Bioventus to Expand Operations and Manufacturing in Memphis

MEMPHIS, TN – November 18, 2021 – Bioventus Inc. (Nasdaq: BVS) (“Bioventus” or the “Company”), a global leader in innovations for active healing, has signed a lease agreement to double its current operations and manufacturing space and relocate from its current facility in suburban Memphis. Bioventus expects to move its 116 employees into the new space in early Q3 of 2022 and add another 40 jobs in the next five years.

“As we revised our operational plan in alignment with the Company’s strategy, we determined that the expansion of our Memphis location would be required to manage our organic growth, vertical integration of key manufacturing capabilities and our additional growth through acquisitions,” said Miguel Beltran-Delgado, Senior Vice President of Operations, Bioventus. “We are very pleased we could identify and secure this new location, which is right across the way from our current site, minimizing the disruption to our employees and customers, while meeting our near and long term operations and manufacturing needs.”

The current location began operations in 2012 and the new facility will be located at 7101 Goodlett Farms Parkway in Cordova, TN. It includes approximately 90,000 total square feet of space and will feature approximately 55,000 square feet dedicated to light manufacturing and operations. The remaining 35,000 square feet will be developed for offices, conference rooms and shared workspaces.

Cushman & Wakefield│Commercial Advisors represented Bioventus on the lease for this new facility.

About Bioventus
Bioventus delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The Innovations for Active Healing from Bioventus include offerings for pain treatment, restorative therapies and surgical solutions. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.bioventus.com, and follow the Company on LinkedIn and Twitter. Bioventus and the Bioventus logo, are registered trademarks of Bioventus LLC.

Forward-Looking Statements
This press release contains 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. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements concerning Bioventus’s plans to expand operations and manufacturing in Memphis. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Factors that could cause actual results to differ materially from those contemplated in this press release include, but are not limited to, the adverse impacts on our business as a result of the COVID-19 pandemic; our dependence on a limited number of products; our ability to develop, acquire and commercialize new products, line extensions or expanded indications; our ability to continue to research, develop and manufacture our products if our facilities are damaged or become inoperable; failure to comply with the extensive government regulations related to our products and operations; and the other risks identified in the Risk Factors section of the Company’s public filings with the Securities and Exchange Commission (“SEC”), including Bioventus’s Annual Report on Form 10-K for the period ended December 31, 2020, as updated by Bioventus’s Quarterly Report on Form 10-Q for the period ended October 2, 2021 and as such factors may be updated from time to time in Bioventus’ other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Bioventus’ website at ir.bioventus.com. Except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection, or forward-looking statement. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in the Company’s business.

 

Investor Inquiries:
Dave Crawford
Bioventus
919-474-6787
[email protected]


Bioventus Announces Chief Financial Officer Transition Plan

DURHAM, NC – November 15, 2021 – Bioventus Inc. (Nasdaq: BVS) (“Bioventus” or “the Company”), a global leader in innovations for active healing, today announced that Greg Anglum is transitioning from his role as Senior Vice President and Chief Financial Officer (CFO) to pursue other career opportunities. To ensure a smooth transition, Mr. Anglum will remain in his current role until a successor is named.

“I want to thank Greg for his dedication to Bioventus over the past five years,” commented Ken Reali, Bioventus’ Chief Executive Officer. “I am grateful for his contributions through our initial public offering and our recent acquisitions of Bioness and Misonix. Greg has instilled the appropriate financial controls as we have made the transition to a public entity, and his efforts to strengthen our balance sheet have positioned us well to continue to invest in an innovative, rapidly growing active healing portfolio. We are working diligently to identify a CFO who brings robust experience leading a rapidly expanding organization and can work with me and my executive team to help take Bioventus to the next level of growth by enhancing the results-driven foundation and culture that we have built.”

Mr. Anglum said, “As I begin the next chapter of my career, I am grateful for my experience working with Ken and the talented team at Bioventus. It has been a privilege to work alongside these dedicated individuals to bring innovative active healing solutions to market and improve the lives of countless patients.”

Bioventus has been actively working with Spencer Stuart to identify a successor to Mr. Anglum.

Mr. Anglum’s departure is unrelated to Bioventus’ business performance, financial reporting, or controls, and the Company is reaffirming its previously issued 2021 financial guidance.

About Bioventus
Bioventus delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The Innovations for Active Healing from Bioventus include offerings for pain treatment, restorative therapies and surgical solutions. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.bioventus.com, and follow the Company on LinkedIn and Twitter. Bioventus and the Bioventus logo, are registered trademarks of Bioventus LLC.

Forward-Looking Statements
This press release contains 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. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements concerning Mr. Anglum’s continued service until a successor is named and the Company’s future financial results. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Factors that could cause actual results to differ materially from those contemplated in this press release include, but are not limited to, the adverse impacts on our business as a result of the COVID-19 pandemic; our dependence on a limited number of products; our ability to develop, acquire and commercialize new products, line extensions or expanded indications; the continued and future acceptance of our existing portfolio of products and any new products, line extensions or expanded indications by physicians, patients, third-party payers and others in the medical community; our ability to differentiate the hyaluronic acid (“HA”) viscosupplementation therapies we own or distribute from alternative therapies for the treatment of osteoarthritic; the proposed down-classification of non-invasive bone growth stimulators, including our Exogen system, by the U.S. Food and Drug Administration (“FDA”); our ability to achieve and maintain adequate levels of coverage and/or reimbursement for our products, the procedures using our products, or any future products we may seek to commercialize; our ability to recognize the benefits of our investments; our ability to complete acquisitions or successfully integrate new businesses, products or technologies in a cost-effective and non-disruptive manner, including the Misonix acquisition; competition against other companies; the negative impact on our ability to market our HA products due to the reclassification of HA products from medical devices to drugs in the United States by the FDA; our ability to attract, retain and motivate our senior management and qualified personnel; our ability to continue to research, develop and manufacture our products if our facilities are damaged or become inoperable; failure to comply with the extensive government regulations related to our products and operations; enforcement actions if we engage in improper claims submission practices or in improper marketing or promotion of our products; the FDA regulatory process and our ability to obtain and maintain required regulatory clearances and approvals; failure to comply with the government regulations that apply to our human cells, tissues and cellular or tissue-based products; the clinical studies of any of our future products that do not product results necessary to support regulatory clearance or approval in the United States or elsewhere; and the other risks identified in the Risk Factors section of the Company’s public filings with the Securities and Exchange Commission (“SEC”), including Bioventus’s Annual Report on Form 10-K for the period ended December 31, 2020, as updated by Bioventus’s Quarterly Report on Form 10-Q for the period ended October 2, 2021 and as such factors may be updated from time to time in Bioventus’ other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Bioventus’ website at ir.bioventus.com. Except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection, or forward-looking statement. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in the Company’s business.

 

Investor Inquiries:
Dave Crawford
919-474-6787
[email protected]

 


Bioventus Reports Third Quarter Results; Updates Full-Year 2021 Financial Guidance

DURHAM, NC – November 9, 2021 – Bioventus Inc. (Nasdaq: BVS) ("Bioventus" or "the Company"), a global leader in innovations for active healing, today reported financial results for three and nine months ended October 2, 2021.

Q3 Financial Summary & Recent Highlights:

  • Net Sales of $108.9 million, up $23.0 million, or 26.8%, year-over-year, comprising:
    • Net Sales from legacy Bioventus Inc. of $98.1 million, representing organic revenue growth* of 14.2% year-over-year, and
    • Net Sales from the acquisition of Bioness Inc. of $10.8 million.
  • Net Loss of ($2.3) million, compared to Net Income of $8.0 million in prior year.
  • Adjusted EBITDA* of $21.3 million, compared to $23.1 million in prior year.
  • Updates full-year 2021 Net Sales guidance to $425-$430 million, up from $405-$415 million, driven by strong Q3 results, Q4 expectations, and the inclusion of the Company's recent acquisition of Misonix Inc.

“During the third quarter, we continued building momentum across our diversified portfolio as the Bioventus team demonstrated strong execution and resiliency, driving double-digit organic growth despite some pandemic related headwinds in our Bone Graft Substitutes business,” stated Ken Reali, Bioventus’ chief executive officer.  “The strong performance of our organization has enabled us to again raise our full-year revenue guidance.”

 Mr. Reali continued, “We are on-track to complete the integration of Bioness in the first quarter of 2022 and deliver on our cost synergy targets over the course of the next year.  Finally, we are excited to have closed our acquisition of Misonix and to welcome the Misonix employees to Bioventus.  This is a significant milestone that will enable multiple growth levers within the combined business.  Our new Bioventus organization will allow us to go deeper with our customers leveraging our infrastructure and driving significant shareholder value over the near and medium term.”

 Third Quarter 2021 Financial Results:

The following table represents net sales by geographic region, and by vertical, for the three months ended October 2, 2021 and September 26, 2020, respectively:

Three Months Ended Change
($ thousands, except for percentage) October 2, 2021 September 26, 2020 $ %
By Geographic Region:
U.S. $ 99,162 $ 78,886 $ 20,276 25.7 %
International 9,728 7,022 2,706 38.5 %
Net Sales $ 108,890  $ 85,908  $ 22,982  26.8  %
By Vertical:
Pain Treatments and Joint Preservation $ 60,635 $ 48,781 $ 11,854 24.3 %
Restorative Therapies 30,475 20,000 10,475 52.4 %
Bone Graft Substitutes 17,780 17,127 653 3.8 %
Net Sales $ 108,890  $ 85,908  $ 22,982  26.8  %

Net sales of $108.9 million compared to $85.9 million for the third quarter of 2020, an increase of $23.0 million, or 26.8%, year-over-year, primarily due to acquisitions, strong commercial execution and ongoing recovery from the COVID-19 pandemic. International net sales for the third quarter of 2021 increased 38.5% year-over-year, or 34.7% on a constant currency* basis.

Gross profit was $79.1 million, or 72.6% of net sales, compared to $62.5 million, or 72.7% of net sales, for the third quarter of 2020, an increase of $16.6 million, or 26.6%, year-over-year. Non-GAAP gross profit*  was $85.7 million, or 78.7% of net sales, compared to $67.9 million, or 79.1% of net sales, for the third quarter of 2020, an increase of $17.8 million, or 26.1%, year-over-year.

