Q4 2021 Recro Pharma Inc Earnings Call

[music].

Good day, ladies and gentlemen, and welcome to the <unk> fourth quarter and year end 2021 financial results Conference call at this time all part.

<unk> are in a listen only mode. Later, we will conduct a question and answer session and instructions will follow at that time.

As a reminder, this conference call may be recorded I would now like to hand, the conference over to Stephanie Diaz, So <unk> Investor Relations Group. Please go ahead.

Thank you.

Hello, and thank you for joining us on today's call, we have David and low President and CEO and Brian Lane, Chief Financial Officer.

Today, we'll be providing an overview of <unk> contract development and manufacturing business, including updates on corporate activities and financial results for the quarter and year ended December 31 2021.

After our prepared remarks, we will welcome your questions.

Before we begin I would like to caution that comments made during this conference call. Today March one 2022 will contain certain forward looking statements within the meaning of the private Securities Litigation Reform Act of 1095 concerning the current beliefs of the company, which involve a number of assumptions risks and uncertainties actual.

Results could differ from these statements and the company undertakes no obligation to revise or update any statements made today I.

I encourage you to review all of the Companys filings with the Securities and Exchange Commission concerning these and other matters.

Our earnings press release, and this call will include discussion of certain non-GAAP information.

You can find our earnings press release, including relevant non-GAAP reconciliations on our corporate website at Ri grow CMO Dot com.

With that I'll turn the call over to David Hello, Rick <unk>, President and CEO .

Thank you Stephanie and thank you, everyone, who has dialed in and to those who are participating today via webcast.

And Im on slide three now of the accompanying deck one year ago I hosted my first earnings call as <unk>, New CEO haven't been onboard less than three months at that time, I announced a new strategic vision for the company comprised of four areas of focus for 2021.

Including expansion and diversification of <unk> customer base strengthening of our balance sheet position in order to better support both organic and inorganic growth.

Augmentation of our leadership as well as restructuring our operational organization and finally, continuing to upgrade and expand our capabilities and facilities to support growing customer demand.

<unk> had great optimism at that time and I'm very pleased to report that we've made great progress with each of these goals. During 2021, our success over the last year has placed the company on a new and exciting trajectory for 2022.

I will provide a review of our 2021 achievements as well as our vision for 2022, following an overview of our Q4 and full year financial results for that I'll turn the call over to Ryan.

Thank you David Good afternoon, everyone before I begin in addition to the brief financial overview I will provide on the call today additional details on our financial results for the fourth quarter and full year ended December 31, 2021 are included in our press release issued prior to this call.

And in our Form 10-K , which will be on file with the SEC.

Turning now to slide four I'll begin with an overview of our financial results for the fourth quarter revenues for the quarter ended December 31, 2021, or $22 3 million. This represents a 125% increase compared to revenues of $9 9 million reported during the prior year period.

The increase of $12 4 million was primarily the result of increases in revenue due to the acquisition of irises higher revenues from our non legacy business as well as higher revenue from our legacy commercial business due to timing of customer orders in 2020, which resulted in much lower sales in the fourth quarter of 2012.

<unk>.

Cost of sales for the quarter ended December 31, 2021 was $15 7 million compared to $12 5 million for the comparable period of 2020 the.

The increase of $3 2 million was primarily due to costs from the San Diego facility due to the acquisition of viruses and higher product and clinical material sales offset by increased production volumes.

Selling general and administrative expenses for the fourth quarter were $5 3 million compared to 4 million recorded in the 2020 period.

The increase of $1 3 million was primarily related to deal and integration costs related to the acquisition of irises in administrative expenses associated with our San Diego team offset by lower public company costs and stock based compensation expense.

As a result of our integration and reorganization effective October one 2021 certain expenses associated with employees, who now support our multi site organizational structure and operations are classified in selling general and administrative expenses prior to October one 2021. These.

Employees supported our plant operations and Werent classified in cost of sales <unk>.

Interest expense was $3 5 million for the three months ended December 31, 2021, a decrease compared to $4 4 million for the comparable period of 2020. The decrease of <unk> 9 million was primarily due to reduced term loan borrowings under the credit agreement with a theory as well as an overall decrease.

And the rate of interest on our term loans under the credit agreement.

This decrease was partially offset by an increase in interest from the seller's note, which was a component of the <unk> acquisition purchase price for.

For the quarter ended December 31, 2021, the company recorded a net loss of $2 4 million or <unk> <unk> per diluted share as compared to a net loss of $11 7 million or <unk> 48 per diluted share for the comparable period of 2020 EBITDA as adjusted for the period was three.

2 million compared to <unk> 3 million in the prior year period.

I will now provide an overview of our financial results for the full year of 2021 moving to slide five revenue for the year ended December 31, 2021 was $75 4 million, a 13% increase compared to $66 5 million for the same period in 2020 the <unk>.

<unk> of $8 9 million in revenue was primarily the result of increased revenues due to the acquisition of irises as well as higher revenues from our non legacy business, including revenue from our commercial product Tech transfer projects. Despite the discontinuation of two commercial product lines by our commercial partners announced in the <unk>.

First quarter of 2020, our legacy commercial business has remained relatively flat in 2021 compared to 2020 as our other commercial products saw growth in 2021 compared to 2020 rebounding from lower volumes in 2020 due to the impacts of the market from COVID-19.

Cost of sales for the year ended December 31, 2021 was $55 6 million compared to $54 1 million for the same period in 2020.

The cost of sales increase of one 5 million was primarily due to costs from the San Diego facility due to the acquisition of viruses and is partially offset by lower costs due to the prior year reduction in force and certain employment incentive tax credits in 2021.

Selling general and administrative expenses for the year ended December 31, 2021 were $18 4 million compared to $18 1 million for the same period in 2020.

The increase of <unk> 3 million was primarily related to deal and integration costs related to the acquisition of irises in administrative expenses associated with the addition of our San Diego team offset by lower public company costs and stock based compensation expense.

Interest expense was $15 1 million and $19 2 million. During the years ended December 31, 2021, and 2020, respectively. The decrease of $4 1 million was primarily due to reduced term loan borrowings under the credit agreement with this area as well as an overall decrease in the rate of intra.

<unk> on our term loans under the credit agreement.

This decrease was partially offset by an increase in interest from the seller's note, which was a component of the irises acquisition purchase price.

For the year ended December 31, 2021, <unk> reported a net loss of 11 4 million or <unk> 26 per diluted share compared to a net loss of $27 5 million or $1 16 per diluted share for the comparable period in 2020 EBITDA as adjusted for the period was $16 six.

Million compared to $14 million in the prior year period.

Our cash and cash equivalents as of December 31, 2021, or $25 2 million compared to $23 8 million as of the end of the prior fiscal year.

This concludes my financial overview.

For those interested in reviewing our non-GAAP reconciliations. Please see slide 15 in the slide deck I will now turn the call back over to David for an update on operations and achievements during the period.

Thank you Ryan at this time last year, we announced an ambitious plan for 2021.

I believe it is fair to say that we successfully delivered on every element of our plan and I would like to provide an overview of these accomplishments. Our first goal was to expand and diversify the company's customer base I am pleased to announce that during 2021, our customer base more than tripled a significant increase for a company our size.

This achievement is the result of several factors, including our acquisition of Iris since last August , which I'll address in greater detail later as well as the efforts of the company's business development team, which was entirely reconstituted in 2021.

