Good afternoon, ladies and gentlemen, and welcome to the Fourth Quarter and Fiscal Year 2018 Earnings Conference Call for Organogenesis Holdings, Incorporated. At this time, all participants have been placed in a listen-only mode.

Please note that this conference call is being recorded and the recording will be available on the Company’s website for replay shortly.

Before we begin, I would like to remind everyone that our remarks today may contain forward-looking statements that are based on current expectations of management and involve inherent risks and uncertainties that could cause actual results to differ materially from those indicated, including the risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission, including Item 1A Risk Factors, of the Company’s Form 10-K of the year ended December 31, 2018.

You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made, although it may voluntarily do so from time to time.

The Company undertakes no commitment to update or revise these forward-looking statements whether as a result of new information, future events or otherwise except as required by applicable securities laws.

This call will also include references to certain financial measures that are not calculated in accordance with generally accepted accounting principles or GAAP. We generally refer to these as non-GAAP financial measures.

Reconciliations of those non-GAAP financial measures to the most comparable measures calculated and presented in accordance with GAAP are available in the earnings press release on the Investor Relations portion of our website. I would now like to turn the call over to Mr. Gary Gillheeney, Organogenesis Holdings’ Chief Executive Officer.

Please go ahead, sir..

Thank you, Mark, and welcome, everyone to Organogenesis Holdings fourth quarter 2018 earnings conference call, which also marks our first quarterly earnings call as a newly public company. I’m joined today on the call by Tim Cunningham, our Chief Financial Officer. Let me start off with a brief agenda of what we will cover during our prepared remarks.

I’ll start out with a brief introduction of our company and our business, then we’ll provide a high level overview of our financial performance during the fourth quarter and full year 2018.

After my opening remarks, Tim will provide you with a more in-depth review of our quarterly and fiscal year financial results, as well as an overview of our financial guidance for 2019, which we reaffirmed today in our earnings press release.

Then following Tim’s discussion of our financial results and outlook, I will share some thoughts on why we believe we are well positioned for strong performance in 2019 in solid long-term growth going forward. And then we will open up the floor for questions. This is our first quarterly conference call.

We thought it would be helpful to spend a few minutes describing our company. Organogenesis is a leading regenerative medicine company focused on the development, manufacture and commercialization of product for the Advanced Wound Care and Surgical & Sports Medicine markets.

Our mission is to provide integrated healing solutions that substantially improve medical outcomes and the lives of patients while lowering the overall cost of care. The company was founded in 1985 as a spin-off technology developed at MIT. Our corporate headquarters are in Canton, Massachusetts.

And after many years of research, the Company launched this first product in 1998, the product Apligraf, which essentially created the field of regenerative medicine.

Our two primary markets are Advanced Wound Care and Surgical & Sports Medicine representing a total opportunity of nearly $12 billion and are attractive high growth markets that are benefiting from strong secular tailwinds, including the aging population, a greater incidence of comorbidities such as diabetes, obesity, cardiovascular and peripheral vascular disease, and an increasing adoption of advanced technologies to treat complex wounds and muscular skeletal conditions by both providers and payers.

Importantly, we focus our commercial strategy on addressing the fastest growing segments within each of these primary markets. Within the broader Advanced Wound Care market, we are focused on the skin substitute category, the fastest growing category of Advanced Wound Care, which is expected to grow at 14.5% compounded growth through 2020.

Within the broadest Surgical and Sports Medicine market, we focus our commercial strategy on addressing another strong growth category, the regenerative orthobiologics space, which supports the healing of musculoskeletal injuries including chronic degenerative conditions such as osteoarthritis and tendinitis.

Today, we have a differentiated and comprehensive portfolio of seven commercial products. These products are a direct result of our research and development capabilities.

In addition to our portfolio of differentiated products, we also offer in-house customer support to a wide range of healthcare customers including hospitals, wound care centers, government facilities, ambulatory surgery centers, and physician offices.

We have a robust R&D platform, that is the primary engine of future growth for the company and we expect to introduce five new products over the next two years. We have robust clinical data supporting our products. We have over 200 publications covering our products in over 3000 patients have been studied utilizing our products.

Furthermore, we have 14 clinical studies currently underway with over 1600 patients being studied. These studies are designed to support our commercial adoption in marketing of our current products and our pipeline products as well as our efforts to obtain additional commercial insurance coverage for our portfolio.