Operating loss was ($1.0) million, compared to operating income of $6.9 million for the third quarter of 2020, a decrease of ($8.0) million, or (115.1%), year-over-year. Operating margin was (1.0%) of net sales, compared to 8.1% of net sales for the third quarter of 2020.

Non-GAAP operating income* was $15.1 million, compared to $14.7 million for the third quarter of 2020, an increase of $0.3 million, or 2.3%, year-over-year. Non-GAAP operating margin* was 13.8% of net sales, compared to 17.1% of net sales for the third quarter of 2020.

Net Loss was ($2.3) million compared to net income of $8.0 million for the third quarter of 2020, a change of ($10.2) million or (128.5%), year-over-year.

Adjusted EBITDA* was $21.3 million, compared to $23.1 million for the third quarter of 2020, a decrease of ($1.8) million, or (7.7%), year-over-year.

Non-GAAP net income* was $13.8 million, compared to $12.6 million, for the third quarter of 2020, an increase of $1.3 million, or 10.1%, year-over-year.

As of October 2, 2021, the Company had $80.9 million in cash and cash equivalents and $177.4 million in debt obligations, compared to $86.8 million in cash and cash equivalents and $188.4 million in debt obligations as of December 31, 2020.

Updated Full Year 2021 Financial Guidance:

For the twelve months ending December 31, 2021, the Company now expects:

  • Net sales of $425 million to $430 million, up approximately 32% to 34% year-over-year. The full year 2021 net sales guidance range is comprised of:
    • Net sales from legacy Bioventus Inc. of $378.1 million to $382.1 million, representing organic revenue growth* in the range of approximately 18% to 19% year-over-year, and,
    • Net sales from the recent acquisitions of Bioness Inc and Misonix Inc of approximately $46.9 million to $47.9 million.
  • Net income of $1.8 million to $3.7 million, compared to net income of $14.7 million for the twelve months ended December 31, 2020.
  • Non-GAAP net income* of $72.1 million to $75.6 million, compared to $47.4 million for the twelve months ended December 31, 2020.
  • Adjusted EBITDA* of $77.8 million to $82.0 million, compared to $72.4 million for the twelve months ended December 31, 2020.

The Company's guidance reflects its current expectations regarding the impact of COVID-19 on its business. The severity and duration of the COVID-19 pandemic are outside of the Company’s control and, given the uncertain nature of the pandemic, could cause the Company’s future operating results to be different from our current expectations, particularly if the impact of the pandemic worsens.

Presentation: This press release presents historical results, for the periods presented, of Bioventus Inc., including Bioventus LLC, the predecessor of Bioventus Inc. for financial reporting purposes.

Third Quarter 2021 Earnings Conference Call:

Management will host a conference call to discuss the Company’s financial results and provide a business update, with a question and answer session, at 8:30 a.m. Eastern Time on November 9, 2021. Those who would like to participate may dial 844-945-2085 (442-268-1266 for international callers) and provide access code 9652759.

A live webcast of the call and any accompanying materials will also be provided on the investor relations section of the Company's website at https://ir.bioventus.com/.

The webcast will be archived on the Company’s website at https://ir.bioventus.com/ and available for replay until November 8, 2022.

About Bioventus

Bioventus delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The Innovations for Active Healing from Bioventus include offerings for pain treatments, restorative therapies and surgical solutions. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.bioventus.com, and follow the Company on LinkedIn and Twitter. Bioventus and the Bioventus logo are registered trademarks of Bioventus LLC.

Legal Notice Regarding Forward-Looking Statements

This press release contains 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. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements concerning our business strategy, position and operations; expected sales trends, opportunities and growth; the ongoing COVID-19 pandemic; the expected benefits and impact of Bioventus’ products, including in certain regions, and biologic drug candidates; the benefits of and expected completion of integration efforts for the Bioness and Misonix acquisitions; and the Company’s financial guidance and expected financial performance. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Factors that could cause actual results to differ materially from those contemplated in this press release include, but are not limited to, statements about the adverse impacts on our business as a result of the COVID-19 pandemic; our dependence on a limited number of products; our ability to develop, acquire and commercialize new products, line extensions or expanded indications; the continued and future acceptance of our existing portfolio of products and any new products, line extensions or expanded indications by physicians, patients, third-party payers and others in the medical community; our ability to differentiate the hyaluronic acid (“HA”) viscosupplementation therapies we own or distribute from alternative therapies for the treatment of osteoarthritic; the proposed down-classification of non-invasive bone growth stimulators, including our Exogen system, by the U.S. Food and Drug Administration ("FDA"); our ability to achieve and maintain adequate levels of coverage and/or reimbursement for our products, the procedures using our products, or any future products we may seek to commercialize, including any potential changes by Centers for Medicare and Medicaid Services in the manner in which our HA viscosupplementation products are reimbursed, our ability to complete acquisitions or successfully integrate new businesses, products or technologies in a cost-effective and non-disruptive manner; including the Misonix acquisition; competition against other companies; the negative impact on our ability to market our HA products due to the reclassification of HA products from medical devices to drugs in the United States by the FDA; our ability to attract, retain and motivate our senior management and qualified personnel; our ability to continue to research, develop and manufacture our products if our facilities are damaged or become inoperable; failure to comply with the extensive government regulations related to our products and operations; enforcement actions if we engage in improper claims submission practices or in improper marketing or promotion of our products; the FDA regulatory process and our ability to obtain and maintain required regulatory clearances and approvals; failure to comply with the government regulations that apply to our human cells, tissues and cellular or tissue-based products; the clinical studies of any of our future products that do not produce results necessary to support regulatory clearance or approval in the United States or elsewhere; and the other risks identified in the Risk Factors section of the Company’s public filings with the Securities and Exchange Commission (“SEC”), including Bioventus’ Annual Report on Form 10-K for the year ended December 31, 2020, as updated in our Quarterly Report on Form 10-Q for the three months ended October 2, 2021 and as such factors may be further updated from time to time in Bioventus’ other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Bioventus’ website at ir.bioventus.com. Except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection, or forward-looking statement. Actual results may differ materially from those set forth in the forward-looking statements.

BIOVENTUS INC.
Consolidated condensed balance sheets
As of October 2, 2021 and December 31, 2020
(Amounts in thousands, except share amounts) (unaudited)

October 2, 2021   December 31, 2020
Assets
Current assets:
Cash and cash equivalents $ 80,917 $ 86,839
Accounts receivable, net 105,442 88,283
Inventory 36,565 29,120
Prepaid and other current assets 23,154 7,552
Total current assets 246,078 211,794
Restricted cash 50,000
Property and equipment, net 10,297 6,879
Goodwill 52,885 49,800
Intangible assets, net 248,794 191,650
Operating lease assets 16,938 14,961
Deferred tax assets 481
Investment and other assets 29,317 19,382
Total assets $ 654,790 494,466
Liabilities and Members’ Equity
Current liabilities:
Accounts payable $ 10,897 $ 4,422
Accrued liabilities 107,554 88,187
Accrued equity-based compensation 10,875 11,054
Current portion of long-term debt 15,000 15,000
Current portion of contingent consideration 13,386
Other current liabilities 2,993 3,926
Total current liabilities 160,705 122,589
Long-term debt, less current portion 162,437 173,378
Accrued equity-based compensation, less current portion 29,249
Deferred income taxes 47,687 3,362
Contingent consideration, less current portion 30,906
Other long-term liabilities 22,558 21,728
Total liabilities 424,293 350,306
Stockholders’ and Members’ Equity:
Members' equity 144,160
Preferred stock, $0.001 par value, 10,000,000 shares authorized, 0 shares issued
Class A common stock, $0.001 par value, 250,000,000 shares authorized,

41,097,292 shares issued and outstanding

41
Class B common stock, $0.001 par value, 50,000,000 shares authorized,

15,786,737 shares issued and outstanding

16
Additional paid-in capital 158,480
Accumulated deficit (6,238)
Accumulated other comprehensive income 204
Total stockholders’ equity attributable to Bioventus Inc. and members’ equity 152,503 144,160
Noncontrolling interest 77,994
Total stockholders’ and members’ equity 230,497 144,160
Total liabilities and stockholders’ and members’ equity $ 654,790 $ 494,466

 

BIOVENTUS INC.
Consolidated condensed statements of operations and comprehensive (loss) income
(Amounts in thousands, except share and per share data, unaudited)

Three Months Ended   Nine Months Ended
October 2, 2021   September 26, 2020   October 2, 2021   September 26, 2020
Net sales $ 108,890 $ 85,908 $ 300,484 $ 222,570
Cost of sales (including depreciation and amortization of $6,637 and $5,477, $17,491 and $16,076 respectively) 29,821 23,444 85,546 62,521
Gross profit 79,069 62,464 214,938 160,049
Selling, general and administrative expense 69,636 50,295 173,372 131,104
Research and development expense 6,153 3,569 11,936 8,311
Restructuring costs 1,798 1,798
Change in fair value of contingent consideration 651 1,292
Depreciation and amortization 1,878 1,667 5,655 5,305
Impairment of variable interest entity assets 5,674
Operating (loss) income (1,047) 6,933 15,211 15,329
Interest expense 1,347 1,880 152 7,095
Other expense (income) 757 (3,285) 2,821 (4,539)
Other expense (income) 2,104 (1,405) 2,973 2,556
(Loss) income before income taxes (3,151) 8,338 12,238 12,773
Income tax (benefit) expense (882) 373 759 302
Net (loss) income (2,269) 7,965 11,479 12,471
Loss attributable to noncontrolling interest 1,198 492 8,260 1,164
Net (loss) income attributable to Bioventus Inc. $ (1,071) $ 8,457 $ 19,739 $ 13,635
Net (loss) income $ (2,269) $ 7,965 $ 11,479 $ 12,471
Other comprehensive (loss) income, net of tax
Change in foreign currency translation adjustments (366) 943 (1,225) 687
Comprehensive (loss) income (2,635) 8,908 10,254 13,158
Comprehensive loss attributable to noncontrolling interest 1,300 492 8,182 1,164
Comprehensive (loss) income attributable to Bioventus Inc. $ (1,335) $ 9,400 $ 18,436 $ 14,322
Loss per share of Class A common stock(1):
Basic and diluted $ (0.03) $ (0.15)
Weighted-average shares of Class A common stock outstanding(1):
Basic and diluted 41,837,581 41,816,706
(1) Per share information for the nine months ended October 2, 2021 represents loss per share of Class A common stock and weighted-average shares of Class A common stock outstanding from February 16, 2021 through October 2, 2021, the period following Bioventus Inc.'s initial public offering and related transactions described in Note 1. Organization and Note 7. Earnings per share within the Notes to the Unaudited Condensed Consolidated Financial Statements in the Company's Quarterly Report on Form 10-Q for the quarter ended October 2, 2021.

