Market Newsdesk

NEW YORK, March 31, 2023 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of BRIUMVI™ (ublituximab-xiiy) for the treatment of adult patients relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.

BRIUMVI is the first and only anti-CD20 monoclonal antibody approved in the U.S. for adult patients with RMS that can be administered in a one-hour infusion following the starting dose. BRIUMVI was granted approval by the U.S. Food and Drug Administration on December 28, 2022, for the treatment of RMS in adults.

Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, stated, “The positive recommendation to approve BRIUMVI by the CHMP takes us one step closer to delivering BRIUMVI to patients and healthcare providers in Europe. Following today’s recommendation, we look forward to hearing a decision on the marketing authorization application by the European Commission in the coming months.”

Hans-Peter Hartung, MD, PhD, FRCP, Professor of Neurology at Heinrich-Heine University Düsseldorf and Steering Committee Member for the ULTIMATE I & II trials stated, “Today’s announcement from the CHMP marks an important milestone for patients living in the EU with MS, a chronic condition affecting millions worldwide. The data from the ULTIMATE I & II trials establish BRIUMVI as an effective MS treatment which can be administered in a one-hour infusion twice a year following the starting dose. I look forward to the potential approval of BRIUMVI and it being available to those in need of treatment alternatives in the EU.”

The positive CHMP Opinion is based on data from the ULTIMATE I & II Phase 3 trials, which demonstrated superiority over teriflunomide in significantly reducing the annualized relapse rate (ARR, the primary endpoint), the number of T1 Gd-enhancing lesions and the number of new or enlarging T2 lesions. Results from the ULTIMATE I & II trials were published in August 2022 in The New England Journal of Medicine.

Based on the CHMP recommendation, a decision by the European Commission is expected in approximately two months. If granted by the European Commission, the centralised marketing authorisation is valid in all European Union (EU) Member States, Iceland, Norway and Liechtenstein.

ABOUT THE ULTIMATE I & II PHASE 3 TRIALS

ULTIMATE I & II are two randomized, double-blind, double-dummy, parallel group, active comparator-controlled clinical trials of identical design, in patients with RMS treated for 96 weeks. Patients were randomized to receive either BRIUMVI, given as an IV infusion of 150 mg administered in four hours, 450 mg two weeks after the first infusion administered in one hour, and 450 mg every 24 weeks administered in one hour, with oral placebo administered daily; or teriflunomide, the active comparator, given orally as a 14 mg daily dose with IV placebo administered on the same schedule as BRIUMVI. Both studies enrolled patients who had experienced at least one relapse in the previous year, two relapses in the previous two years, or had the presence of a T1 gadolinium (Gd)-enhancing lesion in the previous year. Patients were also required to have an Expanded Disability Status Scale (EDSS) score from 0 to 5.5 at baseline. The ULTIMATE I & II trials enrolled a total of 1,094 patients with RMS across 10 countries. These trials were led by Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University. Additional information on these clinical trials can be found at www.clinicaltrials.gov (NCT03277261; NCT03277248).

ABOUT BRIUMVI™ (ublituximab-xiiy) 150 mg/6 mL Injection for IV

BRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as RMS. BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses.

BRIUMVI is indicated for the treatment of adults with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

A list of authorized specialty distributors can be found at www.briumvi.com.

IMPORTANT SAFETY INFORMATION

Contraindications: BRIUMVI is contraindicated in patients with:

• Active HBV infection
• A history of life-threatening infusion reaction to BRIUMVI

WARNINGS AND PRECAUTIONS

Infusion Reactions: BRIUMVI can cause infusion reactions, which can include pyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat irritation, erythema, and an anaphylactic reaction. In MS clinical trials, the incidence of infusion reactions in BRIUMVI-treated patients who received infusion reaction-limiting premedication prior to each infusion was 48%, with the highest incidence within 24 hours of the first infusion. 0.6% of BRIUMVI-treated patients experienced infusion reactions that were serious, some requiring hospitalization.

Observe treated patients for infusion reactions during the infusion and for at least one hour after the completion of the first two infusions unless infusion reaction and/or hypersensitivity has been observed in association with the current or any prior infusion. Inform patients that infusion reactions can occur up to 24 hours after the infusion. Administer the recommended pre-medication to reduce the frequency and severity of infusion reactions. If life-threatening, stop the infusion immediately, permanently discontinue BRIUMVI, and administer appropriate supportive treatment. Less severe infusion reactions may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment.

