On May 4, 2022 Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) reported financial results for the first quarter of 2022 and recent business achievements (Press release, Ionis Pharmaceuticals, MAY 4, 2022, View Source [SID1234613507]).

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"We are off to a strong start this year highlighted by progress in our rich late- and mid-stage pipeline. We remain on track for data from the NEURO-TTRansform study of eplontersen in patients with hereditary ATTR polyneuropathy by mid-year. Assuming positive data, we plan to file for regulatory approval by the end of this year. We recently increased the size and duration of our CARDIO-TTRansform study of eplontersen in patients with ATTR cardiomyopathy. Our aim is to generate even more robust data and ensure a highly positive study outcome to successfully compete in this growing and dynamic market," said Brett P. Monia, Ph.D., chief executive officer of Ionis. "We also reported positive data from two potential best-in-class medicines. In the Phase 2b ETESIAN study, ION449, our investigational medicine targeting PCSK9, demonstrated robust LDL-C and PCSK9 reductions in statin-treated patients with hypercholesterolemia. ION449 was generally well tolerated in this study. Additional positive data from the Phase 2 study of donidalorsen demonstrated significant improvements in quality of life in people with hereditary angioedema. Looking ahead, we expect to provide additional key mid-stage data readouts and updates on our technology advancements. These upcoming catalysts, together with our recent achievements, position us well to continue to drive substantial growth and value for all stakeholders."

First Quarter 2022 Summary Financial Results

On track to achieve 2022 financial guidance, based on the following first quarter results:

$142 million in total revenues
$173 million of operating expenses on a non-GAAP basis(1) and $199 million on a GAAP basis
$39 million net loss on a non-GAAP basis(1) and $65 million on a GAAP basis
$2.1 billion of cash and short-term investments
"A key element of Ionis’ financial strength is our ability to generate substantial revenue from multiple diverse sources on a sustained basis. Our first quarter financial results in which revenues grew more than 25 percent year over year were an excellent example of this. We generated revenues from our marketed products, including SPINRAZA, and from numerous partnered medicines as they advanced. Our first quarter financial results also reflect our investments in our rich late-stage pipeline and in activities to prepare for our launches of eplontersen, olezarsen and donidalorsen," said Elizabeth L. Hougen, chief financial officer of Ionis. "We are on track to meet our 2022 financial guidance. With $2.1 billion of cash, we are well capitalized with the resources we need to continue investing in our large agenda to drive substantial future growth."

Recent Marketed Products Highlights

SPINRAZA: the global market leader for the treatment of spinal muscular atrophy (SMA) patients of all ages

$473 million in worldwide SPINRAZA sales in the first quarter
Biogen provided updates from the ASCEND, RESPOND and NURTURE studies of SPINRAZA at the Muscular Dystrophy Association (MDA) Clinical and Scientific conference and the American Academy of Neurology (AAN) annual meeting
TEGSEDI and WAYLIVRA: important medicines approved for the treatment of patients with polyneuropathy caused by hereditary TTR amyloidosis and familial chylomicronemia syndrome, respectively

Continued to progress into new and existing markets in Europe and Latin America in the first quarter through Swedish Orphan Biovitrum AB (Sobi) and PTC Therapeutics, respectively
First Quarter 2022 and Recent Events

Advancing Ionis’ near-term commercial opportunities toward the market

Increased study size and duration in the Phase 3 CARDIO-TTRansform study of eplontersen in patients with ATTR cardiomyopathy with the aim to generate even more robust data and ensure a highly positive study outcome to successfully compete in this growing and dynamic market. Data from this study are expected in the first half of 2025
The U.S. FDA granted orphan drug designation to eplontersen for the treatment of patients with ATTR
Published positive data from the Phase 2 study of olezarsen in patients with hypertriglyceridemia and either at high risk for or with established cardiovascular disease in the European Heart Journal
Initiated a study of olezarsen in patients with hypertriglyceridemia to support the broad Phase 3 program
Published positive data from the Phase 2 study of donidalorsen in patients with hereditary angioedema (HAE) in the New England Journal of Medicine
Presented additional positive data from the Phase 2 study of donidalorsen in patients with HAE at the American Academy of Allergy, Asthma and Immunology (AAAAI) annual meeting
Advancing Ionis’ leading cardiovascular disease franchise

