Mois : mars 2021

Bioventus Acquires Bioness, Inc.

DURHAM, NC – March 30, 2021 – Bioventus Inc. (Nasdaq: BVS) (“Bioventus” or the “Company”), a global leader in innovations for active healing, has acquired Bioness, Inc. (“Bioness”), a global leader in neuromodulation and rehabilitation medical devices through its innovative peripheral nerve stimulation (“PNS”) therapy and premium rehabilitation solutions, for $45 million in up-front consideration, with up to $65 million of contingent consideration related to the achievement of certain key milestones. The acquisition includes the entire portfolio of Bioness products as well as its research and development pipeline. Under the merger agreement, Bioness has become a wholly-owned subsidiary of Bioventus, and all Bioness employees have become employees of Bioventus. The up-front consideration is being funded exclusively through the use of cash on hand.

The acquisition of Bioness is directly aligned with Bioventus’ mission of helping patients regain active lifestyles, and the strategy of accretive revenue growth through acquisitions that leverage the Company’s existing infrastructure. Bioness, based in Valencia, California, was founded by the Al Mann Foundation in 2004 with the mission of helping improve lives and restore function for those living with peripheral pain and neurological deficit. The total addressable market for medical devices currently marketed by Bioness is estimated to be more than $8 billion.

“Bioness has developed groundbreaking and best in class technologies, and we are excited about the opportunity for Bioventus to further Bioness’ vision of improving the lives of patients,” said Ken Reali, CEO of Bioventus. “We aim to accelerate Bioness’ revenue growth by leveraging our existing global network of approximately 300 sales representatives calling on orthopedic, pain and podiatric physicians as well as expanding market access and reimbursement processing capabilities. Most importantly, we welcome the Bioness team of dedicated employees to Bioventus and look forward to working with them to further market adoption.”

Bioness is a category leader in rehabilitation solutions globally with the broadest portfolio of offerings, including proprietary electrical stimulation exoskeletal devices for both the upper and lower extremities, robotic gait and fall safety systems, and high-tech, interactive software learning and recovery assessment platforms. These products play an essential role in helping patients regain mobility due to stroke, traumatic brain injury, multiple sclerosis and osteoarthritis, and are used by physical or occupational therapists in a clinical setting or by the patient at home, with the guidance of a clinician through telemedicine.

Bioness’ StimRouter^® PNS System is an emerging therapy for patients suffering from pain after surgery on an extremity, which affects over 16 million patients each year globally. The PNS market is experiencing significant growth, largely driven by a lack of effective alternatives and a desire to reduce opioid usage. StimRouter has been implanted in over 3,000 patients since 2017 and is sold in more than 10 countries, including the United States. Bioness’ patent protected PNS technology is ideally suited to treat pain in the periphery, and StimRouter is the only PNS device backed by a randomized control trial.

In 2020, Bioness generated approximately $40 million in revenue and had loss from operations of approximately $14.0 million. Bioventus expects the acquisition to be accretive to Bioventus’ revenue, enhance its multi-year revenue growth profile, and have a positive contribution to net income (excluding purchase accounting and transaction costs) by the end of year one post-close.  The Company expects full year net sales for the twelve months ending December 31, 2021 to be between $390 to $402 million, including Bioness’ anticipated net sales from the date of the acquisition.

About Bioness
Bioness is a leading provider of innovative technologies helping people regain mobility and independence. Bioness solutions include implantable and external neuromodulation systems, robotic systems and software based therapy programs providing functional and therapeutic benefits for individuals affected by pain, central nervous system disorders and orthopedic injuries. Currently, Bioness offers six medical devices within its commercial portfolio, which are distributed and sold on five continents and in over 40 countries worldwide. Bioness innovations have been implemented in many of the most prestigious and well-respected institutions around the globe with 17 of the top 20 rehabilitation hospitals in the United States currently using one or more Bioness solutions. For more information, visit www.bioness.com.

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 osteoarthritis, surgical and non-surgical bone healing. 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 our business strategy, operations and market opportunities, financial guidance and expected financial performance and condition of Bioness and the Company, including as a result of the acquisition of Bioness, and estimated total addressable market for Bioness medical devices. 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; 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; 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’ Annual Report on Form 10-K for the period ended December 31, 2020, 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.

Media Contact:
Thomas Hill
 
[email protected]

Investor Inquiries:
Mike Piccinino, CFA, IRC
Westwicke/ICR
[email protected]

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by Scott Petrie

Bioventus Inc. Reports Fourth Quarter and Full Year 2020 Financial Results; Introduces Full Year 2021 Financial Guidance

DURHAM, NC – March 25, 2021 – Bioventus Inc. (Nasdaq: BVS) (“Bioventus” or the “Company”), a global leader in innovations for active healing, today reported financial results for the fourth quarter and year ended December 31, 2020. This press release presents historical results, for the periods presented, of Bioventus, LLC, the predecessor of Bioventus Inc. for financial reporting purposes.

