Q2 2020 Antares Pharma Inc Earnings Call
Morning difficult time, and our country's history and were driven in large part by sales growth of our flagship product zions debt as well as year over year growth of for to Teva generic at B. Penn.
The highlights of the second quarter saw as I've said grow 136% versus the same period last year and 274% over the first six months of 2020 with June recording the highest number of shipments and prescriptions filled the date.
In addition last week Zioptan recorded the highest number of total prescriptions filled in one week according to symphony prescription data.
In our alliance business, the combined revenue of device sales and royalties generated from Teva generic at B. Penn grew 61% in the second quarter and 83% over to first six months of this year as compared to the same periods in 2019.
We believe this is impressive revenue growth by any standard for both products.
Our proprietary products Zioptan, and Otrexup, which represents our highest margin business had a 65% increase in the quarter versus the same period last year and doubled over the first six months versus the same period in 2019.
Our commercial team has driven impressive growth as I've said, while maintaining otrexup as a steady contributor to our business.
On slide five you will see that prescription trends resides they continue their upward slope through second quarter with June totaling another record month.
Since the product launch last year more than 132000 prescriptions have been filled through June thirtyth and approximately 6000 different physicians have prescribed zions that to more than 20000 patients.
Second quarter total prescriptions increased 11% sequentially from the first quarter of this year. Despite the limitations, our salesforce and placed on them when they were unable to physically interact with physicians and their staff coupled with reduced number of patient visits.
We believe our decision at the ended the first quarter to strategically shift to an existing virtual detailing platform early in their pandemic.
As well as leveraging our social media presence to connect with our existing and potential customers and health care professionals.
As led to a positive impact on zions that prescription growth in sales.
Since early July most of our sales professionals have been able to resume limited in person detailing and we'll continue to work virtually in those offices or regions that don't allow access to the physician's office based on the varying stayed home orders restrictions and phased openings.
Since since May continue to have limited access to physicians, we made a tactical decision last quarter to shift our messaging as it relates to the unique product attributes as I've said, which was developed as an easy once weekly subcutaneously administered product designed for at home use.
We have heard from physicians at some testosterone deficient patients may not be able to or willing to visit their offices for treatment.
If a patient has already satisfied the prior prior authorization requirements from their insurance provider to initiate testosterone therapy. They can be easily switched from a physician administered therapy to self administration as I've said at home.
We will continue to target these physicians with our switch messaging as well as physicians, who are new to the as I've said story, who may be unaware of the virtually painless administration that has been shown to produce steady state testosterone levels throughout the once weekly dosing period.
We believe the benefits of Zions dead will continue to drive demand for an AD honed injection option.
Recently, we had the opportunity to welcome patch Jay the entire organization as our senior Vice President of commercial.
Pat joins us with over three decades of sales marketing market access and commercial operations experience.
His past commercial leadership roles include the development of strategic marketing plans for products associated with men's health urology pain management and oncology.
That has a proven track record of leading pharmaceutical commercial organizations, both large and small and we believe it will be a valuable asset to us as we enter next phase of growth resides that and our proprietary commercial business.
I would also like to take this time to thank Ed Catholic re leadership during the launch of Zions, Dan and his contribution and making it the fastest growing branded testosterone product on the market.
And is chosen to retire after successful career in the industry and we wish him well in his future endeavors.
Turning now to slide six and some exciting news from our development partner Teva.
This past July we announced the first commercialization of our multi dose pan platform in Europe.
Have a launch teriparatide injection the generic version of Eli Lilly's European brand product for sale.
Hair parity side is a drug device combination product used for the treatment of osteopetrosis. The product was initially launched in eight European countries and he recently advised US that this product has also been launched in Denmark, Ireland, Israel in Canada.
Teriparatide is currently approved and 17 countries in Europe, and Teva has indicated that they expect to launch in other European countries. Later this year.
The European launch represent another milestone achievement and our collaboration with Teva. This is the third successful approval and commercialization of a drug device combination product with our partner and fall as in previous launches of the generic Apis Epon efron and generic Sumatriptan auto injectors.
