Revenue growth and adjusted EBITDA1 exceeded expectations in the fourth quarter and full year
OA Pain Management achieved record annual revenues of
Announces cost reduction initiatives providing annualized savings of approximately
Anika positioned to generate adjusted EBITDA1 of
Fourth Quarter 2023 Financial Summary
- Revenue in the fourth quarter of 2023 was
$43.0 million , up 8% compared to$39.6 million in the fourth quarter of 2022.- OA Pain Management revenue of
$25.1 million , up 12%, on growing global commercial adoption and some order timing - Joint Preservation and Restoration revenue of
$15.3 million , up 7% - Non-Orthopedic revenue of
$2.6 million , down 8%
- OA Pain Management revenue of
- Gross margin was 61%, including
$1.6 million of non-cash acquisition-related intangible asset amortization; Adjusted gross margin1 was 65%. - Recorded a non-recurring, non-cash impairment charge in the fourth quarter of
$62.2 million for the intangible assets associated with the Q1-2020 acquisitions of Arthrosurface and Parcus Medical. - Including the non-cash impairment charge, net loss was
($63.0) million , or ($4.30 ) per share, compared to net loss of($4.9) million , or ($0.34 ) per share, in the prior year period. - Adjusted net income1 was
$0.8 million , or$0.05 per diluted share, compared to adjusted net loss1 of($3.0) million , or ($0.21 ) per share, in the fourth quarter of 2022. - Adjusted EBITDA1 was
$5.8 million , compared to$1.4 million in the fourth quarter of 2022. - Cash from operations was
$3.6 million ; ending cash balance rose to$72.9 million .
Full Year 2023 Financial Summary
- Revenue for fiscal 2023 increased 7% to
$166.7 million , compared with$156.2 million in 2022.- OA Pain Management revenue of
$101.9 million , up 11% - Joint Preservation and Restoration revenue of
$54.9 million , up 9% - Non-Orthopedic revenue of
$9.9 million , down 29%
- OA Pain Management revenue of
- Gross margin was 62%, including
$6.2 million of non-cash acquisition-related intangible asset amortization and$0.7 million of product rationalization charges. Adjusted gross margin1, excluding these charges, was 66%. - Including the fourth quarter non-cash impairment charge, net loss was
($82.7) million , or ($5.64 ) per share, compared to net loss of($14.9) million , or ($1.02 ) per share, in 2022. Net loss also included$18.1 million , or ($1.23 ) per share, for charges associated with product rationalization, acquisition related amortization, discontinuation of software development,Parcus arbitration settlement and shareholder activism. - Adjusted net loss1 for the year was
($4.3) million , or ($0.30 ) per share, compared to adjusted net loss of($7.1) million , or ($0.49 ) per share in 2022. - Adjusted EBITDA1 for the year was
$15.5 million , compared to$12.6 million in 2022. - Cash used in operations was
$1.8 million .
1 See description of non-GAAP financial information contained in this release.
“We are pleased to report strong fourth quarter and full year results, including a record year in OA Pain Management. These results reflect the evolution of our differentiated HA franchise and the launch of exciting new products in Regenerative, Sports Medicine and Arthrosurface Joint Solutions,” said
Fiscal 2023 and Recent Business Highlights
- Strengthening Leadership Position in OA Pain Management
- Achieved record annual revenues of
$102 million in OA Pain Management on global growth of its Monovisc® single injection viscosupplement and continued double-digit international growth of its Cingal® next generation non-opioid single injection pain product, on growing global commercial adoption and some order timing; increasing #1 U.S. market share position2. - Awaiting FDA feedback on proposed non-clinical next steps regarding Cingal
U.S. regulatory approval following a Type C meeting with the FDA in early 2023 and its success in meeting its latest Phase III Pivotal primary endpoint in the fall of 2022. - Continuing to explore commercial partnerships for Cingal in the
U.S. and select Asian markets.