We have significant and scalable infrastructure. We have developed in-house regulatory expertise and we are a leading manufacturer and distributor in logistics capabilities organization. We employ over 700 people today including 215 direct selling representative and have over 130 independence selling agencies as of the end of 2018.

We’ve recently enhanced our balance sheet with a $92 million equity financing and a new $100 million credit agreement, both of which will help fund our strategic growth initiatives going forward.

With that, let me turn the call over to Tim for a detailed review of our financial results in the fourth quarter and fiscal 2018, as well as our review of our 2019 guidance.

Tim?.

Thank you, Gary. I’ll begin with a review of our fourth quarter financial results. Net revenues for the fourth quarter of 2018 was $63.6 million, compared to $53.1 million for the fourth quarter of 2017, an increase of $10.5 million or 19.7% on the fourth quarter of 2017.

Revenue from Advanced Wound Care products of the fourth quarter of 2018 was $54.6 million compared to revenue of $47.2 million for the fourth quarter of 2017, an increase of $7.4 million or 15.8% year-on-year. Revenue from Advanced Wound Care products represented 85% of total net revenue in fiscal 2018, compared to 90% in the prior year period.

Revenue from Surgical & Sports Medicine products for the fourth quarter of 2018 was $9 million compared to $6 million for the fourth quarter of 2017, an increase of $3 million, up 50.6% year-over-year.

Revenue from Surgical & Sports Medicine products represented 14% of total revenue, total net revenue in the fourth quarter of 2018 compared to 11% in the prior year.

Revenue from PuraPly products for the fourth quarter of 2018 was $28.5 million compared to $28.2 million in the fourth quarter of 2017, an increase of $0.3 million or 1.1% year-over-year.

Revenue from PuraPly products represented approximately 45% of the total net revenue in the fourth quarter of 2018 compared to 53% of total net revenue in the fourth quarter of 2017. As previously disclosed, PuraPly reinstatement of tax to reimbursement status began on October 1, 2018 and continues through September 30, 2020.

Gross profit for the fourth quarter of 2018 was $46.1 million compared to $36.7 million for the fourth quarter of 2017, an increase of $9.4 million, up 25.5% the largest contributed to the improvement of gross profit from the year earlier period is a more favorable product mix of revenue in the fourth quarter of 2018.

Gross profit margin for the fourth quarter of 2018 was 72.5% of net revenue compared to 69.1% of net revenue for the fourth quarter of 2017. Operating expenses for the fourth quarter of 2018 were $50.6 million compared to $39.1 million for the fourth quarter of 2017, an increase of $11.4 million or 29.3%.

The increase in operating expenses in the fourth quarter of 2018 as compared to the fourth quarter of 2017 was driven primarily by higher selling, general and administrative expenses, which increased to $47.5 million compared to $36.4 million in the fourth quarter of 2017, an increase of $11.1 million, up 30.5%.

The increase in selling and general, administrative expenses due to additional headcount, primarily hiring in our direct sales force, higher sales commissions, increase marketing and promotional expenses and higher intangible asset expense and amortization expense.

R&D expenses were $3.1 million in the fourth quarter of 2018 compared to $2.7 million in the fourth quarter of 2017, an increase of $0.4 million or 13%. The increase was primarily due to additional personnel and clinical programs.

Fourth quarter operating expenses also included non-recurring expenses of $2.3 million related to our merger with the Avista Healthcare Public Acquisition Corp. or AHPAC during the quarter.

The operating loss for the fourth quarter of 2018 was $4.5 million compared to an operating loss of $2.4 million for the fourth quarter of 2017, an increase of $2.1 million or 86.5% due to the aforementioned reasons.

Total other expenses for the fourth quarter of 2018 were $4.8 million compared to $2.3 million for the fourth quarter of 2017, an increase of $2.5 million or 111.3%.

The increase was driven primarily by a $2.1 million non-cash loss on the extinguishment of debt related to the write-off of unamortized debt issuance costs upon repayment or the conversion to equity of all its affiliate debt in December of 2018.

The net loss for the fourth quarter was – 2018 was $9.3 million or $0.12 a share compared to a net loss of $4.4 million or $0.07 per share for the fourth quarter of 2017, an increase of $4.8 million, or 109%.

Adjusted EBITDA loss for the fourth quarter of 2018 was $133,000 compared to an adjusted EBITDA loss of $1.2 million for the fourth quarter of 2017, a decrease of $1.1 million or 89%.

We have provided a full reconciliation of our adjusted EBITDA results in our press release, 8-K and a 10-K all of which were filed with the Securities and Exchange Commission this afternoon. In the fourth quarter of 2018, we announced the closing of a reverse merger with AHPAC.