Fourth Quarter 2020 Financial Results Summary:

• Net sales of $98.6 million, up $1.0 million, or 1%, year-over-year.
  • Net sales, by geography, is based upon:
    • U.S. net sales of $89.7 million, up $2.8 million, or 3%, year-over-year.
    • International net sales of $8.9 million, down $1.8 million, or 17%, year-over-year. International net sales declined 19% year-over-year on a constant currency basis.*
  • Net sales, by vertical, is based upon:
    • Net sales of osteoarthritic (OA) joint pain treatment and joint preservation products of $52.2 million, down $2.2 million, or 4%, year-over-year.
    • Net sales of minimally invasive fracture treatment products of $27.2 million, up $0.4 million, or 2%, year-over-year.
    • Net sales of bone graft substitutes products of $19.2 million, up $2.8 million, or 17%, year-over-year.
  • Net income from continuing operations of $2.3 million, down $3.1 million, or 58%, year-over-year.
  • Adjusted EBITDA^* was $28.2 million, down $2.6 million, or 8% year-over-year.
  • Net income attributable to common unit holders of $0.5 million, down $2.0 million, or 80%, year-over-year.
  • Non-GAAP net income attributable to common unit holders^* of $11.4 million, up $1.6 million, or 16%, year-over-year.

Full Year 2020 Financial Results Summary:

• Net sales of $321.2 million, down $19.0 million, or 6%, year-over-year.
  • Net sales, by vertical, is based upon:
    • Net sales of OA joint pain treatment and joint preservation products of $171.2 million, down $10.9 million, or 6.0%, year-over-year.
    • Net sales of minimally invasive fracture treatment products of $88.6 million, down $14.9 million, or 14%, year-over-year.
    • Net sales of bone graft substitutes products of $61.4 million, up $6.8 million, or 12%, year-over-year.
  • Net income from continuing operations of $14.7 million, up $6.6 million, or 81%, year-over-year.
  • Adjusted EBITDA of $72.4 million, down $6.7 million, or 9% year-over-year.
  • Net income (loss) attributable to common unit holders of $4.4 million, up $5.0 million, year-over-year.
  • Non-GAAP net income attributable to common unit holders of $37.1 million, up $8.4 million, year-over-year.

Fourth Quarter 2020 and Recent Highlights:

• On November 10, 2020, the Company announced that beginning January 1, 2021, Bioventus will gain preferred access through the CVS Caremark Formulary, to DUROLANE^®, GELSYN-3^® and SUPARTZ FX^®, for the treatment of knee OA pain.
• On November 16, 2020, the Company announced the appointment of Chris Yamamoto as Senior Vice President of Business Development and Strategy. Yamamoto is responsible for developing a business development growth strategy for the Company that is accretive to the company’s current organic growth and executing deals that will drive long-term value and further the Company’s mission of helping patients regain active lifestyles.
• On November 18, 2020, the Company announced that it received authorization to proceed under its investigational new drug application from the U.S. Food and Drug Administration (the “FDA”), allowing it to proceed to clinical trials of PTP-001. PTP-001 (commercial trade name MOTYS™) is a placental tissue particulate comprised of amnion, chorion and umbilical cord from full-term, healthy births and is provided sterile in micronized form. Bioventus plans to evaluate the safety and efficacy of PTP-001 to treat osteoarthritis of the knee through an open-label, dose-escalation study.  Further, on March 11, 2021, the Company announced that the first patients had been enrolled and dosed in its Phase 1 open-label, dose-escalation study of MOTYS (PTP-001) with Dr. Shailesh Patel, M.D. at Coastal Carolina Research Center, South Carolina.
• On January 19, 2021, the Company announced the appointment of Miguel O. Beltrán-Delgado as Senior Vice President of Operations. Beltrán-Delgado is responsible for continual improvement of operations including driving productivity while continuing to meet evolving quality standards, reducing cycle times and optimizing the Company’s manufacturing and supply chain footprint.
• On March 4, 2021, the Company announced the appointment of Larry Chen as Managing Director of China and Asia Pacific. Based in Shenzhen, China, he is responsible for significantly increasing penetration of Bioventus products across key Asia Pacific markets, with a focus on China.

“Bioventus finished 2020 with improved momentum in our overall business with second half net sales increasing 3% year-over-year, and fourth quarter net sales increasing 15% on a quarter-over-quarter basis, as we continued to rebound from the global pandemic,” stated Ken Reali, Chief Executive Officer of Bioventus. “We are proud of the strong operating and financial performance we delivered in 2020, despite the unprecedented challenges presented by the external environment. We believe this performance is a direct result of our results oriented culture at Bioventus and the focus by our team on our mission to make a difference by helping patients resume and enjoy active lives.”

