Organogenesis Holdings Inc. (ORGO) Q2 2019 Earnings Call Transcript

Organogenesis Holdings, Inc. (ORGO -23.32%)
Q2 2019 Earnings Call
Aug. 9, 2019, 8:00 a.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Good morning, ladies and gentlemen, and welcome to the second quarter 2019 earnings conference call for Organogenesis Holdings, Inc. At this time, all participants have been placed in a listen-only mode. Please note that this conference call is being recorded, and that the recording will be available on the company's website for replay shortly.

Before we begin, I would like to remind everyone that all remarks today may contain forward-looking statements that are based on the 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 the Item 1A, "Risk Factors," of the company's Form 10-K for the year ended December 31, 2018. You are cautioned to not 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 the forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by the 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 made 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 Gillheeny, Organogenesis Holdings' Chief Executive Officer. Please go ahead, sir.

Gary S. Gillheeny, Sr. -- Director, President, and Chief Executive Officer

Thank you, Victor, and welcome, everyone, to Organogenesis Holdings' second quarter 2019 earnings conference call. I'm joined on the call today by Tim Cunningham, our Chief Financial Officer. Let me start with a brief agenda of what we will cover during our prepared remarks. I'll start with a high-level overview of our revenue performance during the second quarter of 2019. After my opening remarks, Tim will provide you with a more in-depth review of our quarterly financial results, as well as an overview of our financial guidance for 2019, which we've updated today in our earnings release. Following Tim's discussion of our financial results and outlook, I will then share some thoughts on why we believe we are well positioned for strong performance in 2019 and solid long-term growth going forward, and then we'll open it up for calls and questions.

So, let me begin. After a strong start to the year in the first quarter, the momentum continued in the second quarter, as our continued execution drove impressive results. Our total revenue increased 54% over the first half of 2019, our gross profit increased 81%, and we reported strong improvements in profitability, with our operating loss and our adjusted EBITDA loss decreasing 47% and 51% respectively year over year. We are focused on continuing to execute over the balance of 2019, a year in which we expect to increase net revenue by 29-35% year over year, as reflected in our full-year guidance, which we updated, as I mentioned this morning, in our press release.

For the second quarter, we reported total revenue growth of 49% year over year, driven by sales growth in our advanced wound care products of 50% and sales growth in our surgical and sports medicine products of 46% year over year. This strong growth was driven by our investments that we've made in expanding our sales force over the last 12-18 months, where we've increased our direct sales team from approximately 190 at the end of 2017 to approximately 245 as of June 30, 2019, an increase of over 30% over this period, and we also expanded the number of independent agencies we are working with in the surgical and sports medicine market to approximately 145 as of quarter end.

Our second-quarter results also benefited from the favorable reimbursement decision for our largest product line, PuraPly. You may recall that on October 1, 2018, CMS resumed making pass-through payments for PuraPly applications in the outpatient hospital setting and ambulatory surgery setting. Revenue from PuraPly products for the second quarter of 2019 was $29.7 million compared to $12.8 million for the second quarter of 2018, an increase of $16.9 million or 133% year over year.

We also reported stronger than expected revenue growth in our surgical and sports medicine business this quarter, fueled by a strong portfolio of differentiated orthobiologic products, including NuCel for bone effusion in spine and extremities, and also NuShield for surgical applications and targeted soft tissue repairs, and the investments we've made in our sales force combined to drive sales growth of 46% in the second quarter.

Second-quarter total revenue growth also benefited from sales of our non-PuraPly commercially available products, which increased 31% year over year, reflecting the strong execution of our sales force against our strategy, and leveraging the strong adoption of PuraPly into broader adoption and utilization of our non-PuraPly products. In addition, the second quarter benefited from an increase in our amniotic capacity and an improvement in our ability to meet customer demand. With that, let me turn the call over to Tim to review our financial results in the second quarter and the first half of 2019. Tim?

Timothy M. Cunningham -- Chief Financial Officer

Thank you, Gary. I will begin with a review of our second-quarter financial results. Revenue for the second quarter of 2019 was $64.9 million compared to $43.6 million of the second quarter of 2018, an increase of $21.4 million, or 49% year over year. Unless otherwise specified, all growth is based on a year-over-year basis. Revenue from advanced wound care products for the second quarter of 2019 was $55.2 million compared to revenue of $36.9 million for the second quarter of 2018, an increase of $18.3 million or 50%. Revenue from advanced wound care products represented 85% of total revenue in the second quarter of 2019, consistent with the prior-year period. The increase in advanced wound care revenue was primarily attributable to additional sales personal, PuraPly regaining pass-through reimbursement status for the two-year period effective October 1st, 2018, and the continued growth in adoption of our amniotic products.