AHPAC is special purpose acquisition corporation, which was a publicly traded investment vehicle formed for the sole purpose of merging with a private company with strong growth prospects looking to access to public equity markets. If we move onto a review of our full year financial results.

Net revenue for the year ended December 31, 2018 was $193.4 million compared to $198.5 million for 2017, a decrease of $5.1 million or 2.5%.

Revenue from Advanced Wound Care products for the year ended December 31, 2018 was $164.3 million compared to revenue of $178.9 million for the year ended December 31, 2017, a decrease of $14.6 million or 8.1% year-over-year.

Revenue from Advanced Wound Care products represented 85% of total revenue in fiscal year 2018 compared to 90% in the prior year. Revenue from Surgical & Sports Medicine products for the year ended December 31, 2018 was $29.1 compared to $19.6 million for the year ended December 31, 2017, an increase of $9.5 million or 48.5% year-on-year.

Revenue from Surgical & Sports Medicine products represented 15% of total net revenue in fiscal year 2018, compared to 10% of total net revenue in the prior year. Revenue from PuraPly products for the year ended December 31, 2018 was $69.8 million, compared to $109.1 million for the year ended December 31, 2017, a decrease of $39.3 million or 36%.

Revenue from PuraPly products represented approximately 36% of total net revenue in fiscal year 2018, compared to 55% of net revenue in the prior year. Gross profit for the year ended December 31, 2018 was $124.6 million compared to $137.3 million for the year end December 31, 2017, a decrease of $12.6 million, or 9.2%.

The decrease in gross profit results primarily from the decrease in our Advanced Wound Care revenue driven by the loss of pass-through reimbursement status on PuraPly for the first nine months of 2018, which partially offset by the increase in revenue from our Surgical & Sports Medicine products.

Gross profit for the year ended December 31, 2018 were 64.4% of total net revenue compared to 69.2% of total net revenue in the prior year. Operating expenses for the year ended December 31, 2018 were $176.2 million compared to $142.8 million for the year ended December 31, 2017 and the increase of $33.4 million or 23.4%.

The increase in operating expenses in 2018 was driven primarily by higher selling, general and administrative expenses, which increased to $162 million for the year ended December 31, 2018, as compared to $133.7 million for the year ended December 31, 2017, an increase of $28.2 million or 21.1%.

The increase in selling, general and administrative expenses as primarily due to a $25.2 million increase related to additional headcount, primarily in our direct sales force, an increase of $1.7 million due to increase marketing and promotional expenses, an increase of $1.6 million in amortization expense as a result of a full year of amortization of intangible assets acquired from acquisition of NuTech in 2017.

R&D expense was $10.7 million for the year ended December 31, 2018, compared to at $9.1 million for the year ended December 31, 2017, an increase of $1.7 million or 18.5%. This is primarily due to additional headcount and clinical programs spent.

Additionally, included in operating expenses in 2018 was a one-time write-off of $3.5 million related to cost accumulated in connection with a proposed initial public offering. These costs were written-off when the company decided to pursue the reverse merger with AHPAC.

Full year 2018 operating costs also included $3.1 million of merger transaction costs. The operating loss for the year ended December 31, 2018 was $51.6 million compared to an operating loss of $5.5 million for 2017, an increase of $46.1 million or excuse me, 838%.

Total other expenses for the year ended December 31, 2018 were $13.2 million, compared to $9.1 million for the year ended December 31, 2017, an increase of $4.1 million or 45.7%.

The increase was driven primarily by $2.1 million non-cash loss on the extinguishment of debt related to the write-off of unamortized debt issuance costs upon the repayment or conversion to equity of all affiliate debt in December, 2018.

The net loss for the year ended December 31, 2018 was $64.8 million, or $0.94 a share, compared to a net loss attributable to Organogenesis Holdings, Inc. common stockholders of $8.4 million, or $0.14 per share, for the year ended December 31, 2017, an increase of $56.4 million or 673%.

As of December 31, 2018, we had approximately 215 direct sales representatives and approximately 130 independent sales agencies. If we turn to the balance sheet now.

As of December 31, 2018, the company had $21.3 million in cash and $59.3 million in debt obligations, of which $17.7 million were capital lease obligations, compared to $2.3 million in cash and $106.8 million of debt obligations, of which $17.8 million were capital lease obligations for the year ended December 31, 2017.