In addition to top line growth this expansion Gabe <unk> with significantly more diversified customer base, which is critical to limiting the revenue variability that can occur due to customer specific or segment specific issues. These customer spend the full range of <unk> capabilities from early clinical trial support to commercial manner.

Fracturing highlighting the company's broad range of services and our ability to meet the needs of companies at any stage of the biopharmaceutical product lifecycle.

Our second goal for 2021 was to strengthen the company's financial position in order to better support both organic and inorganic growth again, we made great progress in this regard we began 2021 with the announcement that the company had successfully and significantly restructured our debt instrument with our finance.

<unk> theory.

Through this restructuring re grow successfully deleveraged, a total of $25 million of debt from our balance sheet in may of 2021, we further strengthen our balance sheet by raising gross proceeds of approximately $34 5 million.

Through an oversubscribed underwritten public offering.

When you combine the progress we made on our debt balance the capital raise and our increase in revenue and EBITDA. During the year, we ended 2021 and a considerably stronger financial position than when we began.

The third and fourth objectives for 2021 were to augment our leadership and restructure our operational organization and finally to continue upgrading and expanding our facilities and capabilities to support growing customer demand.

During the first half of the year, we revamped our business development team and made two critical appointments to our board. The company also continued to enhance and upgrade our existing facilities and capabilities, increasing utilization of our high potency suite as well as a new clinical trial packaging and labeling line in both areas of the company.

We executed according to plan.

Bolstering our early successes during the year last summer the company made a strategic move substantially advanced each of our four objectives. Even further in August 2021 re grow acquired irises, a San Diego based <unk>.

With capabilities that greatly complement our own through this strategic combination re grow further expanded and diversified our customer base enhance the stability of our revenues and strengthen the company's financial position with the addition of the <unk> team the company broadened our CMO leadership experience and tap.

As well as our geographic footprint.

Net result of the organic capital investments made in 2021 as well as the Irish This acquisition all combined with our already impressive commercial oral solid dose infrastructure and strong quality and regulatory track record is a transformation of our company to a stronger and more versatile CMO.

Capable of attracting and efficiently servicing a broader range of customers in the U S and abroad.

As shown in slide six and referencing the diamond shaped icons, which represent the former Irish business. This acquisition significantly expanded our project work in early development through phase II.

We see this segment is critical to our future growth and I'll touch on that again a bit later in my comments as.

As a result of these achievements to fourth quarter and full year 2021 were significantly stronger than the fourth quarter and full year of 2020, respectively. During the fourth quarter. The company recorded $22 $4 million in revenue our highest quarterly revenue since 2019. The company also achieved a significant increase.

$3 million in EBITDA compared to the prior year quarter.

Business development was also strong during the fourth quarter as seen in slide seven new business activity and wins dramatically increased in 2021 as compared to 2020 again in large part due to the expansion and reconstitution of our BD team.

During the period, we had a number of key highlights, including the execution of our commercial Master services and supply agreement with Otsuka pharmaceutical company through which we will be the U S. Based production site for significant commercial product within <unk> portfolio. We are very pleased to expand our work with otsuka and believed.

Disagreement highlights our ability to serve as a trusted U S supply source for developers of small molecule therapeutics.

During the quarter <unk> was also awarded a new development and manufacturing contract by the National Center for advancing translational sciences or in cats at the National Institutes of health.

Under the terms of this contract the company will support CMC development of any us 100.

<unk> dosage form of early and K that is prepared for the encapsulation of early NK and our patent protected molecular envelope technology and deliver via nasal spray device. In addition to providing early stage development support this project will utilize the company's sophisticated spray drying.

<unk> abilities, and we are very pleased to have been selected for this complex process.

And subsequent to the quarter end the company announced that it was awarded a new formulation development and GMP manufacturing contract from a key department of the U S government under terms of the new multi year $1 $5 million contract. The company will formulate manufacture and supply of topical dermal drug product.

Containing a prescribed active pharmaceutical ingredients as well as our matching placebo for a planned cancer prevention clinical study.

These activities will include analytical method development formulation GMP clinical trial manufacturing packaging and labeling services to support the planned clinical trial, which is designed to evaluate the effects of chemo prevention with the investigational compound on the recurrence of basal cell carcinoma again, we believe this broad.

<unk> showcases <unk> broad ranging clinical trial services as well as the company's unique formulation expertise.

While we had a very strong fourth quarter results for the for the full year 2021, we are even more impressive beginning with the company's year over year organic clinical new best business revenue, which grew by 63% when.

When including the <unk> acquisition this revenue growth increases to 147%.

During the year, the Companys gross margin improved by 7% from 19% in fiscal 2020% to 26% in fiscal 2021.

And we expect this trend to continue to improve as we spread our cost structure over a larger client base also EBITDA grew 19% in 2021 to $16 6 million from $14 million in 2020.

Beyond our financial achievements in 2021, the company has successfully expanded and diversified our customer base significantly enhanced our leadership team optimize operations post Irish this acquisition by creating business functions spanning our expanded footprint.

And expanded and enhanced our facilities and capabilities on both coasts.

And it's important to note that the company did this while continuing efforts to build increased sustainability into its operations during the year the company integrated as sustainability efforts into the combined organization and expanded its existing programs designed to reduce the company's environmental impact by building efficiencies into Utah.

Position of materials water and energy consumption, while minimizing waste.

By any measure 2021 was a very strong year for <unk> I would be remiss not to recognize our commercial manufacturing supply chain and quality teams for delivering our commercial products at a 100% on time in full or <unk> level and our Gainesville facility. This is a remarkable accomplishment when you consider.

The numerous additional challenges to Covid pandemic presented we believe the company is exceptionally well positioned to tackle the goals, we've established for 2022 and beyond.

In 2022, the company will focus on a number of goals that we believe will further elevate re grow in this sector.

On slide eight.

Our strategy includes executing segment specific sales and marketing strategies building stronger visibility and an updated identity for the organization enhancing both our customers and our employees experience working with and for the company and continuing to achieve growth and strengthen our financial position.

Our strategic mission is comprised of five key objectives.

The first is to realign our sales strategy to be most successful in each of the specific market segments that we serve and I'm on slide nine now there are three discrete market segments that we're currently supporting the commercial oral solid dose products are legacy profit sharing products such as <unk>.

And finally, the early stage development clients, whose programs we support our 2022 goals tall for the development and execution of specific targeted sales strategies for each segment the decision making processes key drivers in ways. We are measured by our customers are different enough for each of these three segments.

Segments that we believe using this differentiated and focused approach will be most effective for our customer base as well as maximize our ability to optimize our operational and resource prioritization. For example, while we now have a single company wide quality system that we have successfully deployed across our footprint.

We are committed to ensuring we use a risk based phase appropriate approach to quality in order to most effectively manage early stage clinical programs commercial qualification batches and end market ongoing production.

Additionally, our market intelligence during 2021 has highlighted an opportunity to completely refresh our brand in the biopharma market to more effectively communicate <unk> evolution as a partner to our clients as well to our people both present and future.

Historic perspective on recourse skill sets capabilities and culture are somewhat outdated as are those of viruses. We look forward to sharing our new company name logo and look in the coming weeks and believe it will provide a more accurate reflection of who we are and where we're going as a company.

The second objective during 2022, which will continue from the groundwork laid in 2021 is to optimize our organizational structure and expand our capabilities. Following the acquisition of viruses. The company formed an integration team, which is focusing on 15 discrete work streams to ensure.