AstraZeneca presented positive data from the Phase 2b ETESIAN study of ION449 (AZD8233) targeting PCSK9 in statin treated patients with dyslipidemia at the American College of Cardiology (ACC) annual scientific session
Achieved full enrollment in the Phase 2b study of IONIS-AGT-LRx in patients with treatment-resistant hypertension, with data expected in the second half of 2022
Advancing Ionis’ leading neurological disease franchise

Roche plans to initiate a new Phase 2 study of tominersen in patients with Huntington’s disease based on findings from a post-hoc analysis of the GENERATION-HD1 study
Biogen initiated a Phase 1/2 study of ION260 (BIIB132) targeting ataxin-3 (ATXN3) in patients with spinocerebellar ataxia type 3 (SCA3), resulting in an $8 million milestone payment from Biogen
Biogen advanced the Phase 1/2 study of ION859 (BIIB094) targeting LRRK2 in patients with Parkinson’s disease, resulting in a $10 million milestone payment from Biogen
Announced the discontinuation of IONIS-C9Rx (BIIB078) due to lack of patient benefit demonstrated in the Phase 1/2 study in patients with C9orf72-ALS
2022 Pipeline Milestones(2)

Anticipated 2022 Regulatory Updates

Program

Anticipated Indication

Regulatory Action

H1

H2

Eplontersen

ATTRv polyneuropathy

NDA filing

Anticipated Key 2022 Data Readouts

Program

Data Readout

Anticipated Indication

H1

H2

Tominersen

Phase 3 post hoc

Huntington’s disease

✓

ION449 (PCSK9)

Phase 2b (ETESIAN)

Cardiovascular disease

Donidalorsen

Phase 2

HAE

IONIS-C9Rx (BIIB078)

Phase 1/2

C9-ALS

Tofersen

Phase 3 OLE

SOD1-ALS

Eplontersen

Phase 3

ATTRv polyneuropathy

IONIS-AGT-LRx

Phase 2b

Treatment-resistant hypertension

Fesomersen (FXI)

Phase 2b

Thrombosis

Bepirovirsen (HBV)

Phase 2b

Hepatitis B virus infection

Donidalorsen

Phase 2 OLE

HAE

Cimdelirsen (GHR)

Phase 2 (monotherapy)

Acromegaly

Anticipated Key 2022 Study Initiations

Program

Phase

Anticipated Indication

H1

H2

Sapablursen

2

Polycythemia vera

IONIS-MAPTRx (BIIB080)

2

Alzheimer’s disease

ION904 (AGT)

2

Uncontrolled hypertension

ION717 (PRNP)

1/2

Prion disease

Anticipated Key 2022 Technology Advancements

Program

Anticipated Advancement

H1

H2

SMA

Advance follow-on program

Muscle LICA

Advance into preclinical development (IND-supporting)

MsPA Backbone

Advance into preclinical development (IND-supporting)

✓ = achieved • = planned

All non-GAAP amounts referred to in this press release exclude non-cash compensation
expense related to equity awards. In 2021 all non-GAAP amounts also excluded expenses
related to the Akcea Merger and restructured commercial operations and the related tax
effects. Please refer to the detailed reconciliation of non-GAAP and GAAP measures, which is
provided later in this press release.

The Company’s revenue in the first quarter of 2022 increased more than 25 percent compared to the same period last year. The increase was driven by significant partner payments across multiple partnered programs, including $20 million from AstraZeneca for its share of the global Phase 3 program costs for eplontersen. Since Ionis is conducting the ongoing Phase 3 program for eplontersen, Ionis recognizes revenue for the reimbursements it receives from AstraZeneca for development expenses in the same period Ionis recognizes the related development expenses. Refer to the detailed table of costs and reimbursements for the eplontersen collaboration provided later in this release. The Company also earned $40 million from Biogen for advancing several neurology disease programs.

The Company successfully completed the transition of its TEGSEDI and WAYLIVRA operations in the EU and North America to Sobi in the first and second quarters of 2021, respectively. The decrease in TEGSEDI and WAYLIVRA revenue in the first quarter of 2022 compared to the same period last year was due to the shift from product sales to distribution fees based on net sales generated by Sobi. As part of the transition, Ionis restructured its commercial operations in 2021 resulting in substantial cost savings.