- Achieved record annual revenues of
- Advancing a Highly Differentiated Portfolio of HA-Based Regenerative Solutions
- Successfully completed over 100 cases with the Integrity™ Implant System, Anika’s HA-based regenerative rotator cuff patch system, following the limited market release in late
November 2023 ; on-track for full market release in mid-2024 - Fully enrolled Phase III clinical trial for Hyalofast®, Anika’s HA, off-the-shelf, single-stage cartilage repair product; modular PMA submission with break-through device designation commencing in 2024; final PMA module filing expected in 2025 with product launching by 2026.
- Successfully completed over 100 cases with the Integrity™ Implant System, Anika’s HA-based regenerative rotator cuff patch system, following the limited market release in late
- Launched Key Products in Sports Medicine and Arthrosurface Joint Solutions
- X-Twist™ Biocomposite Fixation System launched in Q1-2024, compliments the PEEK version launched in early 2023, together addressing the more than
$600 million U.S. rotator cuff market2. - RevoMotion™ Reverse Shoulder Arthroplasty System full market release in
September 2023 , expanding Anika’s shoulder arthroplasty portfolio into the more than$1 billion U.S. reverse shoulder market2.
- X-Twist™ Biocomposite Fixation System launched in Q1-2024, compliments the PEEK version launched in early 2023, together addressing the more than
2 SmartTRAK Q3-2023 data
Cost Reductions
In 2023, Anika launched multiple meaningful new products and made considerable progress addressing the new MDR regulatory requirements in
Fiscal 2024 Guidance
In 2024, Anika is prioritizing accelerated growth in profitability, with a focus on the products with the greatest growth opportunities and where the Company has the most differentiated right-to-win.
As such, Anika expects revenue for fiscal year 2024 of
- OA Pain Management of
$102 to$104 million , up 0% to 2%, on sustained above-market growth offset by some unfavorable order timing - Joint Preservation and Restoration of
$58 to$60.5 million , up 6% to 10% - Non-Orthopedic of
$8 to$8.5 million , down 14% to 19%
The Company expects adjusted EBITDA for 2024 to be
Strategic Business Update
Beginning in mid-2023, Anika engaged Piper Sandler and conducted a company-wide strategic review, evaluating a wide range of strategic alternatives for the company to increase shareholder value, including a potential sale. Anika remains open to all value enhancing opportunities and regularly reviews what makes the most sense for the business.
Conference Call and Webcast Information
Anika’s management will hold a conference call and webcast to discuss its financial results and business highlights today,
About Anika
ANIKA,
Non-GAAP Financial Information
Non-GAAP financial measures should be considered supplemental to, and not a substitute for, the Company’s reported financial results prepared in accordance with GAAP. Furthermore, the Company’s definition of non-GAAP measures may differ from similarly titled measures used by others. Because non-GAAP financial measures exclude the effect of items that will increase or decrease the Company’s reported results of operations, Anika strongly encourages investors to review the Company’s consolidated financial statements and publicly filed reports in their entirety. The Company presents these non-GAAP financial measures because it uses them as supplemental measures in internally assessing the Company’s operating performance, and, in the case of Adjusted EBITDA, it is set as a key performance metric to determine executive compensation. The Company also recognizes that these non-GAAP measures are commonly used in determining business performance more broadly and believes that they are helpful to investors, securities analysts, and other interested parties as a measure of comparative operating performance from period to period.
Adjusted Gross Margin
Adjusted gross margin is defined by the Company as adjusted gross profit divided by total revenue. The Company defines adjusted gross profit as GAAP gross profit excluding amortization of certain acquired assets and non-cash product rationalization charges.
Adjusted EBITDA
Adjusted EBITDA is defined by the Company as GAAP net income (loss) excluding depreciation and amortization, interest and other income (expense), income taxes, stock-based compensation expense, acquisition related expenses, non-cash charges related to goodwill impairment, non-cash product rationalization charges and charges related to discontinuation of a software project.