With respect to the Anda filing further us Derek version of retail.
Kevin continues to believe they could receive FDA approval later this year.
If approved the generic forteo pan will be fully so suitable at the pharmacy and we believe will receive six months of exclusivity.
Under our global agreement, we sell the devices to Teva at cost plus margin and receive escalating royalties from high single digit to mid teen percentage is based on net sales by Teva.
If approved we believe the product represents a significant opportunity for both companies.
I'd now like to talk about our first in on National distribution opportunity, which we announced earlier this week.
This past Monday, we disclosed and exclusive distribution agreement with were not as global medical supplies to distribute support and promote the sales eyes that in Saudi Arabia, and United Arab Emirates.
And honest has a proven track record of introducing building and maintaining profitable brands in the Arabian Gulf and Middle East regions.
We believe designs that product profile will fit nicely into market, which is currently underserved and Max attractive treatment options for testosterone deficient men.
On a turn to the agreement we will be responsible for the supply of fully packaged product humanitas and our partner will be responsible for submitting and obtaining regulatory approvals resides debt.
Once approved by health authorities non us will also be responsible for all marketing promotion and distribution as I've said in both countries.
We believe this agreement will heavily to ground work necessary to expand our global footprint presided.
We continue to make good progress on our pipeline despite the new co bid work environment.
This lateral rescue pad development program with our partner doors, you Pharmaceuticals continues to advance.
We're working with a dorsey it to develop a rescue pen, which will deliver a potentially fast acting p. too wide 12 antagonist.
Sure. She believes the rescue pan could be self administered at the onset of symptoms to stop the suspected heart attack and preserve muscle and heart functions.
We have initiate the usability and reliability studies with the Quickshot device, while partner adores year prepares to conduct clinical bridging study as well as finalizes the phase III study design with the various health authorities.
The Dorsey has indicated that they expect to initiate their global registration study in the first half of 2021, and we look forward to the start of this exciting trial.
Dorsey will pay for the development on the rescue pen and will review will be responsible for obtaining global regulatory approvals for the product.
In cars will provide fully assembled and labeled finished product to our partner at cost plus margin.
We will then be responsible for global commercialization in the product pending FDA and foreign approval.
We will then be entitled to receive escalating royalties of to double digit percentages on global net sales of the commercial product.
We believe the potential important is as product for patients adores Union Tories can be significant.
Turning now to our development program advisor, we continue to make good progress on this project for an undisclosed rescue pen as a reminder, subject to FDA approval, we will supply Pfizer with a fully package commercial ready product that cost plus margin and then receive escalating royalties from mid single digit to double digit percentages on end sales at a product.
[music].
We anticipate that we will be able to provide estimate on the development timeline. Once we receive we've received clearance from Pfizer.
Shifting now to our own internal pipeline.
As previously disclosed we are in the early stages of developing two new assets in the endocrinology in urology areas.
The endocrinology program is a rescue Pan that is currently in the preclinical and formulation stage of development.
The company had a successful pre I'd meeting with the FDA, which enabled us to identify and agree on a development path forward for a five will probably be to approach for an eventual and da submission.
A formulation development is successful we anticipate filing our initial R&D in 2021.
The next potential product candidate is an asset in urology.
We are working on a potential weekly formulation of an auto injector administered product with a target of obtaining presenting the feedback from the FDA and a first in human clinical study in 2021.
Which could potentially be filed by 90 filing in the same year.
Finally.
I'd now like to update you on some of the day to day changes, we're making to the way we operate as a company.
In response to the pandemic most of our executive and administrative functions are still working remotely and we have limited the number of staff in our facilities to those necessary for essential functions, such as development manufacturing and supply chain.
We have implemented numerous health and safety protocols are taking precautions to help protect our employees.
And targets provides essential medicines to our partners and patients and we are committed to delivering on this important mission.
We're continuing to work closely with our third party manufacturers and distributors in order to manage supply chain activities and mitigate any potential disruptions to our ability to slide products to our customers and or partners during a pandemic.