BIOVENTUS INC.
Consolidated condensed statements of cash flows
(Amounts in thousands, unaudited)

Three Months Ended Nine Months Ended
October 2, 2021 September 26, 2020 October 2, 2021   September 26, 2020
Operating activities:
Net (loss) income $ (2,269) $ 7,965 $ 11,479 $ 12,471
Adjustments to reconcile net income to net cash provided by operating activities from continuing operations:
Depreciation and amortization 8,522 7,276 23,185 21,789
Equity-based compensation 5,938 7,390 (10,621) 619
Change in fair value of contingent consideration 651 1,292
Change in fair value of Equity Participation Rights (2,774) (788)
Change in fair value of interest rate swap (81) (21) (1,391) 1,980
Impairments related to variable interest entity 7,043
Other, net 404 (205) (210) 823
Changes in working capital (2,578) (1,164) (18,129) 9,858
Net cash from operating activities - continuing operations 10,587 21,241 9,874 46,752
Net cash from operating activities - discontinued operations (400) (400)
Net cash from operating activities 10,587 20,841 9,874 46,352
Investing activities:
Purchase of Bioness, Inc., net of cash acquired (1,000) (46,790)
Investments (11,124) (16,630) (11,124) (16,630)
Purchase of property and equipment (1,926) (1,281) (4,568) (2,331)
Other 864 152
Net cash from investing activities - continuing operations (13,186) (17,759) (62,482) (18,961)
Net cash from investing activities - discontinued operations 172
Net cash from investing activities (13,186) (17,759) (62,482) (18,789)
Financing activities:
Proceeds from issuance of Class A common stock sold in initial public offering, net of underwriting discounts and offering costs 107,777
Proceeds from issuance of Class A and B common stock 417 747
Borrowing on revolver 49,000
Payments on revolver (49,000) (49,000)
Payments on long-term debt (3,750) (2,500) (11,250) (5,000)
Refunds (distributions) - members (996) (5,616) (183) (14,691)
Other, net (17) (28)
Net cash from financing activities (4,346) (57,116) 97,063 (19,691)
Effect of exchange rate changes on cash (206) 272 (377) 86
Net change in cash, cash equivalents and restricted cash (7,151) (53,762) 44,078 7,958
Cash, cash equivalents and restricted cash at the beginning of the period 138,068 126,240 86,839 64,520
Cash, cash equivalents and restricted cash at the end of the period $ 130,917 $ 72,478 $ 130,917 $ 72,478

Use of Non-GAAP Financial Measures

Net Sales and International Net Sales Growth on a Constant Currency Basis

Net Sales and International Net Sales Growth on a Constant Currency Basis is a non-GAAP measure, which is calculated by translating current and prior year results at the same foreign currency exchange rate. Constant currency can be presented for numerous GAAP measures, but is most commonly used by management to facilitate the comparison sales in foreign currencies to prior periods and analyze net sales performance without the impact of changes in foreign currency exchange rates.

Organic Revenue Growth

The Company defines the term “organic revenue” as revenue in the stated period excluding the impact from business acquisitions and divestitures. The Company uses the related term “organic revenue growth” to refer to the financial performance metric of comparing the stated period organic revenue with the reported revenue of the corresponding period in the prior year. The Company believes that these non-GAAP financial measures, when taken together with our GAAP financial measures, allows the Company and its investors to better measure the Company’s performance and evaluate long-term performance trends. Organic revenue growth also facilitates easier comparisons of the Company’s performance with prior and future periods and relative comparisons to its peers. The Company excludes the effect of acquisitions and divestitures because these activities can have a significant impact on the Company's reported results, which the Company believes makes comparisons of long-term performance trends difficult for management and investors.

Adjusted EBITDA, Non-GAAP Gross Profit, Non-GAAP Gross Margin, Non-GAAP Operating Income, Non-GAAP Operating Expense, Non-GAAP Operating Margin, Non-GAAP Net Income, and Non-GAAP Earnings per share of Class A Common Stock.

We present Adjusted EBITDA, Non-GAAP Gross Profit, Non-GAAP Gross Margin, Non-GAAP Operating Income, Non-GAAP Operating Expense, Non-GAAP Operating Margin, Non-GAAP Net Income, and Non-GAAP Earnings per share of Class A Common Stock, all non-GAAP financial measures, to supplement our financial reporting, because we believe these measures are useful indicators of our operating performance.

We define Adjusted EBITDA as net income (loss) from continuing operations before depreciation and amortization, provision of income taxes and interest expense (income), adjusted for the impact of certain cash, non-cash and other items that we do not consider in our evaluation of ongoing operating performance. These items include equity compensation, restructuring costs, loss on debt retirement and modification, COVID-19 benefits, net, succession and transition charges, foreign currency impact, acquisitions and integration costs, inventory step-up costs, equity loss in unconsolidated investments, change in fair value of contingent consideration, impairments related to variable interest entity and other non-recurring costs. See the table below for a reconciliation of net income to Adjusted EBITDA. Our management uses Adjusted EBITDA principally as a measure of our operating performance and believes that Adjusted EBITDA is useful to our investors because it is frequently used by securities analysts, investors and other interested parties often use it in their evaluation of the operating performance of companies in industries similar to ours. Our management also uses Adjusted EBITDA for planning purposes, including the preparation of our annual operating budget and financial projections.

Our management uses Non-GAAP Gross Profit, Non-GAAP Gross Margin, Non-GAAP Operating Income, Non-GAAP Operating Expense, Non-GAAP Operating Margin and Non-GAAP Net Income principally as measures of our operating performance and believe that these non-GAAP financial measures are useful to better understand the long term recurring performance of our core business and to facilitate comparison of our results to those of peer companies. Our management also uses these non-GAAP financial measures for planning purposes, including the preparation of our annual operating budget and financial projections.

We define Non-GAAP Gross Profit as gross profit, adjusted for the impact of certain cash, non-cash and other items that we do not consider in our evaluation of ongoing operating performance. These items include depreciation and amortization included in the cost of goods sold and acquisition costs in cost of goods sold. We define Non-GAAP Gross Margin as the calculated ratio of Non-GAAP Gross Profit to net sales. See the table below for a reconciliation of gross profit and gross margin to Non-GAAP Gross Profit and Gross Margin.

We define Non-GAAP Operating Income as operating income, adjusted for the impact of certain cash, non-cash and other items that we do not consider in our evaluation of ongoing operating performance. These items include depreciation and amortization included in the cost of goods sold, amortization included in operating expenses, restructuring costs, change in fair value of contingent consideration, COVID-19 expense, succession and transition charges, acquisition and integration costs, inventory step-up costs, impairments related to variable interest entity and other non-recurring costs. Non-GAAP Operating Margin is defined as defined as Non-GAAP Operating Income divided by net sales. See the table below for a reconciliation of Operating Income and operating margin to Non-GAAP Operating Income and Non-GAAP Operating Margin.

We define Non-GAAP Operating Expense as operating expenses, adjusted to exclude certain cash, non-cash and other items that we do not consider in our evaluation of ongoing operating performance. These items include amortization included in operating expenses, restructuring costs, change in fair value of contingent consideration, COVID-19 expense, succession and transition charges, acquisition and integration costs, impairments related to variable interest entity and other non-recurring costs. See the table below for a reconciliation of Operating Expenses to Non-GAAP Operating Expenses.

We define Non-GAAP Net Income as Net Income, adjusted for the impact of certain cash, non-cash and other items that we do not consider in our evaluation of ongoing operating performance. These items include depreciation and amortization included in the cost of goods sold, amortization included in operating expenses, restructuring costs, change in fair value of contingent consideration, loss on debt retirement and modification, COVID-19 expense, COVID-19 income, succession and transition charges, acquisition and integration costs, inventory step-up costs, impairments related to variable interest entity and other non-recurring costs. See the table below for a reconciliation of Net Income to Non-GAAP Net Income.

We define Non-GAAP Earnings per Class A share as Earnings per Class A share, adjusted for the impact of certain cash, non-cash and other items that we do not consider in our evaluation of ongoing operating performance. These items include depreciation and amortization included in the cost of goods sold, amortization included in operating expenses, restructuring costs, change in fair value of contingent consideration, acquisition and integration costs  and other non-recurring costs, divided by weighted average number of shares of Class A common stock outstanding during the period. See the table below for a reconciliation of loss per Class A share to Non-GAAP Earnings per Class A share.