Sure all synergies and opportunities are being captured and optimized we've created strong synergies and efficiencies in our sales and marketing quality and regulatory systems human resources and people engagement practices, environmental health and safety policies business systems and operational excellence processes.

This work will continue into 2022.

We will also continue to enhance our current capabilities and expand our operations to accommodate our growing customer base and attract new customers.

And as we announced last week, we're making great progress with the first of these offer and expansions are a septic fill finish and lie optimization capabilities as of today. The dedicated suite is very near completion and final validation and commissioning activities are underway.

Our third goal in 2022 is to further improve our customer experience, while <unk> has long enjoying this reputation as a high quality partner. We believe that there is always room to improve in the year ahead as our goal to strengthen our client interactions create unparalleled trust and establish valuable partnerships for.

Process development through commercialization.

It is also important that where it makes sense, we harmonize the experience our clients have at each of our sites. We have effective approaches to client communications and project management and we want to deploy those approaches consistently across our organization.

And while our customers are critical to our success. The same can be said of our outstanding team at <unk> and.

In 2022, we aspire to establish an industry, leading employee experience and corporate culture as our employees drive our success. It is our goal to create an inspiring flexible and rewarding experience for everyone at re growth and doing so we believe we will strengthen both recruitment employee engagement and retention.

<unk>, leading to a better workplace better performance and better outcomes for our clients and for our company's financial performance.

And finally during 2022 the company will continue to take steps to improve its financial strength.

As part of this we will continue to carefully manage our cash work to reduce our debt and engage in a consistent and transparent fashion with the investment community with respect to our debt. We are engaged in several projects to explore noncore assets such as real estate owned which can be monetized in order to pay down our debt in a non dilutive.

Wei.

2021 was a good year.

Given the momentum we have created I am confident in our ability to meet the goals established for the year ahead, and I am very pleased to announce that we are projecting revenue of between 90 and $95 million for the full year of 2022, representing year over year growth of between 20% and 26%.

This year over year topline growth can be further appreciated when you consider that our legacy products, namely the verapamil program, while very profitable for us is anticipated to be basically flat.

Looking at slides 10 through 12 at this point is best illustrated in this series of slides, which shows the progression of growth from 2018 to present as you can see <unk> is highly dependent upon the revenue generated from only a few legacy products in 2018 with advances in organic growth beginning to have an impact.

In 2021.

However, when you take the Irish this acquisition into consideration we are now significantly less dependent upon the revenue from legacy products with multiple new clinical programs driving growth as a result in 2021, we successfully diversified our customer revenues such that the share of our legacy business has been reduced.

From over 90% to approximately 70% of our business and looking ahead to 2025 and beyond we expect this trend to continue.

Looking at Slide 13, now so for us to achieve the growth we are projecting our non legacy business needs to grow by approximately 30% to 50% year over year, assuming full year irises sales in 2021. This is obviously well above industry growth rates and represents the momentum we built in the past several quarters.

Yeah.

I'm now on slide 14.

As with slack as with last year, we have laid out an ambitious plan for the year ahead and like last year. Our team is working diligently taking the steps required to meet expectations and beyond.

We believe that the achievements of 2021, clearly demonstrate our ambition and ability to execute as we met and exceeded each of our goals. In 2021 looking ahead, we plan to leverage our expanded expertise our enhanced service offerings, our dedicated team and our improved financial position to elevate our company to.

Become a leading growth CD ammo.

This concludes my prepared remarks for today, we can now open up the call for questions.

<unk>.

As a reminder to ask a question. Please press star one on your Touchtone telephone again Thats Star one on your Touchtone telephone to ask a question to withdraw your question press the pound key.

Please standby, while we compile the Q&A roster.

Our first question comes from the line of Jacob Johnson of Stephens. Your line is open.

Good afternoon.

David a couple of questions on the sales side and some of the new initiatives. There maybe maybe first on the differentiated sales strategy between the legacy business kind of early phase development work in tech transfer in terms and that seems to make a ton of sense to me in terms of.

Operationally, how how large of a change is that for your sales team and how hard and how do you kind of drive that approach.

Yes, thanks for the question Jacobs so.

There are I would say.

Subtle, but very specific differences in approach that we need to take.

We've got some expertise that we've added to the team in anticipation of this market stratification.

Work that we intended to set forth here as we move forward and so we've been able to add expertise.

We have expertise in the clinical trial services area, we have expertise in the commercial oral solid dose area. We have expertise in the early development <unk> space and so.

It's about.

How those proposals ought to be prepared.

What sort of diligence as required for quality audits with clients in those different spaces.

And quite frankly also who the decision makers are in.

Organizations, depending on where they are with those programs and so.

Those sound like major shifts I think we are prepared for it but we're spending a lot of time talking about how we orient the entire organization towards that we've been able to add.

New director of project management coming in from a major CMO, who will oversee all project management across the entire organization and appreciate and understand the differences in those sorts of programs. So it's an important part of our business strategy and one I feel confident.

With respect to the way we are moving forward.

Got it and then you mentioned I think a couple of times a lot of the new hires on the business development side. Obviously it takes some time for those people to get ramp can you just talk about where we are your business development team is in terms of.

Kind of being familiar with with credit offerings in <unk>.

I'm familiar with their target customers.

So we've spent a lot of so so the team is in place has been in place not quite but essentially a year plus.

Plus minus depending on the individual.

And I'll say that what we've talked about in the past is that we believe it took several quarters for that level of traction to began to ensure success and we're definitely.

Seeing the fruits of that right now with respect to the opportunity.

The size of opportunities many of the number of them and also the types of opportunities. So theres been a lot of training.

Done in San Diego's to make sure that everybody understands those capabilities in a completely different way than before and.

<unk>.

It's a very timely question because there is.

GAAP Arena, those same people and project management and everybody else right now with a different sales training events.

Now focused on.

Rolling out this strategy, so I feel like that the team is up to speed and Theyre rolling and they are working well together and.

I should also say for anybody that.

I can confirm that being able to be back in person in front of clients. While we often can't go to their offices, but still being able to meet with them off site somewhere.

Does accelerate the quantity and quality of conversations that we are able to have about programs got.

Got it.

Just one last one for me.

Going back to the sales strategy, you outlined tech transfer and second source opportunities as kind of one of the key areas. There can you just talk about how large those opportunities usually are how many of them. There are like how many shots on goal. There are for you in that space and then it does it does.

Low probability events. When you go after them or are they easier to win I'm, just kind of curious what that that opportunity set looks like.

Yes, I mean, there is a.

If you look at FDA.

Manufacturing approvals you can see that there.

A greater number of approvals than there are new drugs being approved so there are site.

Transfers that are being approved in.

I don't want to even give a percentage but it's.

It's a measurable piece.

Of activity.

And so the the types of opportunities we're looking at.

We do need to make sure some of them are that we hear about are very small.

And.

And so quite frankly.

The.

Economic impetus for the drug on our to make that transfer or to have a second source is very low I mean, it's a very long payback to be able to do that and then there are a few of them that we've encountered and had an opportunity to bid on.

Would completely.

Which are very large right and David completely consume our capacity, but there is a subset.

And the slot.

Where we can be supportive.

And it would be meaningful for us, but it would not absorb everything that we have with respect to capacity.

So.

I would say that there there is.

Enough of a population that we should expect to see some success and again I want to emphasize the types of conversations that we have with the sponsors for those sorts of programs are very different types of supply chain related conversations than an earlier program, where we're really investing in the science.

