Q2 2021 ADMA Biologics Inc Earnings Call
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Yeah.
Good afternoon, and welcome to asthma Biologics second quarter 2021 financial results and corporate update conference call on Wednesday August 11, 2021 at this time all participants are in a listen only mode there'll be a question and answer session to follow.
Please be advised that this call is being recorded at the company's request and will be available on the company's website approximately two hours following the end of the call.
At this time I would like to introduce Skyler blue.
<unk> Investor Relations and corporate strategy asthma biologic. Please go ahead.
Welcome everyone and thank you for joining us this afternoon to discuss the asthma biologics financial results for the second quarter 2021, and recent corporate updates I'm joined today by Adam.
Grossman, President and Chief Executive Officer, and Brian Lenz, Executive Vice President and Chief Financial Officer. During today's call Adam will provide some introductory comments and provide an update on corporate progress and then Brian will provide an overview of the company's second quarter 2021 financial results. Finally, Adam will then provide some brief summary remarks.
Before opening up the call for questions earlier today, we issued a press release detailing the second quarter of 2021 financial results and summarize certain second quarter achievements in recent corporate updates the release is available.
Available on our website at Www dot asthma biologics dot com.
Before we begin our formal comments I'll remind you that we will be making forward looking assertions during today's call that represent the company's intentions expectations or beliefs concerning future events, which constitute forward looking statements for the purposes of the safe Harbor provisions under the private Securities Litigation Reform Act of 1995.
All forward looking statements are subject to factors risks and uncertainties such as those detailed in today's press release announcing this call and in our filings with the SEC, which may cause actual results to differ materially from the results expressed or implied by such statements.
In addition, any forward looking statements represent our views only as of the date of this call you should not be relied upon as representing our views as of any subsequent date, we specifically disclaim any obligation to update any such statements except as required by the federal Securities laws.
We refer you to the disclosure notice section in our earnings release, we issued today and the risk factors section of our 2020 annual report on Form 10-K, and our quarterly report on Form 10-Q for the second quarter ended June 32021 for a discussion of important factors that could cause actual results to differ materially from these forward looking statements.
With that I would like to now turn the call over to Adam Grossman Adam.
Thank you Skyler good afternoon, everyone and thank you for joining us on today's call we.
We hope those joining us today remain healthy and safe.
Admin continues to excel with the commercial launch and revenue ramp up of its immunoglobulin and hyper immune globulin product portfolio.
As well as more broadly advancing our company's strategic goals to create value for stockholders in the periods to come.
The underlying business trends for our commercial immune globulin business have never been stronger and.
And the operational execution by our organization across business segments cannot be overstated.
The significant strides made during the first half of 2021 form the foundation for continued quarter over quarter revenue growth over the remainder of the year and thereafter.
The totality of our achievements to date will enable admin to enter the next phase of its profit oriented growth strategy from a position of strength.
The multi year investment and remediation initiatives will be successfully winding down with the anticipated approval of the van Rx a septic fill finished machine over the coming months and as a result, the company is now on the precipice of realizing significant operating leverage on its pathway.
Corporate profitability.
During the second quarter of 2021, admin exceeded analysts' consensus topline revenue forecast for the fourth consecutive quarter.
Generating record quarterly revenues of $17.8 million, representing a 129% growth rate compared to the second quarter of 2020.
Additionally, the company successfully narrowed neuro gross and net losses year over year.
And Adam I believe can continue in the coming quarters and further accelerate throughout 2022.
Well I had missed revenue and execution of its business plan have seen record and favorable results over the past several quarters. It is important to highlight that pandemic related headwinds have impacted and continued to impact atmos commercial launch phase.
Further these record second quarter financial results do not yet reflect the added benefits expected from the recent FDA approval of our 4400 leader expanded IV production scale.
The additional plasma center developments, including opening a new plasma center and implementing the new persona.
Our collection software.
Nor includes the operating efficiencies expected from the anticipated van Rx approval over the coming months.
We expect these approvals and enhancements to act as a significant tailwind for our business over the remainder of 2021 and beyond.
Another way through unprecedented adversity admit is just beginning to scratch the surface of the ultimate financial and value potential. We believe this asset base and biologic drug manufacturing organization is now able to support.
We expect the supply chain milestones achieved thus far in 2021.
Will result in greater product yields and cost of goods sold improvements to support both near term and ongoing financial results and importantly.