Infections: Serious, life-threatening or fatal, bacterial and viral infections have been reported in BRIUMVI-treated patients. In MS clinical trials, the overall rate of infections in BRIUMVI-treated patients was 56% compared to 54% in teriflunomide-treated patients. The rate of serious infections was 5% compared to 3% respectively. There were 3 infection-related deaths in BRIUMVI-treated patients. The most common infections in BRIUMVI-treated patients included upper respiratory tract infection (45%) and urinary tract infection (10%). Delay BRIUMVI administration in patients with an active infection until the infection is resolved.

Consider the potential for increased immunosuppressive effects when initiating BRIUMVI after immunosuppressive therapy or initiating an immunosuppressive therapy after BRIUMVI.

Hepatitis B Virus (HBV) Reactivation:
HBV reactivation occurred in an MS patient treated with BRIUMVI in clinical trials. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with anti-CD20 antibodies. Perform HBV screening in all patients before initiation of treatment with BRIUMVI. Do not start treatment with BRIUMVI in patients with active HBV confirmed by positive results for HBsAg and anti-HB tests. For patients who are negative for surface antigen [HBsAg] and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult a liver disease expert before starting and during treatment.

Progressive Multifocal Leukoencephalopathy (PML):
Although no cases of PML have occurred in BRIUMVI-treated MS patients, JCV infection resulting in PML has been observed in patients treated with other anti-CD20 antibodies and other MS therapies.

If PML is suspected, withhold BRIUMVI and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.

MRI findings may be apparent before clinical signs or symptoms; monitoring for signs consistent with PML may be useful. Further investigate suspicious findings to allow for an early diagnosis of PML, if present. Following discontinuation of another MS medication associated with PML, lower PML-related mortality and morbidity have been reported in patients who were initially asymptomatic at diagnosis compared to patients who had characteristic clinical signs and symptoms at diagnosis.

If PML is confirmed, treatment with BRIUMVI should be discontinued.

Vaccinations:
Administer all immunizations according to immunization guidelines: for live or live-attenuated vaccines at least 4 weeks and, whenever possible at least 2 weeks prior to initiation of BRIUMVI for non-live vaccines. BRIUMVI may interfere with the effectiveness of non-live vaccines. The safety of immunization with live or live-attenuated vaccines during or following administration of BRIUMVI has not been studied. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion.

Vaccination of Infants Born to Mothers Treated with BRIUMVI During Pregnancy:
In infants of mothers exposed to BRIUMVI during pregnancy, assess B-cell counts prior to administration of live or live-attenuated vaccines as measured by CD19⁺ B-cells. Depletion of B-cells in these infants may increase the risks from live or live-attenuated vaccines. Inactivated or non-live vaccines may be administered prior to B-cell recovery. Assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted.

Fetal Risk: Based on data from animal studies, BRIUMVI may cause fetal harm when administered to a pregnant woman. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 B-cell depleting antibodies during pregnancy. A pregnancy test is recommended in females of reproductive potential prior to each infusion. Advise females of reproductive potential to use effective contraception during BRIUMVI treatment and for 6 months after the last dose.

Reduction in Immunoglobulins: As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. Decrease in immunoglobulin M (IgM) was reported in 0.6% of BRIUMVI-treated patients compared to none of the patients treated with teriflunomide in RMS clinical trials. Monitor the levels of quantitative serum immunoglobulins during treatment, especially in patients with opportunistic or recurrent infections, and after discontinuation of therapy until B-cell repletion. Consider discontinuing BRIUMVI therapy if a patient with low immunoglobulins develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins.

Most Common Adverse Reactions: The most common adverse reactions in RMS trials (incidence of at least 10%) were infusion reactions and upper respiratory tract infections.

Physicians, pharmacists, or other healthcare professionals with questions about BRIUMVI should visit www.briumvi.com.

ABOUT BRIUMVI PATIENT SUPPORT

BRIUMVI Patient Support is a flexible program designed by TG Therapeutics to support patients through their treatment journey in a way that works best for them. More information about the BRIUMVI Patient Support program can be accessed at www.briumvipatientsupport.com.

ABOUT MULTIPLE SCLEROSIS

Relapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing-remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. It is estimated that nearly 1 million people are living with MS in the United States and approximately 85% are initially diagnosed with RRMS.^1,2 The majority of people who are diagnosed with RRMS will eventually transition to SPMS, in which they experience steadily worsening disability over time. Worldwide, more than 2.3 million people have a diagnosis of MS.¹

ABOUT TG THERAPEUTICS

TG Therapeutics is a fully integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has received approval from the U.S. FDA for BRIUMVI™ (ublituximab-xiiy), for the treatment of adult patients with relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. For more information, visit www.tgtherapeutics.com, and follow us on Twitter @TGTherapeutics and on LinkedIn.

