オルガノジェネシス（ORGO）2026年第3四半期決算説明会：売上高ガイダンスとAmnuvxの遅延

主なポイント

• 2026年第3四半期の製品純売上高は前年同期比70%減の4,550万ドルとなったものの、皮膚代替材市場の環境が改善し始めたことで前期比では6%増加した。
• アドバンスド・ウンド・ケア売上高は73%減の3,820万ドル、サージカル＆スポーツ・メディシン売上高は19%減の730万ドルとなった。
• 売上総利益率は前年同期の76%から52%へと縮小した。オルガノジェネシスは2,960万ドルの純損失および2,240万ドルの調整後EBITDA損失を計上した。
• 経営陣は2026年通期の純売上高ガイダンスを前年比65%〜68%減となる1億7,900万ドル〜2億ドルに更新した。
• 同社は2026年第4四半期の調整後EBITDAについて、ガイダンスレンジの上限では黒字を見込む一方、下限では赤字が続くと予想している。
• FDA（米食品医薬品局）はAmnuvxの審査において、ノーウッド工場で18項目の是正事項を指摘した。オルガノジェネシスは2027年9月30日までに是正措置が完了すると見込んでおり、PDUFA目標期日は2027年4月24日以降に延期される。

主要財務業績

事業および営業業績

70%の減収は、2025年12月における地域保険給付決定（LCD）適用方針の撤回と、廃棄製品に関するメディケア・メディケイド・サービス庁（CMS）のコメントを受けた皮膚代替材市場の混乱を反映したものである。前年同期比では大幅な落ち込みとなったものの、総売上高は第2四半期比で6%増加し、これにはアドバンスド・ウンド・ケアの前期比6%増、サージカル＆スポーツ・メディシンの同10%増が含まれる。

経営陣によると、競合他社が創傷ケア分野へのエクスポージャーを縮小または同カテゴリーから撤退したことで、オルガノジェネシスは市場シェアを獲得した。保険請求データの分析では、同社のシェアは第1四半期と比較して30%超拡大し、主要な既存競合ポートフォリオの2倍を超えるペースで成長したことが示された。Apligraf、PuraPly AM、Affinity、NuShieldはいずれも前期比で改善を示した。

オルガノジェネシスはまた、難治性糖尿病性足潰瘍を対象としたPuraPly AMのPREPARE試験の結果公表を強調した。同試験は主要評価項目を達成し、標準治療にPuraPly AMを併用した場合、12週時点での創傷閉鎖において統計学的に有意な改善を示した。同社によると、PuraPly AMのエビデンスベースは2万3,000人以上の患者を対象としている。

Amnuvx（旧ReNu）については、FDAが2026年6月に生物製剤承認申請（BLA）を受理した。その後実施された承認前査察で18項目の是正事項が特定されたほか、FDAは提出された臨床データに関する追加情報も求めた。同社は、変形性膝関節症を対象とした単回投与の生物製剤治療薬としての承認取得を引き続き目指している。

経営陣のガイダンス

オルガノジェネシスは現在、2026年通期の純売上高を前年比65%〜68%減の1億7,900万ドル〜2億ドルと予想している。見通しの内訳は以下の通り：

• アドバンスド・ウンド・ケア売上高：1億5,100万ドル〜1億7,100万ドル
• サージカル＆スポーツ・メディシン売上高：2,600万ドル〜2,700万ドル
• 助成金収入：190万ドル

経営陣は第4四半期に売上高が前期比で改善すると見込んでいるものの、全体的な回復ペースは当初の想定よりも遅れていると述べた。

同社は、下半期の調整後EBITDA損失について、ガイダンス下限で上半期比60%超、上限で80%超縮小すると予想している。第4四半期の調整後EBITDAの黒字化は、業績がレンジの上限に達した場合にのみ見込まれる。

事業再編および追加のコスト削減策により、年換算の営業費用は約4,500万ドル削減される見込みで、これには事業再編に関連する約3,200万ドルが含まれる。

経営陣は、手元資金、運転資本、および製品販売によるネットキャッシュフローにより、少なくとも今後12カ月間の営業費用と設備投資を賄うことができると見込んでいる。また同社は、Amnuvxの商業化およびスミスフィールド工場への投資に向けた資金調達の選択肢も検討している。