They will set the stage for durable value creation and continued narrowing of both gross and net losses over the longer term.
The recent achievement of FDA, finding no form 483 observations as part of the pre approval inspection for the van Rx a septic fill finished machine should pave the way for an anticipated approval over the coming months.
When approved the licensure of the van Rx machine will cap a successful multiyear remediation process and supply chain investment initiative at the Boca Raton, Florida manufacturing facility propel.
Propelling add my into an elite group of U S based drug manufacturers with comprehensive in house control of a majority of its critical manufacturing functions.
The COVID-19 pandemic has illuminated high profile vulnerabilities and pharmaceutical supply chain.
Our large and mid sized peers.
And it is in this context that we believe the successful remediation of our manufacturing operations.
Tablet Schmitz of end to end supply chain control and Atmos continued commitment to cgmp compliance uniquely differentiates our manufacturing footprint and is a testament to our industry, leading regulatory quality and operational personnel.
In addition to recently revising the plant's annual peak production capacity up to 600000 leaders as well as increasing peak revenue guidance to $300 million or more adama.
Adama will actively explore new contract manufacturing opportunities following the anticipated approval of.
Ban Rx machine in the second half of 2021.
Which could add additional revenue sources presently unquantified in the company's current financial targets.
We intend to provide updates to these financial objectives and communicate developments to the market as appropriate over the coming months.
Ensuring uninterrupted raw material plasma supply has been a strategic priority and investment focus for admin prior to and throughout the COVID-19 pandemic.
Industry wide headwinds pressuring plasma collection remain intact and are likely to sustain due to recent U S government policy restrictions.
<unk> to the U S, Mexico border and plasma collection facilities among other variables.
Accordingly, we believe the 2021 year to date milestones achieved.
Our admin bio centers business unit will yield significant results and largely insulate the company from broader market plasma collection and pricing fluctuations in the periods ahead.
Most notably the first half of 2021 can be defined by three overarching achievements for asthma Bio center segment and ongoing raw material supply.
One the implementation of human medics persona technology across our plasma collection Center network, which is expected to enhanced collection yield by approximately 8%.
To.
The extension of our company's principle third party plasma supply contract through year end 2022.
And three the continued on track expansion of the bio centers plasma collection Center network, which now includes eight centers in various stages of approval and development.
Collectively the benefits of these three elements establish a solid foundation for admin to ensure continuity of product supply.
To an increasingly supply constrained immune globulin market.
Atmos robust inventories of approximately $100 million at the end of the second quarter further validates the company's commitment to generate quarter over quarter revenue growth throughout 2021 and beyond.
As well as meet the production needs to achieve longer term revenue guidance of $300 million or more.
All told Admah remains on track to have 10 or more FDA approved plasma collection facilities in operation by 2024.
Admit is hitting its stride at a moment in time when immune globulin and continuity of plasma supply is arguably never been more critical or threatened.
Less than two years into the commercial launch of our company's immune globulin and hyper immune globulin products portfolio.
<unk> has established a strong foundation to continue to penetrate the rapidly growing U S immune globulin market.
Which reached approximately $9.5 billion in total revenues in 2020.
Up approximately 19% year over year.
With Atmos commercial portfolio now annualizing more than $71 million in top line sales and with losses continuing to narrow we anticipate the next several quarters of forward looking financial results will be reflective of what we believe is a highly undervalued asset base well on its way to generating peak revenues.
A $300 million or more with significant profitability beginning no later than the first quarter of 2024.
Additionally, as previously mentioned, we believe there may be opportunities to formerly revisit the companys current topline revenue and profitability guidance as the year progresses and anticipated regulatory events unfold.
The evaluation of these targets is ongoing and we look forward to communicating more in the periods ahead.
We would like to thank the asthma biologics team for keeping its focus and continuing to execute.
Producing biologics is a very complex process with many constituents throughout the supply chain.
And I commend you all for meeting our top goal delivering for the patients who are counting on us.
Additionally, we are sincerely grateful to our stockholders for their continued support of our efforts to provide lifesaving products to patients in need.
With that said I'd now like to turn the call over to Brian for a review of the second quarter 2021 financials.
Thank you Adam since we issued a press release earlier today outlining our second quarter 2021 financial results I'll just review some of the highlights.