As a result of the commendable efforts of the organization to maintain the momentum of our business and he is unprecedented times. We are taking this opportunity to reinstate our full year 2020 revenue guidance, which we will bleed, which we believe will be in a range of $135 million to $155 million, which represents a year over year growth.
If rate.
But between nine and 25%.
Given the evolving nature of the pandemic the company may revisit revenue guidance at some future point in time.
We will however, stay laser laser focused on our business to be ready to adapt to any changes to market conditions should they occur.
I'd now like to turn the call over to frame for the financial details of our second quarter and six months ended June 32020, Fred.
Thanks, Bob throughout our business, we are very strong quarter. Despite the unusual challenges were all facing we recognized a record record second quarter revenue with $32.4 million and earnings per share of one cents.
These excellent results exceeded street revenue expectations of $30.4 million and breakeven EPS.
The second quarter marks the third time in the last four quarters that the company has achieved profitability.
In addition, we generated $3.7 million in cash from operations during the quarter and for the first six months of 2020 cash generated from operations was $9.3 million. This is a tremendous turnaround of over $20.4 million from 2019, when we used $11.2 million in cash during.
In the first six months of that year.
So let me begin with a more detailed review of the strong financial results by providing a breakdown of our revenue and operating expenses for the second quarter and first six months of 2020.
Total revenue was $32.4 million for the three months ended June Thirtyth, 2020, representing a 14% increase compared to $28.4 million and 29 team.
For the six month period ended June Thirtyth 2020, total revenue was a record $65.5 million, which is a 27% increase from $51.7 million for the comparable period in 2019.
Total product sales were $24.7 million for the second quarter, a 20% increase from $20.6 million in the second quarter 2019.
For the six month period ended June 32020 product sales were $51.8 million, 33% increased from $38.9 million for the comparable period in 2019.
Sales of our proprietary commercial products out seven attracts a totaled $14.8 million and $27.4 million for the three and six months ended June 32020, compared to $9 million and $13.8 million in the same periods of 2019.
The increase in proprietary product sales for three and six month periods in 2020 over 29 team was attributable to the continued growth of south set.
Partnered product sales were $9.8 million and $11.6 million for three months ended June 30 to 2020 in 2019.
And $24.4 million and $25.2 million for the six months ended June 30 to 2020 and 2019.
The three and six month reduction in partnered sales is primarily due to sales in 2019 of the needle free devices to vary.
During the second half of 2019, we completed the sale of that product a ferry and we're no longer recognizing sales on needle free devices.
In addition in 2019, we sold prelaunch quantity of Teriparatide pen starts up.
During the three months in six months ended June through 2020, we have seen significant growth in RFP Penn devices as sales have increased 64% and 76% from the comparable periods in 2019.
Finally, we continue to supply product Amec, who recently indicated to investors that they remain focused on maintaining patient access to the makena product.
Licensing and development revenue was $2.7 million and $4.4 million for the three and six month periods ended June 32020, compared to $2.2 million and $3.2 million for comparable periods in 2019.
The growth in licensing and development revenue for the three and six month periods was primarily from Pfizer rescue pen and the adores. This will outgrow penned development programs.
Royalty revenue was $5 million for the three months ended June 32020, compared to $5.6 million in the same grew 29 team.
For the six month period ended June 30, 2020 royalty revenue was $9.3 million compared to $9.6 million for the comparable period in 2019.
The decrease in royalty revenue for the three and six month periods were primarily attributable to a decline in royalties recognized from AMAG on the net sales of Makena subcutaneous auto injector.
Gross profit increased 24% to $19.9 million for the quarter ended June 32020, as compared to $16 million in the second quarter 29 team.
For the first six months of 2020 gross profit increased 34% to $37.9 million as compared to $28.3 million during the first half of 2019.
It's important to note that our gross profit as percent of total revenue increased to 61% for the quarter ended June 30 to 2020 up from 56% recording the same period in 2019 again. This is driven by the increase in SaaS deferred revenue.
Operating expenses were $16.9 million for the second quarter 2020, compared to $17.6 million on a comparable period in 2019 and $36.3 million and $34.9 million. During the first six months of 2020 and 2019.