And the technical solution.

Got it that makes sense and congrats on all the progress in 2021 I'll leave it there.

Thank you.

Thank you. Our next question comes from Matt Hewitt of Craig Hallum Capital. Your line is open.

Good afternoon, and thank you for taking the questions maybe first off how should we be thinking about the revenue and gross margin cadence this year in relation to your guidance.

Is there any <unk>.

Impact from Covid in Q4, and early Q1 that means it might be more back half weighted or just help us understand how you're thinking about the cadence of the year.

Thanks for the question Matt. This is Ryan So I would say generally we are not giving quarter by quarter guidance, but just the full year guidance.

We feel obviously really good about the guidance that we gave today, 90% to $95 million.

And feel that we're well positioned in the market with our longstanding commercial history and robust capabilities to capture that growth.

In the marketplace.

Our development revenue or non legacy business is expected to increase 30% to 50% assuming the full year <unk> revenues.

Low single digit percentage increase in our legacy business. So overall, the revenue growth rates like 18% to 14%.

For the business and we think we have really good line of sight for.

The non legacy or the development revenue portion, especially with the $24 million in backlog that we have ending the year and our pipeline has never been stronger in terms of the backlog. We have in terms of the open proposals we have with customers what were able to sign during 2020.

One so.

It's exciting for us so.

The other comment.

Comment to your question or.

As with regard to.

Gross margins were expecting gross margins to remain in the mid 20% range.

The 2021 gross margins were a bit high taking into consideration the incentive tax credits that we received during 2021, so with the additional hiring that we have projected in 'twenty. Two we're seeing a benefit of higher revenues and increased utilization and <unk>.

Of our anticipated gross margins that are more than offsetting the incentive tax credits that we received during two.

<unk> 2020.

One.

And then just for <unk>.

Overall EBITDA perspective.

We're projecting roughly $16 million to $18 million.

And EBITDA and excluding the incentive tax credits, that's about a 40% increase compared to 2021 EBITDA.

Excluding those COVID-19 related incentive tax credits so.

Some of the puts and takes there really <unk>.

EBITDA guidance takes into account almost.

$18 million or so in higher revenue and related cost absorption associated with that and is offset by some of the nonrecurring COVID-19 related incentive tax credits as well as increased spend related to hiring and inflation, because we're running really lean in 2021.

Got it that's helpful. Thank you and then maybe just a follow up on some of the sales team.

Feedback that you've provided.

What is the headcount today for that team and how is that is I just want to make sure I understand this correctly is the team split up by those three different segments or is each salesperson.

Are they out kind of selling to all three segments.

Yes. This is David Hi, Matt.

I would say that we hired.

Subject matter expertise.

To be.

Spread and diversified across those offerings, but there is absolutely an expectation and it is happening in that.

<unk> on all of our offerings are being held by any of our BD reps with the clients within they interact and then obviously as soon as it gets a little bit more detailed and technical.

We are bringing in the scientific talent or the other sales folks.

We've seen.

Several opportunities where our existing clients on the GMP clinical trial material fronts. Some.

Some of these new clients, we've been able to add over the past couple of years.

Now coming back to us to talk about clinical trial services packaging label in distribution and it's.

A nice add on and so in those cases the sale.

Members are working in tandem to bring a combined solution.

Got it and then maybe one last one and I'll hop into the queue regarding all of the progress there.

Back at even just your August slide deck, compared to where you're at today, obviously, a tremendous amount of.

Our tremendous increase in the number of opportunities in your pipeline, but as we think about some of those newer opportunities.

You signed the contract how quickly does that do those turn into revenues I mean, I would imagine there is a pretty big variation, but on average once you sign the contract are you typically, especially on the development side are you able to get those started within a quarter or two or does some taking much longer than that thank you.

Thanks for the question Matt.

Generally yes, it takes about three to six months on average, but it really depends on the client their API availability.

And how quickly they are ready to get started.

Got it thank you.

Thanks, Matt.

Thank you. Our next question comes from Kristine <unk> of William Blair. Your question. Please.

Hey, guys congrats on the quarter and good afternoon, I was just hoping to get some color on the telco Tech transfer if you have any updates there do you.

Expect a commercial product production.

The second half of 2022 and have you seen any expansion opportunities beyond that.

Hi, Christine Thanks for the question.

Ryan So we're still on track with the registration batches with the expected completion by the end of the first half of 2022.

We expect to begin manufacturing the commercial quantities either late in 2002 or.

Early 'twenty three really depends on that's been there I think anticipating to receive approval back so thats when that would be kind of a subsequent entering the market thereafter.

But we continue to build a very strong relationship with otsuka and believe that we are delivering on all of their expectations.

Great. That's helpful and then my second one.

Yes.

The core legacy product portfolio.

It seems like.

Hey, good morning Carol.

ADHD and hypertension products.

Are you still seeing ADHD script.

Volumes across from pre pandemic levels is there any potential upside there.

And are you seeing any risks binary or you pretty quickly.

Are you there.

Yes I.

I would say that the ADHD levels are still below a baseline from pre COVID-19 .

But just looking at the 52 week kind of trend of scripts they do show.

Recovery.

In pediatrics.

Pediatric volumes.

And end of year boost I would say.

So we think that's trending positively.

As it relates to.

Teva and brought the mill SLR tab.

Teva contain continues to remain.

Steady and has actually picked up about 10% market share and bringing them to about 60% of the overall per app unless our capsule market. So we view that as a positive.

We also believe that Beatrice is.

Focus has been on Biosimilars and complex generics.

We saw they announced earlier this week and deal with Viacom.

The purchase of the interest is biosimilars business and shift in their strategic attention. So.

This is at least what they said was a first in a series of asset sales.

We view those activities as an opportunity and potential for us for.

Either additional product rationalization by them or it could be positive for us on a number of levels.

Great. Thanks, and then just one last one for me.

How are you seeing in terms of inflationary cost pressures I heard you say those are baked in to 2022 guidance, but any more color there.

It would be great.

So yes, I mean, let me just say this is David Christine.

Certainly.

It is top of mind for us and so we're.

Embracing the fact that there are going to be some increased cost, particularly on the labor side and we are very committed to remaining competitive in the market because one of the real competitive advantages we have quite frankly in the market is.

Stronger than <unk>.

Expected tenure.

From our company.

With respect to our scientific and manufacturing staff and Thats something thats very important to our clients. So we're going to stay out ahead of that and remain competitive in those.

Those wages, obviously are rising.

We expect that our clients expect that the prices are going to go up and we.

Our having those sorts of discussions.

With our clients as we need to anticipate receiving.

More for the services that we're performing to we're not going to be able to subsidize their development program by not raising our prices while our prices are being raised to us. So it's something that we're being very assertive about spending time on and.

Frankly, accessing external expertise as a leadership team to really understand the other nuances of operating a business in an inflationary environment, which a lot of people in our company and everybody's company have never experienced before.

Great. Thanks for the color.

Sure.

Thank you at this time I would like to turn the call back over to David and Lowe for closing remarks, Sir.

Many thanks to all of our clients supply chain and other service providers and partners and particularly to our excellent <unk> team members for an exceptional 2021, we look forward to many great achievements in the year ahead. Thank you again to everybody for participating today and for your continued support of re growth.

This concludes today's conference call. Thank you for participating you may now disconnect.

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For the year.