Operating Expenses

Ionis is advancing a large late-stage pipeline and as a result, its non-GAAP operating expenses increased in the first quarter of 2022 compared to the same period in 2021. Higher R&D expenses were driven by the expanded number of Phase 3 studies the Company is conducting, which doubled over the course of 2021 from three to six studies. Lower SG&A expenses were largely due to the substantial savings Ionis achieved from integrating Akcea and restructuring its commercial operations. These savings were offset in part by the investments Ionis made in advancing its go-to-market activities for its near-term commercial opportunities.

Net Loss

Ionis’ net loss in the first quarter of 2022 decreased compared to the same period in 2021 primarily related to the changes in revenue and operating expenses, as discussed above.

Balance Sheet

As of March 31, 2022 and December 31, 2021, Ionis had cash, cash equivalents and short-term investments of $2.1 billion. Ionis’ debt obligations and working capital did not change significantly from December 31, 2021 to March 31, 2022.

Webcast

Ionis will conduct a webcast today at 11:30 a.m. Eastern time to discuss this announcement and related activities. Interested parties may access the webcast here. A webcast replay will be available for a limited time at the same address.

On May 4, 2022 Umoja Biopharma, Inc., an immuno-oncology company pioneering off-the-shelf, integrated therapeutics that reprogram immune cells in vivo for patients with solid and hematologic malignancies, reported that it will have an oral presentation at the International Society for Cell and Gene Therapy (ISCT) Annual Meeting 2022, to be held May 4-7, 2022 in San Francisco, California (Press release, Umoja Biopharma, MAY 4, 2022, View Source [SID1234613506]).

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On Friday, May 6th, Dave Vereide, Ph.D., Senior Scientist at Umoja Biopharma, will give an oral presentation titled "A synthetic cytokine receptor platform for producing cytotoxic innate lymphocytes as ‘off-the-shelf’ cancer therapeutics." The presentation will highlight Umoja’s rapamycin-activated cytokine receptor (RACR) platform which seeks to address current challenges in the cellular therapy space. Current approaches for differentiating induced pluripotent stem cells (iPSCs) into therapeutic immune cell types often requires expensive exogenous gamma-chain cytokines for expansion and survival, and often, the presence of feeder cells. The RACR platform permits the production of immune effector cells, termed RACR-induced cytotoxic innate lymphocytes (iCILs), in the absence of exogenous cytokines and feeder cells by genetically modifying iPSC-derived progenitor cells to express the RACR synthetic cytokine receptor. A synthetic small molecule ligand then binds RACR to drive the differentiation and expansion of the iCILs. RACR technology can be employed in both a manufacturing setting to generate iCILs and in vivo to enable the selective expansion and survival of iCILs.

"iPSCs are an excellent source of renewable, modifiable, and scalable material for cell therapy manufacturing, yet several limitations exist with the current manufacturing processes for differentiating iPSCs into therapeutic cell types, including the need for exogenous growth factors and feeder cells." said Andy Scharenberg, M.D., co-founder and Chief Executive Officer of Umoja. "At Umoja we are excited about our RACR-iCIL iPSC platform and its capacity to generate immune effector cells in the absence of these limitations. Due to the selective growth advantage provided by our RACR platform, a highly pure iCIL population can be produced during manufacturing. We are evaluating iCILs in pre-clinical studies to assess their in vivo anti-tumor activity, and are optimistic about their potential for development as "off-the-shelf" cell therapies for diverse hematologic malignancies and solid tumors."

