular study.
In the past, we went a little bit surprised that it was somehow impacted really by that by the refocus.
The research units and most of the centers. This is a phase two study we need to remember that in many of the research centers that we will participate in and refocus our resources and doing public type of studies.
We saw little activity on this study over the past few years, having saved that that has changed and now we are much more optimistic based on the refocus and lowered.
Lower impact of the Covid in really the institutional.
Institutions that are participating in this study we are confident that route right now we're going to have a meaningful number of patients coming into the study to be able to have good completion. So we have not changed our guidelines and we are still we're still towards that objective of having data disclosed in the second half of this year.
And the third this study was about local causes mucormycosis.
So mucormycosis as safe as you know a very devastating condition has mortality rates that are typically higher than 50% right now the treatment alternatives are the most commonly used.
In total it can be but even with amphotericin b. It has a very high mortality rate and I hope that it can be hassle CCP.
CCP that typically prevent that from being given for a very long period of time, so to us was extraordinary.
I would say that.
Yes.
Very nice the data to really being able to see that <unk> with a different mechanism of action that uncertainty can be seems to be acting senior logistically against these full guide and in the animal model, we showed a very substantial improvement in survival.
We are able to achieve even half of that in humans. It will be a tremendous advantage are tremendous.
Improvement in the way that these particular bdcs can be treated the beauty study is written right now enabled right now immediately enrollment of patients with immune called Microsoft in a combination therapy with <unk> and what we are doing is speaking with other investigators in the <unk> study and making sure that they understand.
And the date of Newport Midcoast is that we have on hand, and we are actually presenting additional data from newco to Michael is in the Acme, sorry, if I just roll that out but indeed.
But I'll be presenting additional data in yoga Mycosis studies, and we're making sure that investigators understand the potential value that this combination therapy may provide for that indication. So we're very very excited about that.
That's great.
Some updates just a follow up on what you just said was that estimate that you sort of announced that North Carolina.
We have got as of now we only have just to be clear, we only had preclinical data, but we have continue to generate that more preclinical data from the PD is one that we announced and certainly what we're planning to announce that new data in the preclinical setting in aggregate.
And I'm guessing here that Daddy or medical communications directly to say David to just.
Put that put out ahead of the plasma sorry for that.
Yeah.
We don't mind. Thank you.
Michael.
I thought we are going to take one more question.
Thank you. The last question is from Oren <unk> of H C. Wainwright. Please proceed with your question.
Since we're you know letting data slip I thought I'd try to ask about.
Candle.
Yeah.
How are we going to see more data between now or on this call maybe.
With regards to.
Efficacy in a little better understanding how it differentiates from some kind of though what I'm, what I'm really getting at is we saw that obviously your topline data, which tells us a little bit but I imagine there is a lot.
Within that with regards to recurrence rates over that six month follow up.
I'm, hoping you have plans to show us data on that with regards to you know time to recurrence and total number of recurrences over that timeframe. So we can have a better understanding and certainly payers could have a better understanding about how game changing I Brexit asbestos Fluconazole haynesville.
Yes, and I don't know that on this call.
Yeah.
So I think that in the summer medical need. This is where we are planning to really have a further discussion.
Disclosure of additional pieces of information from these from these studies and but certainly yes. We are we are planning you know us we're very very kind of a light to really put a lot of information in the in the medical in the medical meetings and when we tried to share with you as much as we can in a timely basis, but yes. We will you will be hearing about additional efficacy data. Thank you.
For your continued interest and I'm guessing, it's I think that is a brown the summit medical meeting.
All right.
Okay.
Thank you Oren.
Yes.
There are no further questions.
I'll turn the call back to Marco <unk> for closing remarks.
Yes first of all I would like to thank everyone.
That's really weird.
A lot of good questions.
But our products again, we are very optimistic and very confident on the on the success commercial and scientific success of.
I shall from drip. So thank you very much for listening today and thank you for your continued support.
This concludes today's conference you may disconnect your lines at this time. Thank you for your participation.
Okay.
Okay.
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