Revenue from surgical and sports medicine products for the second quarter of 2019 was $9.7 million compared to $6.7 million for the second quarter of 2018, an increase of $3.1 million or 46%. Revenue from surgical and sports medicine products represented 15% of total revenue in the second quarter of 2019, consistent with the prior-year period. The increase in surgical and sports medicine revenue was primarily due to the expansion of our sales force and the penetration of new and existing customer accounts.

As of June 30th, 2019, we had approximately 245 direct sales representatives, up from 215 at year end, and approximately 145 independent agencies, up from 130 at year end. Revenue from PuraPly products for the second quarter of 2019 was $29.7 million compared to $12.8 million in the second quarter of 2018, an increase of $16.9 million or 133%. Revenue from PuraPly products represented approximately 46% of total revenue in the second quarter of 2019 compared to 29% of total revenue in the second quarter of 2018.

Gross profit for the second quarter of 2019 was $45.5 million compared to $26.3 million for the second quarter of 2018, an increase of $19.2 million or 73%. Gross profit margin for the second quarter of 2019 was 70% of revenue compared to 60% for the second quarter of 2018. The improvement in gross profit margin resulted primarily from a more favorable product mix in the second quarter of 2019 and volume-based manufacturing efficiencies.

Operating expenses for the second quarter of 2019 were $52.8 million compared to $43.3 million for the second quarter of 2018, an increase of $9.5 million or 22%. The increase in operating expenses in the second quarter of 2019 as compared to the second quarter of 2018 was driven primarily by higher selling, general, and administrative expenses, which increased to $49 million compared to $37.7 million in the second quarter of 2018, an increase of $11.2 million or 30%. The increase of selling, general, and administrative expenses is primarily due to additional headcount, mainly hiring in our direct sales force, higher sales commissions as a result of increased revenue, and increased marketing and promotional expenses for our products.

R&D expenses for the second quarter of 2019 were $3.9 million compared to $2 million in the second quarter of 2018, an increase of $1.8 million or 89%. The increase was primarily due to additional headcount and investment in new and continuing investments in clinical programs. The operating loss for the second quarter of 2019 was $7.3 million compared to an operating loss of $17 million in the second quarter of 2018, a decrease of $9.7 million or 57%. The decrease in operating loss in the second quarter of 2019 was driven by the 73% increase in gross profit, partially offset by a 22% increase in operating expenses. Total other expenses net for the second quarter of 2019 were $2.3 million compared to $3 million for the second quarter of 2018, a decrease of $0.7 million or 22%. The decrease was primarily driven by a $0.6 million decrease in interest expense.

Net loss for the second quarter of 2019 was $9.6 million or $0.11 per share compared to a net loss of $20 million or $0.30 per share for the second quarter of 2018, a decrease of $10.4 million or 52%. The adjusted EBITDA loss for the second quarter of 2019 was $4.8 million compared to an adjusted EBITDA loss of $11.5 million for the second quarter of 2018, a decrease of $6.6 million or 58%. We have provided a full reconciliation of our adjusted EBITDA results in our earnings release, Form 8-K, and Form 10-Q, all of which were filed with the Securities and Exchange Commission this morning.

Turning to our financial results for the first six months of 2019, revenue for the first half of 2019 was $122.1 million compared to $79.1 million for the first half of 2018, an increase of $43 million or 54%. Revenue from advanced wound care products for the first half of 2019 was $103.1 million compared to revenue of $66.1 million for the first half of 2018, an increase of $36.9 million or 56%. Revenue from advanced wound care products represented 84% of total revenue in the first half of 2019, consistent with the prior year. The increase in advanced wound care revenue was primarily attributed to additional sales personnel, strength in PuraPly sales, and the continued growth and adoption of our amniotic products.

Revenue from surgical and sports medicine products for the first half of 2019 was $19 million compared to $13 million for the first half of 2018, an increase of $6 million or 47%. The increase in surgical and sports medicine revenue was primarily due to the expansion of our sales force and the penetration of new and existing customer accounts. Revenue from surgical and sports medicine products represented 16% of total revenue in the first of 2019, consistent with the prior year. The increase in surgical and sports medicine revenue was primarily due to the expansion of our sales force and penetration of new and existing customer accounts.

Revenue from PuraPly products for the first half of 2019 was $55.1 million compared to $23.4 million for the first half of 2018, an increase of $31.8 million or 136%. Revenue from PuraPly products represented approximately 45% of total revenue in the first half of 2019 compared to 30% of revenue in the first half of 2018.