Presentation details:

Presentation Title: A synthetic cytokine receptor platform for producing cytotoxic innate lymphocytes as ‘off-the-shelf’ cancer therapeutics
Presenting Author: Dave Vereide, Ph.D., Senior Scientist at Umoja Biopharma
Abstract Number: 44
Oral Presentation Session: Gene Editing/Gene Therapies
Oral Presentation Date, Time: Friday May 6, 2022; 4:45-5:45 p.m. PT
Poster Presentation Session: Poster Networking Reception 2
Poster Presentation Date, Time: Thursday May 5, 2022; 5:45-7:15 p.m. PT

On May 4, 2022 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN), reported that Jean-Jacques Bienaimé, Chairman and Chief Executive Officer, will present at the BofA Securities Healthcare Conference on May 12 at 8:40am PT/11:40am ET in Las Vegas (Press release, BioMarin, MAY 4, 2022, View Source,-Thursday,-May-12-at-8-40amPT-11-40amET [SID1234613505]). To access the live webcast, please visit the BioMarin website, View Source

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BioMarin to Present at the 2022 BofA Securities Healthcare Conference on May 12, 2022
A replay of the webcast will be available for 90 days.

On May 4, 2022 Stephan Sturm, CEO of Fresenius reported that We have made a solid start into 2022 – somewhat better, even, than expected at Fresenius Helios and Fresenius Kabi (Press release, Fresenius, MAY 4, 2022, View Source [SID1234613502]). The first quarter was burdened by the ongoing coronavirus pandemic, the war in Ukraine, supply chain bottlenecks and, above all, cost increases that are in some cases significant. We will have to watch all these factors very closely. Still, our businesses developed well. With the announced transactions at Fresenius Kabi and Fresenius Medical Care we’ve taken important steps in the realization of our growth strategy, thereby improving the foundations for our future business success. We therefore continue to expect overall healthy sales and earnings growth, and to look ahead with confidence to the rest of our business year and beyond."

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FY/22 Group guidance confirmed
For FY/22, Fresenius confirms its guidance and projects sales growth1 in a mid-single-digit percentage range in constant currency. Net income2,3 is expected to grow in a low-single-digit percentage range in constant currency. Implicitly, net income2 for the Group excluding Fresenius Medical Care is also expected to grow in a low-single-digit percentage range in constant currency.

Without further acquisitions4, Fresenius projects an improvement of the net debt/EBITDA5 ratio (December 31, 2021: 3.51×6) into the self-imposed target corridor of 3.0x to 3.5x by the end of 2022. Fresenius expects the net debt/EBITDA ratio to slightly increase once the acquisitions of Ivenix and the majority stake in mAbxience are closed.

The Group’s cost and efficiency program is evolving according to plan and Fresenius confirms its increased savings targets provided in February 2022 of at least €150 million p.a. after tax and minority interest in 2023. For the years thereafter, a further significant increase in sustainable cost savings is expected.

1 FY/21 base: €37,520 million
2 Net income attributable to shareholders of Fresenius SE & Co. KGaA
3 FY/21 base: €1,867 million; before special items; FY/22: before special items
4 Cut-off date 22 February 2022
5 At LTM average exchange rates for both net debt and EBITDA; pro forma closed acquisitions/divestitures;
excluding further potential acquisitions; before special items; including lease liabilities
6 At LTM average exchange rates for both net debt and EBITDA; pro forma closed acquisitions/divestitures;
before special items; including lease liabilities

For a detailed overview of special items please see the reconciliation tables on pages 18-19 in the PDF.

Assumptions for guidance FY/22
COVID-19 will continue to impact Fresenius’ operations in 2022. Fresenius expects COVID-19 case numbers to decline going forward and consequently the number of elective treatments and staff availability to improve. An unlikely but possible significant deterioration of the situation triggering containment measures that could have a significant and direct impact on the health care sector without any appropriate compensation is not reflected in the Group’s FY/22 guidance.

The war in Ukraine is affecting Fresenius Group’s operations. The adverse effect of the war amounted to €14 million at net income level of Fresenius Group in the first quarter and is treated as a special item. Fresenius will continue to monitor closely the potential effects of the war.

With the increased uncertainty and volatility related to the Ukraine war, Fresenius now expects more pronounced cost inflationary effects and supply chain disruptions in 2022.

The Management Board assumes an unchanged corporate tax rate in the United States.

Furthermore, the assumptions for Fresenius Medical Care’s FY/22 guidance are also fully applicable to Fresenius Group’s FY/22 guidance.

All of these assumptions are subject to considerable uncertainty.

The recently announced acquisitions of Ivenix and the majority stake in mAbxience as well as any further potential acquisitions are excluded from guidance.