Cautionary Statement

This press release contains forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release. In addition to the risk factors identified from time to time in our reports filed with the U.S. Securities and Exchange Commission (SEC), factors that could cause our actual results to differ materially include the below.

Such forward looking statements include but are not limited to statements regarding the results of the ULTIMATE I & II Phase 3 studies and BRIUMVI as a treatment for relapsing forms of Multiple Sclerosis (RMS). Additional factors that could cause our actual results to differ materially include the following: the risk that the data from the ULTIMATE I & II trials that we announce or publish may change, or the product profile of BRIUMVI may be impacted, as more data or additional endpoints are analyzed; the risk that data may emerge from future clinical studies or from adverse event reporting that may affect the safety and tolerability profile and commercial potential of BRIUMVI; the risk that any individual patient’s clinical experience in the post-marketing setting, or the aggregate patient experience in the post-marketing setting, may differ from that demonstrated in controlled clinical trials such as ULTIMATE I and II; the risk that BRIUMVI will not be commercially successful in the US or ex US; our ability to expand our commercial infrastructure, and successfully market and sell BRIUMVI in RMS, specifically in the EU where the Company currently does not have a commercial presence and where a commercialization partner has not yet been identified; the Company’s reliance on third parties for manufacturing, distribution and supply, and a range of other support functions for our commercial and clinical products, including BRIUMVI, and the ability of the Company and its manufacturers and suppliers to produce and deliver BRIUMVI to meet the market demand for BRIUMVI; the failure to obtain and maintain requisite regulatory approvals, including in the EU, and including the risk that the Company fails to satisfy post-approval regulatory requirements; the uncertainties inherent in research and development; and general political, economic and business conditions, including the risk that the ongoing COVID-19 pandemic could have on the safety profile of BRIUMVI and any of our other drug candidates as well as any government control measures associated with COVID-19 that could have an adverse impact on our research and development plans or commercialization efforts. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022 and in our other filings with the U.S. Securities and Exchange Commission.

Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

CONTACT:

Investor Relations

Email: [email protected]
Telephone: 1.877.575.TGTX (8489), Option 4

Media Relations:

Email: [email protected]
Telephone: 1.877.575.TGTX (8489), Option 6

Acquisition of 100% of Tingo Mobile Completed on November 30, 2022, making the Company significantly profitable from December 1, 2022

Company’s Integration with Tingo Mobile saw a Significant Acceleration in Growth of the Combined Group During Q4 2022, with the Signing of Major New Trade Partnerships, International Expansion and Launch of Several Significant New Products and Businesses

Acquisition of Tingo Foods Plc Completed on February 7, 2023

Name Change to Tingo Group, Inc. Reflects Importance of Tingo Brand and the Company’s Focus on Leveraging its Significant Market Presence

MONTVALE, N.J., March 31, 2023 (GLOBE NEWSWIRE) — Tingo Group, Inc. (NASDAQ: TIO) (“Tingo” or the “Company”) today announced its financial results for the fiscal year ended December 31, 2022.

The acquisition of 100% of Tingo Mobile Limited (“Tingo Mobile”), which was completed on November 30, 2022, has resulted in the consolidation of its financial results into the Company from December 1, 2022. Today’s earnings presentation and this press release also includes pro forma financial information for the full year ended December 31, 2022, with comparative pro forma financial information for the year ended December 31, 2021, so as to provide shareholders with a fuller understanding of the performance and growth of the acquisition and its expected impact on the Company.