Adjusted Net Income (Loss) and Adjusted EPS
Adjusted net income (loss) is defined by the Company as GAAP net income excluding acquisition related expenses, inclusive of the impact of purchase accounting, on a tax effected basis, non-cash charges related to goodwill impairment, non-cash product rationalization charges and charges related to discontinuation of a software project. Adjusted diluted EPS is defined by the Company as GAAP diluted EPS excluding acquisition related expenses and the impact of purchase accounting, each on a tax-adjusted per share basis, non-cash product rationalization charges and charges related to discontinuation of a software development project.
A reconciliation of adjusted gross profit to gross profit (and the associated adjusted gross margin calculation), adjusted EBITDA to net income (loss), adjusted net income (loss) to net income (loss) and adjusted diluted EPS to diluted EPS, the most directly comparable financial measures calculated and presented in accordance with GAAP, is shown in the tables at the end of this release.
Forward-Looking Statements
This press release may contain forward-looking statements, within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, concerning the Company's expectations, anticipations, intentions, beliefs or strategies regarding the future which are not statements of historical fact, including statements in the sub-headings, Dr. Blanchard’s quote, and the section titled Cost Reductions about potential cost savings and future profitability, the statements in Dr. Blanchard’s quote and the section titled Fiscal 2023 and Recent Business Highlights about the timing of future product launches, and the statements made in the section titled Fiscal 2024 Guidance. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks, uncertainties, and other factors. The Company's actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including, but not limited to, (i) the Company's ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all; (ii) the Company's ability to obtain pre-clinical or clinical data to support domestic and international pre-market approval applications, 510(k) applications, or new drug applications, or to timely file and receive FDA or other regulatory approvals or clearances of its products; (iii) that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company's research and product development efforts and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company's clinical studies, manufacturing operations, and production planning; (vi) the strength of the economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company's ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company's ability to provide an adequate and timely supply of its products to its customers; and (x) the Company's ability to achieve its growth targets. Additional factors and risks are described in the Company's periodic reports filed with the Securities and Exchange Commission, and they are available on the SEC's website at www.sec.gov. Forward-looking statements are made based on information available to the Company on the date of this press release, and the Company assumes no obligation to update the information contained in this press release.
For Investor Inquiries:
Vice President, Investor Relations,
investorrelations@anika.com
Consolidated Statements of Operations | |||||||||||||||
(in thousands, except per share data) | |||||||||||||||
(unaudited) | |||||||||||||||
For the Three Months Ended | For the Twelve Months Ended | ||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||
Revenue | $ | 42,971 | $ | 39,622 | $ | 166,662 | $ | 156,236 | |||||||
Cost of Revenue | 16,642 | 15,491 | 63,574 | 62,660 | |||||||||||