Reconciliation of Net (Loss) Income to Adjusted EBITDA (unaudited)

Three Months Ended Nine Months Ended
($, thousands) October 2, 2021 September 26, 2020 October 2, 2021 September 26, 2020
Net (loss) income $ (2,269) $ 7,965  $ 11,479  $ 12,471 
Depreciation and amortization(a) 8,522 7,276 23,185 21,789
Income tax (benefit) expense (882) 373 759 302
Interest expense 1,347 1,880 152 7,095
Equity compensation(b) 5,938 7,390 (10,621) 619
Restructuring costs(c) 1,798 1,798
COVID-19 benefits, net(d) (3,057) (4,158)
Succession and transition charges(e) 771 344 5,345
Foreign currency impact(f) 17 (98) (47) (58)
Acquisition and integration costs(g) 1,575 6,604
Inventory step-up costs(h) 2,106
Equity loss in unconsolidated investments(i) 419 1,320
Change in fair value of contingent

consideration(j)

651 1,292
Impairments related to variable interest entity(k) 7,043
Other non-recurring costs(l) 4,199 601 6,858 884
Adjusted EBITDA $ 21,315  $ 23,101  $ 52,272  $ 44,289 
  • Includes for the three months ended October 2, 2021 and September 26, 2020 and the nine months ended October 2, 2021 and September 26, 2020, respectively, depreciation and amortization of $6,637, $5,477, $17,491 and $16,076 in cost of sales and $1,878, $1,667, $5,655 and $5,305 presented in the consolidated statements of operations and comprehensive (loss) income with the balance in research and development.
  • The three and nine months ended October 2, 2021 primarily includes equity-based compensation expense (income) resulting from awards granted under the Company’s current equity based compensation plan (2021 Plan) and compensation costs. The nine months ended October 2, 2021 also includes the change in fair market value of accrued equity-based compensation related to the BV LLC Phantom Profits Interest Plan (Phantom Plan) due to expected pricing with our IPO. Equity compensation expenses for the three and nine months ended September 26, 2020 represents compensation from the Company’s management incentive plan and Phantom Plan as well as the change in fair market value of accrued equity-based compensation related to the plans due to the impact of the COVID-19 pandemic on our business.
  • Costs incurred as a result of adopting a restructuring plan for businesses recently acquired to reduce headcount, reorganize management structure and consolidate certain facilities.
  • Represents income resulting from the Coronavirus Aid, Relief and Economic Security ("CARES") Act offset by additional cleaning and disinfecting expenses and contract termination fees for canceled events.
  • Primarily represents costs related to the CEO transition.
  • Foreign currency impact represents realized and unrealized gains and losses from fluctuations in foreign currency and is included within other (income) loss in the consolidated statements of operations and comprehensive (loss) income.
  • Represents costs incurred to acquire and integrate Bioness.
  • Amortization of the inventory step-up associated with the Bioness acquisition.
  • Represents CartiHeal equity investment losses.
  • Represents changes in fair value of contingent consideration associated with the Bioness acquisition.
  • Represents loss on impairment on Harbor's long-lived assets, and the Company's investment in Harbor.
  • Other non-recurring costs primarily includes charges associated with strategic transactions, such as potential acquisitions and public company preparation costs, primarily accounting and legal fees.

Reconciliation of Net (Loss) Income to Non-GAAP Net Income (unaudited)

Three Months Ended Nine Months Ended
($, thousands) October 2, 2021 September 26, 2020 October 2, 2021 September 26, 2020
Net (loss) income $ (2,269) $ 7,965  $ 11,479  $ 12,471 
Depreciation & amortization included in cost of goods sold 6,637 5,477 17,491 16,076
Amortization included in operating expenses 1,241 1,408 3,813 4,537
Restructuring costs(a) 1,798 1,798
Change in fair value of contingent consideration 651 1,292
COVID-19 expense(b) 130 277
COVID-19 income(c) (3,187) (4,435)
Succession and transition charges (d) 771 344 5,345
Acquisition and Integration costs(e) 1,575 6,604
Inventory step-up costs(f) 2,106
Impairments related to variable interest entity(g) 7,043
Other non-recurring items(h) 4,199 6,858
Non-GAAP Net income $ 13,832  $ 12,564  $ 58,828  $ 34,271 
  • Costs incurred as a result of adopting a restructuring plan for businesses recently acquired to reduce headcount, reorganize management structure and consolidate certain facilities.
  • Additional cleaning and disinfection expenses and contract termination fees for canceled events included in operating expenses.
  • Represents income resulting from the Coronavirus Aid, Relief and Economic Security ("CARES") Act.
  • Primarily represents costs related to the CEO transition.
  • Represents costs incurred to acquire and integrate Bioness.
  • Amortization of the inventory step-up associated with the Bioness acquisition.
  • Represents loss on impairment on Harbor's long-lived assets, and the Company's investment in Harbor.
  • Other non-recurring costs primarily includes charges associated with strategic transactions, such as potential acquisitions and public company preparation costs, primarily accounting and legal fees.

 Reconciliation of Loss per share of Class A Common Stock to Non-GAAP Earnings per share of Class A Common Stock (unaudited)

Three Months Ended October 2, 2021
Weighted average Class A Common Stock outstanding, basic & diluted 41,837,581
Loss per share of Class A Common Stock (basic & diluted) $ (0.03)
Depreciation and amortization included in cost of goods sold 0.12
Amortization included in operating expenses 0.02
Restructuring costs(a) 0.03
Change in fair value of contingent consideration 0.01
Acquisition and Integration costs(b) 0.03
Other non-recurring items(c) 0.07
Non-GAAP Earnings per share of Class A Common Stock (basic & diluted) $ 0.25 
  • Costs incurred as a result of adopting a restructuring plan for businesses recently acquired to reduce headcount, reorganize management structure and consolidate certain facilities.
  • Costs related to the Bioness acquisition.
  • Other non-recurring primarily consists of charges associated with potential strategic transactions, such as potential acquisitions.

Reconciliation of Gross Profit to Non-GAAP Gross Profit and Gross Margin to Non-GAAP Gross Margin (unaudited)

Three Months Ended Nine Months Ended
($, thousands) October 2, 2021 September 26, 2020 October 2, 2021 September 26, 2020
Gross Profit $ 79,069 $ 62,464 $ 214,938 $ 160,049
Gross Margin 72.6  % 72.7  % 71.5  % 71.9  %
Depreciation and Amortization included in cost of goods sold 6,637 5,477 17,491 16,076
Acquisition costs in cost of goods sold 2,106
Non-GAAP Gross Profit $ 85,706 $ 67,941 $ 234,535 $ 176,125
Non-GAAP Gross Margin 78.7  % 79.1  % 78.1  % 79.1  %

Reconciliation of Operating (Loss) Income to Non-GAAP Operating Income and Operating Margin to Non-GAAP Operating Margin (unaudited)

Three Months Ended Nine Months Ended
($, thousands) October 2, 2021 September 26, 2020 October 2, 2021 September 26, 2020
Operating (loss) income $ (1,047) $ 6,933  $ 15,211  $ 15,329 
Operating Margin (1.0  %) 8.1  % 5.1  % 6.9  %
Depreciation and Amortization included in cost of goods sold 6,637 5,477 17,491 16,076
Amortization included in operating expenses 1,241 1,408 3,813 4,537
Restructuring costs(a) 1,798 1,798
Change in fair value of contingent consideration 651 1,292
COVID-19 expense(b) 130 277
Succession and transition charges(c) 771 344 5,345
Acquisition and Integration costs(d) 1,575 6,604
Inventory step-up costs(e) 2,106
Impairments related to variable interest entity(f) 5,674
Other non-recurring items(g) 4,199 6,858
Non-GAAP Operating Income $ 15,054  $ 14,719 $ 61,191  $ 41,564
Non-GAAP Operating Margin 13.8  % 17.1  % 20.4  % 18.7  %
  • Costs incurred as a result of adopting a restructuring plan for businesses recently acquired to reduce headcount, reorganize management structure and consolidate certain facilities.
  • Additional cleaning and disinfection expenses and contract termination fees for canceled events included in operating expenses.
  • Primarily represents costs related to the CEO transition.
  • Costs related to the Bioness acquisition.
  • Amortization of the inventory step-up associated with the Bioness acquisition.
  • Represents loss on impairment on Harbor's long-lived assets.
  • Other non-recurring primarily consists of charges associated with potential strategic transactions, such as potential acquisitions.

Reconciliation of Operating Expenses to Non-GAAP Operating Expenses (unaudited)

Three Months Ended Nine Months Ended
($, thousands) October 2, 2021 September 26, 2020 October 2, 2021 September 26, 2020
Operating Expenses $ 80,116  $ 55,531  $ 199,727  $ 144,720 
Amortization included in operating expenses 1,241 1,408 3,813 4,537
Restructuring costs(a) 1,798 1,798
Change in fair value of contingent consideration 651 1,292
COVID-19 expense(b) 130 277
Succession and transition charges(c) 771 344 5,345
Acquisition and Integration costs(d) 1,575 6,604
Impairments related to variable interest entity(e) 5,674
Other non-recurring items(f) 4,199 6,858
Non-GAAP Operating Expenses $ 70,652  $ 53,222  $ 173,344  $ 134,561 
  • Costs incurred as a result of adopting a restructuring plan for businesses recently acquired to reduce headcount, reorganize management structure and consolidate certain facilities.
  • Additional cleaning and disinfection expenses and contract termination fees for canceled events included in operating expenses.
  • Primarily represents costs related to the CEO transition.
  • Costs related to the Bioness acquisition.
  • Represents loss on impairment on Harbor's long-lived assets.
  • Other non-recurring primarily consists of charges associated with potential strategic transactions, such as potential acquisitions.

Reconciliation of Guidance Range for Gross Profit to Non-GAAP Gross Profit and Gross Margin to Non-GAAP Gross Margin for the twelve months ending December 31, 2021

($, thousands) 2021 Guidance

Low

2021 Guidance

High

Twelve

Months Ended

December 31,

2020

Net Sales $ 425,000 $ 430,000 $ 321,161
Cost of Sales 123,700 125,600 87,642
Gross Profit 301,300 304,400 233,519
Gross Margin 70.9  % 70.8  % 72.7  %
Depreciation and Amortization included in

cost of goods sold

25,200 26,000 21,169
Acquisition costs in cost of goods sold 4,100 4,100
Non-GAAP Gross Profit $ 330,600 $ 334,500 $ 254,688
Non-GAAP Gross Margin 77.8  % 77.8  % 79.3  %

Reconciliation of Guidance Range for Net Income to Non-GAAP Net Income for the twelve months ending December 31, 2021

($, thousands) 2021 Guidance

Low

2021 Guidance

High

Twelve

Months Ended

December 31,

2020

Net income $ 1,800  $ 3,700  $ 14,722 
Depreciation and Amortization included in

cost of goods sold

25,600 26,400 21,168
Amortization included in operating expenses 5,500 5,500 5,868
Loss on debt retirement and modification 2,000 2,000
COVID-19 expense 576
COVID-19 income (4,699)
Succession & Transition 300 300 5,609
Restructuring costs 2,800 3,000 563
Acquisition and Integration costs 13,100 13,100
Inventory step-up costs 4,100 4,100
Change in fair value of contingent consideration 1,900 2,000
Impairments related to variable interest entity 7,000 7,000
Other non-recurring costs (a) 8,000 8,500 3,590
Non-GAAP Net income $ 72,100  $ 75,600  $ 47,397 
  • Represents anticipated charges in connection with potential strategic investments.