Mr. Reali continued: “The substantial improvements in our execution and operating achievements that we delivered in 2020 have continued in 2021. We have significantly enhanced our balance sheet and financial condition with the net proceeds raised in our IPO in February and believe we are well positioned to execute our growth strategy going forward. We introduced financial guidance for 2021 that reflects revenue growth in the range of 12% to 16% year-over-year, fueled primarily by anticipated strong global growth in sales of our leading portfolio of PMA-approved therapies for OA joint pain and our portfolio of clinically efficacious and cost effective bone graft substitutes and continuing to build on our minimally invasive fracture treatment franchise. Importantly, we look forward to potential acceleration in our multi-year growth profile fueled by continued progress in our clinical, product development and new product pipeline and our pursuit of in-organic business development opportunities that are accretive to our long-term growth profile and leverage our significant customer presence across orthopedics, broaden our portfolio and increase our global footprint.”

Presentation & Initial Public Offering:

• This press release presents historical results, for the periods presented, of Bioventus, LLC, the predecessor of Bioventus Inc. for financial reporting purposes.
• The financial results of Bioventus Inc. have not been included in this press release as it had no material assets or liabilities and no material business transactions or activities during the periods presented.

• On February 16, 2021, the Company successfully closed its initial public offering ("IPO") of common stock at a price to the public of $13.00 per share. The Company issued 9,200,000 shares of Class A common stock, which included 1,200,000 shares sold to the underwriters pursuant to their over-allotment option, and received net proceeds of approximately $111.2 million, after underwriter discounts and commissions.
• Accordingly, these historical results do not purport to reflect what the results of operations of Bioventus Inc. would have been had the IPO and related transactions occurred prior to such periods. For example, these historical results reference LLC common units and not common stock, and do not reflect the attribution of net income to non-controlling interest or the provision for corporate income taxes on the income attributable to Bioventus Inc. that the Company expects to recognize in future periods.

 

Fourth Quarter 2020 Financial Results:

The following table represents net sales by geographic region, and by vertical, for the three months ended December 31, 2020 and December 31, 2019, respectively:

	Three Months Ended  December 31,				Change
($ thousands, except for percentage)	2020		2019		$		%
By Geographic Region:
U.S.	$          89,675		$        86,844		$     2,831		3.3%
International	8,916		10,710		(1,794)		(16.8%)
Net Sales	$          98,591		$        97,554		$     1,037		1.1%
By Vertical:
OA joint pain treatment and joint preservation	$          52,246		$        54,459		$    (2,213)		(4.1%)
Minimally invasive fracture treatment	27,191		26,755		436		1.6%
Bone graft substitutes	19,154		16,340		2,814		17.2%
Net Sales	$          98,591		$        97,554		$     1,037		1.1%

Net sales of $98.6 million, compared to $97.6 million for the fourth quarter of 2019, an increase of $1.0 million, or 1%, year-over-year. The increase in net sales, by geography, was driven by an increase of $2.8 million, or 3%, year-over-year, in U.S. net sales, partially offset by a decrease of $1.8 million, or 17%, year-over-year, in international net sales. International net sales for the fourth quarter ended December 31, 2020 declined 19% year-over-year on a constant currency basis. The increase in net sales, by vertical, was driven by an increase of $2.8 million, or 17%, year-over-year, in bone graft substitutes sales and an increase of $0.4 million, or 2%, year-over-year, in minimally invasive fracture treatment sales, partially offset by a decrease of $2.2 million, or 4%, year-over-year, in OA joint pain treatment and joint preservation sales.

Gross profit was $73.5 million, or 74.5% of net sales, compared to $73.4 million, or 75.3% of net sales, for the fourth quarter of 2019, an increase of 0.1%, year-over-year. Non-GAAP gross profit* was $78.6 million, or 79.7% of net sales, compared to $78.7 million, or 80.7% of net sales, for the fourth quarter of 2019, a decrease of $0.1 million, or 0.1%, year-over-year.

Operating income was $5.9 million, compared to $13.7 million for the fourth quarter of 2019, a decrease of $7.8 million, or 57%, year-over-year. Operating margin was 6.0% of net sales, compared to 14% of net sales for the fourth quarter of 2019.  Non-GAAP operating income* was $17.0 million, compared to $21.0 million for the fourth quarter of 2019, a decrease of $3.9 million, or 19%, year-over-year. Non-GAAP operating margin* was 17.3% of net sales, compared to 21.5% of net sales for the fourth quarter of 2019.

Total other expense was $2.8 million, compared to $7.5 million for the fourth quarter of 2019, a decrease of $4.7 million, or 63%, year-over-year, primarily due to decreased debt interest resulting from refinancing our debt in December 2019 as well as the decline in interest rates. Income tax expense was $0.9 million, compared to $0.9 million in the fourth quarter of 2019.

Net income from continuing operations was $2.3 million, or $0.46 per common unit, compared to $5.3 million, or $1.08 per common unit, for the fourth quarter of 2019, a decrease of $3.1 million, or 58%, year-over-year.

Adjusted EBITDA was $28.2 million, compared to $30.7 million for the fourth quarter of 2019, a decrease of $2.6 million, or 8%, year-over-year.

Net income attributable to common unit holders was $0.5 million, or $0.10 per common unit, compared to $2.5 million, or $0.52 per common unit, for the fourth quarter of 2019, a decrease of $2.0 million, or 80%, year-over-year.