リスクと注視すべきポイント

• 皮膚代替材の需要は、保険償還の変更、廃棄製品に関する規則を巡る不透明感、そして特にApligrafを中心とした臨床医の混乱による影響を引き続き受けている。
• 経営陣は、第3四半期の皮膚代替材売上高の20%近くが、すでに市場から撤退した企業が保有していた在庫によるものと推計した。この在庫は今後1〜2四半期で解消されると見込んでいる。
• AmnuvxのPDUFA目標期日は2027年4月24日以降に延期される。改定後の目標期日は提示されていない。
• ノーウッド工場の是正費用は約800万ドルと見込まれており、これには約400万ドルの追加支出と、前倒しされた計画済みの施設改修費用400万ドルが含まれる。このうち約25%が2026年に、残りは2027年第3四半期までに発生する見通しである。
• 現金・現金同等物および使途制限付き現金は、2025年末時点の9,430万ドルから2,690万ドルに減少した。

アナリスト質疑応答の主なポイント

経営陣は、第3四半期の完全な市場データはまだ得られていないものの、皮膚代替材市場は底を打ち、再び拡大し始めていると述べた。過剰在庫が解消され、臨床医が保険償還の変更に適応するにつれて、第1四半期までに価格および販売数量の動向がより明確になると予想している。

同社は、実績のある製品と臨床エビデンスに支えられた主要競合4〜5社により、市場が2桁成長へと回帰する可能性があると考えている。また経営陣は、LCD方針の復活の可能性は残されているとしたものの、具体的な時期や確実性については明言しなかった。

第4四半期の収益性について経営陣は、調整後EBITDAの黒字化は売上高がガイダンスの上限に達するかどうかにかかっていると説明した。下限となった場合、事業再編によるコスト削減や継続的な費用抑制にもかかわらず、調整後EBITDAは赤字にとどまる見込みである。

決算説明会トランスクリプト全文

決算説明会の完全なトランスクリプト

経営陣による説明

Operator

I would like to remind everyone that our 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 Item 1A, Risk Factors, of the company's most recent annual report and its subsequently filed quarterly report. 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 the forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by applicable 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 those 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 S. Gillheeney, Sr., Organogenesis Holdings President, Chief Executive Officer, and Chair of the Board. Please go ahead, sir.

Gary Gillheeney

Thank you, operator, and welcome everyone to Organogenesis Holdings' third quarter 2026 earnings conference call. I'm joined on the call today by Dave Francisco, our Chief Financial Officer.

Let me start with a brief agenda of what we'll cover during our prepared remarks. I'll begin with a brief review of our results and key developments in the third quarter and in recent months. Dave will then provide you with an in-depth review of our third quarter financial results, our balance sheet and financial condition at quarter end, as well as our financial outlook for 2026, which we updated in our press release this afternoon. I'll then provide you some closing comments before we open up the call for your questions.

Beginning with a review of our results and key developments in Q3, our revenue results reflect a significant contraction and slow pace of recovery in the skin substitute market following the withdrawal of the LCD coverage policies for skin substitutes and CMS's published comments regarding discarded product in December of 2025. On balance, we were encouraged to see the operating environment improve from what we experienced during the second quarter, particularly as it relates to improving clinician confusion. Although net product revenue declined 70% year over year in the third quarter, our net product revenue increased 6% quarter over quarter in Q3.

As a leader in the industry, we leveraged our most comprehensive portfolio across multiple FDA classifications, specifically the only biologic PMA-approved product, Apligraf, to enhance our market share position with an increase in volume on a quarter-over-quarter basis, outperforming the declines that have been reported across the industry. As discussed on our second quarter conference call, the competitive landscape has changed dramatically in the months following CMS's sweeping changes to payment policy. Distributor-driven competitors, high-priced amniotic players, and companies engaged in fraudulent practices have been substantially reduced. Many of the remaining players are diversifying away from wound care or exiting the category altogether.