The increase for the six months ended June 32020 was primarily attributable to increased headcount as well as increase non cash incentive compensation expense.
For the quarter ended June 32020, net income was $2.2 million or one cents per share compared to a net loss of $2.2 million or loss of one cents per share for the same period in 2019 and for the first six months of 2020 net loss was 200000 or breakeven per share as compare.
From a net loss of $7.8 million or five cents per share during the same period last year.
Finally, our cash and short term investments at the end of the second quarter increase of $51.6 million compared to $45.7 million at December 30, Onest 2019.
Ill now turn the call back to Bob Bob.
Thanks, Brad.
In summary, we had a great quarter with exceptional growth of our flagship product Zeiss did and continued growth of our at B. Penn business that drove strong operating and net income in addition to expanding our product offerings.
And advancing our internal pipeline.
I would like to once again, thank personally all of our employees and our stakeholders as we navigate through this unusual period of time.
Anyone here at Antargaz is make an extraordinary effort to maintain this positive momentum on the business. We are focused on driving growth through the commercial success of our proprietary and partnered products. We hope all of our employees and stakeholders remained safe and healthy.
This concludes my prepared remarks for today operator could you. Please open the lines up for the question and answer session.
Thank you Sir if you have by to ask your question. Please signal by pressing star one on your telephone keypad.
If you are using the speakerphone. Please make sure your mute function is turned off to allow your signal to reach our equipment.
Again, Please press star one to ask a question.
Pause for just a moment to allow everyone opportunity to signal for questions.
Thank you our first question will come from Elliot Wilbur with Raymond James.
Hey, Thanks, Good morning busy day, I am going apologize in advance of by.
As something that you.
Mentioned in your prepared commentary here, but first I guess for Bob and just thinking about the reinstatement of full year guidance in the range.
Within that expectation want to get your perspective on just short of three different items and how they may impact youre thinking about the the the range itself first is with respect to Mckenna looks like that product has stabilized based on a Max number last couple quarters.
Just wondering kind of how you're thinking about that product for the balance of the year in terms of.
Contribution to your numbers number to what you're seeing in terms of Epee pen order flow from Teva headed into the peak selling months given the uncertainty around.
Back to school dynamics across the.
The country, and then sort of how you're thinking about.
The.
Ability to get back and try to get resume normal thing in terms of detailing trends with respect to in office physician visits and what that.
What that means for Zydus dead in the back half the year, obviously, you've you've done very well with the asset kind of given the the constrained environment, but just thinking about I'm wondering sort of what you're thinking about in terms of.
How much how much of an incremental acceleration directory is dependent on kind of getting back into the office in front of physicians. Thanks.
Great. Thank daily.
Let me, let me focus on the first party year and it gets a ladder. The last part of your question was around the size dead.
And we've been seeing about.
25% of our details overall being in person and that really fluctuate depending on the spikes in co bid and so forth ever seen across the country, but otherwise.
Our sales reps have been able to effectively detail the offices with the virtual platform and I think you've seen that.
The result of that in a very difficult time.
In the April May June timeframe of the pandemic, where I think a lot of patients were actually really concerned about even go into doctors' offices, and we still we're able to grow our overall prescriptions from quarter to quarter, 11% and we saw the growth from the revenue standpoint, as well presides that I think what's different this time is ed.
The offices are more prepared for it and pandemic. So theres now seeing patients on a more regular basis is not as it's not as it was before the pandemic, but it's still a I think the protocols are in place and patients are coming in the ceded doctor. So we see that is a positive change over the last month or so.
For for our sales reps, because importantly for us it's really about the patients coming in the seat adopters and less about the access that we have to the offices because our ramps can effectively detail.
The doctors via the virtual platform.
We are able to view.
Virtual launches were able to do virtual detailing we're able to do sample get samples that a physician so all those.
The key tactical items can be done the key for US is for the patients to keep coming in and right now we definitely see a difference from the early part of the pandemic. So I think there's going to be continued growth as I've said and you know our range of our.