Non-GAAP net income attributable to common unit holders was $11.4 million, or $2.32 per common unit, compared to $9.8 million, or $2.00 per common unit, for the fourth quarter of 2019, an increase of $1.6 million, or 16%, year-over-year.

As of December 31, 2020, the Company had $86.8 million in cash and cash equivalents and $188.4 million in debt obligations, compared to $64.5 million in cash and cash equivalents and $198.0 million in debt obligations as of December 31, 2019.

Full Year 2020 Financial Results:

The following table represents net sales by geographic region, and by vertical, for the twelve months ended December 31, 2020 and December 31, 2019, respectively:

	Twelve Months Ended December 31,				Change
($ thousands, except for percentage)	2020		2019		$		%
By Geographic Region:
U.S.	$        293,697		$      305,072		$  (11,375)		(3.7%)
International	27,464		35,069		(7,605)		(21.7%)
Net Sales	$        321,161		$      340,141		$  (18,980)		(5.6%)
By Vertical:
OA joint pain treatment and joint preservation	$        171,178		$      182,082		$  (10,904)		(6.0%)
Minimally invasive fracture treatment	88,624		103,504		(14,880)		(14.4%)
Bone graft substitutes	61,359		54,555		6,804		12.5%
Net Sales	$        321,161		$      340,141		$  (18,980)		(5.6%)

Net sales of $321.2 million, compared to $340.1 million for the year ended December 31, 2019, a decrease of $19.0 million, or 6%, year-over-year. The decrease in net sales, by geography, was driven by a decrease of $11.4 million, or 4%, year-over-year, in U.S. net sales and a decrease of $7.6 million, or 22%, year-over-year, in international net sales. International sales for the year ended December 31, 2020 declined 22% year-over-year on a constant currency basis. The decrease in net sales, by vertical, was driven by a decrease of $14.9 million, or 14%, year-over-year, in minimally invasive fracture treatment sales, a decrease of $10.9 million, or 6%, year-over-year, in OA joint pain treatment and joint preservation sales, partially offset by an increase of $6.8 million, or 12%, year-over-year, in bone graft substitutes sales.

Net income from continuing operations was $14.7 million, or $3.00 per common unit, compared to $8.1 million, or $1.66 per common unit, for the year ended December 31, 2019, an increase of $6.6 million, or 81%, year-over-year.

Adjusted EBITDA was $72.4 million, compared to $79.2 million for the year ended December 31, 2019, a decrease of $6.7 million, or 9%, year-over-year.

Net income attributable to common unit holders was $4.4 million, or $0.89 per common unit, compared to a Net loss attributable to common unit holders of ($0.7 million), or ($0.13) per common unit, for the year ended December 31, 2019, an increase of $5.0 million year-over-year.

Non-GAAP net income attributable to common unit holders was $37.1 million, or $7.56 per common unit, compared to $28.6 million, or $5.84 per common unit, for the year ended December 31, 2019, an increase of $8.4 million, year-over-year.

Full Year 2021 Financial Guidance:

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

• Net sales of $360 million to $372 million.
• Net income attributable to common shareholders of $15 million to $19 million.
• Non-GAAP net income attributable to common shareholders of $43 million to $46 million.
• Adjusted EBITDA of $79 million to $83 million.

Fourth Quarter 2020 Earnings Conference Call:

Management will host a conference call to discuss its financial results and provide a business update, with a question and answer session, at 5:00 p.m. Eastern Time on March 25, 2021. Those who would like to participate may dial 844-945-2085 (442-268-1266 for international callers) and provide access code 2158468. 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 March 25, 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 osteoarthritis, surgical and non-surgical bone healing. 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 Noitce 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 tax treatment, 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; 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 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; 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’ 424(b)(4) prospectus filed on February 12, 2021 in connection with the Company’s initial public offering, 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 materially from those set forth in the forward-looking statements.

BIOVENTUS LLC

Consolidated balance sheets

December 31, 2020 and 2019

(Amounts in thousands, unaudited)

	2020		2019
Assets
Current assets:
Cash and cash equivalents	$                    86,839		$                   64,520
Accounts receivable, net	88,283		85,128
Inventory	29,120		27,326
Prepaid and other current assets	7,552		6,059
Total current assets	211,794		183,033
Property and equipment, net	6,879		4,489
Goodwill	49,800		49,800
Intangible assets, net	191,650		216,510
Operating lease assets	14,961		15,267
Investment and other assets	19,382		3,308
Total assets	$                  494,466		$                  472,407
Liabilities and Members’ Equity
Current liabilities:
Accounts payable	$                      4,422		$                     6,440
Accrued liabilities	88,187		52,827
Accrued equity-based compensation	11,054		15,547
Current portion of long-term debt	15,000		10,000
Other current liabilities	3,926		4,201
Total current liabilities	122,589		89,015
Long-term debt, less current portion	173,378		187,965
Accrued equity-based compensation, less current portion	29,249		25,255
Deferred tax liability	3,362		3,874
Other long-term liabilities	21,728		20,681
Total liabilities	350,306		326,790
Commitments and contingencies
Members’ equity (preferred unit liquidation preference of $210,576 and $204,443 at December 31, 2020 and 2019, respectively)	285,173		285,147
Accumulated other comprehensive income (loss)	1,607		(465)
Accumulated deficit	(144,539)		(141,700)
Equity attributable to unit holders	142,241		142,982
Noncontrolling interest	1,919		2,635
Total members’ equity	144,160		145,617
Total liabilities and members’ equity	$                  494,466		$                  472,407