For the second quarter of 2021, total revenues were $17.8 million compared to $7.8 million for the second quarter of 2020 and.
This represents an increase of $10 million or approximately 129%.
The revenue growth for the second quarter of 2021 compared to the second quarter of 2020 was favorably impacted by the continued commercial ramp up of our <unk> product portfolio and expanding customer base at both our bio centers plasma collection segment as well as in our bio manufacturing segment.
Additionally, admin grew its total asset base to a quarter end balance of approximately $232.8 million, which includes approximately $100 million of inventory.
<unk> expects that robust inventories, which are recorded at the company's cost to support quarter over quarter revenue growth throughout 2021, and beyond as well as meet the production needs to achieve longer term revenue guidance of $300 million or more.
This inventory balance consists of raw materials, including source plasma and other materials expect it to be used in the production as well as work in process and finished goods inventories comprised of our commercial IV products and intermediate fractions.
In the periods ahead, admin anticipates continuing to purchase raw materials, while also growing its internal plasma collection Center network building work in process inventories as well as finished goods inventories give.
Given the ongoing industry plasma collection constraints as Adam previously characterized we intend to retain a portion of our growing inventories as safety stock, which we believe will help solidify our emerging position as a reliable supplier to our customers distribution partners and prescribers over the coming quarters.
Our consolidated net loss for the second quarter of 2021 was approximately $18.9 million or <unk> 15 cents loss per basic and diluted share compared to a consolidated net loss of approximately $22 million or a 23 loss per basic and diluted share for the second quarter of 2020 the.
The decrease in year over year net loss was primarily attributable to increased revenues and improved gross margins.
With this being the fourth consecutive quarter of revenue growth. We anticipate this trend to continue in the periods ahead with that I will now turn the call back over to Adam for closing remarks.
Thank you Brian.
Within two years following FDA approval of a Senate and began.
<unk> has successfully established end to end control of its manufacturing chain and while doing so has also built a high caliber commercial organization well positioned to compete in the rapidly growing U S immune globulin market.
This market is expected to reach approximately $17.2 billion in annual revenues by 2027.
Admins 2021 year to date accomplishments across business segments.
We will enable the company to accelerate robust financial trends in the period ahead and enter the next phase of what we believe will be a multi decade profit oriented lifecycle opportunity.
In the short term, we now anticipate exiting 2021 with an annualized revenue run rate of approximately $100 million or more.
Additionally in.
And as communicated in prior calls.
We as a management team and board of directors have invested significant capital into the company.
And we are acutely aware of the valuation disconnect between Adam is appreciating intrinsic value and the company's current market cap.
We are aligned with you our stockholders.
As such we are considering alternative business opportunities to maximize stockholder value, including for example, the acquisition or sale of specific assets or businesses.
However, Asian, and or license agreements or other co development agreements or arrangements.
We look forward to a strong remainder of 2021 and the bright future for asthma biologics.
In closing I'd like to thank you our stockholders for your continued support as.
Is your investment in that and it helps to advance our mission to save lives make good efficacious safe products that help our friends family and neighbors.
Please donate plasma and help save lives.
And with that I'd now like to open up the call for your questions.
And thank you.
As a reminder to ask a question you will need to press star one on your telephone to withdraw your question press the pound key please standby, while we compile the Q&A roster.
And our first question comes from Anthony Petrone from Jefferies. Your line is now open.
Thanks, Good afternoon, everyone. Congratulations on an another shrunk to queue here.
Thanks Anthony.
I'm going to start with.
The 100 million target.
Exiting this year, just wondering what the mix of.
If again navi and incentive is in there.
So that'd be the first question and then on the.
The disclosure here on the C. D M O arrangements, when we think about the plant in Boca.
Eventually getting to an operational capacity of 600000 leaders what should we be thinking about in terms of.
Allocation to future potential CMO agreements and I'll have a couple of follow ups.
Sure. Thanks, Anthony Thanks for your kind words hope you're staying safe.
Up there in New York, So yes, we are.
It's a great time to be in the immune globulin business some might think that.
You stay on top of current events with the collection segment as well as how that flows through to finished goods.
A number of our competitors large midsize and smaller players they are not taking on new customers right now they're talking about.
Having tightness of supply anticipated later this year early next year.
We're hearing that there are are substantial countries in Europe in the EU that are truly under supplied at the present time and I'm not sure how much longer the competitors are able to take product from one country and bring it into the U S. So the.