5% sales increase in constant currency
Group sales increased by 8% (5% in constant currency) to €9,720 million (Q1/21: €8,984 million). Organic growth was 3%. Acquisitions/divestitures contributed net 2% to growth. Currency translation increased sales growth by 3%. Excluding estimated COVID-19 effects1, Group sales growth would have been 5% to 6% in constant currency (Q1/21: 4% to 5%).

3% net income2,3 growth in constant currency
Group EBITDA before special items increased by 2% (-2% in constant currency) to €1,658 million (Q1/212: €1,631 million). Reported Group EBITDA was €1,595 million (Q1/21: €1,628 million).

Group EBIT before special items decreased by 1% (-5% in constant currency) to €996 million (Q1/212: €1,009 million) driven by the COVID-19-related excess mortality among Fresenius Medical Care’s patients as well as elevated labor, material and logistic costs. The EBIT margin before special items was 10.2% (Q1/212: 11.2%). Reported Group EBIT was €902 million (Q1/21: €1,006 million).

Group net interest before special items improved to -€119 million (Q1/212: -€137 million) mainly due to successful refinancing activities. Reported Group net interest also improved to -€118 million (Q1/21: -€137 million).

Group tax rate before special items was 22.7% (Q1/212: 22.8%) while the reported Group tax rate was 23.6% (Q1/21: 22.8%).

Noncontrolling interests before special items were -€216 million (Q1/212: -€237 million) of which 88% were attributable to the noncontrolling interests in Fresenius Medical Care. Reported noncontrolling interests were -€186 million (Q1/21: -€236 million).

1 For estimated COVID-19 effects in Q1/22 and Q1/21 please see table on page 16 in the PDF.
2 Before special items
3 Net income attributable to shareholders of Fresenius SE & Co. KGaA

For a detailed overview of special items please see the reconciliation tables on pages 18-19 in the PDF.

Group net income1 before special items increased by 6% (3% in constant currency) to €462 million (Q1/212: €436 million). Excluding estimated COVID-19 effects3, Group net income1 before special items would have been broadly stable (-2% to 2% in constant currency (Q1/21: 0% to 4%)). Reported Group net income1 decreased to €413 million (Q1/21: €435 million).

Earnings per share1 before special items increased by 6% (3% in constant currency) to €0.83 (Q1/212: €0.78). Reported earnings per share1 were €0.74 (Q1/21: €0.78).

Continued investment in growth
Spending on property, plant and equipment was €338 million corresponding to 3% of sales (Q1/21: €384 million; 4% of sales). These investments served primarily for the modernization and expansion of dialysis clinics, production facilities as well as hospitals and day clinics.

Total acquisition spending was €162 million (Q1/21: €149 million), mainly for the acquisition of dialysis clinics by Fresenius Medical Care and hospitals by Helios Spain.

Cash flow development
Group operating cash flow decreased to €101 million (Q1/21: €652 million) with a margin of 1.0% (Q1/21: 7.3%), mainly driven by working capital build-up from higher raw material inventories and receivables, among others, as well as phasing effects. Free cash flow before acquisitions and dividends decreased to -€255 million (Q1/21: €241 million). Free cash flow after acquisitions and dividends decreased to -€403 million (Q1/21: €117 million).

1 Net income attributable to shareholders of Fresenius SE & Co. KGaA
2 Before special items
3 For estimated COVID-19 effects in Q1/22 and Q1/21 please see table on page 16 in the PDF.

For a detailed overview of special items please see the reconciliation tables on pages 18-19 in the PDF.

Solid balance sheet structure
Group total assets increased by 2% (0% in constant currency) to €73,114 million (Dec. 31, 2021: €71,962 million) given currency translation effects and the expansion of business activities. Current assets increased by 3% (2% in constant currency) to €18,002 million (Dec. 31, 2021: €17,461 million), mainly driven by the increase of trade accounts receivables. Non-current assets increased by 1% (0% in constant currency) to €55,112 million (Dec. 31, 2021: €54,501 million).

Total shareholders’ equity increased by 4% (3% in constant currency) to €30,584 million (Dec. 31, 2021: €29,288 million). The equity ratio was 41.8% (Dec. 31, 2021: 40.7%).