Gross profit for the first half of 2019 was $85.6 million compared to $47.3 million for the first half of 2018, an increase of $38.4 million or 81%. Gross profit margin for the first half of 2019 was 70% of revenue compared to 60% of revenue for the first half of 2018. The improvement in gross profit margin resulted primarily from a more favorable product mix in the first half of 2019 and volume-based manufacturing efficiencies.

Operating expenses for the first half of 2019 were $105.1 million compared to $84.3 million for the first half of 2018, an increase of $20.8 million or 25%. The increase in operating expenses in the first half of 2019 as compared to the first half of 2018 was driven primarily by higher selling, general, and administrative expenses, which increased to $97.9 million compared to $75.9 million in the first half of 2018, an increase of $22 million or 29%. The increase in selling, general, and administrative expenses is primarily due to additional headcount, mainly hiring in our direct sales force, higher sales commissions as a result of higher revenue, and increased marketing and promotional expenses for our products.

R&D expenses for the first half of 2019 were $7.2 million compared to $4.9 million in the first half of 2018, an increase of $2.4 million or 49%. The increase was primarily due to additional headcount, investment in new and continuing clinical programs. Net operating loss for the first half of 2019 was $19.4 million compared to an operating loss of $37 million for the first half of 2018, a decrease of $17.6 million or 47%. The decrease in operating loss in the first half of 2019 was driven by strong operating leverage, as gross profit increased 81%, partially offset by operating expenses increasing 25%.

Total other expenses net for the first half of 2019 were $5.8 million compared to $5.4 million for the first half of 2018, an increase of $0.4 million or 7%. The increase was driven primarily by a $1.9 million non-cash loss on the extinguishment of debt related to the write-off of unamortized debt discount and prepayment penalties upon the repayment of our master lease agreement when we closed the new $100 million Silicon Valley Bank-led financing in March of 2019. This was offset in part by a decrease in interest of $1.2 million and a decrease in the change in the fair value of our warrant liability of $0.2 million compared to the prior-year period.

Net loss for the first half of 2019 was $25.3 million or $0.28 per share, compared to a net loss of $42.5 million or $0.56 per share for the first half of 2018, a decrease of $17.2 million or 40%. Adjusted EBITDA loss for the first half of 2019 was $14.2 million compared to an adjusted EBITDA loss of $28.8 million for the first half of 2018, a decrease of $14.6 million or 51%.

Turning to the balance sheet, as of June 30th, 2019, the company had $20 million in cash and $90.2 million in debt obligations, of which $17.1 million were capital lease obligations, compared to $21.3 million in cash and $59.3 million in capital lease and debt obligations, of which $17.7 million were capital lease obligations in December 2018. The net change in cash of approximately $1.3 million for the six months ended June 30th, 2019 was driven by $21.9 million of cash provided by financing activities, offset by $21.7 million of cash used in operating activities and $1.5 million of cash used in investing activities during the period.

Turning to our view of our 2019 revenue guidance, which we updated in our earnings release this morning, for the 12 months ended December 31st, 2019, the company now expects total revenue of between $250-262 million, representing growth at the midpoint of the range of approximately 32% year over year. This compares to our prior guidance range of $249-262 million, representing growth of approximately 32%. The 2019 revenue forecast assumes revenue from advanced wound care products of between $219-224 million, representing growth of approximately 33-36% year over year as compared to $164.3 million for the 12 months ended December 31st, 2018.

Revenue from surgical and sports medicine products of between $31-38 million, representing growth of approximately 6-31% year over year, as compared to revenue of $29.1 million for the 12 months ended December 31st, 2018. The 2019 revenue guidance range now assumes that revenue from the sale of our PuraPly products will represent between $110-120 million, representing growth of approximately 58-72% year over year as compared to revenue of $69.8 million for the 12 months ended December 31st, 2018.

Additionally, on July 22nd, 2019, the company announced an exchange offer for the holders of all 30.9 million outstanding public warrants, exercise of approximately $15.5 million of Class A common stock that were issued in connection with the initial public offering. The offer is to exchange 0.95 shares of Class A common stock for each warrant tendered. This translates to approximately one share for every 11 public warrants tendered. On July 12th, 2019, in anticipation of the planned exchanged offer, the company entered into a warrant exchange agreement with the Vista Capital Partners, pursuant to which if Vista agreed to exchange an aggregate of 4.1 million PIPE warrants for the company's Class A common stock at an exchange rate ratio of 0.95 shares of Class A common stock for each warrant tendered. The exchange of these PIPE warrants is subject to the company's acceptance of the tender offer of 65% or more of the outstanding public warrants in the exchange offer.