Reconciliation of Guidance Range for Net Income to Adjusted EBITDA

for the twelve months ending December 31, 2021

($, thousands) 2021 Guidance

Low

2021 Guidance

High

Twelve

Months Ended

December 31,

2020

Net Income $ 1,800  $ 3,700  $ 14,722 
Depreciation and amortization 33,700 34,500 28,643
Loss on debt retirement and modification 2,000 2,000
Income tax expense 2,400 2,900 1,192
Interest expense 2,800 3,000 9,751
Equity compensation (3,900) (3,900) 10,103
COVID-19 benefits, net (4,123)
Succession and transition charges 300 300 5,609
Restructuring costs 2,800 3,000 563
Foreign currency impact (117)
Equity loss in unconsolidated investments 1,800 1,800 467
Acquisition and Integration costs 13,100 13,100
Inventory step-up costs 4,100 4,100
Change in fair value of contingent consideration 1,900 2,000
Impairments related to variable interest entity 7,000 7,000
Other non-recurring costs (a) 8,000 8,500 5,633
Adjusted EBITDA $ 77,800  $ 82,000  $ 72,443 
  • Represents anticipated charges in connection with potential strategic investments.

 

Investor Inquiries:
Dave Crawford
Bioventus
919-474-6787
[email protected]

 


Sharon Klugewicz Joins Bioventus as Senior Vice President, Quality and Regulatory Affairs

DURHAM, NC – November 1, 2021 – Bioventus Inc. (Nasdaq: BVS) (“Bioventus” or the “Company”), a global leader in innovations for active healing, has appointed Sharon Klugewicz as Senior Vice President, Quality and Regulatory Affairs. In this role, she will be responsible for all regulatory and quality functions globally, facilitating strong alignment across commercial, operations and R&D teams.

“We are very pleased to welcome Sharon to Bioventus as she helps us integrate Misonix into the Company and lead this important function,” said Ken Reali, CEO, Bioventus. “We will leverage her significant experience in quality assurance, regulatory affairs, product development, and manufacturing operations as we continue to grow our overall business and expand globally with our offerings for pain treatment, restorative therapies and surgical solutions.”

Since 2019, Klugewicz served as Chief Operating Officer of Misonix, a global ultrasonic surgical equipment and medical technology company recently acquired by Bioventus. During her tenure, Klugewicz played a key role in the launch of the company’s revolutionary ultrasonic surgical platform, the neXus® Ultrasonic Surgical System, in the US, EU and Canada.

Prior to that, she spent nearly seven years at Chembio Diagnostic Systems, joining first as its Vice President, QA/QC/Technical Operations, before being promoted to COO, then later President, Americas Region. She served as the company’s interim CEO for five months in 2017 and was later named Chief Quality & Regulatory Affairs Officer. Klugewicz began her career at Pall Corporation in 1991 serving in several progressive technical, marketing and quality roles during her 21 year tenure with the company’s Medical, Biopharmaceuticals, and Life Sciences Divisions. In 2009, she was promoted to Senior Vice President, Global Scientific & Laboratory Services and led that function until 2012.

Klugewicz received a Master of Science in Biochemistry from Adelphi University and a Bachelor of Science in Neurobiology from Stony Brook University. 

About Bioventus
Bioventus delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The Innovations for Active Healing from Bioventus include offerings for pain treatment, restorative therapies and surgical solutions. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.bioventus.com, and follow the Company on LinkedIn and Twitter. Bioventus and the Bioventus logo are registered trademarks of Bioventus LLC. neXus is a trademark of Misonix, Inc.

Forward-Looking Statements
This press release contains 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. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements concerning Bioventus’s future growth, strategy and integration of Misonix. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Factors that could cause actual results to differ materially from those contemplated in this press release include, but are not limited to, the adverse impacts on our business as a result of the COVID-19 pandemic; our dependence on a limited number of products; our ability to develop, acquire and commercialize new products, line extensions or expanded indications; the continued and future acceptance of our existing portfolio of products and any new products, line extensions or expanded indications by physicians, patients, third-party payers and others in the medical community; our ability to differentiate the hyaluronic acid (“HA”) viscosupplementation therapies we own or distribute from alternative therapies for the treatment of osteoarthritic; the proposed down-classification of non-invasive bone growth stimulators, including our Exogen system, by the U.S. Food and Drug Administration (“FDA”); our ability to achieve and maintain adequate levels of coverage and/or reimbursement for our products, the procedures using our products, or any future products we may seek to commercialize; our ability to recognize the benefits of our investments; our ability to complete acquisitions or successfully integrate new businesses, products or technologies in a cost-effective and non-disruptive manner, including the Misonix acquisition; competition against other companies; the negative impact on our ability to market our HA products due to the reclassification of HA products from medical devices to drugs in the United States by the FDA; our ability to attract, retain and motivate our senior management and qualified personnel; our ability to continue to research, develop and manufacture our products if our facilities are damaged or become inoperable; failure to comply with the extensive government regulations related to our products and operations; enforcement actions if we engage in improper claims submission practices or in improper marketing or promotion of our products; the FDA regulatory process and our ability to obtain and maintain required regulatory clearances and approvals; failure to comply with the government regulations that apply to our human cells, tissues and cellular or tissue-based products; the clinical studies of any of our future products that do not product results necessary to support regulatory clearance or approval in the United States or elsewhere; and the other risks identified in the Risk Factors section of the Company’s public filings with the Securities and Exchange Commission (“SEC”), including Bioventus’s Annual Report on Form 10-K for the period ended December 31, 2020, as updated by Bioventus’s Quarterly Report on Form 10-Q for the period ended July 3, 2021 and as such factors may be updated from time to time in Bioventus’ other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Bioventus’ website at ir.bioventus.com. Except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection, or forward-looking statement. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in the Company’s business.

 

Investor Inquiries:
Dave Crawford
Bioventus
919-474-6787
[email protected]


Bioventus Completes the Acquisition of Misonix

DURHAM, NC – October 29, 2021 – Bioventus Inc. (Nasdaq: BVS) (“Bioventus” or the “Company”), a global leader in innovations for active healing, has completed the acquisition of Misonix, Inc. (“Misonix”), a provider of minimally invasive therapeutic ultrasonic technologies and regenerative medicine that are designed to enhance clinical outcomes, for cash and common stock. Pursuant to the terms of the merger agreement, Misonix has become a wholly owned subsidiary of Bioventus.

As of the effective time of the transaction, Misonix stockholders have the right to receive either (i) 1.6839 shares of Bioventus class A common stock or (ii) $28.00 in cash, without interest, for each share of Misonix common stock they hold, subject to proration based on an aggregate maximum cash amount payable by Bioventus equal to $10.50 per share of Misonix common stock outstanding shortly prior to the completion of the transaction.

The completed transaction creates a high growth medical device company that will conduct business as Bioventus Inc. With a $15B total addressable market and the ability to gain significant market share across multiple surgical applications as well as wound healing the combined organization can deliver consistent double digit revenue growth. The acquisition is directly aligned with Bioventus’ mission of delivering innovations for active healing to patients and providers. The deal also furthers the Company’s strategy of accelerated revenue growth through acquisitions that leverage the Company’s existing infrastructure.  Together the Company will have a significant sales force focused across surgical applications in spinal fusion, neurosurgery of the cranium and wound treatments including diabetic foot ulcers.

“The commercial reach of the new Bioventus is significantly broader, deeper and even more global. The acquisition has significant revenue growth opportunities via sales call point synergies that we share with Misonix including spinal and lower extremity surgeons. We expect it will accelerate the adoption of the recently launched neXus® platform used to facilitate ultrasonic procedures across spinal decompressions using the BoneScalpel®, SonaStar® for tumor ablation in the cranium and SonicOne® for tissue debridement in chronic wounds. Leading wound products including TheraSkin® will now be available to the entire customer continuum from the office to the wound centers,” said Ken Reali, CEO, Bioventus. “The combination with Misonix allows us to go deeper with our customer base leveraging our infrastructure and benefiting patients, physicians, surgeons as well as our more than 1,200 employees worldwide.”

Governance
Stavros Vizirgianakis and Patrick Beyer, each of whom were members of Misonix’s Board of Directors, have joined the Bioventus Board of Directors as of the closing of the transaction.

About Bioventus
Bioventus delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The Innovations for Active Healing from Bioventus include offerings for pain treatment, restorative therapies and surgical solutions. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.bioventus.com, and follow the Company on LinkedIn and Twitter. Bioventus and the Bioventus logo, are registered trademarks of Bioventus LLC. BoneScalpel, SonaStar, SonicOne and neXus are registered trademarks of Misonix, Inc. TheraSkin® is a registered trademark of Soluble Systems, LLC.

Forward-Looking Statements
This press release contains 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. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements concerning Bioventus’s future growth and strategy and the benefits of the Misonix acquisition. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Factors that could cause actual results to differ materially from those contemplated in this press release include, but are not limited to, the adverse impacts on our business as a result of the COVID-19 pandemic; our dependence on a limited number of products; our ability to develop, acquire and commercialize new products, line extensions or expanded indications; the continued and future acceptance of our existing portfolio of products and any new products, line extensions or expanded indications by physicians, patients, third-party payers and others in the medical community; our ability to differentiate the hyaluronic acid (“HA”) viscosupplementation therapies we own or distribute from alternative therapies for the treatment of osteoarthritic; the proposed down-classification of non-invasive bone growth stimulators, including our Exogen system, by the U.S. Food and Drug Administration (“FDA”); our ability to achieve and maintain adequate levels of coverage and/or reimbursement for our products, the procedures using our products, or any future products we may seek to commercialize; our ability to recognize the benefits of our investments; our ability to complete acquisitions or successfully integrate new businesses, products or technologies in a cost-effective and non-disruptive manner, including the Misonix acquisition; competition against other companies; the negative impact on our ability to market our HA products due to the reclassification of HA products from medical devices to drugs in the United States by the FDA; our ability to attract, retain and motivate our senior management and qualified personnel; our ability to continue to research, develop and manufacture our products if our facilities are damaged or become inoperable; failure to comply with the extensive government regulations related to our products and operations; enforcement actions if we engage in improper claims submission practices or in improper marketing or promotion of our products; the FDA regulatory process and our ability to obtain and maintain required regulatory clearances and approvals; failure to comply with the government regulations that apply to our human cells, tissues and cellular or tissue-based products; the clinical studies of any of our future products that do not product results necessary to support regulatory clearance or approval in the United States or elsewhere; and the other risks identified in the Risk Factors section of the Company’s public filings with the Securities and Exchange Commission (“SEC”), including Bioventus’s Annual Report on Form 10-K for the period ended December 31, 2020, as updated by Bioventus’s Quarterly Report on Form 10-Q for the period ended July 3, 2021 and as such factors may be updated from time to time in Bioventus’ other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Bioventus’ website at ir.bioventus.com. Except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection, or forward-looking statement. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in the Company’s business.