The net change in cash of $19 million in 2018 was driven by $81.6 million of cash provided by financing activities, partially offset by net cash use and operating activities of $60.7 million and to a lesser extent $1.8 million of cash use in investing activities during this period.

Cash flow provided by financing activities of $81.6 million consisted primarily of $92 million in proceeds from the issuance of common stock, the sale of stock, $15 million of proceeds from affiliate debt and $8.9 million in net borrowings under our credit agreement, less the repayment of affiliate debt of $22.7 million as well as the repayment, excuse me, as well as the payment of recapitalization costs of $11.2 million.

Net cash used in operating activities for the year was $60.7 million resulting from our net loss of $64.8 million, cash used to working capital of $13.2 million and the payments have accrued interest on affiliate debt of $9.2 million. This was offset by $26.5 million of non-cash items during the period.

As detailed in our 8-K on March 14, 2019, we secured a new credit agreement with Silicon Valley Bank, the lead agent and midcap financial. The agreement provides for credit facility and the aggregate amount of $100 million consisting of a $60 million term loan and a $40 million revolving credit facility.

The agreement contains customary representations, warranties, covenants, including financial covenants and requires the achievement of certain financial milestones in order to draw the final $20 million of the term loan facility by December 31, 2019.

The proceeds from the term loan and revolving credit facility we used for general corporate purposes as well as $26.5 million repayment of the company’s existing credit facility and a $17.6 million pay-off of loans from Eastwood Capital Partners.

Turning to a review of our fiscal year 2019 revenue guidance, which we reaffirmed in our press release this afternoon.

For the 12 months ended December 31, 2019, the company continues to expect total revenue of between $248 million and $259 million representing growth of approximately 28% to 34% year-over-year as compared to total revenue $193.4 million for the 12 months ended December 31, 2018.

The 2019 revenue forecast assumes revenue from Advanced Wound Care products of between $219 million and $229 million representing growth of approximately 33% to 39% year-over-year as compared to revenue of $164.3 million for the 12 months ended December 31, 2018.

Revenue from Surgical & Sports Medicine products between $29.5 million and $31 million representing growth of approximately 1% to 6% year-over-year as compared to revenue of $29.1 million for the 12 months ended December 31, 2018.

The 2019 revenue guidance also assumes a net revenue from the sale of our PuraPly Products will represent between $96 million and $103 million of net revenue representing growth of approximately 38% to 48% year-over-year as compared to revenue of $69.8 million for the 12 months ended December 31, 2018. With that, I’ll turn the call back over to Gary.

Gary?.

Thanks, Tim. Overall, we are pleased with the significant progress that our organization has achieved during 2018 and in recent months as well. We believe we have several unique strengths that have been instrumental to our success and position us well for future growth.

We are a leader in the regenerative medicine space with a strong brand recognition for our portfolio. We are well positioned in a large attractive and growing global markets, specifically Advanced Wound Care and Surgical & Sports Medicine.

We have a comprehensive suite of products to address the clinical and economic needs of our patients, but also the providers and the payers as well.

We have a large and growing body of clinical data in a portfolio of products with FDA, PMA approvals or FDA clearances, and we’ve established extensive customer relationships and across the entire continuum of wound care including hospitals, wound care centers, government facilities, ambulatory surgery centers and physicians office to sell our broad portfolio products.

We’ve established a scalable regulatory manufacturing and commercial infrastructure. Our executive management team has extensive experience in the regenerative medicine industry, boasting over a 100 years of collective experience in the space.

This experience allows us to operate from a deep understanding of the underlying trends in regenerative medicine and the scientific, clinical and regulatory issues that drive the success of our industry. So, we look forward to speaking with you again, in the future and appreciate your interest in Organogenesis Holdings.

And with that, Mark, I’ll turn it back to you..

Thank you. [Operator Instructions] And our first question comes from the line of Ryan Zimmerman of BTIG. Your line is now open..

Thank you. And Gary, Tim, congrats on your first public earnings call..

Thank you, Ryan..

Thanks, Ryan..

So maybe, we could just begin with your guidance for a little bit. If you can just walk us through the puts and takes on the guidance and where you see opportunities to exceed guidance for 2019 potentially, or to put you – stay at the top end of the range versus the lower end of the range and I have a follow-up question. Thank you..

It’s a good question, Ryan. We just reaffirm this guidance today and we’re not going to raise the guidance today. So, I would say that any other comment that Gary has to add….