The outlook for our revenue growth really looks very very strong again, we've got more product.
The supply chain and coming online than we've ever had before.
Regarding your question about the <unk>.
Hundred million potential <unk>.
One rate that we would be achieving later this year as we've previously said.
To you and others and on these calls our current mix is pretty much 90, 10, 80.20, right now began being the majority of the product that we are producing and distributing and selling out of this plant we are seeing growth in our.
Hyper immune products segment, Utah.
Utilization of Navi and the press release earlier this week regarding now having the one ml size back on the market.
Certainly as a welcome to our customers.
So we're very very excited there and we hope to gain some more market share back since.
We haven't had the one ml product on the market for a while and assertive is.
Growing at a steady pace.
Both in the outpatient and inpatient segment.
We feel very very confident that.
The J code has really helped to bolster.
And solidify reimbursement.
In multiple treatment settings, and we're just very proud of the work that we're doing and the acceptance of our products.
Again, we've got more product available and we are taking new customers we are.
Adding people to our distribution network, we are selling through distributors and pulling it through and we are also adding new specialty pharmacies hospitals homecare organizations all the time so.
Really things are going very well for us from a commercial standpoint I think your next question was around capacity.
Again, it's going to take us a little while to get up to the 600000 leader.
<unk>.
What we do say is that.
Within three or four years, or so we should be able to generate revenues.
We say $250 million.
Or more in 2024, and then potentially generating more thereafter.
It's probably going to take US 2020 for 2025 to get to really that 600000 liter capacity Anthony.
We're currently expanding our adenovirus centers business segment. So you saw that press release, yes.
Yesterday after market and we're really very proud of the work that's.
Being accomplished there and you take our.
Vertically integrated plasma collection, coupled with our third party supply agreements and some new contracts that are going to come online later this year and next year and.
We reiterate all previously stated financial and strategic objectives with respect to quarter over quarter revenue growth and we anticipate that's going to continue all the way through profitability forecasted for Q1.2024.
Hopefully that answers your question, you've got sure and I can add a little bit more color to the revenue net revenue mix Anthony as we saw in this quarter actually compared to the first quarter of 'twenty. One we had a negative 11% gross margin, we actually that number has been cut in half now to a negative 6% gross margin and that's really attributable to sell.
More of our hyper immune globulin products.
So that product mix is already starting to see a shift the hyper immune globulin is as we mentioned previously had a 70% to 80% gross margin and our standard <unk> product.
<unk> have a gross margin of 20% to 30%. So we've already started seeing that product mix really start in the second quarter, we think that thats going to.
Continue that trend. We are also in this quarter as a result of the increased revenues we've seen more customers that have been added we've expanded our customer base and again, we're selling more of our hyper immune products into the market and are being well received.
That's helpful. And then a couple of follow ups here would be one just to reiterate on implies on the collection side you're at eight.
In the process of getting to the eight centers I just want to confirm that exiting 2022. The target is still 410 operational centers. So that would be the first question and then and then secondly, just as you speak to inventories.
And you mentioned safety stock, maybe what should we be thinking of as we look at the inventory going forward what percent of your balances will be represented by safety stock. Thanks again.
Congrats again on the quarter.
Sure. Okay. So I can take take those questions.
With regards to the centers. We currently do have eight centers in various stages of development to our FDA approved five centers are collecting plasma at present.
By the end of 2022, we want to have 10 centers or more under our corporate umbrella by 2024, we'd like to have all those 10 centers or more FDA approved and really being in a place will be self sufficient to bring in from a supply chain standpoint. The majority if not all of our raw materials 400 to 600.
Leaders of revenue liters of plasma coming in from our plasma centers.
As you look at our inventories ending the second quarter of 2021, we have $100 million in inventory.
And half of that inventory. This is a testament to show how much production, we have really been able to ramp up here in Boca.
Our work in process is close to $50 million and Thats, a really I think that's a <unk>.
Testament to show how much the production has continued to increase here. We just got the 4400 approval process approved by the FDA just in April. So we think that that with number is going to continue to grow which is a good sign because as that with number of work in process number moves through the manufacturing and filling and filling phase of our.
Seven to 12 months production lifecycle.
That product is not going to go into the final phase. The finished good phase so to answer your question roughly how much finished goods would we estimate to have on a quarterly basis. If we're if we since we've guided to $250 million Anthony in 2024, and we say roughly a blended margin of about 50%.