 

Investor Inquiries:
Dave Crawford
Bioventus
919-474-6787
[email protected]


Bioventus to Release Third Quarter of Fiscal Year 2021 Financial Results on November 9, 2021

DURHAM, NC – October 27, 2021 – Bioventus Inc. (Nasdaq: BVS) (“Bioventus” or the “Company”), a global leader in innovations for active healing, today announced that third quarter of fiscal year 2021 financial results will be released before the market opens on Tuesday, November 9, 2021.

Management will host a conference call to discuss its financial results and provide a business update, with a question and answer session, at 8:30 a.m. Eastern Time on November 9, 2021. Those who would like to participate may dial 844-945-2085 (442-268-1266 for international callers) and provide access code 9652759. A live webcast of the call and any accompanying materials will also be provided on the investor relations section of the Company’s website at https://ir.bioventus.com/.

The webcast will be archived on the Company’s website at https://ir.bioventus.com/ and available for replay until November 9, 2022.

About Bioventus
Bioventus delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The Innovations for Active Healing from Bioventus include offerings for pain treatment, restorative therapies and bone graft substitutes. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.bioventus.com, and follow the Company on LinkedIn and Twitter. Bioventus and the Bioventus logo are registered trademarks of Bioventus LLC.

Investor Inquiries:
Dave Crawford
919-474-6787
[email protected]

 


Bioventus and Misonix Stockholders Approve the Acquisition of Misonix by Bioventus

DURHAM, NC and FARMINGDALE, NY – October 26, 2021 – Bioventus Inc. (Nasdaq: BVS) (“Bioventus” or the “Company”), a global leader in innovations for active healing, and Misonix, Inc. (Nasdaq: MSON) (“Misonix”), a provider of minimally invasive therapeutic ultrasonic technologies and regenerative medicine that enhance clinical outcomes, today announced that the stockholders of Bioventus approved the issuance of shares of Bioventus class A common stock to the stockholders of Misonix in connection with the previously announced Agreement and Plan of Merger, dated July 29, 2021, by and among Bioventus, Misonix and other parties thereto, pursuant to which Misonix will be acquired by, and become a wholly-owned subsidiary of, Bioventus (the “Merger Agreement”) and the stockholders of Misonix have approved the proposal to adopt the Merger Agreement.

Detailed information regarding the voting results was made available by Bioventus and Misonix in a Form 8-K filed with the US Securities and Exchange Commission (“SEC”) on October 26, 2021, respectively.

“We are pleased by the outcome of today’s vote and thank our stockholders for supporting the acquisition,” said Ken Reali, Chief Executive Officer, Bioventus. “The combination with Misonix creates significant value and provides a deeper global portfolio of pain treatments, restorative therapies and surgical solutions for patients. We are excited to welcome the Misonix team to Bioventus.”

“We are excited about our progress in completing the transaction that will drive long term value for Misonix shareholders and look forward to closing,” said Stavros Vizirgianakis, Chief Executive Officer of Misonix.

Under the terms and subject to the conditions set forth in the Merger Agreement, Misonix stockholders will receive either (i) 1.6839 shares of Bioventus class A common stock or (ii) $28.00 in cash, without interest, for each share of Misonix common stock they hold, subject to proration based on an aggregate maximum cash amount payable by Bioventus equal to $10.50 per share of Misonix common stock outstanding shortly prior to the completion of the transaction.

The aggregate share consideration to Misonix stockholders is expected to represent approximately 25% of the combined company on a fully-diluted basis. The aggregate per-share value for Misonix represents approximately a 25% premium to Misonix’s 30-day VWAP as of July 27, 2021, two trading days prior to the entry by Bioventus and Misonix into the Merger Agreement. Subject to the satisfaction of customary closing conditions, the acquisition is expected to close on or around October 29, 2021.

About Bioventus
Bioventus delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The Innovations for Active Healing from Bioventus include offerings for pain treatment, restorative therapies and bone graft substitutes. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.bioventus.com and follow the Company on LinkedIn and Twitter. Bioventus and the Bioventus logo are registered trademarks of Bioventus LLC.

About Misonix
Misonix, Inc. (Nasdaq: MSON) is a provider of minimally invasive therapeutic ultrasonic medical devices and regenerative tissue products. Its surgical team markets and sells BoneScalpel and SonaStar, which facilitate precise bone sculpting and removal of soft and hard tumors and tissue, primarily in the areas of neurosurgery, orthopedic, plastic and maxillo-facial surgery. Misonix’ wound team markets and sells TheraSkin, Therion, TheraGenesis and SonicOne to debride, treat and heal chronic and traumatic wounds in inpatient, outpatient and physician office sites of service. At Misonix, Better Matters! That is why throughout Misonix’ history, Misonix has maintained its commitment to medical technology innovation and the development of products that radically improve outcomes for patients. Additional information is available on the Misonix’ web site at www.misonix.com.

Forward-Looking Statements
Certain statements contained in this press release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the benefits to Bioventus of the Misonix acquisition, the expected closing of the acquisition and integration plans. These forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “believes,” “plans,” “anticipates,” “projects,” “estimates,” “expects,” “intends,” “strategy,” “future,” “opportunity,” “may,” “will,” “should,” “could,” “potential,” or similar expressions. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties. Forward-looking statements speak only as of the date they are made, and Misonix undertakes no obligation to update any of them publicly in light of new information or future events. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: (1) conditions to the closing of the transaction may not be satisfied; (2) the transaction may involve unexpected costs, liabilities or delays; (3) the respective businesses of Bioventus and Misonix may suffer as a result of uncertainty surrounding the transaction; (4) the outcome of any legal proceedings related to the transaction; (5) Bioventus and Misonix may be adversely affected by other economic, business, and/or competitive factors; (6) the occurrence of any event, change or other circumstances that could give rise to the termination of the Merger Agreement; (7) the effect of the announcement of the transaction on the ability of Bioventus or Misonix to retain and hire key personnel and maintain relationships with customers, suppliers and others with whom Bioventus or Misonix does business, or on Bioventus’ or Misonix’s operating results and business generally; and (8) other risks to consummation of the transaction, including the risk that the transaction will not be consummated within the expected time period or at all. Additional factors that may affect the future results of Bioventus and Misonix are set forth in their respective filings with the SEC, including Bioventus’ most recent Form S-4 and definitive proxy statement filed with Rule 424(b)(3) prospectus, Misonix’s most recent definitive proxy statement, each of Bioventus’ and Misonix’s most recently filed Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, which are available on the SEC’s website at www.sec.gov, specifically under the heading “Risk Factors.” The risks and uncertainties described above and in Bioventus’ most recent Quarterly Report on Form 10-Q and Misonix’s most recent Quarterly Report on Form 10-Q are not exclusive and further information concerning Bioventus and Misonix and their respective businesses, including factors that potentially could materially affect their respective businesses, financial condition or operating results, may emerge from time to time. Readers are urged to consider these factors carefully in evaluating these forward-looking statements, and not to place undue reliance on any forward-looking statements. Readers should also carefully review the risk factors described in other documents that Bioventus and Misonix file from time to time with the SEC. The forward-looking statements in these materials speak only as of the date of these materials. Except as required by law, Bioventus and Misonix assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.

 

Bioventus Investor Inquiries:
Dave Crawford
Bioventus
919-474-6787
[email protected]

Misonix Contact:
Joe Dwyer
Chief Financial Officer
Misonix, Inc.
631-927-9113


Bioventus Inc. and Misonix, Inc. Announce Election Deadline of 5:00 p.m. New York City Time, on October 25, 2021 for Misonix Stockholders to Elect Form of Merger Consideration

DURHAM, NC and FARMINGDALE, NY – October 18, 2021Bioventus Inc. (Nasdaq: BVS) and Misonix, Inc. (Nasdaq: MSON) (“Misonix”), today announced an election deadline of 5:00 p.m., New York City Time, on October 25, 2021 (the “Election Deadline”) for stockholders of Misonix to elect the form of consideration they wish to receive for their shares of Misonix common stock in connection with the proposed merger of Oyster Merger Sub I, Inc., a newly-formed, wholly-owned subsidiary of Bioventus (“Merger Sub I”), with and into Misonix, immediately followed by the merger of Misonix with and into Oyster Merger Sub II, LLC, another newly-formed, wholly-owned subsidiary of Bioventus (“Merger Sub II”), pursuant to the Agreement and Plan of Merger (the “Merger Agreement”), dated as of July 29, 2021, by and among Bioventus, Merger Sub I, Merger Sub II and Misonix (the “Mergers”). If the Election Deadline is delayed or extended for any reason, Bioventus and Misonix will promptly announce the delay and, when determined, the rescheduled Election Deadline.

As previously announced, as a result of the Mergers, each share of Misonix common stock outstanding at the effective time of the Mergers will be converted into the right to receive 1.6839 shares of Bioventus class A common stock (“stock consideration”) or $28.00 in cash (“cash consideration”), subject to proration and reallocation as described in the Merger Agreement and the Joint Proxy Statement/Prospectus (for more information on the Joint Proxy Statement/Prospectus, see “Additional Information and Where to Find It” below).  Misonix stockholders are entitled to elect whether they wish to receive (a) the stock consideration for all of their shares of Misonix common stock, (b) the cash consideration for all of their shares of Misonix common stock, (c) the cash consideration for some shares of Misonix common stock and the stock consideration for the other shares of Misonix common stock or (d) make no election with respect to all of the shares of Misonix common stock held, subject in each case, to proration and reallocation as described in the Merger Agreement and the Joint Proxy Statement/Prospectus.