The purpose of the exchange offer is to reduce the number of shares that would otherwise become outstanding upon the exercise of the public warrants. The company's board of directors believes that by allowing holders of the public warrants to exchange one public warrant for 0.95 shares, the company can potentially reduce the substantial number of shares that would be issuable upon exercise of the public warrants, thus providing investors and potential investors with greater certainty as to the company's capital structure.

For illustrative purposes, if all outstanding public warrants are tended in the exchange offer and all outstanding PIPE warrants are exchanged pursuant to the warrant exchange agreement, the company would issue approximately 3.3 million shares for all tendered warrants. However, if all of the public warrants and PIPE warrants are exercised pursuant to their terms, the company would issue approximately 17.5 million shares.

Thus, assuming all public warrants and PIPE warrants are exchanged, the dilution would be approximately 3.5% versus 16.1%. Any public warrants acquired pursuant to the exchange offer will be retired and canceled. The exchange offer is scheduled to expire on August 16th, 2019. Holders of public warrants should refer to the offer exchange letter and related materials that the company has filed with the Securities and Exchange Commission, which sets forth all the terms and conditions of the exchange. With that, I'll turn the call back over to Gary. Gary?

Gary S. Gillheeny, Sr. -- Director, President, and Chief Executive Officer

Thanks, Tim. Overall, we are pleased with our operating and financial performance over the first six months of 2019, and we are focused on continuing to execute over the balance of 2019, a year in which we expect increase on net revenue by 29-35% year over year as we continue to drive strong adoption and utilization of our comprehensive product portfolio in both advanced wound care and surgical sports medicine. We have a strong commercial strategy, and our continued success in executing the strategy will result in strong adoption and utilization of our differentiated product solutions for both markets we serve.

In addition to strong commercial execution, our strategic growth plan includes priorities in the areas of operational progress, including capacity and margin improvement, the continued development of our new product pipeline, and improving our overall profitability profile. Importantly, we are committed to delivering on our mission to provide integrated healing solutions to substantially improve medical outcomes while lowering the overall cost of care for the healthcare systems.

And, we believe we have several unique strengths that position us well for future growth. We are a leader in the regenerative medicine space, with strong brand recognition. We're well positioned in large, attractive, and growing 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 and our providers. We have a large and growing body of clinical data and a portfolio of products with FDA and PMA approvals and FDA clearances, and we've established robust and extensive customer relationships with hospitals, wound care centers, government facilities, ambulatory surgery centers, and physician offices to sell our broad portfolio of products.

We've built and established a scalable regulatory, manufacturing, and commercial infrastructure in both markets we serve, and our executive management team has extensive experience in regenerative medicine, boasting over 100 years of collective experience and accomplishments in the space. This experience allows us to operate from a deep understanding of the underlying trends in regenerative medicine in the scientific, clinical, regulatory, commercial, and manufacturing requirements necessary to succeed in our industry. We look forward to speaking with the investment community in the future, and we appreciate your interests. With that, operator, I will turn it over to you.

Questions and Answers:

Operator

Thank you. If you'd like to ask a question, please signal by pressing *1 on your telephone keypad. If you're using a speakerphone, please make sure your mute function is turned off to allow your signal to reach our equipment. And, our first question will come from the line of Ryan Zimmerman from BTIG. You may begin.

Ryan Zimmerman -- BTIG Research -- Director

Great, thank you. Can you hear me OK?

Gary S. Gillheeny, Sr. -- Director, President, and Chief Executive Officer

Yes, Ryan.

Ryan Zimmerman -- BTIG Research -- Director

All right. Gary, Tim, congrats on the continued execution. Just to begin, let's start with guidance. You have a few moving pieces, it looks like. PuraPly is doing exceedingly well. I think your guidance raise implies about a 15.5% increase at the midpoint for PuraPly, so I would just love if you could walk us through how you're thinking about that PuraPly guidance and the run rate you're thinking about going forward, or just the formulation that you're coming up with for that PuraPly guidance. And, I have some follow-ups.

Timothy M. Cunningham -- Chief Financial Officer

Sure. This is Tim, Ryan. I'll start, and then I'll let Gary take over. We tighten the range as we get further into the year, so first off, we tightened the range. With that, we raised the surgical and sports medicine range, we brought up the lower end of the range, and by bringing up surgical and product to midpoint, with PuraPly, as you recall, in January in the first quarter, we took Affinity off the market, so what we have done is we've sold more PuraPly as well as NuShield to make up for taking that product off the market.

Ryan Zimmerman -- BTIG Research -- Director

That's very helpful.