I mean as Tim mentioned, we are comfortable with the guidance what’s driving our growth is our portfolio, obviously at PuraPly or Surgical & Sports Medicine, we’re investing in our infrastructure, our commercial infrastructure in both Advanced Wound Care and Surgical & Sports Medicine.

We have additional products, five additional products coming out of the next two years that we’re excited about. So, we have several engines that will continue to drive growth in the near future. So, we’re pretty comfortable that those, those trends are going to be positive for us..

That’s helpful guys. And then my other question is you had some really positive data out of a product renew at AAOS recently.

And help us maybe; you can recap for investors just at a high level, what you learned and how you think about bringing that product to market?.

Well, as you mentioned, the information was presented by Dr. Farr at the AAOS Conference. We’ve submitted that information for publication and until it’s been received in public, it’s not much we can really talk about it.

but we are pretty comfortable that we’ll continue to invest in the regulatory requirements to get that product through the BLA process and we’ll continue to invest in moving the clinical data forward and when it’s published, we’ll certainly make everyone aware of it..

All right. Thank you guys. I’ll hop back in queue..

Thank you. [Operator Instructions] Our next question comes from the line of Kristen Stewart of Barclays. Your line is now open..

Hi everyone. Congratulations on the first quarter, two out of the gate..

Thank you..

Thank you..

I was just wondering if you could just maybe further explain or expand on renew and just talk through what you believe is the pathway for the BLA process and just kind of how do we kind of get to the various milestones before commercializing that product?.

Well, as we mentioned, we do expect to file a BLA for the product. We’re still in the process of preparing the clinical study and preparing for meetings with the FDA. So, we have no specific timelines at this point on when that filing will be made. But when we do, we’ll certainly make you aware of it..

Okay, perfect. And then the other question that I had just relates to PuraPly, I was wondering if you could comment just on how you’ve kind of seen the trends since you were able to kind of reclaim pass-through status and kind of how ASP trends maybe heading if you’re able to kind of recapture on the pricing side since the reimbursement.

It’s kind of an ASP plus and just the level of confidence in achieving the full-year guidance at this point..

Sure. So, with PuraPly, particularly PuraPly AM, which is the most significant product in the PuraPly line. As we expect to continue to grow, even when we were not in pass-through in PuraPly AM actually had record unit sales.

So, it speaks to the efficacy of the product that speaks to the additional physician specialties that are now adopting the product. So, we’re extremely comfortable with the trend in the potential for that product. You’re being back on pass through there is an opportunity to increase the ASP and we’ve done that. That does a couple of things.

Once it provides additional funding to get broader access to the product, which is really the strategic benefit of pass-through is to get the product in the hands of more clinicians and more specialties to broaden the use of the product. And it also will help improve ASP going forward. So, we do expect to see some benefit from that in 2019..

Okay. And then any updates just on the timing of PuraPly XT and MZ? I think those were both flared in for launch some time this year..

Yes. We expect them to be launched in 2019 later in the year..

Okay. Thanks very much guys..

Thank you..

Thank you..

[Operator Instructions] And we’ve got a follow-up question from Kristen Stewart of Barclays. Your line is now open..

Thanks for taking the follow-up.

Tim, is there anything that you can kind of add just on the color of – with the new proceeds, just how we should think about the run rate of kind of the cash flows as you guys are building out the sales force, how should we just think about the company’s ability with getting to break-even?.

That’s many questions Kristen, so let’s unravel it a little bit. So, based on what we announced today, so we’ve been – in the last several months, we’ve basically – we have 92 of equity and $100 million to its debt, because working capital studies provide the company sufficient resources to conduct this business in continuous operation.

So, we feel confident that we have the resources today to execute on the guidance we’ve put forth this year..

Okay, perfect. Thank you..

Okay..

And we have a follow-up question from the line of Ryan Zimmerman of BTIG. Your line is now open..

Thank you. Just one quick one for me. you ended the year with pretty nice gross margins of step-up from what we saw in the fourth quarter of 2017.

Just maybe your thoughts around where you think you can take your gross margins over the next two quarters and just giving the introduction to some of the newer products, should that be accretive to your gross margin? Thank you..

Well, I would refer you back to the financial model that we presented to you that was filed with an 8-K the Securities Exchange Commission, or if I’m not mistaken on February 12th, but we can double-check that number and refer you to it. So, we talked about that our gross margins to what to expect from us low-to-mid 70s..

Great. Thank you..

Sure..

That does conclude our conference call for today. Thank you for your participation..

Thank you very much..

Thank you..