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Good day, ladies and gentlemen, and welcome to the <unk> fourth quarter and year end 2021 financial results Conference call. At this time all participants are in a listen only mode. Later, we will conduct a question and answer session and instructions will follow at that time as a reminder, this conference call maybe recorded.

I would now like to hand, the conference over to Stephanie Diaz, So Rick Rose Investor Relations Group. Please go ahead.

Thank you.

Hello, and thank you for joining us on today's call, we have David and low President and CEO and Brian Lane, Chief Financial Officer.

Today, we'll be providing an overview of regret a contract development and manufacturing business, including updates on corporate activities and financial results for the quarter and year ended December 31 2021.

After our prepared remarks, we will welcome your questions.

Before we begin I'd like to caution that comments made during this conference call. Today March one 2022 will contain certain forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995 concerning the current beliefs of the company, which involve a number of assumptions risks and uncertainties actual.

Results could differ from these statements and the company undertakes no obligation to revise or update any statements made today I.

I encourage you to review all the Companys filings with the Securities and Exchange Commission concerning these and other matters.

Our earnings press release, and this call will include discussion of certain non-GAAP information.

You can find our earnings press release, including relevant non-GAAP reconciliations on our corporate website at Ri grow CMO Dot com.

With that I'll turn the call over to David at low recourse President and CEO .

Thank you Stephanie and thank you to everyone, who has dialed in and to those who are participating today via webcast.

And I'm on slide three now of the company and that one year ago I hosted my first earnings call as <unk>, New CEO haven't been onboard less than three months at that time, I announced a new strategic vision for the company comprised of four areas of focus for 2021.

Including expansion and diversification of <unk> customer base strengthening of our balance sheet position in order to better support both organic and inorganic growth.

Augmentation of our leadership as well as restructuring our operational organization and finally, continuing to upgrade and expand our capabilities and facilities to support growing customer demand.

Had great optimism at that time and I am very pleased to report that we've made great progress with each of these goals. During 2021, our success over the last year has placed the company on a new and exciting trajectory for 2022.

I will provide a review of our 2021 achievements as well as our vision for 2022, following an overview of our Q4 and full year financial results for that I'll turn the call over to Ryan.

Thank you David Good afternoon, everyone before I begin in addition to the brief financial overview I will provide on the call today additional details on our financial results for the fourth quarter and full year ended December 31, 2021 are included in our press release issued prior to this call.

And in our Form 10-K , which will be on file with the SEC.

Turning now to slide four I'll begin with an overview of our financial results for the fourth quarter revenues for the quarter ended December 31, 2021, or $22 3 million. This represents a 125% increase compared to revenues of $9 9 million reported during the prior year period.

The increase of $12 4 million was primarily the result of increases in revenue due to the acquisition of irises higher revenues from our non legacy business as well as higher revenue from our legacy commercial business due to timing of customer orders in 2020, which resulted in much lower sales in the fourth quarter of 2020.

<unk>.

Cost of sales for the quarter ended December 31, 2021 was $15 7 million compared to $12 5 million for the comparable period of 2020 the.

The increase of $3 2 million was primarily due to costs from the San Diego facility due to the acquisition of viruses and higher product and clinical material sales offset by increased production volumes.

Selling general and administrative expenses for the fourth quarter were $5 3 million compared to 4 million recorded in the 2020 period.

The increase of $1 3 million was primarily related to deal and integration costs related to the acquisition of irises in administrative expenses associated with our San Diego team offset by lower public company costs and stock based compensation expense.

As a result of our integration and reorganization effective October one 2021 certain expenses associated with employees. We now support our multi site organizational structure and operations are classified in selling general and administrative expenses prior to October one 2021.

Employees supported our plant operations and Werent classified in cost of sales <unk>.

Interest expense was $3 5 million for the three months ended December 31, 2021, a decrease compared to $4 4 million for the comparable period of 2020. The decrease of <unk> 9 million was primarily due to reduced term loan borrowings under the credit agreement with this theory as well as an overall decrease.

And the rate of interest on our term loans under the credit agreement.

This decrease was partially offset by an increase in interest from the seller's note, which was a component of the Irish This acquisition purchase price for.

For the quarter ended December 31, 2021, the company recorded a net loss of $2 4 million or <unk> <unk> per diluted share as compared to a net loss of $11 7 million or <unk> 48 per diluted share for the comparable period of 2020 EBITDA as adjusted for the period was three.

$2 million compared to <unk> 3 million in the prior year period.

I will now provide an overview of our financial results for the full year of 2021 moving to slide five revenue for the year ended December 31, 2021 was $75 4 million, a 13% increase compared to $66 5 million for the same period in 2020 the <unk>.

Kris at $8 $9 million in revenue was primarily the result of increased revenues due to the acquisition of irises as well as higher revenues from our non legacy business, including revenue from our commercial product Tech transfer projects. Despite the discontinuation of two commercial product lines by our commercial partners announced in the <unk>.

First quarter of 2020, our legacy commercial business has remained relatively flat in 2021 compared to 2020 as our other commercial products saw growth in 2021 compared to 2020 rebounding from lower volumes in 2020 due to the impacts of the market from COVID-19.

Cost of sales for the year ended December 31, 2021 was $55 6 million compared to $54 1 million for the same period in 2020.

The cost of sales increase of one 5 million was primarily due to costs from the San Diego facility due to the acquisition of viruses and is partially offset by lower costs due to the prior year reduction in force and certain employment incentive tax credits in 2021.

Selling general and administrative expenses for the year ended December 31, 2021 were $18 4 million compared to $18 1 million for the same period in 2020.

The increase of <unk> 3 million was primarily related to deal and integration costs related to the acquisition of viruses and administrative expenses associated with the addition of our San Diego team offset by lower public company costs and stock based compensation expense.

Interest expense was $15 1 million and $19 2 million. During the years ended December 31, 2021, and 2020, respectively. The decrease of $4 1 million was primarily due to reduced term loan borrowings under the credit agreement with this area as well as an overall decrease in the rate of interest.

Just on our term loans under the credit agreement.

This decrease was partially offset by an increase in interest from the seller's note, which was a component of the irises acquisition purchase price.

For the year ended December 31, 2021, <unk> reported a net loss of 11 4 million or <unk> 26 per diluted share compared to a net loss of $27 5 million or $1 16 per diluted share for the comparable period in 2020 EBITDA as adjusted for the period was $16 six.

Compared to $14 million in the prior year period.

Our cash and cash equivalents as of December 31, 2021, or $25 2 million compared to $23 8 million as of the end of the prior fiscal year.

This concludes my financial overview.

For those interested in reviewing our non-GAAP reconciliations. Please see slide 15 in the slide deck I will now turn the call back over to David for an update on operations and achievements during the period.

Thank you Brian at this time last year, we announced an ambitious plan for 2021.

I believe it is fair to say that we successfully delivered on every element of our plan and I would like to provide an overview of these accomplishments. Our first goal is to expand and diversify the company's customer base I am pleased to announce that during 2021, our customer base more than tripled a significant increase for a company our size.

This achievement is the result of several factors, including our acquisition of Irises last August which I'll address in greater detail later as well as the efforts of the company's business development team, which was entirely reconstituted in 2021.

In addition to topline growth. This expansion gave <unk> is significantly more diversified customer base, which is critical to limiting the revenue variability that can occur due to customer specific or segment specific issues. These customers span the full range of <unk> capabilities from early clinical trial support to commercial manner.