Record holders of Misonix common stock should have already received a Letter of Election and Transmittal, which permits the stockholder to make an election as to the type of merger consideration.  Record holders are reminded that if they wish to make an effective election, they must complete and return their Letter of Election and Transmittal, along with their stock certificate(s) (if any) and any other documents noted in the instructions to the Letter of Election and Transmittal, to American Stock Transfer & Trust Company, LLC, the Exchange Agent, no later than the Election Deadline, which is 5:00 p.m., New York City time, on October 25, 2021.

Misonix stockholders who hold their shares in “street name” through a bank, brokerage firm or other nominee (including through The Depository Trust Company), should have received instructions from the bank, brokerage firm or other nominee that is holding their shares of Misonix common stock with instructions for making elections. Election forms must be returned to the broker, bank or nominee in time for it to respond prior to the Election Deadline, therefore, applicable Misonix stockholders are encouraged to pay close attention to, and abide by, any election deadlines provided by the bank, brokerage firm or other nominee holding their shares, as that deadline may be earlier than the Election Deadline described above. Misonix stockholders who have no received these instructions are encouraged to contact the bank, brokerage firm or other nominee holding their shares of Misonix common stock as soon as possible.

Misonix stockholders who do not submit a valid election by the Election Deadline (or who submit a valid election indicating no election), will be deemed to have made no election and will therefore receive the cash consideration or the stock consideration or a combination of both, depending on the elections made by other Misonix stockholders (as described in the Joint Proxy Statement/Prospectus on pages 137-138 under the section entitled “The Merger—Merger Consideration—Proration and Reallocation”).

Misonix stockholders who have questions or need assistance to complete and return the Letter of Election and Transmittal or who want additional copies of the Letter of Election and Transmittal, should contact the Information Agent, D.F. King & Co., Inc. as follows:

D.F. King & Co., Inc.
48 Wall Street, 22nd Floor
New York, NY 10005
Banks & Brokers May Call: (212) 269-5550
All Others Call Toll-Free: (800) 431-9645
Email: [email protected]

A special meeting of the stockholders of Misonix is being held at Misonix’s corporate offices, located at 1938 New Highway, Farmingdale, NY 11735 on October 26, 2021, beginning at 10:00 a.m., Eastern Time for purposes of considering and voting on a proposal to adopt the Merger Agreement. Misonix stockholders who have questions about how to vote or direct a vote in respect of their shares of Misonix common stock at the special meeting of the Misonix stockholders, please contact, MacKenzie Partners, Inc., Misonix’s proxy solicitor, by telephone toll-free at 1-800-322-2885, Monday through Friday (except bank holidays), between 8:00 a.m. and 8:00 p.m., Eastern time, or by email at [email protected]

Misonix stockholders who have any questions about the Merger or the Merger Agreement should contact Misonix at [email protected] or write to Misonix, Inc., Attn: Secretary, at its principal executive offices at 1938 New Highway, Farmingdale, New York 11735.

About Bioventus
Bioventus delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The Innovations for Active Healing from Bioventus include offerings for pain treatment & joint preservation, restorative therapies and bone graft substitutes. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.bioventus.com, and follow the Company on LinkedIn and Twitter. Bioventus and the Bioventus logo, are registered trademarks of Bioventus LLC.

About Misonix
Misonix, Inc. (Nasdaq: MSON) is a provider of minimally invasive therapeutic ultrasonic medical devices and regenerative tissue products. Its surgical team markets and sells BoneScalpel and SonaStar, which facilitate precise bone sculpting and removal of soft and hard tumors and tissue, primarily in the areas of neurosurgery, orthopedic, plastic and maxillo-facial surgery. Misonix’ wound team markets and sells TheraSkin, Therion, TheraGenesis and SonicOne to debride, treat and heal chronic and traumatic wounds in inpatient, outpatient and physician office sites of service. At Misonix, Better Matters! That is why throughout Misonix’ history, Misonix has maintained its commitment to medical technology innovation and the development of products that radically improve outcomes for patients. Additional information is available on the Misonix’ web site at www.misonix.com.

Additional Information and Where to Find It
In connection with the proposed transaction, the Joint Proxy Statement/Prospectus was filed on Form S-4 by Bioventus with the Commission on September 8, 2021 (as amended from time to time, the “Form S-4”), and amended by that Amendment No. 1 to Form S-4, filed by Bioventus with the Commission on September 22, 2021, and filed on Schedule 14A by Misonix with the Commission on September 24, 2021, each of which include a preliminary proxy statement for the stockholders of Bioventus and Misonix. After the Form S-4 was declared effective by the Commission, Bioventus and Misonix mailed or otherwise provided the Joint Proxy Statement/Prospective and other relevant documents in connection with the proposed transaction to their respective stockholders. Before making a voting decision, Bioventus’ and Misonix’s stockholders are urged to read the Joint Proxy Statement/Prospectus and any other documents filed by each of Bioventus and Misonix with the Commission in connection with the proposed transaction or incorporated by reference therein carefully and in their entirety when they become available because they will contain important information about Bioventus, Misonix and the proposed transactions. Investors and stockholders may obtain a free copy of these materials and other documents filed by Bioventus and Misonix with the Commission at the Commission’s website at www.sec.gov, at Bioventus’ website at www.bioventus.com, at Misonix’s website at www.misonix.com or by sending a written request to Bioventus at 4721 Emperor Boulevard, Suite 100 Durham, North Carolina 27703, Attention: Investor Relations or by telephone at (919) 474-6700. The documents filed by Misonix with the Commission may be obtained free of charge at Misonix’s website at www.misonix.com or at the Commission’s website at www.sec.gov. These documents may also be obtained free of charge from Misonix by requesting them by mail at Misonix, Inc., 1938 New Highway, Farmingdale, New York 11735, Attention: Investor Relations, or by telephone at (631) 694-9555.

Participants in the Solicitation
This document does not constitute a solicitation of a proxy, an offer to purchase or a solicitation of an offer to sell any securities. There will be no sale or purchase of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended. Bioventus and Misonix and their respective directors, executive officers and certain other members of management and employees may be deemed to be participants in soliciting proxies from their respective stockholders in connection with the proposed transaction. Information regarding the persons who may, under the rules of the Commission, be considered to be participants in the solicitation of Bioventus’ and Misonix’s stockholders, respectively, in connection with the proposed transaction is set forth in the Form S-4 if and Bioventus and Misonix. Security holders may obtain information regarding the names, affiliations and interests of Bioventus’ directors and officers in Bioventus’ Annual Report on Form 10-K for the fiscal year ended December 31, 2020, which was filed with the Commission on March 26, 2021. Security holders may obtain information regarding the names, affiliations and interests of Misonix’s directors and officers in Misonix’s Annual Report on Form 10-K for the fiscal year ended June 30, 2021, which was filed with the Commission on September 2, 2021. To the extent the holdings of Bioventus securities by Bioventus’ directors and executive officers or the holdings of Misonix’s securities by Misonix’s directors and executive officers have changed since the amounts set forth in Bioventus’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020 or Misonix’s Annual Report on Form 10-K for the fiscal year ended June 30, 2021, respectively, such changes have been or will be reflected on Statements of Change in Ownership on Form 4 filed with the Commission. Additional information regarding these individuals and any direct or indirect interests they may have in the proposed transaction is set forth in the Form S-4, at Bioventus’ website at www.bioventus.com and at Misonix’s website at www.misonix.com.

Forward-Looking Statements
Certain statements contained in this filing may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the transaction and the ability to consummate the mergers. These forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “believes,” “plans,” “anticipates,” “projects,” “estimates,” “expects,” “intends,” “strategy,” “future,” “opportunity,” “may,” “will,” “should,” “could,” “potential,” or similar expressions. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties. Forward-looking statements speak only as of the date they are made, and Misonix undertakes no obligation to update any of them publicly in light of new information or future events. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: (1) Bioventus and Misonix may be unable to obtain their respective requisite stockholder approvals as required for the proposed transaction; (2) conditions to the closing of the transaction may not be satisfied; (3) the transaction may involve unexpected costs, liabilities or delays; (4) the respective businesses of Bioventus and Misonix may suffer as a result of uncertainty surrounding the transaction; (5) the outcome of any legal proceedings related to the transaction; (6) Bioventus and Misonix may be adversely affected by other economic, business, and/or competitive factors; (7) the occurrence of any event, change or other circumstances that could give rise to the termination of the Merger Agreement; (8) the effect of the announcement of the transaction on the ability of Bioventus or Misonix to retain and hire key personnel and maintain relationships with customers, suppliers and others with whom Bioventus or Misonix does business, or on Bioventus’ or Misonix’s operating results and business generally; and (9) other risks to consummation of the transaction, including the risk that the transaction will not be consummated within the expected time period or at all. Additional factors that may affect the future results of Bioventus and Misonix are set forth in their respective filings with the Commission, including Bioventus’ Form S-4, each of Bioventus’ and Misonix’s most recently filed Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Commission, which are available on the Commission’s website at www.sec.gov, specifically under the heading “Risk Factors.” The risks and uncertainties described above and in Bioventus’ most recent Quarterly Report on Form 10-Q and Misonix’s most recent Quarterly Report on Form 10-Q are not exclusive and further information concerning Bioventus and Misonix and their respective businesses, including factors that potentially could materially affect their respective businesses, financial condition or operating results, may emerge from time to time. Readers are urged to consider these factors carefully in evaluating these forward-looking statements, and not to place undue reliance on any forward-looking statements. Readers should also carefully review the risk factors described in other documents that Bioventus and Misonix file from time to time with the Commission. The forward-looking statements in these materials speak only as of the date of these materials. Except as required by law, Bioventus and Misonix assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.

Bioventus Investor Inquiries:
Dave Crawford
Bioventus
919-474-6787
[email protected]

 

Misonix Contacts:
Joe Dwyer
Chief Financial Officer
Misonix, Inc.
631-927-9113

Norberto Aja, Jennifer Neuman
JCIR
212-835-8500
[email protected]

 


DUROLANE Among High-Molecular Weight Hyaluronic Acid Treatments Linked to Significant Improvements in Knee Osteoarthritis Pain by American Academy of Orthopaedic Surgeons

DURHAM, NC – September 20, 2021 – Bioventus Inc., (Nasdaq: BVS) (“Bioventus” or the “Company”), a leader in innovations for active healing, announced that the American Academy of Orthopaedic Surgeons (AAOS) recently released updated clinical practice guidelines (CPG) indicating that high molecular weight cross-linked hyaluronic treatments, including Bioventus treatment DUROLANE, showed statistically significant improvement in certain knee osteoarthritis (OA) patients. The recommendation follows a review of 28 studies assessing intra-articular hyaluronic acid (HA) injections when compared to controls.