Guidance is really you know it did we didn't change it it's still.
Between 130 555, a lot of that originally was meant for the uncertainty around Mckenna I think the range now is really around the uncertainty of coded depending on what happens in the next few months I guess I think gives us the flexibility is to maintain that range across all of our business.
So things I'd say is going to continue to grow and we're really excited about.
The recent trends we had our all time high just last week on a prescription basis.
We're seeing new patients new patient starts increasing coming back.
Two.
Almost pre pre Kobe levels.
Generally patients are saying on the drug and we believe that the product will continue to grow on the FNF really front.
I think if you listen to Teva is call yesterday after netting was a leg they call that a strong driver of growth for them as had been a strong driver of growth for us.
But clearly we did.
Kevin did mention across their generic business there was a much higher.
Looking level that was or purchasing level that was done by patients in Q1 edge kind of dropped in Q2, we saw that a little bit on APB, but overall it was still really nice growth for our company.
Going into the back to school timeframe and the order flow from them.
We we from a device standpoint.
We can see pretty far out their demand and it's pretty high. We're we're we're doing everything we can to keep up with demand.
And so we don't see any.
Any issue related to back to school related to our device backs.
With related to what they ultimately sell.
In which is affects our royalty that's a more difficult.
Kind of question to ask as I don't know.
If the.
Virtual schooling is going to have a significant impact on happened Efrain I think that most parents are still going to refill their FNF run.
They are happy at B. Penn.
The scripts because they expire really in 18 months or less and I think that.
It's hard for us predict how cold it is going to impact that.
Biggest quarter for FNF and products, but overall I'd say the business is extremely strong.
Teva is doing a great job.
Of.
Making that a successful product for both us and them and.
Right now that's a that's a big part of our guidance for 2020.
And then your first question about Makena kind of put them in the order of importance.
Mckenna in our model, we assume that it continues to sell there's been no indication at this point that mid of that AMAG will not be able to continue to provide mckenna to pick to patients. They are working with the FDA.
But it is a a less material part of our business and so it's really for US we're continuing to supply them. The the the auto injectors to fully package product, we continue to get a royalty and it's a nice part of our business, but it's really not a primary car cover the growth of our of our of our business and our and our.
Opening so.
They continue to do well with it and we expect that to continue for the balance of the year.
Okay.
Okay.
Thank you. Our next question will come from Anthony Petrone with Jefferies.
Thanks, and hope everyone's doing while staying healthy.
Of couple on on Xyo Stead, and then and then I'll have won a tear apartheid just on Xyo stead, Bob can you give us a.
A sense within the the gross number you know what's coming from actually newly prescribed.
Our t. patients versus.
Kind of the pull through from I am patients that previously received the two blood draw clearance.
And then just on Teriparatide you know as we look at Lilly's numbers can you give us a level said on what the Canadian and European mixes in there no trailing 12 month numbers and I'll have one quick follow up thanks.
Sure on the on.
And as I've said as far as our new patient starts I think it's about it's probably equal that about half of the our new patient starts are switches and in half of our new to therapy.
And you know weekend were focusing on both both patients are.
Excellent targets for us.
As far as you know new new opportunities.
The this switches had been.
A little bit easier to get.
Just because we have patients that were doing I am injections in the doctor's offices in a they I.
I think that a lot of them still are not uncomfortable going in every two weeks.
And you also had some business from the the the old.
Implantable testosterone pellets.
That's you know not only is there a difficulty in getting into the office, but theres also a shortage of pellets.
Just because you know there's not a whole lot of demand for that.
So I think the switches are really what we're focusing on because it's a it's you don't have to go through the.
Prior authorization process, they don't have to get the blood draws its a bit easier for both us and the patients to get sized it on the new patient starts are there are still there still coming up.
The new patients are being introduced designs that on a regular basis on the offices are doing more tele health, but they still have to go in and get their blood draws and again I think the offices have been able to figure out there the appropriate protocols how to treated patients without them being exposed hopefully.
They go in there socially distance the stagger the number of patients in the office at any given time and that again has had a positive impact on the patient flow of new patients on Zions dead. So.