Fracturing, highlighting the companys broad range of services and our ability to meet the needs of companies at any stage of the biopharmaceutical product lifecycle.

Our second goal for 2021 was to strengthen the company's financial position in order to better support both organic and inorganic growth again, we've made great progress in this regard we began 2021 with the announcement that the company had successfully and significantly restructured our debt instrument with our finance.

Partner a theory.

This restructuring re grow successfully deleveraged, a total of $25 million of debt from our balance sheet in may of 2021, we further strengthen our balance sheet by raising gross proceeds of approximately $34 $5 million.

Through an oversubscribed underwritten public offering.

When you combine the progress we made on our debt balance the capital raise and our increase in revenue and EBITDA. During the year, we ended 2021 and a considerably stronger financial position than when we began.

The third and fourth objectives for 2021 were to augment our leadership and restructure our operational organization and finally to continue upgrading and expanding our facilities and capabilities to support growing customer demand.

During the first half of the year, we revamped our business development team and made two critical appointments to our board. The company also continued to enhance and upgrade our existing facilities and capabilities, increasing utilization of our high potency suite as well as a new clinical trial packaging and labeling line in both areas of the company.

We executed according to plan.

Bolstering our early successes during the year last summer the company made a strategic move that substantially advanced each of our four objectives. Even further in August 2021 re grow acquired irises, a San Diego based <unk> with capabilities that greatly complement our own.

Through this strategic combination re grow further expanded and diversified our customer base enhanced the stability of our revenues and strengthen the company's financial position with the addition of the irises team the company broadened our CMO leadership experience and talent as well as our geographic footprint.

Net result of the organic capital investments made in 2021 as well as the Irish This acquisition all combined with our already impressive commercial oral solid dose infrastructure and strong quality and regulatory track record is a transformation of our company to a stronger and more versatile CMO.

<unk> of attracting and efficiently servicing a broader range of customers in the U S and abroad.

As shown on slide six and referencing the diamond shaped iphones, which represent the former Irish <unk> business. This acquisition significantly expanded our project work in early development through phase II.

We see this segment is critical to our future growth and I'll touch on that again a bit later in my comments as.

As a result of these achievements to fourth quarter and full year 2021 were significantly stronger than the fourth quarter and full year of 2020, respectively. During the fourth quarter. The company recorded $22 $4 million in revenue our highest quarterly revenue since 2019. The company also achieved a significant increase.

$3 million in EBITDA compared to the prior year quarter.

Business development was also strong during the fourth quarter as seen in slide seven new business activity and wins dramatically increased in 2021 as compared to 2020 again in large part due to the expansion and reconstitution of our BD team.

During the period, we had a number of key highlights, including the execution of our commercial Master services and supply agreement with Otsuka pharmaceutical company through which we will be the U S. Based production sites for our significant commercial product with a notes because portfolio. We are very pleased to expand our work with otsuka and believe.

Disagreement highlights our ability to serve as a trusted us supply source for developers of small molecule therapeutics.

During the quarter <unk> was also awarded a new development and manufacturing contract by the National Center for advancing translational sciences or in cats at the National Institutes of health.

Under the terms of this contract the company will support CMC development of any F 100 <unk>.

Grow particle dosage form of <unk> that is prepared for the encapsulation of <unk> K and a patent protected molecular envelope technology and deliver via nasal spray device. In addition to providing early stage development and support this project will utilize the company's sophisticated spray drying.

Abilities, and we are very pleased to have been selected for this complex process.

And subsequent to the quarter end the company announced that it was awarded a new formulation development and GMP manufacturing contract from a key department of the U S government under terms of the new multi year $1 $5 million contract. The company will formulate manufacture and supply of topical dermal drug product.

Containing a prescribed active pharmaceutical ingredients as well as the matching placebo for a planned cancer prevention clinical study.

These activities will include analytical method development formulation GMP clinical trial manufacturing packaging and labeling services to support the planned clinical trial, which is designed to evaluate the effects of chemo prevention with the investigational compound on the recurrence of basal cell carcinoma again, we believe this.

Next showcases regrows broad ranging clinical trial services as well as the company's unique formulation expertise.

While we had a very strong fourth quarter results for the for the full year 2021, we are even more impressive beginning with the company's year over year organic clinical new best business revenue, which grew by 63% when.

When including the irises acquisition this revenue growth increases to 147%.

During the year, the Companys gross margin improved by 7% from 19% in fiscal 2020% to 26% in fiscal 2021.

And we expect this trend to continue to improve as we spread our cost structure over a larger client base also EBITDA grew 19% in 2021 to $16 6 million from $14 million in 2020.

Beyond our financial achievements in 2021, the company successfully expanded and diversified our customer base significantly enhanced our leadership team optimize operations post Iris this acquisition by creating business functions spanning our expanded footprint.

And expanded and enhanced our facilities and capabilities on both coasts.

And it's important to note that the company did this while continuing efforts to build increased sustainability into its operations during the year the company integrated as sustainability efforts into the combined organization and expanded its existing programs designed to reduce the company's environmental impact by building efficiencies into utilization.

Materials water and energy consumption, while minimizing waste.

By any measure 2021 was a very strong year for re grow.

Would be remiss not to recognize our commercial manufacturing supply chain and quality teams for delivering our commercial products at a 100% on time in full or <unk> level and our Gainesville facility. This is a remarkable accomplishment when you consider the numerous additional challenges to Covid pandemic presented.

We believe the company is exceptionally well positioned to tackle the goals, we've established for 2022 and beyond.

In 2022, the company will focus on a number of goals that we believe will further elevate <unk> in the sector.

On slide eight.

Strategy includes executing segment specific sales and marketing strategies building stronger visibility and an updated identity for the organization enhancing both our customers and our employees experienced working with and for the company and continuing to achieve growth and strengthen our financial positions. This.

Strategic mission is comprised of five key objectives.

The first is to realign our sales strategy to be most successful in each of the specific market segments that we serve and I'm on slide nine now there are three discrete market segments that we are currently supporting the commercial oral solid dose products are legacy profit sharing products such as <unk>.

And finally, the early stage development clients, whose programs we support our 2022 goals tall for the development and execution of specific targeted sales strategies for each segment the decision making processes key drivers in ways. We are measured by our customers are different enough for each of these three <unk>.

Segments that we believe using this differentiated and focused approach will be most effective for our customer base as well as maximize our ability to optimize our operational and resource prioritization. For example, while we now have a single company wide quality systems that we have successfully deployed across our footprint.

We are committed to ensuring we use a risk based phase appropriate approach to quality in order to most effectively manage early stage clinical programs commercial qualification batches and end market ongoing production.

Additionally, our market intelligence during 2021 has highlighted an opportunity to completely refresh our brand in the biopharma market to more effectively communicate <unk> evolution as a partner to our clients as well to our people both present and future historic perspective on recourse skill set capability.

<unk> and culture are somewhat outdated as are those of viruses. We look forward to sharing our new company name logo and look in the coming weeks and believe it will provide a more accurate reflection of who we are and where we're going as a company.

The second objective during 2022, which will continue from the groundwork laid in 2021 is to optimize our organizational structure and expand our capabilities. Following the acquisition of viruses. The company formed an integration team, which is focusing on 15 discrete work streams.

To ensure all synergies and opportunities are being captured and optimized we've created strong synergies and efficiencies in our sales and marketing quality and regulatory systems human resources and people engagement practices, environmental health and safety policies business systems and operational excellence processes.