 BIOVENTUS LLC

Consolidated statements of operations and comprehensive income

(Amounts in thousands, except unit and per unit data, unaudited)

	Three Months Ended Dec 31, 2020		Three Months Ended Dec 31, 2019		Twelve Months Ended Dec 31, 2020		Twelve Months Ended Dec 31, 2019
Net sales	$      98,591		$       97,554		$   321,161		$     340,141
Cost of sales (including depreciation and amortization of $5,093, $5,249, $21,169, and $22,399 respectively)	25,121		24,125		87,642		90,935
Gross profit	73,470		73,429		233,519		249,206
Selling, general and administrative expense	61,974		54,454		193,078		198,475
Research and development expense	2,891		3,144		11,202		11,055
Restructuring costs	563		35		563		575
Depreciation and amortization	2,134		2,093		7,439		7,908
Operating income	5,908		13,703		21,237		31,193
Interest expense	2,656		7,644		9,751		21,579
Other loss (income)	111		(146)		(4,428)		(75)
Other expense	2,767		7,498		5,323		21,504
Income from continuing operations before income taxes	3,141		6,205		15,914		9,689
Income tax expense	890		892		1,192		1,576
Net income from continuing operations	2,251		5,313		14,722		8,113
Loss from discontinued operations, net of tax	—		199		—		1,815
Net income	2,251		5,114		14,722		6,298
Loss attributable to noncontrolling interest	525		523		1,689		553
Net income attributable to unit holders	2,776		5,637		16,411		6,851
Other comprehensive income (loss), net of tax
Change in prior service cost and unrecognized loss for defined benefit plan adjustment	(54)		(78)		(54)		(78)
Change in foreign currency translation adjustments	1,439		255		2,126		(322)
Other comprehensive income (loss)	1,385		177		2,072		(400)
Comprehensive income	$       4,161		$        5,814		$     18,483		$        6,451
Net income from continuing operations attributable to unit holders	$       2,776		$        5,836		$     16,411		$        8,666
Accumulated and unpaid preferred distributions	(1,608)		(1,534)		(6,133)		(5,955)
Net income allocated to participating shareholders	(670)		(1,555)		(5,895)		(1,555)
Net income from continuing operations attributable to common unit holders	498		2,747		4,383		1,156
Loss from discontinued operations, net of tax	-		199		-		1,815
Net income  (loss) attributable to common unit holders	$          498		$        2,548		$       4,383		$          (659)
Net income (loss) per unit attributable to common unit holders-basic and diluted
Net income from continuing operations	$         0.10		$          0.56		$         0.89		$          0.24
Loss from discontinued operations, net of tax	-		0.04		-		0.37
Net income (loss) attributable to common unit holders	$         0.10		$          0.52		$         0.89		$         (0.13)
Weighted average units used in computing basic and diluted net income (loss) per common unit	4,900,000		4,900,000		4,900,000		4,900,000

  

BIOVENTUS LLC

Consolidated statements of cash flows

Years ended December 31, 2020 and 2019

(Amounts in thousands, unaudited)

Operating activities:
Net income	$                14,722		$                 6,298
Net loss from discontinued operations	—		1,815
Net income from continuing operations	14,722		8,113
Adjustments to reconcile net income to net cash provided by operating activities from continuing operations:
Depreciation and amortization	28,643		30,316
Payment of contingent consideration in excess of amount established in purchase accounting	—		(945)
Provision for expected credit losses	1,215		2,242
Profits interest plan, liability-classified and other equity awards compensation	10,103		10,844
Change in fair value of Equity Participation Rights unit	644		565
Change in fair value of interest rate swap	1,599		—
Deferred income taxes	(511)		(348)
Amortization of debt discount and capitalized loan fees, net	543		1,583
Loss on debt retirement and modification	—		3,352
Other, net	(67)		395
Changes in operating assets and liabilities:
Accounts receivable	(3,941)		(14,909)
Inventories	(528)		(1,427)
Accounts payable and accrued expenses	20,510		6,646
Other current assets and liabilities	(733)		(3,882)
Net cash provided by operating activities from continuing operations	72,199		42,545
Net cash used in operating activities of discontinued operations	(400)		(1,832)
Net cash provided by operating activities	71,799		40,713
Investing activities:
Investment and acquisition of distribution rights	(16,579)		(6,000)
Acquisition of VIE	—		430
Purchase of property and equipment	(4,093)		(2,342)
Net cash used in investing activities from continuing operations	(20,672)		(7,912)
Net cash provided by investing activities from discontinued operations	172		—
Net cash used in investing activities	(20,500)		(7,912)
Financing activities:
Borrowing on revolver	49,000		—
Payment on revolver	(49,000)		—
Proceeds from the issuance of long-term debt, net of issuance costs	—		198,134
Payments on long-term debt	(10,000)		(199,500)
Other financing activities	317		(448)
Distribution to members	(19,886)		(9,137)
Net cash used in financing activities	(29,569)		(10,951)
Effect of exchange rate changes on cash	589		(104)
Net change in cash and cash equivalents	22,319		21,746
Cash and cash equivalents at the beginning of the period	64,520		42,774
Cash and cash equivalents at the end of the period	$                86,839		$               64,520