Gross Profit | 26,329 | 24,131 | 103,088 | 93,576 | |||||||||||
Operating expenses: | |||||||||||||||
Research and development | 7,585 | 7,749 | 32,690 | 28,182 | |||||||||||
Selling, general and administrative | 20,335 | 23,049 | 95,847 | 84,794 | |||||||||||
Impairment of intangible assets | 62,190 | - | 62,190 | - | |||||||||||
Total operating expenses | 90,110 | 30,798 | 190,727 | 112,976 | |||||||||||
Loss from operations | (63,781 | ) | (6,667 | ) | (87,639 | ) | (19,400 | ) | |||||||
Interest and other income (expense), net | 577 | 276 | 2,312 | 654 | |||||||||||
Loss before income taxes | (63,204 | ) | (6,391 | ) | (85,327 | ) | (18,746 | ) | |||||||
Benefit from income taxes | (204 | ) | (1,483 | ) | (2,660 | ) | (3,887 | ) | |||||||
Net loss | $ | (63,000 | ) | $ | (4,908 | ) | $ | (82,667 | ) | $ | (14,859 | ) | |||
Net loss per share: | |||||||||||||||
Basic | $ | (4.30 | ) | $ | (0.34 | ) | $ | (5.64 | ) | $ | (1.02 | ) | |||
Diluted | $ | (4.30 | ) | $ | (0.34 | ) | $ | (5.64 | ) | $ | (1.02 | ) | |||
Weighted average common shares outstanding: | |||||||||||||||
Basic | 14,647 | 14,640 | 14,656 | 14,561 | |||||||||||
Diluted | 14,647 | 14,640 | 14,656 | 14,561 | |||||||||||
Consolidated Balance Sheets | |||||||
(in thousands, except per share data) | |||||||
(unaudited) | |||||||
ASSETS | 2023 | 2022 | |||||
Current assets: | |||||||
Cash and cash equivalents | $ | 72,867 | $ | 86,327 | |||
Accounts receivable, net | 35,961 | 34,627 | |||||
Inventories, net | 46,386 | 39,765 | |||||
Prepaid expenses and other current assets | 8,095 | 8,828 | |||||
Total current assets | 163,309 | 169,547 | |||||
Property and equipment, net | 46,198 | 48,279 | |||||
Right-of-use assets | 28,767 | 30,696 | |||||
Other long-term assets | 18,672 | 17,219 | |||||
Deferred tax assets | 1,489 | 1,449 | |||||
Intangible assets, net | 4,626 | 74,599 | |||||
7,571 | 7,339 | ||||||
Total assets | $ | 270,632 | $ | 349,128 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 9,860 | $ | 9,074 | |||
Accrued expenses and other current liabilities | 21,199 | 18,840 | |||||
Total current liabilities | 31,059 | 27,914 | |||||
Other long-term liabilities | 404 | 398 | |||||
Deferred tax liability | - | 6,436 | |||||
Lease liabilities | 26,904 | 28,817 | |||||
Stockholders’ equity: | |||||||
Common stock, | 147 | 146 | |||||
Additional paid-in-capital | 90,009 | 81,141 | |||||
Accumulated other comprehensive loss | (5,943 | ) | (6,443 | ) | |||
Retained earnings | 128,052 | 210,719 | |||||
Total stockholders’ equity | 212,265 | 285,563 | |||||
Total liabilities and stockholders’ equity | $ | 270,632 | $ | 349,128 | |||
Reconciliation of GAAP Gross Profit to Adjusted Gross Profit | |||||||||||||||
(in thousands) | |||||||||||||||
(unaudited) | |||||||||||||||
For the Three Months Ended | For the Twelve Months Ended | ||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||
Gross Profit | $ | 26,329 | $ | 24,131 | $ | 103,088 | $ | 93,576 | |||||||
Product rationalization related charges | - | 563 | 748 | 3,199 | |||||||||||
Acquisition related intangible asset amortization | 1,560 | 1,560 | 6,244 | 6,240 | |||||||||||
Adjusted Gross Profit | $ | 27,889 | $ | 26,254 | $ | 110,080 | $ | 103,015 | |||||||
Unadjusted Gross Margin | 61 | % | 61 | % | 62 | % | 60 | % | |||||||
Adjusted Gross Margin | 65 | % | 66 | % | 66 | % | 66 | % | |||||||
Reconciliation of GAAP Net Income to Adjusted EBITDA | |||||||||||||||
(in thousands) | |||||||||||||||
(unaudited) | |||||||||||||||
For the Three Months Ended | For the Twelve Months Ended | ||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||
Net loss | $ | (63,000 | ) | $ | (4,908 | ) | $ | (82,667 | ) | $ | (14,859 | ) | |||
Interest and other (income) expense, net | (577 | ) | (276 | ) | (2,312 | ) | (654 | ) | |||||||