Group debt remained stable (0% in constant currency) at €27,211 million (Dec. 31, 2021: € 27,155 million). Group net debt increased by 3% (2% in constant currency) to € 25,134 million (Dec. 31, 2021: € 24,391 million).

As of March 31, 2022, the net debt/EBITDA ratio increased to 3.60×1,2 (Dec. 31, 2021: 3.51×1,2) mainly driven by COVID-19 effects weighing on operating cash flow.

1 At LTM average exchange rates for both net debt and EBITDA; pro forma closed acquisitions/divestitures
2 Before special items

For a detailed overview of special items please see the reconciliation tables on pages 18-19 in the PDF.

Business Segments

Fresenius Medical Care (Financial data according to Fresenius Medical Care press release)

Fresenius Medical Care is the world’s largest provider of products and services for individuals with renal diseases. As of March 31, 2022, Fresenius Medical Care was treating 343,493 patients in 4,153 dialysis clinics. Along with its core business, the Renal Care Continuum, the company focuses on expanding in complementary areas and in the field of critical care.

• Higher than anticipated COVID-19-related excess mortality, but declining throughout the quarter
• Earnings development affected by ongoing significantly elevated labor costs compounded by effects from Omicron in Health Care Services and by increased material and logistic costs in Health Care Products
• Earnings development in EMEA additionally impacted by the war in Ukraine

Sales increased by 8% (3% in constant currency) to €4,548 million (Q1/21: €4,210 million). Organic growth was 2%. Currency translation increased sales growth by 5%.

EBIT decreased by 27% (-30% in constant currency) to €348 million (Q1/21: €474 million) resulting in a margin of 7.6% (Q1/21: 11.3%). EBIT before special items, i.e. costs incurred for FME25 and the impact related to the war in Ukraine, decreased by 15% (-19% in constant currency) to €403 million (Q1/21: €477 million), resulting in a margin1 of 8.9% (Q1/21: 11.3%). At constant currency, the decline was mainly due to higher labor costs, adverse COVID-19-related effects, as well as inflationary and supply chain cost increases. These effects were only partially mitigated by the partial reversal of an accrual related to a revenue recognition adjustment for accounts receivable in legal dispute.

1 Before special items
2 Net income attributable to shareholders of Fresenius Medical Care AG & Co. KGaA

For a detailed overview of special items please see the reconciliation tables on pages 18-19 in the PDF.

Net income1 decreased by 37% (-39% in constant currency) to €157 million (Q1/21: €249 million). Net income1 before special items decreased by 20% (-23% in constant currency) to €200 million (Q1/21: €251 million) mainly due to the mentioned negative effects on operating income.

Operating cash flow was €159 million (Q1/21: €208 million) with a margin of 3.5% (Q1/21: 4.9%). The decrease was mainly due to continued recoupment of the U.S. government’s payments received in 2020 under the CARES Act and a decrease in net income, partially offset by a favorable impact from trade accounts and other receivables.

For FY/22, Fresenius Medical Care confirms its outlook and expects revenue2 and net income1,3 to grow at low- to mid-single-digit percentage rates in constant currency4.

For further information, please see Fresenius Medical Care’s press release at View Source

1 Net income attributable to shareholders of Fresenius Medical Care AG & Co. KGaA
2 FY/21 base: €17,619 million
3 FY/21 base: €1,018 million, before special items; FY/22 before special items
4 These targets are based on the 2021 results excluding the costs related to FME25 of €49 million (for net income). They are based on the assumptions outlined in the press release on the Q4 and FY 2021 results (Feb.22, 2022), in constant currency and exclude special items. Special items include further costs related to FME25, the impacts related to the war in Ukraine, and other effects that are unusual in nature and have not been foreseeable or not foreseeable in size or impact at the time of giving guidance.

On May 4, 2022 Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, reported financial results and business highlights for the first quarter ended March 31, 2022 (Press release, Vericel, MAY 4, 2022, View Source [SID1234613483]).