Use of Non-GAAP Financial Measures

International Net Sales Growth on a Constant Currency Basis

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 of international net sales to prior periods and analyze net sales performance without the impact of changes in foreign currency exchange rates.

Adjusted EBITDA, Non-GAAP Gross Profit, Non-GAAP Gross Margin, Non-GAAP Operating Income, and Non-GAAP Net Income Attributable to Common Unit Holders

We present Adjusted EBITDA, Non-GAAP Gross Profit, Non-GAAP Gross Margin, Non-GAAP Operating Income, Non-GAAP Operating Expense and Non-GAAP Net Income Attributable to Common Unit Holders, 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, 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, change in fair value of contingent consideration, COVID-19 benefits, succession and transition charges, loss on impairment of intangible assets, losses associated with debt refinancing, restructuring costs, foreign currency impact and other non-recurring costs. See the table below for a reconciliation of net income from continuing operations 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 frequently 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, and Non-GAAP Net Income Attributable to Common Unit Holders 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.  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 in operating expenses, COVID-19 expenses, succession and transition charges, restructuring costs and other non-recurring costs. 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 Net Income Attributable to Common Unit Holders as net income attributable to common unit holders, 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 in operating expenses, COVID-19 expense and income, succession and transition charges, losses associated with debt retirement and modification, restructuring costs, and other non-recurring costs. See the table below for a reconciliation of net income attributable to common unit holders to Non-GAAP Net Income Attributable to Common Unit Holders.

Reconciliation of Net Income from continuing operations to Adjusted EBITDA (unaudited)

 

($, thousands)	Three Months Ended December 31, 2020		Three Months Ended December 31, 2019		Twelve Months Ended December 31, 2020		Twelve Months Ended December 31, 2019
Net Income from continuing operations	$                        2,251		$                                  5,313		$                      14,722		$                        8,113
Depreciation and amortization  (a)	6,854		7,344		28,643		30,316
Income tax expense	890		892		1,192		1,576
Interest expense	2,656		7,644		9,751		21,579
Equity compensation  (b)	9,484		7,592		10,103		10,844
COVID-19 benefits, net  (c)	35		-		(4,123)		-
Succession and transition charges  (d)	264		-		5,609		-
Restructuring costs   (e)	563		35		563		575
Foreign currency impact   (f)	(59)		(138)		(117)		8
Equity loss in unconsolidated investments (g)	467		-		467		-
Other non-recurring costs  (h)	4,749		2,023		5,633		6,177
Adjusted EBITDA	$                         28,154		$                                30,705		$                      72,443		$                      79,188

(a) Includes for the years ended December 31, 2020 and 2019, depreciation and amortization of $21.2 million and $22.4 million in cost of sales and also includes $7.4 million and $7.9 million, respectively, and for the quarters ended December 31, 2020 and 2019, depreciation and amortization of $5.1 million and $5.2 million in cost of sales, and also includes $1.8 million and $2.1 million, respectively, presented in the consolidated statements of operations and comprehensive income (loss), with the balance in research and development.
(b) Represents compensation as well as the change in fair market value resulting from two equity-based compensation plans, the Management Incentive Plan and the Phantom Profits Interest Plan.
(c) 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.
(d) Primarily represents costs related to the CEO transition.
(e) Represents costs related to a shift from direct to an indirect distribution model in our International business to improve performance. Various international subsidiaries were dissolved and or merged into other Bioventus LLC entities.
(f) 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 income (loss).
(g) Represents our share in the losses of CartiHeal for the year and quarter ended December 31, 2020.
(h) Other non-recurring items in 2020 includes settlement and legal costs of $1.9 million with the Office of Inspector General of the U.S. Department of Health and Human Services (“OIG”). The remaining balance in 2020 and the activity in 2019 primarily consists of charges associated with potential strategic transactions, such as potential acquisitions and preparing to become a public company, primarily accounting and legal fees.