In this new market, customers are deciding which products and which partners they can trust, and they are deciding based on efficacy, outcomes, and evidence. And that is the foundation Organogenesis was built on and the primary driver of the continued growth and market share we're achieving this year. And these gains are broad-based, with Apligraf, PuraPly AM, Affinity, and NuShield all demonstrating meaningful improvements. That breadth tells us that customers are placing their confidence in our portfolio, not just a single product. We are also treating more patients and utilization of our skin substitutes is increasing. Our team's commitment to our customers and their patients is paying dividends.

Claims data analysis further supports the fact that Organogenesis is gaining market share, with our share increasing more than 30% versus Q1 and increasing at a rate more than double the major established competitive portfolios. While this growth is more measured than we contemplated in our guidance at the beginning of 2026, we're strengthening our position as this market reshapes.

I want to make it clear that I remain very optimistic about our future. With more than 40 years in regenerative medicine and the most diverse evidence-based portfolio with technologies in each FDA category, we believe we are best positioned in the skin substitute market and will continue to be a leader in the space with the best evidence-based portfolio in the market. It's from this strong long-term market position that we are making important strategic decisions and prioritizing our investments that will support our company's future growth and continued leadership in this market.

We are increasing our focus on clinical evidence with new published studies because science and evidence have always been core to our foundation. As coverage policies evolve, evidence will be the currency of credibility, and we intend to remain in the lead. We continue to advance our strategic initiative to expand the company's mission into entirely new markets with the Amnuvx program. Let me share a few updates on our progress in each of these important strategic initiatives in recent months.

On October 12th, we announced the publication of previously released results from PREPARE, a prospective multicenter randomized controlled trial evaluating the safety and efficacy of PuraPly AM in the management of non-healing diabetic foot ulcers, or DFUs. The trial achieved its primary endpoints, and the results published in the Journal of Wound Care demonstrate statistically significant improvements in wound closure at 12 weeks among patients treated with PuraPly AM plus standard of care, providing clinical evidence supporting the use of PuraPly AM in one of the most costly and difficult-to-treat chronic wound populations. We believe publications of these impactful results will strongly support PuraPly AM's inclusion in any future coverage policies, underscoring its critical role in the wound healing algorithm.

We have built a significant body of evidence on the clinical benefit of PuraPly AM, including publications on comparative effectiveness research and a prospective analysis of a large patient registry. Together, this compelling evidence spans more than 23,000 patients studied, reflecting both the primary and supporting data CMS considers when making coverage determinations. Peer-reviewed data continues to differentiate Organogenesis in a recalibrated market where we are gaining share while competitors without comparable evidence are pivoting away from wound care or exiting the market altogether.

Turning to an update on our ReNu program. Amnuvx, formerly ReNu, is our initiative to bring a new regenerative therapy intended to meaningfully change the treatment paradigm for knee osteoarthritis. Knee OA is a leading cause of chronic pain, functional impairment, disability, and reduced quality of life. And unfortunately, this patient population progresses through temporary measures until the only option is a total knee replacement. No biologic therapy for knee OA pain has been approved by the FDA, leaving no disease-directed option between conventional injections and joint replacement.

If approved, Amnuvx will establish a new market category for a biologic product that addresses this massive treatment gap for more than 30 million Americans living with symptomatic knee osteoarthritis. We believe this highly differentiated regenerative therapy has the potential to meaningfully change the treatment paradigm by offering a non-surgical biologic option designed to address pain and improve function, particularly for patients with severe disease who lack approved non-surgical options. We completed the BLA submission for Amnuvx with the FDA in April of this year. In June of this year, the FDA accepted the BLA for review.

During the third quarter, the FDA completed a pre-license inspection of our Norwood facility and identified 18 items requiring remediation. In addition, we received information requests from the FDA related to the clinical data we submitted in the BLA following a mid-cycle communication telecon. We are preparing responses to the information request and currently expect to complete the identified remediation work in the Norwood facility by September 30th, 2027. Accordingly, the PDUFA target date will be extended from April 24th, 2027. While the timeline has been extended, our commitment to pursuing a BLA for this unique, non-surgical single-injection biologic is unchanged. We have well-established leading capabilities in manufacturing and living technology, and therefore are confident that we will resolve the identified observations, and we look forward to continuing engagement with the FDA as we complete their review. With that, let me turn the call over to Dave.