Benefit from income taxes | (204 | ) | (1,483 | ) | (2,660 | ) | (3,887 | ) | |||||||
Depreciation and amortization | 1,787 | 1,880 | 7,069 | 7,340 | |||||||||||
Stock-based compensation | 3,815 | 3,813 | 15,243 | 14,315 | |||||||||||
Product rationalization | - | 563 | 748 | 3,199 | |||||||||||
Arbitration settlement | - | - | 3,250 | - | |||||||||||
Acquisition related intangible asset amortization | 1,787 | 1,786 | 7,148 | 7,147 | |||||||||||
Impairment of intangible assets | 62,190 | - | 62,190 | - | |||||||||||
Discontinuation of software development project | - | - | 4,473 | - | |||||||||||
Costs of shareholder activism | - | - | 3,033 | - | |||||||||||
Adjusted EBITDA | $ | 5,798 | $ | 1,375 | $ | 15,515 | $ | 12,601 | |||||||
Reconciliation of GAAP Net Income to Adjusted Net Income | |||||||||||||||
(in thousands) | |||||||||||||||
(unaudited) | |||||||||||||||
For the Three Months Ended | For the Twelve Months Ended | ||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||
Net loss | $ | (63,000 | ) | $ | (4,908 | ) | $ | (82,667 | ) | $ | (14,859 | ) | |||
Product rationalization, tax effected | - | 456 | 725 | 2,410 | |||||||||||
Arbitration settlement, tax effected | - | - | 3,148 | - | |||||||||||
Acquisition related intangible asset amortization, tax effected | 1,781 | 1,446 | 6,926 | 5,386 | |||||||||||
Impairment of intangible assets, tax effected | 61,991 | - | 60,250 | - | |||||||||||
Discontinuation of software development project, tax effected | - | - | 4,333 | - | |||||||||||
Costs of shareholder activism, tax effected | - | - | 2,938 | - | |||||||||||
Adjusted net income (loss) | $ | 772 | $ | (3,006 | ) | $ | (4,347 | ) | $ | (7,063 | ) | ||||
Reconciliation of GAAP Diluted Earnings Per Share to Adjusted Diluted Earnings Per Share | |||||||||||||||
(in thousands, except per share data) | |||||||||||||||
(unaudited) | |||||||||||||||
For the Three Months Ended | For the Twelve Months Ended | ||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||
Diluted net loss per share | $ | (4.30 | ) | $ | (0.34 | ) | $ | (5.64 | ) | $ | (1.02 | ) | |||
Product rationalization, tax effected | - | 0.03 | 0.05 | 0.17 | |||||||||||
Arbitration settlement, tax effected | - | - | 0.21 | - | |||||||||||
Acquisition related intangible asset amortization, tax effected | 0.12 | 0.10 | 0.47 | 0.36 | |||||||||||
Impairment of intangible assets, tax effected | 4.23 | - | 4.11 | - | |||||||||||
Discontinuation of software development project, tax effected | - | - | 0.30 | - | |||||||||||
Costs of shareholder activism, tax effected | - | - | 0.20 | - | |||||||||||
Adjusted diluted net income (loss) per share | $ | 0.05 | $ | (0.21 | ) | $ | (0.30 | ) | $ | (0.49 | ) | ||||
Stock-based compensation, tax effected | 3,803 | 3,088 | 14,767 | 10,783 | |||||||||||
Stock-based compensation (EPS impact) | $ | 0.26 | $ | 0.21 | $ | 1.01 | $ | 0.74 | |||||||
Revenue by Product Family | |||||||||||||||||||||||||
(in thousands, except percentages) | |||||||||||||||||||||||||
(unaudited) | |||||||||||||||||||||||||
For the Three Months Ended | For the Twelve Months Ended | ||||||||||||||||||||||||
2023 | 2022 | $ change | % change | 2023 | 2022 | $ change | % change | ||||||||||||||||||
OA Pain Management | $ | 25,072 | $ | 22,451 | $ | 2,621 | 12 | % | $ | 101,927 | $ | 91,984 | $ | 9,943 | 11 | % | |||||||||
Joint Preservation and Restoration | 15,296 | 14,347 | 949 | 7 | % | 54,879 | 50,402 | 4,477 | 9 | % | |||||||||||||||
Non-Orthopedic | 2,603 | 2,824 | (221 | ) | -8 | % | 9,856 | 13,850 | (3,994 | ) | -29 | % | |||||||||||||
Revenue | $ | 42,971 | $ | 39,622 | $ | 3,349 | 8 | % | $ | 166,662 | $ | 156,236 | $ | 10,426 | 7 | % | |||||||||
Source:
2024 GlobeNewswire, Inc., source