Reconciliation of Net income attributable to common unit holders to Non-GAAP Net income attributable to common unit holders (unaudited)

 

($, thousands)	Three Months Ended December 31, 2020		Three Months Ended December 31, 2019		Twelve Months Ended December 31, 2020		Twelve Months Ended December 31, 2019
Net income attributable to common unit holders	$                           498		$                                  2,548		$                        4,383		$                          (659)
Depreciation & amortization included in cost of goods sold	5,093		5,249		21,168		22,399
Amortization included in operating expenses	1,331		1,599		5,868		5,927
Loss on debt retirement and modification (a)	-		367		-		367
COVID-19 expense (b)	299		-		576		-
COVID-19 income (c)	(264)		-		(4,699)		-
Succession and transition charges (d)	264		-		5,609		-
Restructuring costs (e)	563		35		563		575
Other non-recurring items (f)	3,590		-		3,590		-
Non-GAAP Net income attributable to common unit holders	$                       11,374		$                                  9,798		$                        37,058		$                        28,609

Reconciliation of Net Income attributable to common unit holders per common unit to Non-GAAP Net Income attributable to common unit holders per common unit (unaudited)

	Three Months Ended December 31, 2020		Three Months Ended December 31, 2019		Twelve Months Ended December 31, 2020		Twelve Months Ended December 31, 2019
Weighted average common Units used in computing basic and diluted net income per common Unit	4,900,000		4,900,000		4,900,000		4,900,000
Net income attributable to common unit holders per basic and diluted common Unit	$                          0.10		$                                   0.52		$                          0.89		$                         (0.13)
Depreciation & amortization included in cost of goods sold	1.04		1.07		4.32		4.57
Amortization included in operating expenses	0.27		0.33		1.20		1.21
Loss on debt retirement and modification (a)	-		0.07		-		0.07
COVID-19 expense (b)	0.06		-		0.12		-
COVID-19 income (c)	(0.05)		-		(0.96)		-
Succession and transition charges (d)	0.05		-		1.14		-
Restructuring costs (e)	0.11		0.01		0.11		0.12
Other non-recurring items (f)	0.73		-		0.73		-
Non-GAAP Net income attributable to common unit holders per basic and diluted common Unit	$                            2.32		$                                   2.00		$                            7.56		$                           5.84

(a) Represents charges with our 2019 debt refinancing that were included in selling, general and administrative expense on the consolidated statements of operations and comprehensive income (loss).
(b) Additional cleaning and disinfecting expenses and contract termination fees for canceled events included in operating expenses.
(c) Represents income resulting from the CARES Act.
(d)  Primarily represents costs related to the CEO transition.
(e) Represents costs related to a shift from direct to an indirect distribution model in our International business to improve performance. Various international subsidiaries were dissolved and or merged into other Bioventus LLC entities.
(f) Other non-recurring items in 2020 primarily includes settlement and legal costs of $1.9 million with the OIG.

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

 

($, thousands)	Three Months Ended December 31, 2020		Three Months Ended December 31, 2019		Twelve Months Ended December 31, 2020		Twelve Months Ended December 31, 2019
Gross Profit	73,470		73,429		233,519		249,206
Gross Margin	74.5%		75.3%		72.7%		73.3%
Depreciation & Amortization included in cost of goods sold	5,093		5,249		21,168		22,399
Non-GAAP Gross Profit	78,564		78,678		254,687		271,605
Non-GAAP Gross Margin	79.7%		80.7%		79.3%		79.9%

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

 

($, thousands)	Three Months Ended December 31, 2020		Three Months Ended December 31, 2019		Twelve Months Ended December 31, 2020		Twelve Months Ended December 31, 2019
Operating Income	5,908		13,703		21,237		31,193
Operating Margin	6.0%		14.0%		6.6%		9.2%
Depreciation & Amortization included in cost of goods sold	5,093		5,249		21,168		22,399
Amortization included in operating expenses	1,331		1,599		5,868		5,927
Succession and transition charges (a)	264		-		5,609		-
Restructuring costs (b)	563		35		563		575
COVID-19 expense (c)	299		-		576		-
Other non-recurring items (d)	3,590		367		3,590		367
Non-GAAP Operating Income	17,048		20,953		58,611		60,462
Non-GAAP Operating Margin	17.3%		21.5%		18.2%		17.8%

(a) Primarily represents costs related to the CEO transition.
(b) Represents costs related to a shift from direct to an indirect distribution model in our International business to improve performance. Various international subsidiaries were dissolved and or merged into other Bioventus LLC entities.
(c) Additional cleaning and disinfecting expenses and contract termination fees for canceled events included in operating expenses.
(d) Other non-recurring items in 2020 primarily includes settlement and legal costs of $1.9 million with the OIG.

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

($, thousands)	2021 Guidance Low		2021 Guidance High
Net income attributable to common shareholders	15,349		19,317
Plus: Amortization included in cost of goods sold	22,260		21,260
Plus: Amortization included in operating expenses	5,323		5,323
Non-GAAP Net income attributable to common shareholders	42,932		45,900

Reconciliation of Guidance Range for Net Income from continuing operations to Adjusted EBITDA
for the twelve months ending December 31, 2021

($, thousands)	2021 Guidance Low		2021 Guidance High
Net Income from continuing operations	13,958		17,926
Depreciation and amortization	30,000		29,000
Income tax expense	5,162		6,630
Interest expense	3,400		2,900
Equity compensation	21,500		22,500
Other non-recurring costs (a)	5,000		4,000
Adjusted EBITDA	79,020		82,956

(a) Represents anticipated charges in connection with potential strategic investments.