Gary S. Gillheeny, Sr. -- Director, President, and Chief Executive Officer

Hi, Ryan. Just to add to that, Tim is correct. Affinity off the market certainly put some pressure on the company, but our portfolio has responded, and PuraPly and NuShield is clearly picking up that slack. In fact, in the first half of the year, we actually exceeded our expectations for Affinity with the excess in addition sales of PuraPly and NuShield, so we're pretty excited about that. We're also seeing deeper penetration in additional and new physician specialties, and we're seeing more and more use of the product in smaller wounds. Actually, today, over 70% of the units that we sell are on the smaller side, and today, would fit under the bundle if, in fact, the product was still under the bundle. So, we're seeing good adoption, we're seeing an expansion of the product profile in smaller wounds and different physician specialties, which is our strategy.

Ryan Zimmerman -- BTIG Research -- Director

That's very helpful. And then, looking at surgical and sports medicine, it continues to trend really well. The implied guidance, though, in the back half of the year does imply bit of a step-down, so is that conservatism on your part? You seem to be doing better than I think even you initially expected on the surgical sports medicine side.

Gary S. Gillheeny, Sr. -- Director, President, and Chief Executive Officer

Yeah, Ryan. This is Gary. So, last year, we had a strong third and fourth quarter, but more importantly, in Q4, we typically see what we call a seasonal bump, but last year, that seasonal bump was extremely strong, and we weren't sure whether that's an anomaly and not comfortable guiding to that additional bump in Q4, but we are seeing strong trends, we're continuing to add agencies, so if we do experience a similar seasonal bump in Q4 this year, we would be trending toward the higher end of the range, but we're not comfortable putting it in our guidance because we've seen it basically one time.

Ryan Zimmerman -- BTIG Research -- Director

Fair enough. I'll let others ask some questions and hop back in queue. Thank you.

Operator

Thank you. And, as a reminder, ladies and gentlemen, that's *1 for questions. Our next question comes from the line of Steven Lichtman from Oppenheimer. You may begin.

Steven Lichtman -- Oppenheimer & Company -- Managing Director

Thank you. Hi, guys. Just building on Ryan's question, on PuraPly, you're coming in higher than expected. Can you update us on efforts to capitalize on the pass-through period here? I know you talked about expanding payer coverage, adding sizes, increasing education. Can you provide an update on those potential efforts?

Gary S. Gillheeny, Sr. -- Director, President, and Chief Executive Officer

Sure. As it relates to PuraPly, we are seeing much more usage of our smaller sizes of our PuraPly products. That's very encouraging to us because those small sizes do, today, fall under the bundle from a pricing perspective, so that revenue is somewhat protected. We're also seeing additional physician specialties. We're seeing more product in the office, we're seeing more product in plastic and some of the trauma cases, so the expansion is working, and those sales are fairly sticky the way we see them, and we're pretty excited about it.

Steven Lichtman -- Oppenheimer & Company -- Managing Director

Okay, great. Thanks, Gary. And then, sales force hires and independent agency adds continue to be strong. Any changes in your thoughts on how many adds you'll have on both fronts in 2019?

Gary S. Gillheeny, Sr. -- Director, President, and Chief Executive Officer

I think we're still comfortable that we're going to be adding 50-60 direct sales reps in our advanced wound care business and 25-30 new agencies in our surgical sports medicine business, so we're comfortable with that, and we're building that sales force consistent with our capacity increases, particularly on the amnion side, so as we ramp up our capacity -- and, we've seen a nice boost in capacity of our amniotic production in Q2 for NuShield, which, again, is taking a part of the burden of the Affinity product being off the market, along with PuraPly -- we don't expect to see another significant material improvement in productivity until Q4, so the addition of our reps and the expected improvement in revenue will follow that capacity.

Steven Lichtman -- Oppenheimer & Company -- Managing Director

Got it. Thanks, Gary. I'll jump back in queue.

Gary S. Gillheeny, Sr. -- Director, President, and Chief Executive Officer

Thank you.

Operator

Thank you. And, I'm currently showing no further questions at this time. That does conclude our conference for today. Thank you participation.

Gary S. Gillheeny, Sr. -- Director, President, and Chief Executive Officer

Thank you very much.

Timothy M. Cunningham -- Chief Financial Officer

Thank you.

Duration: 34 minutes

Call participants:

Gary S. Gillheeny, Sr. -- Director, President, and Chief Executive Officer

Timothy M. Cunningham -- Chief Financial Officer

Ryan Zimmerman -- BTIG Research -- Director

Steven Lichtman -- Oppenheimer & Company -- Managing Director

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