On a quarterly basis, you are looking at somewhere between 60 and $70 million a quarter at 50% gross margin income somewhere around $30 million to $40 million and it's at our cost of finished goods. So we're certainly well on our way, having a balance sheet of $100 million of inventory at our cost thinking again about 50% gross margin on that number where search.
Really setting ourselves up for a very strong foundation that we've created to be.
<unk> are achieved quarter over quarter year over year revenue growth again, which is a testament to these recently published financials for our second quarter.
Thanks again.
Thank you.
Thank you and our next question comes from Elliot Wilbur from Raymond James Your line is now open.
Thanks. Good afternoon first question for Brian maybe just following up on some of your.
The commentary around Cogs in inventory, specifically thinking about the Cogs line always a lot of questions. When you have negative margins, but just trying to think about how this line congratulated or changes going forward as your top line increases I guess, if I look at second quarter revenue went up sequentially around one eight.
Cards went up around $1 million.
Is that.
How we're going to see things progress going forward basically youre going to start to see.
40%, 50% income margin per incremental revenue dollar on top of sort of the average Cogs run rate we've seen in the last quarter, just trying to figure out how exactly that number is going to trend is.
Sales continue to accelerate.
Sure. Thanks for the question Elliot So a couple of things with Cogs.
When we achieve.
The $250 million run rate from a revenue standpoint in 2024, we will essentially be at very close to full capacity production, 90% to 100% capacity production producing that much product to get to that level. We're certainly not there yet. So we currently do have some unabsorbed manufacturing overhead costs that are still in the cost of product revenue line.
But as we continue to scale up operations. Most importantly, as I mentioned about 4400 scale up as we continue to produce more <unk> at the 4400 leader more product more margins are going to be improved to essentially generate those additional revenues. So when you think about the really the main variable cost.
<unk> going from a two 202, a 4400 liter batch is just the raw material.
Not not.
Very small modest amount of additional direct labor, but the overhead is essentially the same so revenues to put it simplistically will be outpacing the overall cogs number in the not too distant future number one.
Of the 4400 liter batches, we're producing now that we're going to be releasing next year.
Number two the second half of this year, we have the $4.4400 liter batches. The conformance batches that we manufactured previously once we got the FDA approval to just this past April a couple of months ago, we're hoping to be selling we hope to expect to be selling those batches in the second half of this year. So you'll see margins continuing to improve there and again just thinking about the lifes.
Cycle timeframe of 4400 leader production it'll take seven to 12 months. So we're going to start realizing some of those synergies cost efficiencies margin improvement as we've seen this quarter from the previous quarter. We expect those trends to continue the second half of this year and certainly accelerating into the first half of 2022.
Sure.
I also think Elliot if I can just add something some something else too.
Take note of is that with any drug manufacturing and I think in the comments.
Brian and I have both said that producing biologics.
Certainly complicated complex and not the easiest thing in the world, but there's always the possibility of some onetime one off charges and expenses.
And they are unpredictable.
These are just things that.
It's hard for US to guide you as an analyst and others, but I think that that as we continue to produce more the.
The effects of maybe some of these.
Discrepancies and one off occurrences.
It could be less meaningful Additionally, I think with the pandemic and.
Certain issues regarding supply chain raw material disposables consumables.
Testing reagents et cetera. Other supplies there are some costs shipping charges, one time expenses I mean honestly.
Sure I don't have to really save these types of things, but you need to get a truck delivered with ethanol, but there is no driver, but you may have to offer the driver an extra five grand to get into the truck to come down here to drive it to you I mean there are.
There are some very interesting things that are going on across industries with the supply chain that.
Theyre just unpredictable right now but.
To Brian's point, we expect revenues to continue to increase the product mix is certainly.
Improving the acceptance of our hyper immune is growing and I think that.
As we've reported previously.
The margins on our hyper immune products are typically call it 60% to 80% gross margin product the more of those that we can sell.
The better our overall Cogs are going to be as an operating.
Business unit in the bio manufacturing segment.
Thanks, Adam if I can ask you a question as well I mean, historically <unk> has been a relatively steady product but.
Can you speak to any factors that might be driving.
Marginally increased demand there and similar question on.
<unk>.
Assertive.