David Francisco

Thanks, Gary. I'll begin with a review of our third quarter financial results. Unless otherwise specified, all growth rates referenced during my prepared remarks are for the 3-month period ending September 30th, 2026, and are on a year-over-year basis. Net product revenue was $45.5 million, down 70%. Our Advanced Wound Care net product revenue was $38.2 million, down 73%. Net product revenue from Surgical & Sports Medicine products was $7.3 million, down 19%.

Importantly, our third quarter results reflect an encouraging improvement in growth trends on a sequential basis. Specifically, our total revenue increased 6% quarter over quarter, driven by a 6% increase in sales of Advanced Wound Care products and a 10% increase in sales of our Surgical & Sports Medicine products. Gross profit was $23.6 million, or 52% of net product revenue, compared to 76% last year.

Operating expenses were $75 million compared to $130.1 million last year, a decrease of $55.2 million, or 42%. Excluding cost of goods sold of $21.9 million in Q3 and $36.3 million last year, our non-GAAP operating expenses were $53 million compared to $93.9 million last year, a decrease of $41 million, or 44%. The year-over-year change in operating expenses, excluding cost of goods sold, was driven by a $34.7 million, or 43% decrease in SG&A expenses, and a $5.3 million, or 40% decrease in research and development expenses.

Operating loss was $29.5 million compared to operating income of $20.7 million last year, a decrease of $50.2 million. Net loss was $29.6 million compared to net income of $21.6 million last year. Net loss to common stockholders was $32.7 million compared to net income of $14.5 million last year. Net loss to common stockholders includes the impact of the cumulative dividend and the non-cash accretion to redemption value of our convertible preferred stock.

Adjusted net loss was $29.3 million compared to adjusted net income of $23.2 million last year. Adjusted EBITDA loss was $22.4 million compared to adjusted EBITDA of $30.1 million last year. We have included a detailed reconciliation of GAAP to non-GAAP adjusted net loss and adjusted EBITDA loss in our press release this afternoon.

Turning to the balance sheet, as of September 30th, 2026, the company had $26.9 million in cash, cash equivalents, and restricted cash, and no outstanding debt obligations, compared to $94.3 million in cash, cash equivalents, and restricted cash and no outstanding debt obligations as of December 31st, 2025. We expect that our cash on hand and other components of working capital as of September 30th, 2026, plus net cash flows from product sales will be sufficient to fund our operating expenses and capital expenditure requirements for at least the next 12 months. We continue to evaluate alternative financing strategies to accelerate key investments, including Amnuvx commercialization and enhancing capacity and efficiencies from our Smithfield facility.

Turning to our 2026 outlook, which we've updated in this afternoon's press release, while our 2026 outlook continues to reflect the expectation that we see sequential improvement in our revenue trends in the third and fourth quarters, our updated total revenue range now reflects the expectation that we see a more measured recovery in the overall operating environment in the second half of 2026. We now expect total net revenue for the full year of 2026 of $179 million to $200 million, representing a decline in the range of 65% to 68% year over year, and compared to our prior guidance, which assumed a decline in the range of 62% to 68% year over year.

Note that our total net revenue range assumes sales of Advanced Wound Care products in the range of $151 million to $171 million, sales of our Surgical & Sports Medicine products in the range of $26 million to $27 million, and grant income of $1.9 million.

With respect to our profitability expectations, our updated guidance continues to assume improving quarterly adjusted EBITDA performance on a sequential basis, which is expected to result in more than a 60% reduction in adjusted EBITDA loss in the second half of 2026 as compared to the first half of 2026 at the low end of the range, and more than an 80% reduction in adjusted EBITDA loss in the second half of 2026 as compared to the first half of 2026, including the expectation of positive adjusted EBITDA generation in the fourth quarter.

Note that we have materially reduced our expense profile this year. Cost savings related to our March 2026 and June 2026 restructurings and incremental cost reduction activities in the second half of 2026 are expected to result in a total reduction in operating expense of approximately $45 million, of which approximately $32 million is related to restructuring. With that, I'll turn the call back over to Gary for closing remarks.