This work will continue into 2022, we will also continue to enhance our current capabilities and expand our operations to accommodate our growing customer base and attract new customers.

And as we announced last week, we're making great progress with the first of these offer and expansions are a subject fill finish and lie optimization capabilities as of today. The dedicated suite is very near completion and final validation and commissioning activities are underway.

Our third goal in 2022 is to further improve our customer experience. While <unk> has long enjoyed its reputation as a high quality partner. We believe that there is always room to improve in the year ahead as our goal to strengthen our client interactions create unparalleled trust and establish valuable partnerships from <unk>.

<unk> development through commercialization.

It is also important that where it makes sense, we harmonize the experience our clients have at each of our sites. We have effective approaches to client communications and project management and we want to deploy those approaches consistently across our organization.

And while our customers are critical to our success. The same can be said of our outstanding team at <unk> in 2022, we aspire to establish an industry, leading employee experience and corporate culture as our employees drive our success. It is our goal to create an inspiring flexible.

And rewarding experience for everyone at re growth and doing so we believe we will strengthen both recruitment employee engagement and retention leading to a better workplace better performance and better outcomes for our clients and for our company's financial performance.

And finally during 2022 the company will continue to take steps to improve its financial strength.

As part of this we will continue to carefully manage our cash work to reduce our debt and engage in a consistent and transparent fashion with the investment community.

With respect to our debt we have engaged in several projects to explore noncore assets such as real estate owned which can be monetized in order to pay down our debt in a non dilutive way.

2021 was a good year.

Given the momentum we have created I am confident in our ability to meet the goals established for the year ahead, and I am very pleased to announce that we are projecting revenue of between 90 and $95 million for the full year of 2022, representing year over year growth of between 20% and 26%.

This year over year topline growth can be further appreciated when you consider that our legacy products, namely the verapamil program, while very profitable for us is anticipated to be basically flat.

Looking at slides 10 through 12 at this point is best illustrated in this series of slides, which shows the progression of growth from 2018 to present as you can see <unk> is highly dependent upon the revenue generated from only a few legacy products in 2018 with advances in organic growth beginning to have an impact.

In 2021.

However, when you take the <unk> acquisition into consideration, we are now significantly less dependent upon the revenue from legacy products with multiple new clinical programs driving growth as a result in 2021, we successfully diversified our customer revenues such that the share of our legacy business has been reduced.

Over 90% to approximately 70% of our business and looking ahead to 2025 and beyond we expect this trend to continue.

Yes.

Looking at Slide 13, now so for us to achieve the growth we are projecting our non legacy business needs to grow by approximately 30% to 50% year over year, assuming full year irises sales in 2021. This is obviously well above industry growth rates and represents the momentum we've built over the past several quarters.

I'm now on slide 14.

Asthma slide as with last year, we have laid out an ambitious plan for the year ahead and like last year. Our team is working diligently taking the steps required to meet expectations and beyond.

We believe that the achievements of 2021, clearly demonstrate our ambition and ability to execute as we met and exceeded each of our goals. In 2021 looking ahead, we plan to leverage our expanded expertise our enhanced service offerings, our dedicated team and our improved financial position to elevate our company. So.

Become a leading growth CD ammo.

This concludes my prepared remarks for today, we can now open up the call for questions.

Operators.

As a reminder to ask a question. Please press star one on your Touchtone telephone again Thats Star one on your Touchtone telephone to ask a question to withdraw your question press the pound key please standby, while we compile the Q&A roster.

Our first question comes from the line of Jacob Johnson of Stephens. Your line is open.

Hey, good afternoon.

David a couple of questions on the sales side and some of the new initiatives. There maybe maybe first on the differentiated sales strategies between the legacy business kind of early phase development work in tech transfer in terms and that seems to make a ton of sense to me in terms of <unk>.

Operationally, how how large of a change is that for your sales team and how hard and how do you kind of drive that approach.

Yes, thanks for the question Jacob so.

There are I would say.

Subtle, but very specific differences in approach that we need to take.

We've got some expertise that we've added to the team in anticipation of this market stratification.

Work that we intended to set forth here as we move forward and so we've been able to add expertise.

We have expertise in the clinical trial services area, we have expertise in the commercial oral solid dose area. We have expertise in the early development CDMA space and so.

It's about.

How those proposals ought to be prepared.

What sort of diligence as required for quality audits with clients in those different spaces.

And quite frankly also who the decision makers are in.

Organizations, depending on where they are with those programs and so.

Those sound like major shifts I think we are prepared for it but we're spending a lot of time talking about how we orient the entire organization towards that we've been able to add.

A new director of project management coming in from a major CMO, who will oversee all project management across the entire organization.

And I appreciate and understand the differences in those sorts of programs. So it's an important part of our business strategy and one I feel confident with respect to the way we are moving forward.

Got it and then you mentioned I think a couple of times a lot of the new hires on the business development side, obviously it takes some time for those people.

Can you just talk about where we are your business development team is in terms of.

Kind of being familiar with with credit offerings in.

And being familiar with their target customers.

Yes. So we've spent a lot of so so the team is in place has been in place not quite but essentially a year.

Minus depending on the individual.

And I'll say that what we've talked about in the past is that.

We believe it took several quarters for that level of traction to began to ensure success and we're definitely.

Seeing the fruits of that right now with respect to the opportunity.

The size of opportunities many of the number of them and also the types of opportunities. So theres been a lot of training.

Done in San Diego's to make sure that everybody understands those capabilities in a completely different way than before.

And.

<unk>.

It's a very timely question because there is.

Sure.

GAAP Arena, those same people and project management and everybody else right now with a different sales training events.

Now focused on.

Rolling out this strategy, so I feel like that the team is up to speed and they are rolling and they are working well together and.

I should also say for anybody that.

I can confirm that being able to be back in person in front of clients. While we often can't go to their offices, but still being able to meet with them off site somewhere.

Does accelerate the quantity and quality of conversations that we're able to have about programs got.

Got it.

Just one last one for me.

Going back to the sales strategy, you outlined tech transfer and second source opportunities as kind of one of the key areas. There can you just talk about how large those opportunities usually are how many of them. There are like how many shots on goal. There are for you in that space and then are those does low probability events. When you go after them.

Them or are they easier to win I'm, just kind of curious what that that opportunity set looks like.

Yes, I mean, there is a.

If you look at FDA.

Manufacturing approvals you can see that there are a greater number of approvals than there are new drugs being approved so so there are site.

<unk>.

That are being approved in.

I don't want to even give a percentage but it's.

It's a measurable piece of activity.

And so the.

The types of opportunities we're looking at.

We do need to make sure some of them are that we hear about are very small.

And so quite frankly.

<unk>.

Economic impetus for the drug on our to make that transfer or to have a second source is very low I mean, it's a very long payback to be able to do that and then there are a few of them that we've encountered and had an opportunity to bid on which would completely cancer, which are very large.

Right and they were completely consume our capacity, but there is a subset.

And the slot, where we can be supported.

And it would be meaningful for us, but it would not absorb everything that we have with respect to capacity.

So.

I would say that there there is.

Enough of a population that we should expect to see some success and again I want to emphasize the types of conversations that we have with the sponsors for those sorts of programs are very different types of supply chain related conversations than earlier.

Earlier program, where we're really investing in the science and the technical solution.

Got it that makes sense and congrats on all the progress in 2021 I'll leave it there.

Thank you.