We expect that to continue.
As you see obviously here in the news there's a lot of spikes in a lot of regions and we're just trying to deal with those as best we can but overall the product continues to grow and it's doing well.
Helpful and then.
Then just looking into the Teriparatide launch again.
What is the branded mix candidate in Europe, and immune to follow up there would be is there any kind of indication.
From Teva, how they're going to proceed with pricing initially.
And.
And maybe just a clear of the timing on the US launch is that sort of a first half 21 event. Thanks again congratulations.
As Anthony as far as Teriparatide pricing and content is going to end.
Introduced their products into those markets, that's really a question for Teva.
We have no insight into their strategy there all.
What we're doing is we make sure that we're we supply then the depends for that product.
They are.
They then do other distribution they do all the marketing and so we Havent received our first royalty report so to be honest I just don't have any insight as to insight is said their pricing and the net selling price and things like that.
I guess launched a few weeks ago and.
We were excited about the launch and they continue to add countries and I think thats. The most important thing.
Adding Canada was a surprise for us because you know is outside of Europe, and they got the approval and were able to get to launch going there and they continue to add countries pretty much at which it appears to be like every week and so.
Our first royalty report will be do after like 90 days after the quarter and then we'll get a sense as to.
Where theyre seeing the best penetration.
Obviously you know.
Retail is an expensive product in the U.S.. It's not this it's not price the same way in Europe and in other countries out obviously most.
Other products are.
Less expensive and in Europe, and in Canada, and we don't see any any difference in that with Tevas for Tayo.
But overall the biggest piece in a market potentially as the us.
And the only thing I can say about that as you know.
We still believe that there's.
Got to be an approval for that product.
By the.
We ended it before the end of this year and launch plans will really be dictated by Teva and how quickly. They can can get the product ready for the U.S. after the approval.
So unfortunately, I can't give you any specific timing, but overall, we feel pretty good about.
You know Teriparatide and Forteo.
And look forward to that launch in the U.S. as well as the launch in Europe and in Canada.
Thank you very much club.
Thank you once again, we are holding for questions. Please press star one now if you would like to ask a question.
And that is star wanted to ask a question we will pause for just a moment.
Thank you we have a follow up from Elliot Wilbur with Raymond James.
Let's put Fred and the in the had say.
Specifically on a couple expense items, you've done a good job of holding that spending in lying I guess sort of at the peak of the pandemic, but obviously wed expect numbers are kind of ramp up in the second half of the year can you just maybe give us a little bit of a directional.
Color on FCC ne.
And R&D trends.
As well as a little bit of guidance or leased your perspective on how we should be thinking about operating cash flow trends in the second half the year. Thanks sure sure enough no problem at all as you know we give our you know we have guidance for revenue, we don't give it for Essen. So.
We're looking at right now for for the trends.
Our really impacted by by called it a if we continue to see the cool covert impacting commercial operations in particular, where we should see relatively flat commercial expenses for the rest of the year no significant increases or decreases as Bob said were about 25% back in the field. So if we remain at that level.
No I wouldn't be surprised if we were to take the first six months of this year and then really look to.
Double that's again the approximate amount for the for the full year.
When it comes to.
Gionee expenses again, that's fairly level, we're not looking at any significant increases or decreases we've been very fortunate that we've been having a growing business. We've maintained all of our staff and we.
We see the business is being very very strong and going forward and so as I mentioned, if we look at the first half of this year again, that's a good indicator of what we should be looking at the back half of the year.
When it comes through the R&D piece again, we may see some increases, but I would suspect that it would be relatively flat.
Bob went through a presentation as to our internal pipeline, where we're at with the programs with the P.I. NBS and looking at 2021 for for clinical trials, and that's really where we would see the uptick in the expenses take place in 2021, and so overall, we're looking at about the.
36 million.
Dollars for the first half of the year in our total operating expenses.
Surprise, it's very similar to that the back half maybe a slight the slight increase but not much of a change overall from a first two quarters versus backup.
Thank you and then you also asked me about the cash question, sorry about that and then.