Gary Gillheeney

Thanks, Dave. The market disruption has reshaped the skin substitute category, and while we support many of the revisions to reimbursement, the uncertainty around comments on discarded product has created real confusion for our customers, particularly around Apligraf. During the past year, we've been engaging constructively with federal policymakers on the distinct value of living cell-based biologic therapies, including why discarded product rules should reflect how these products are manufactured and administered. As that work continues, we're encouraged by the progress as customers increasingly are returning to products proven to deliver positive outcomes for patients.

Biologic cell therapy is made from biologic sources and as a living cell-based biologic, Apligraf is supplied as a single fixed-size unit with a limited shelf life. For more than 25 years, the science behind our technologies has been clear. Our biologic PMA products, Apligraf, Dermagraft, and Transcyte have been rigorously studied and FDA approved based on clinical data. We believe our biologic PMAs and clinical evidence that underpin them will be the cornerstone of the market going forward. Organogenesis introduced living cell technology with Apligraf, and today we are building on that foundation to define a sustainable future for advanced wound care. We are emerging from this reset as a biologic company supported by multiple regenerative technology platforms.

Amnuvx, now under BLA review, would, if approved, add to our arsenal of biologic therapies that harness the body's natural healing mechanisms. Going forward, we will continue to leverage our advanced science and unmatched breadth of clinical data as part of our vision to be a force for meaningful change and set a higher expectation in healing and recovery. With that, I'll turn the call over to the operator to open the call up for questions. Thank you.

Operator

[Operator Instructions]

Our first question comes from the line of Ryan Zimmerman of BTIG.

質疑応答

Ryan Zimmerman

Good afternoon, Gary and Dave. Can you hear me okay?

Gary Gillheeney

We can, Ryan.

Ryan Zimmerman

Great. So, you know, a lot of things are up in the air in this market. It's been, you know, I think more challenging for everyone than anticipated. What is your current thinking, Gary, around kind of how the recovery curve will take shape? And what I'm trying to understand is just, as we've cycled through this, it's taken longer than I think everyone's anticipated. And so, do you have a sense for when you think you kind of come out the other side of this dynamic? And given we saw the PFS rates, we saw the OPPS last night, not a whole lot changed from what was proposed, and so it seems like Medicare is kind of sticking with kind of what they intended from the proposal.

Gary Gillheeney

So, you know, for us, you know, we think we certainly are coming up on the other side. The market has clearly bottomed out. We're seeing an improvement in overall market expansion. We've seen it from Q1 to Q2. Q3 data is still not available yet, but based on our market share gains and our growth, our expectation is the market is expanding again. So as the market absorbs all of the changes that are going on, right, and there's still a lot of inventory in the market. You know, we estimate almost 20% of the sale of skin substitutes in Q3 are from companies who are no longer in the space that have actually -- just dumped a lot of inventory.

So as that processes through, which we think it will in the next quarter or two, as confusion, particularly around our products and the utilization of Apligraf is getting clearer, we're starting to see a path forward. So I think we've certainly hit the bottom and we're coming up on the other side. It's just a matter of who's left in the market and how customers respond to who's left in the market. We think the focus on efficacy and evidence is really important. There's audits going on still out there and the ones that win are the ones that have evidence, RCTs in those audits. So, you know, it's a moving back to evidence, which is what we've always wanted it to be.

Ryan Zimmerman

Right. And just to be clear, Gary, if there's a price versus volume dynamic that's occurring here where there is lower price for these products, but the volumes are starting to pick up. That began in Q1, so arguably by the end of the fourth quarter, we should be through that kind of, you know, dynamic.

Gary Gillheeney

I would think by the end of the year, certainly through Q1, we're going to understand and start to see a lot more clarity, because price can only go so far. So I think the volume and price will settle out at least by Q1, and we'll get a better sense of how the market's really moving and what the potential of the market is.

Ryan Zimmerman

Okay. And then Dave, for you, you know, you made a comment. You guys have done a lot of cost cutting, you know, through this year to manage through things. I'm just wondering if you could spend a minute on the adjusted EBITDA comments in fourth quarter being positive, given the guidance. Maybe help us bridge from the revenue composition to the positive adjusted EBITDA, because given what we saw this quarter, it does require some tighter expense control again in fourth quarter.