Thank you. Our next question comes from Matt Hewitt of Craig Hallum Capital. Your line is open.

Good afternoon, and thank you for taking the questions maybe first off how should we be thinking about the revenue and gross margin cadence this year in relation to your guidance.

Is there any.

Impact from Covid in Q4, and early Q1 that means it might be more back half weighted or just help us understand how you're thinking about the cadence of the year.

Thanks for the question Matt. This is Ryan So I would say generally we are not giving quarter by quarter guidance, but just the full year guidance.

We feel obviously really good about the guidance that we gave today, 90% to $95 million.

And feel that we're well positioned in the market with our long standing commercial history and.

Robust capabilities to capture that growth.

In the marketplace.

Our development revenue or non legacy business is expected to increase 30% to 50% assuming the full year <unk> revenues.

And low single digit percentage increase in our legacy business. So overall, the revenue growth rates like 18% to 14%.

For the business and we think we have really good line of sight for.

The non legacy or the development revenue portion, especially with the $24 million in backlog that we have ending the year end.

Our pipeline has never been stronger in terms of the backlog we have in terms of the open proposals we have with customers. What we were able to sign during 2021 so.

It's exciting for us so the other thing.

Comment to your question or.

As with regard to.

Gross margins were expecting gross margins to remain in the mid 20% range.

The 2021 gross margins were a bit high taking into consideration the incentive tax credits that we received during 2021, so with the additional hiring that we have projected in 'twenty. Two we're seeing a benefit of higher revenues and increased utilization and terms.

Of our anticipated gross margins that are more than offsetting the incentive tax credits that we received.

2020.

One.

And then just from an overall EBITDA perspective.

We're projecting roughly $16 million to $18 million.

And EBITDA and excluding the incentive tax credits, that's about a 40% increase compared to 2021 EBITDA.

Excluding those dose COVID-19 related incentive tax credits so.

Some of the puts and takes there really that the EBITDA guidance takes into account.

$18 million or so in higher revenue <unk>.

<unk> cost absorption associated with that and is offset by some of the nonrecurring COVID-19 related incentive tax credits as well as increased spend related to hiring and inflation, because we're running really lean in 2021.

Got it that's helpful. Thank you and then maybe just a follow up on some of the sales team.

Feedback that you've provided.

What is the headcount today for that team and how is that is I just want to make sure I understand this correctly is the team split up by those three different segments or is each salesperson.

Or are they all kind of selling to all three segments.

Yes. This is David Hi, Matt.

I would say that we hired subject matter expertise.

To be <unk>.

Spread and diversified across those offerings, but there is absolutely an expectation and it is happening in that conversations on all of our offerings are being held by any of our BD reps with the clients with whom they interact and then obviously as soon as it gets a little bit more detail and technical.

Paul.

We are bringing in the scientific talent through the other sales folks.

So we've seen some.

Several opportunities where our existing clients on the GMP clinical trial material fronts.

Some of these new clients, we've been able to add over the past couple of years are now coming back to us to talk about clinical trial services packaging label in distribution and it's.

A nice add on and so in those cases the sales members are working in tandem to bring a combined solution.

Got it and then maybe one last one and I'll hop into the queue.

Guarding all of the progress there I mean I was looking back at even just your August slide deck compared to where you're at today, obviously, a tremendous amount of.

Our tremendous increase in the number of opportunities in your pipeline, but as we think about some of those newer opportunities you sign the contract how quickly does that do those turn into revenues.

I would imagine there is a pretty big variation, but on average once you sign the contract are you typically, especially on the development side are you able to get those started within a quarter or two or does some taking much longer than that thank you.

Yeah. Thanks for the question, Matt So I would say generally yes. It takes about three to six months on average.

And it really depends on the client their API availability.

And how quickly they are ready to get started.

Got it thank you.

Thanks, Matt.

Thank you. Our next question comes from Kristine <unk> of William Blair. Your question. Please.

Hi, yes.

That's on the quarter and good afternoon, I was just hoping to get some color on the telco Tech transfer if you have any updates there.

We expect our commercial product production in the second half of 2022 and have you seen any expansion opportunities beyond that.

Hi, Christine Thanks for the question. This is Brian So we're still on track with the registration batches with the expected completion by the end of the first half of 2022.

We expect to begin manufacturing the commercial quantities either late in 2002 or an.

Early 'twenty three really depends on that's been there I think anticipating to receive approval back so thats when that would be kind of a subsequent entering the market thereafter.

But we continue to build a very strong relationship with <unk> and.

Believe that we are delivering on all of their expectations.

Great. That's helpful and then my second one chip.

The core legacy product portfolio.

It seems like Youre.

That's great.

ADHD and hypertension products.

Are you still seeing ADHD.

Volumes across from pre pandemic levels is there any potential upside there.

And are you seeing any risks binary or you're pretty comfortable with the ability to act.

Yes.

I would say that the ADHD levels are still below a baseline from pre COVID-19 .

But just looking at the 52 week kind of trend of script they do show.

Recovery.

Pediatric volumes, Scott and end of the year boost I would say.

So we think that's trending positively.

As it relates to tap.

Teva and brought the mill SLR tab.

Teva containing continues to remain.

Steady and has actually picked up about 10% market share and bringing them to about 60% of the overall per app unless our capital markets. So we view that as a positive.

We also believe that <unk>.

Interest is.

Our focus has been on Biosimilars and complex generics and you probably saw they announced earlier this week and deal with Viacom.

The purchase of the interest is biosimilars business and shift in their strategic attention. So this.

This is at least what they said was a first in a series of asset sales.

We view those activities is.

An opportunity and potential for us for.

Either additional product rationalization by them or it could be positive for us on a number of levels.

Great. Thanks, and then just one last one for me.

How are you seeing in terms of wasting and inflationary cost pressures I heard you say those are baked in to 2022 guidance, but any more color you give there.

Hi, your supply chain that would be great.

So yes, let me just say this is David Christine.

Certainly.

It is top of mind for us and so we're.

Embracing the fact that there are going to be some increased cost, particularly on the labor side and we are very committed to remaining competitive in the market because one of the real competitive advantages we have quite frankly in the market is.

Stronger than expected.

Expected tenure.

From our company.

With respect to our scientific and manufacturing staff and Thats something thats very important to our clients. So we're going to stay out ahead of that and remain competitive in those.

Those wages, obviously are rising.

We we expect that our clients expect that the prices are going to go up and we.

Having those sorts of discussions.

With our clients as we need to anticipate receiving.

More for the services that we're performing.

We're not going to be able to subsidize their development program by not raising our prices while our prices are being raised to us. So it's something that we're being very assertive about spending time on and.

Frankly, accessing external expertise as a leadership team to really understand the other nuances of operating a business in an inflationary environment, which a lot of people in our company and everybody's company have never experienced before.

Great. Thanks for the color.

Sure.

Thank you at this time I would like to turn the call back over to David and Lowe for closing remarks, Sir.

Many thanks to all of our clients supply chain and other service providers and partners and particularly to our excellent <unk> team members for an exceptional 2021, we look forward to many great achievements in the year ahead. Thank you again to everybody for participating today and for your continued support of re growth.

This concludes today's conference call. Thank you for participating you may now disconnect.

Q4 2021 Recro Pharma Inc Earnings Call

Demo

Societal CDMO

Earnings

Q4 2021 Recro Pharma Inc Earnings Call

SCTL

Tuesday, March 1st, 2022 at 9:30 PM

Transcript

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