What may be driving the incremental volume there or is it just overall demand for IV <unk> and then there is capacity constrained.
Strange or is it more specifically tied to.
The emergence or the increase in RSV infections that we've been.
Hearing about in the media.
Sure with respect to Nabil.
Be ebbs and flows across the market again, we're not.
Im not hearing about any of our competitors, having supply chain issues, but you never know whats occurring there, we've got a pretty competitive pricing in the marketplace.
I know that.
Some of our competitors.
Across our immunoglobulin portfolio.
And they are immunoglobulin portfolio as they have taken some price increases.
We feel very good about our pricing across products and we've we've recently announced the price increase that's going to take effect I think in the next week or so.
And we've got a competitive price we've got a good product as you know it's got a brand name out there.
There are some other factors I think people are still hunkering down and cohabitation with other people with hepatitis certainly.
As a labeled indicated use for four for the drug and quite frankly, I think awareness.
Maybe some of the marketing programs and some of the campaigns that we spent money on and invested on I like to think that.
That they are working.
With respect to assertive.
No.
As you know what differentiates <unk> from began and from other immune globulins on the market is our patented method.
How we identify and screen plasma donors.
And we collect from donors who are tested to have.
High levels of neutralizing antibodies to respiratory syncytial virus.
And our patent state that.
These donors also.
Seem to have.
Hi, antibody levels to a panel of other respiratory viral pathogens.
<unk>.
I cannot explain it defies everything that I've ever learned throughout my 25 year career in the.
<unk> RSV immune globulin space.
But.
Global awareness of RSV is is.
Heightened.
The CDC put out some guidelines a couple of months ago at least for the southeast region of the United States.
RSV is on high alert and we are seeing in.
An increased rate of RSV infections in advance of what's typically the normal and customary.
RSV season so.
The drug also in an outpatient setting I mean look when you look at again when you visit the <unk> website, we talk about patients that are suffering from chronic and persistent bacterial and viral infections. They may be on concurrent antibiotic therapy and receiving other other drugs. There I mean, I think our commercial team.
And the investments that we've made into the commercial launch both through the face to face approach the virtual Congresses. The websites media campaigns everything that we've done I mean, we've we've made us.
Significant investment into.
The launch of this of this product again, getting the J code and solidifying reimbursement I think helps but I think that we're starting to see a good return on our investments that we've made.
It's something that I talk about.
And I mentioned it in my prepared remarks today is.
We do a lot of things here at <unk> and one of the things that we do is we built an entire commercial organization to support our three commercial products and we've got a store.
Delaware Salesforce, a stellar national accounts team, we've got some of the leading market access and reimbursement folks in.
I'm proud of where these people have cut their teeth and come from and now they're bringing their expertise to Adam of biologics.
They're able to flourish here and I think that.
I take my hat off to this team and Hasnt been easy it's been a challenge during COVID-19 and the pandemic too.
Engage with clinicians and.
Let's just say.
When the country opened up this past summer.
Summer late spring early summer when things are opening up.
<unk> pushed me too resumed traveling they were some of the first to get vaccinated in.
They have been pounding the pavement and seeing the expense reports coming through so.
We're starting to see some hospital closures, we're starting to see hospital beds fill up and we're hearing and reading the articles that I am sure you are as well but.
I think it's all a mix of.
The chaos that is stemming from the pandemic.
Immune globulin is is what you use to prevent or treat certain infectious diseases in immune compromised people remember immune compromised patients typically don't respond well to vaccines.
So be it and influenza vaccine in RSV vaccine, we know that there are trials that are ongoing.
The COVID-19 vaccine and all the other normal and customary vaccines I mean, that's that's the purpose.
Immune globulin is to provide passive immunity.
<unk> infectious pathogen so.
I think it's all coming together and.
I say it.
But I really do mean it it's not a it's not a bad time to be in the immune globulin business, we continue to.
Receive inbound phone calls and our salesforce follows up with them and.
Were taken on new customers.
Where we're really proud of it and.
Yes.
The supply chain cycle.
There is there is improvements anticipated with the upcoming potential approval of the ban Rx machine in us taking control in house.
But you are never going to really speed it up faster than that 789.10 months timeframe.
That's how long it takes to make these drugs and you got to think about it like Gestating a baby.
Sometimes they come a little quicker, sometimes they take a little longer but most of the time youre looking at nine months.
You can accelerate this process so.