David Francisco

Yes, so you're right, Ryan. We have done quite a bit. As we mentioned, we've done two RIFs. And then as you kind of look at the differential between the operating expenses between the second quarter and the third, we're down about $10 million on an adjusted basis. So from our standpoint, that's, call it $40 million annualized. And then there was $8 million, almost $8.5 million of incremental savings on headcount that was in COGS. So that's where we came up with the -- some of these are project deferrals and things of that nature. So that's where we're at about $45 million on an annualized basis.

So we have made a lot of progress there. I think when you look at the differential between the potential for break-even position that we've got in the fourth quarter, it's really at the high end of the range. So we've continued to see progress in, you know, a reduction in adjustment -- some of that was revenue, some of it was cost cuts, but down, you know, call it, you know, $12 million to $13 million each quarter in improvement. And so, again, if we're on the low end, it's still negative, but on the higher end, if we hit those numbers, then we expect to be net positive.

Ryan Zimmerman

Okay, understood. I'll leave it there and hop back in queue, guys. Thank you.

Gary Gillheeney

Thanks, Ryan.

David Francisco

Thanks, Ryan.

Operator

One moment for our next question. Our next question comes from the line of Ravi Misra of Truist Securities.

Ravi Misra

So just one, I guess, on the market size, you know, you wonder if a little bit of a last-man-standing type of environment here. And it looks like, you know, at least the sequential commentary that you've made. Just curious if you're willing to, based on that and the competitors exiting the space, are you looking to call a bottom here, or is there visibility in sight on the other end yet in terms of where this market is shaping out, you know, kind of the -- it was a miss on the top line, at least versus consensus, but it was better, right, than we had expected, I think, versus the prior quarters? So just help me understand, you know, what's the trajectory, I guess, of any recovery that may or may not be emerging, if you could give detail on that.

Gary Gillheeney

Good question. Sure. So obviously, I don't think anyone can predict with great accuracy this market, but I think what we've seen, the change between Q1 and Q2, as it relates to market expansion, the market coming back, we're seeing something similar in Q3, though again, the data isn't complete yet. So we clearly have seen the bottom without question. We've seen the bottom. I think the challenge is there is a lot of low-cost inventory that's going to flush through that's, you know, impacting the market when that code goes through the system, which we believe it'll be gone by the end of the year. I think that the trajectory forward is going to be strong. We think it'll be double digit from a market expansion perspective, and we think there'll be 4 or 5 major competitors in the space with quality products.

We think if the LCDs are put back in place, which we think that is a strong possibility that could happen, that would also redefine the market probably to those same 4 or 5 competitors with solid products and solid evidence. And then I think the market will steadily grow because the wounds aren't going away. The fact that a lot of patients are not being treated, things are a lot worse in those hospitals right now and they need to be treated. So they will get treated. It's just a matter of over time, clinicians getting comfortable enough to step back in with skin substitutes.

Ravi Misra

Thanks. And then just on the PDUFA commentary, I'm sorry if you discussed this already, we've been jumping through calls. With the push out now on the date and the expense management that you were talking about with Ryan just now, how do we think about the incremental costs, I guess, around that delay and how should that be, you know, built into your model in the sense of, is the identification of the remediation efforts going to take 1 year, 2 years? Any framework around timing or expenses you could put around that would be great.

Gary Gillheeney

Sure. So based on our current estimate, we expect the remediation to be done by September 30th, 2027. So that's our expected timeframe right now. We believe the incremental cost, I should say the total cost for the remediation is about $8 million, which is about $4 million of incremental cost. The other $4 million are kind of pulled-forward things that we were going to do anyway to enhance the facility and improve margins. You know, the FDA wants us to put them in place now, which is fine. So it's an $8 million total spend, a $4 million pull forward. Dave?

David Francisco

That's right, that's right. With about 25% of that done in 2026, the remainder in '27 through, as Gary said, the third quarter.

Operator

I am showing no further questions remaining at this time. That does conclude our conference for today. Thank you for your participation.

This live transcript is auto-generated without human intervention or review.