Investor Inquiries:
Mike Piccinino, CFA, IRC
Westwicke/ICR
[email protected]

Press and Media Inquiries:
Bioventus
Thomas Hill
[email protected]

 

*See below under “Use of Non-GAAP Financial Measures” for a definition and reconciliation of this measure.

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by Scott Petrie

Bioventus Reports First Patients Enrolled in Phase 1 Clinical Trial of MOTYS(TM) (PTP-001) for the Treatment of Knee OA

DURHAM, NC – March 11, 2021 – Bioventus Inc. (Nasdaq: BVS) (“Bioventus” or the “Company”), a leader in solutions for innovative healing, reported that the first patients have been enrolled and dosed in its Phase 1 open-label, dose-escalation study of MOTYS (PTP-001) with Dr. Shailesh Patel, M.D. at Coastal Carolina Research Center, South Carolina. MOTYS is a placental tissue particulate comprised of amnion, chorion and umbilical cord tissue from full-term, healthy births and is provided sterile in micronized form.

The study is evaluating the safety and efficacy of MOTYS (PTP-001) to treat osteoarthritis (OA) of the knee. Researchers are enrolling 20 patients with each patient receiving a single injection of PTP-001. Patients will be followed up to evaluate local and systemic reactions to the drug candidate, as well as to assess any improvements in pain and mobility over the course of this clinical study.

Current treatments for knee OA are limited to corticosteroids and hyaluronic acid (HA) injections. Other options to manage pain, like opioids, are associated with high risks. Bioventus is one of several market leaders in HA therapy used to treat osteoarthritis knee pain with the largest portfolio of HA products including DUROLANE^®, GELSYN-3^® and SUPARTZ FX^® and believes products such as PTP-001, fill a need and provide more options for physicians and patients in an osteoarthritis market that is growing in scope with the aging population.

“The announcement that the first patients have been enrolled and dosed in this Phase 1 clinical study of PTP-001 is an important milestone for Bioventus especially given the challenging environment many clinical research centers are navigating due to COVID-19,” said Alessandra Pavesio, Senior Vice President and Chief Science Officer, Bioventus. “This trial represents the first of multiple studies that Bioventus intends to conduct to demonstrate the safety and efficacy of our innovative biologic drug candidate designed to treat a prevalent, growing and debilitating condition like knee osteoarthritis, which significantly affects the quality of life of more than 14 million Americans.”

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 osteoarthritis, surgical and non-surgical bone healing. 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 and Bioventus, MOTYS and GELSYN-3 are trademarks of Bioventus LLC. SUPARTZ FX is a trademark of Seikagaku Corp.

Summary of Indications for Use:
DUROLANE is indicated for the treatment of pain in osteoarthritis 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 in patients with knee joint infections, skin diseases, or other infections in the area of the injection site. Do not administer to patients with known hypersensitivity or allergy to sodium hyaluronate preparations. Risks can include transient pain or swelling at the injection site. DUROLANE has not been tested in pregnant or lactating women, or children. Full prescribing information can be found in package insert, at DUROLANE.com, or by contacting Bioventus Customer Service at 1-800-836-4080.

GELSYN-3 is indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e.g. acetaminophen). Do not administer to patients with known hypersensitivity (allergy) to sodium hyaluronate preparations. Do not inject GELSYN-3 into the knees of patients having knee joint infections or skin diseases or infections in the area of the injection site. GELSYN-3 is not approved for pregnant or nursing women, or children. Risks can include general knee pain, warmth and redness or pain at the injection site. Full prescribing information can be found in product labeling, at www.GELSYN3.com or by contacting customer service at 1-800-836-4080.

SUPARTZ FX is indicated for treatment of pain in osteoarthritis (osteoarthritis) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. You should not use SUPARTZ FX if you have infections or skin diseases at the injection site or allergies avian (bird) products (feathers and eggs). SUPARTZ FX is not approved for pregnant or nursing women, or children. Risks can include general knee pain, warmth and redness or pain at the injection site. Full prescribing information can be found in product labeling, at www.SupartzFX.com or by contacting customer service at 1-800-836-4080.

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 MOTYS (PTP-001) study and additional intended studies, expectations regarding the safety and efficacy of our biologic drug candidate and the results and impact of Bioventus’ products. 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 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; 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’ 424(b)(4) prospectus filed on February 12, 2021 in connection with the Company’s initial public offering, 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.goc 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.

Media Contact:
Thomas Hill
 
[email protected]

Investor Inquiries:
Mike Piccinino, CFA, IRC
Westwicke/ICR
[email protected]

 

 

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by Scott Petrie