We appreciate our shareholders patience as we continue to grow and build our manufacturing throughput as.
As we secure our plasma supply, but at the end of the day, we really want people to feel confident that we've got an excellent commercial team leading the charge out there theyre, putting the product into the channel and they're pulling it through the utilization is there. The reimbursement is there and all of this is coming together and I think with our revised guidance that we put out.
This quarter.
We anticipate the potential to exit this year with a $100 million revenue run rate.
And that's only going to grow as we proceed through 2022, I mean, Brian and I can't be more bullish on the amount of finished goods that we're going to be able to provide to the market and.
We want the patient community and the patient advocacy community to know that if you have a problem obtaining IAG from your standard supplier. We're here and we've got we've got Graham's available.
Thanks, and one last question if I if I may could you just talk a little bit about the 100 ml.
While offering how important that is to expanding the franchise I know it's available in limited quantities currently.
But when do you have what are your kind of.
At full run rate with respect to that.
Presentation, just just curious if that just allows you to expand business with existing customers does it open new doors, just because that's sort of the preferred offering.
And the market just strategically what does that mean in terms of growing the franchise going forward.
First of all it's.
It's something all of our competitors have.
We have been commercial with a five Gram 50 ml vial size.
When I was a younger man and I was selling IV AIG.
When you only had five gram violence to sell with a lot harder than having tens or <unk> if.
If you think about it the product is dose typically immune globulin is dose at 500 milligrams per kg of body weight. So you take a 70 kilogram adult youre talking roughly 30% to 40 grams is a dose.
So when a hospital pharmacist or when a when a homecare pharmacist is preparing the immune globulin for infusion typically.
You will either pull it into a type of infusion transfer bag or youre going to hang each individual vial would you rather hang three vials or pool, three vials or would you rather pool seven vials I mean, it's it's it's a factor of labor costs and when Youre looking at are our customer.
And in our customer really are the homecare companies in the hospital a better.
Place where patients are infusing the products.
Look at this like they are a manufacturing organization also and their time is worth money in and they look at these things so.
Having 100 ml vial, certainly helps us to be more competitive, especially in the higher volume higher throughput specialty pharmacies homecare organizations and hospitals, where time is extremely valuable.
I think that it also demonstrates our commitment to.
Improving product quality and the diversity of our available offerings.
These are all things that in our commercial.
Manufacturing business does.
So I think when you factor all of this together.
Look we don't have plans in the short term for additional vial sizes. We plan to offer for began both the five and $10.50 ml 100 ml vial.
The 100 ml vial is available now.
So those are available for sale and as Brian mentioned, the vials that we currently have.
Produced.
And those four conformance batches that.
Were the basis for the prior approval supplement submission.
For the approval from FDA so.
Elliot coming from a place where we.
You took over this plant with a warning letter it was not in commercial production at that point in time to you fast forward. Our four year anniversary. If you will was in the second quarter June 6th.
Was our was our fourth anniversary and to get to a place where we've got.
Our fill finish line that we just completed an FDA pre approval inspection.
With a zero 43 observations.
We've got new container closure system out there that means new vial label packaging stopper cap.
Multiple vial sizes across.
Our our product portfolio of three products approved.
Plasma center expansion and build out.
Is exceeding our expectations I mean, we've accomplished a lot of things in four years.
And I think that our customers see it and I know, it's a long answer to your question about 100 ml size, but.
I think it all really makes a difference and it puts ad.
On the same playing field.
The CSL Takeda is <unk> <unk> and <unk>.
I don't think that there is a hospital pharmacy or a home care company out there that isn't aware that.
Adam a biologics as a player and has graham's available should they need them with big game incentive and.
BHP.
Thank you Adam.
And thank you.
And with that ladies and gentlemen, we are currently out of time I would like to turn the call back to Adam for additional closing remarks.
Thanks, everybody I hope you found the call interesting again to the <unk> team Thats listening truly proud of you you guys are doing a great job, let's keeps helping the patients that are counting on us to our shareholders again. We appreciate your continued support and your investment in this business allows us to do.
Great work and helps.
Our fellow citizens. So thanks again, thanks for dialing into the call donate plasma help save lives.
Sure.
We wish you all a healthy and safe evening take care.
Ladies and gentlemen, this does conclude the conference call for today, we appreciate your participation.
Participation and you may disconnect.
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