With cash I I suspect that we will continue to have a cash generated from from our operations. We think if we're going to have a you know.
Our revenue will continue to.
The guidance that's out there for expenses remained fairly consistent we generated cash you know over $9 million, an operating cash in the first half of this year. There's no reason why we wouldn't continue to generate operating cash in the back half of this year as well so I think when a goods good position there financially as we look at our cash and.
Investments.
Thank you. Our next question comes from Anthony Petrone with Jefferies.
Okay.
Great just follow up here.
On I Dorsey or the phase three.
Ababa, Fred just just wondering how how large that that study and.
Intended to be in.
What's sort of uplift you would expect in and auto injectors once that gets under way.
And maybe you know how.
You know what that would suggest me on the manufacturing front, maybe towards the end of this year. Thanks again.
Thanks, Anthony as far as.
The Dorsey a phase three.
That's what they're still working that out with the health authorities, but it's estimated that there's probably going to be about 15000 patients in that study, which is typical for cardiovascular type of study and so it's a significant amount of auto injectors, where clearly not delivering a mall before the end of this year.
You know phase three is starting in the first half of next year, but we will be working towards devices for the bridging study as well as the phase three so you know the a those devices are in our in our forecast or in our in our guidance because we we know we have to deliver a you know that there.
What the volume is it requesting at least by the end of year.
So there shouldn't be any significant change into you know.
Our product revenue other than just the growth that we expect to see in order to hit our guidance.
So we think program is is going to you know.
Drive some additional development revenue as well as device revenue, but that again that all the in our guidance.
Okay and then the last one would be on the rescue pen five of the pathway in the filing it.
The the right way to think about that is it the actual filing would be.
A 2021 event.
We would fit in.
Yeah. The R&D would be 2021, it's a relatively short program. What we believe that we can get it done and timely fashion, but when it make sure we get formulation right, we want to get the that the.
Oh.
And the PK program to the yet yeah, FDA and then we'll be able to get better guidance.
But overall.
I think it'll be a you know.
A relatively short clinical program.
With a nice potential product that will disclose once we go into the I Andy.
Okay, all right. Thanks again.
Thank you. Our next question comes from Wally Walker with Hana Road capital.
Hi, good morning, and congratulations on the progress in quarter.
Yes, the reinstatement of the four irreverent guidance infers acceleration in revenue in the second half a year.
You say to elaborate on what gives you a confidence.
So and again thanks for the question when we look at the two main drivers of our business being Zioptan an happy.
I'd say, we're just we're.
We're looking at the trends were saying you know, we're seeing a lot of positive trends on.
The growth into prescriptions were seeing positive trends, obviously on the net selling price, which always happens you know the best we always do the vast in is that lapped the second half of the of the year for net selling price because we've gone through co pay support we've gone through you know a lot of the support that we have to get the patients in order to get to drop.
Rather than the first two quarters. So the net selling price goes up so as I've said is a big growth driver for us for the second half of the year and in the same with at with Abbvie. You know, we like I mentioned earlier, we have pretty good visibility into the demand from a from a device standpoint from Teva and until we know what we need to deliver.
Barring any issues with Toby.
A you know we we expected to be able deliver those are so far we've been fortunate with our manufacturers and our suppliers and it hasn't impacted us tremendously. We obviously you've had the same impacted most other companies where there is.
You know people coming in and out of the other plants with elevated so you have to deal with that but overall the MP business is pretty predictable and we expect that to be a a growth driver and on top of that the our development programs continue to ramp up you know the doors, yet and Pfizer and in some of that have a work that we do you know we have a.
Lot of development work, that's getting done in the second part of the year. So you'll see you know additional development revenue that's driving.
The growth of the revenue as well.
Great. Thanks very helpful.
Thank you once again, we'll pause for questions. Please press star one now to join the queue.
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Okay. Thanks again for joining us on todays conference call. If you have any follow up questions. You can reach me at six or 93593, 016 that completes todays call.
Thank you ladies and gentlemen. This concludes today's teleconference. You may now disconnect.