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First Quarter 2022 Financial Highlights
•Total net revenue of $36.1 million, compared to $34.6 million in the first quarter of 2021
•MACI net revenue of $26.0 million, Epicel net revenue of $9.9 million, and NexoBrid revenue of $0.2 million related to the U.S. Biomedical Advanced Research and Development Authority ("BARDA") procurement for emergency response preparedness
•Gross margin of 65%, compared to 66% in the first quarter of 2021
•Net loss of $7.1 million, or $0.15 per share, compared to $3.3 million, or $0.07 per share, in the first quarter of 2021
•Non-GAAP adjusted EBITDA of $3.2 million, compared to $4.6 million in the first quarter of 2021
•Operating cash flow of $3.5 million
•As of March 31, 2022, the Company had approximately $130 million in cash, restricted cash and investments, and no debt

Business Highlights and Updates
•Double-digit growth in surgeons taking MACI biopsies compared to the first quarter of 2021, with the second highest monthly biopsies in March 2022 since the launch of MACI
•Growth of more than 20% in burn centers treating patients and taking Epicel biopsies compared to the first quarter of 2021, with a record monthly high in Epicel biopsies in March 2022
•Remain on track for a planned mid-year 2022 resubmission of the NexoBrid Biologics License Application to the FDA, and
1
Exhibit 99.1
•Expanded the Company’s commercial leadership team with the appointment of Mike Gilligan as Vice President, MACI National Sales

"The Company executed well in the first quarter and we remain on track to deliver another year of significant revenue growth, margin expansion, and operating cash flow driven by continued strong results for both MACI and Epicel," said Nick Colangelo, President and CEO of Vericel. "We also continue to advance important regulatory and clinical programs across both our sports medicine and burn care franchises as we remain on track for a mid-year resubmission of the NexoBrid BLA and for planned discussions with the FDA to review both the MACI arthroscopic and ankle development programs, initiatives that we believe will support continued strong growth in the years ahead."

2022 Financial Guidance
The Company reaffirmed financial guidance for full-year 2022
•Total net revenue for 2022 expected to be in the range of $178 to $189 million
◦MACI revenue expected to be in the range of $132 to $141 million
◦Epicel revenue expected to be in the range of $45.5 to $47.5 million
•Gross margin expected to be approximately 70%
•Adjusted EBITDA margin expected to be approximately 21%

First Quarter 2022 Results
Total net revenue for the quarter ended March 31, 2022 increased 4% to $36.1 million, compared to $34.6 million in the first quarter of 2021. Total net product revenue for the quarter increased 7% and included $26.0 million of MACI (autologous cultured chondrocytes on porcine collagen membrane) net revenue and $9.9 million of Epicel (cultured epidermal autografts) net revenue, compared to $23.8 million of MACI net revenue and $9.8 million of Epicel net revenue, respectively, in the first quarter of 2021. Total net revenue for the quarter also included $0.2 million of revenue related to the procurement of NexoBrid (concentrate of proteolytic enzymes enriched in bromelain) by BARDA for emergency response preparedness, compared to $0.9 million in the first quarter of 2021.

Gross profit for the quarter ended March 31, 2022 was $23.5 million, or 65% of net revenue, compared to $23.0 million, or 66% of net revenue, for the first quarter of 2021.

Total operating expenses for the quarter ended March 31, 2022 were $30.7 million, compared to $26.3 million for the same period in 2021. The increase in operating expenses was primarily due to higher stock-based compensation expense.

Net loss for the quarter ended March 31, 2022 was $7.1 million, or $0.15 per share, compared to a net loss of $3.3 million, or $0.07 per share, for the first quarter of 2021.

Non-GAAP adjusted EBITDA for the quarter ended March 31, 2022 was $3.2 million, or 9% of net revenue, compared to $4.6 million, or 13% of net revenue, for the first quarter of 2021. A table reconciling non-GAAP measures is included in this press release for reference.

As of March 31, 2022, the Company had approximately $130 million in cash, restricted cash and investments, and no debt.

Conference Call Information
Today’s conference call will be available live at 8:30am Eastern Time and can be accessed through the Investor Relations section of the Vericel website at View Source A slide presentation with highlights from today’s conference call will be available on the webcast and in the Investor Relations section of the Vericel website. Please access the site at least 15 minutes prior to the scheduled start time in order to download the required audio software, if necessary. To participate in the live call by telephone, please call (877) 312-5881 and reference Vericel Corporation’s first quarter 2022 investor conference call. If calling from outside the U.S., please use the international phone number (253) 237-1173.