The CPG states that viscosupplementation, in the form of intra-articular HA injections, can represent a viable option for some patients who failed other treatments when appropriately indicated. Patients with low to moderate arthritic knees (Kellgren Lawrence (KL) I-III) have better results than those with severely affected knees (KL IV). In addition, the CPG highlights statistically significant results that were associated with high molecular weight cross-linked HA, but not with mid or low molecular weight HA.

DUROLANE is a single-injection osteoarthritis (OA) treatment that is lightly cross-linked and has the highest reported molecular weight of all US-approved HA products.1, 2  

“These updated guidelines from AAOS now match how we have always recommended the utilization of our HA products for knee OA pain,” said John Nosenzo, Chief Commercial Officer, Bioventus. “Now patients and physicians will have even more confidence in using HA therapies with high molecular weight such as DUROLANE.”

“The updated clinical practice guidelines from AAOS better aligns with the clinical practice and experience of most physicians. HA injections, including DUROLANE, are a viable option for patients who fail treatments such as NSAID’s, weight loss, and exercise,” said Vinod Dasa MD. “We applaud the Academy for recognizing the patient population that benefits from these treatments to manage their low to moderate OA knee pain.”

DUROLANE, which has more Level 1 clinical studies than any other single-injection HA, has demonstrated providing greater reduction in OA knee pain versus Synvisc-One®.3 It has longer lasting pain relief versus a steroid injection, is safe for repeated courses of therapy, and repeated use of DUROLANE does not increase the incidence of adverse events.4, 5 Visit www.durolane.com for more information.

About Bioventus
Bioventus delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The Innovations for Active Healing from Bioventus include offerings for pain treatment & joint preservation, restorative therapies and bone graft substitutes. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.bioventus.com, and follow the Company on LinkedIn and Twitter.

Bioventus, the Bioventus logo, and DUROLANE are registered trademarks of Bioventus LLC. NASHA is a registered trademark. Synvisc-One is a registered trademark of Genzyme Corporation.

Indications for Use: DUROLANE is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacological therapy or simple analgesics, e.g. acetaminophen. Do not inject DUROLANE with knee joint infections, infections, or skin disease in the area of the injection site. Do not administer to patients with known hypersensitivity (allergy) to HA preparations. Risks can include transient pain or swelling at the injection site. DUROLANE has not been tested in pregnant or lactating women, or children.

NOTE: The above indications presented are for the US market; indications may vary by country. Consult with your local Bioventus representative for approved use within your region of interest. Full prescribing information can be found in product labeling, at www.durolane.com or by contacting Bioventus Customer Service at 800-836-4080.

References: 1.Bioventus LLC. Q-Med Molecular Weight of DUROLANE, MA-10789. Data on file, RPT-001313. June 2021. 2.Nicholls M, Manjoo A, Shaw P, Niazi F, Rosen J. Rheological Properties of Commercially Available Hyaluronic Acid Products in the United States forth Treatment of Osteoarthritis Knee Pain. Clin Med Insights Arthritis Musculoskelet Disord. 2018 Jan 3;11:1179544117751622. doi: 10.1177/1179544117751622. PMID: 29326532; PMCID: PMC5757428. 3. McGrath AF, McGrath AM, Jessop ZM, et al. A comparison of intra-articular hyaluronic acid competitors in the treatment of mild to moderate knee osteoarthritis. J Arthritis. 2013; 2(1):108. doi:10.4172/2167-7921.1000108. 4 Leighton R, Åkermark C, Therrien R, et. al. NASHA® hyaluronic acid vs methylprednisolone for knee osteoarthritis: a prospective, multi-centre, randomized, non-inferiority trial. Osteoarthritis Cartilage. 2014; 22(1):17-25. 5. DUROLANE [package insert]. Durham, NC: Bioventus LLC; 2018.

Forward-Looking Statements

This press release contains 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. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements concerning the expected benefits, clinical development and market opportunities of DUROLANE. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Factors that could cause actual results to differ materially from those contemplated in this press release include, but are not limited to, statements about the adverse impacts on our business as a result of the COVID-19 pandemic; our dependence on a limited number of products; the continued and future acceptance of our existing portfolio of products and any new products, line extensions or expanded indications by physicians, patients, third-party payers and others in the medical community; our ability to differentiate the hyaluronic acid (“HA”) viscosupplementation therapies we own or distribute from alternative therapies for the treatment of osteoarthritic; the proposed down-classification of non-invasive bone growth stimulators, including our Exogen system, by the U.S. Food and Drug Administration (“FDA”); our ability to achieve and maintain adequate levels of coverage and/or reimbursement for our products, the procedures using our products, or any future products we may seek to commercialize; our ability to complete acquisitions or successfully integrate new businesses, products or technologies in a cost-effective and non-disruptive manner; competition against other companies; the negative impact on our ability to market our HA products due to the reclassification of HA products from medical devices to drugs in the United States by the FDA; failure to comply with the extensive government regulations related to our products and operations; enforcement actions if we engage in improper claims submission practices or in improper marketing or promotion of our products; the FDA regulatory process and our ability to obtain and maintain required regulatory clearances and approvals; and the other risks identified in the Risk Factors section of the Company’s public filings with the Securities and Exchange Commission (“SEC”), including Bioventus’ Annual Report on Form 10-K for the period ended December 31, 2020, as updated in our Quarterly Report on Form 10-Q for the quarter ended July 3, 2021 and as such factors may be further updated from time to time in Bioventus’ other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Bioventus’ website at ir.bioventus.com. Except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection, or forward-looking statement. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in the Company’s business.

Investor Inquiries:
Dave Crawford
Bioventus
919-474-6787
[email protected]

 


Bioventus Proceeds with Option Structure Agreement with CartiHeal

DURHAM, NC – August 30, 2021 – Bioventus Inc. (Nasdaq: BVS) (“Bioventus” or the “Company”), a global leader in innovations for active healing, has elected to make a $50 million escrow payment pursuant to its Option and Equity Purchase Agreement with CartiHeal Ltd., signaling its intent to move forward with an acquisition of CartiHeal. The Company’s decision came following its review of a statistical analysis report of the pivotal clinical trial of the Agili-C implant, reimbursement coding analysis and significant market diligence including surgeon interviews with respect to Agili-C’s commercialization opportunity and ultimate market potential.

The Company’s obligation to consummate the Potential Transaction is subject to the exercise by the Company of the call option provided under the Option Agreement, or the exercise by CartiHeal of its put option provided under the Option Agreement. The put option may only be exercised following premarket approval (PMA) by the Food and Drug Administration (FDA) of the Agili-C implant, which was granted Breakthrough Device Designation by the FDA last year, and the satisfaction of certain other conditions pursuant to the Option Agreement. Following the exercise of such option rights, the closing of the Potential Transaction is subject to certain customary conditions to closing. CartiHeal plans to submit the clinical module of their PMA later this year.

Agili-C is indicated for the treatment of a cartilage and osteochondral defects (defined as ICRS grade III or above) in the knee joint, in patients without severe osteoarthritis (Kellgren-Lawrence (KOOS) grade 0-3). The implant is designed to provide a cost effective solution in patients indicated for Agili-C.

“The robust data generated from the pivotal clinical trial, a randomized controlled trial with Agili-C, demonstrated superiority over surgical standard of care, microfracture and debridement, in KOOS overall compared to baseline. We believe this product could be a strong alternative for the approximately 650,000 US patients annually receiving microfracture or debridement along with other cartilage treatment options,” said Alessandra Pavesio, Senior Vice President and Chief Science Officer, Bioventus. “In combination with our HA products, Agili-C represents an exciting potential new offering for our portfolio designed to address the spectrum of osteoarthritis disease.”

In the next several quarters, Bioventus plans to continue to work closely with the CartiHeal team in advance of potential FDA approval to be ready to execute on commercialization and reimbursement activities should the Potential Transaction be consummated.

About Bioventus
Bioventus delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The Innovations for Active Healing from Bioventus include offerings for pain treatment & joint preservation, restorative therapies and bone graft substitutes. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.bioventus.com, and follow the Company on LinkedIn and Twitter.

Bioventus and the Bioventus logo are registered trademarks of Bioventus LLC. Agili-C is a trademark of CartiHeal.

Legal Notice Regarding Forward-Looking Statements

This press release contains 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. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, the expected timing of submission of a PMA for Agili-C and potential FDA approval, the Company’s potential acquisition of CartiHeal and related conditions to closing, and the benefits of an acquisition of CartiHeal. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Factors that could cause actual results to differ materially from those contemplated in this press release include, but are not limited to, our ability to recognize the benefits of the investment in CartiHeal; the adverse impacts on our business as a result of the COVID-19 pandemic; our dependence on a limited number of products; our ability to develop, acquire and commercialize new products, line extensions or expanded indications; the continued and future acceptance of our existing portfolio of products and any new products, line extensions or expanded indications by physicians, patients, third-party payers and others in the medical community; our ability to achieve and maintain adequate levels of coverage and/or reimbursement for our products, the procedures using our products, or any future products we may seek to commercialize, including any potential changes by Centers for Medicare and Medicaid Services in the manner in which our HA viscosupplementation products are reimbursed; our ability to complete acquisitions or successfully integrate new businesses, products or technologies in a cost-effective and non-disruptive manner; including the potential CartiHeal acquisition; competition against other companies; and the other risks identified in the Risk Factors section of the Company’s public filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, as updated by the Company’s Quarterly Report on Form 10-Q for the quarter ended July 3, 2021 and as such factors may be further updated from time to time in the Company’s other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investor Relations page of the Company’s website at ir.bioventus.com. Except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection, or forward-looking statement. Actual results may differ materially from those set forth in the forward-looking statements.

 

Investor Inquiries:
Dave Crawford
Bioventus
919-474-6787
[email protected]