Highlights & Recent Developments

Financial Results

• Tingo Group cash balances at December 31, 2022, amounted to $500.3 million, compared to $96.6 million at December 31, 2021.
• Net revenues of Tingo Group for 2022 (including Tingo Mobile for one month only from December 1, 2022) were $146.0 million, compared to $55.7 million in 2021.
• Pro Forma Consolidated Revenues for 2022 were $1.152 billion, compared to $921.5 million for the prior year, which after stripping out non-recurring mobile handset sales in 2021 of $301.0 million, represented an increase of 85.5%.
• Tingo Mobile’s Handset Leasing Revenues for 2022 were $476.3 million, up 50.3% on 2021 revenues of $316.9 million.
• Nwassa Agri Fintech platform revenues for 2022 were $532.2 million, up 168.0% on 2021 revenues of $198.6 million.
• Operating loss of Tingo Group for 2022 (including Tingo Mobile for one month only from December 1, 2022) was $11.8 million, after accounting for non-recurring transaction expenses of $9.6 million and share based payments of $6.6 million, which if added back would result in an operating profit of $4.3 million, compared to a loss of $37.9 million for 2021.
• Pro Forma Consolidated Operating Income for 2022 was $554.6 million, compared to a loss of $47.0 million in 2021.
• Pro Forma Consolidated EBITDA¹ for 2022 was $954.5 million, compared to a Pro Forma Consolidated EBITDA¹ of $275.6 million for 2021.
• Tingo Mobile increased the customer numbers on its Nwassa Agri Fintech platform to 11.4 million at December 31, 2022, from 9.3 million at September 30, 2022, and handled more than $1 billion of customer transactions in the month of December.

¹

EBITDA (Earnings Before Interest Tax Depreciation and Amortization
)
is considered a non-GAAP measure of financial performance)

Operational Milestones

• Signed major trade partnership with the All Farmers Association of Nigeria (“AFAN”) on October 20, 2022, which launched ahead of schedule on November 16 2022, and includes commitment to enroll a minimum of 20 million new customers with Tingo Mobile.
• Launched operations in Ghana on November 10, 2022, and signed a landmark trade deal with the Kingdom of Ashanti covering major agricultural and cocoa farming region, including a commitment to enroll a minimum of 2 million new customers with Tingo Mobile and a target to increase enrollments to more than 4 million.
• Launched global commodity platform and export business on December 12, 2022, in partnership with the Dubai Multi Commodities Centre (“DMCC”), the world’s no.1 free trade zone, with the aim of generating a substantial increase in sales demand for the crops produced by Tingo Mobile’s farmers.
• Launched in Malawi on December 14, 2022, representing a sizeable market in its own right, and also constituting a strategically important base from which to expand into East Africa, including the neighbouring countries of Tanzania, Zambia and Mozambique.
• Acquired 100% ownership of Tingo Foods Plc on February 9, 2023, a recently established food processing business with the capacity to offtake large volumes of raw crops from Tingo Mobile’s farmers into finished food and beverage products. Since its inception in September 2022, Tingo Foods generated more than $400 million of highly profitable revenues during the four months ended December 31, 2022.
• Tingo Foods, through a joint venture, has recently committed to fit-out and operate a $1.6 billion state of the art food processing facility in the Delta State of Nigeria, which is believed to be the largest of its kind on the African continent, and is expected to multiply the company’s food processing capacity, as well as expand its range of food and beverage products.
• Launched the TingoPay Super App and a pan-African partnership with Visa on February 14, 2023, which once fully rolled out will offer retail customers an integrated digital Visa card, together with payments services, an e-wallet, and a wide range of value-added services. TingoPay, with Visa, will also offer a full range of merchant services to businesses, including to Tingo Mobile’s farmers.
• Appointed specialist legal counsel and a team of expert advisors in February 2023 to investigate market manipulation and unlawful naked short selling of stock, and take appropriate action to prosecute any parties that have perpetrated illegal activity, and protect the Company from any such action in the future.
• A special dividend plan and share buyback program are being considered as possible means of increasing shareholder value and to address the significant disconnect between the Company’s share price and its real value (in line with valuation multiples applied to other comparable Nasdaq listed companies).

Darren Mercer, MICT’s Chief Executive Officer, commented, “I am delighted with the remarkable transformation that we achieved in 2022. At the beginning of the year, we were faced with the backdrop of huge disruption in our domestic markets of China and Hong Kong, due to widespread Covid lockdown measures, and a significant downturn in the global financial services sector, in response to which we pivoted the Company both geographically and strategically, and acquired a business that is not only growing strongly but is also addressing some of the world’s biggest problems, namely food insecurity, financial exclusion and poverty. I feel privileged to be involved with Tingo and have acquired a business whose success is aligned with improving global food supply, and also with helping Africa and other emerging markets to become food sustainable.

“Our focus for much of 2022 was on completing and integrating our acquisition. After completing extensive due diligence and analysis on Tingo Mobile with a first-class team of globally renown advisors, including Ernst & Young, Dentons and Houlihan Lokey, before then restructuring the transaction so as to expedite its completion, and improve the terms for our shareholders, we were delighted to close the transaction to combine the companies before year end. This has considerably strengthened our balance sheet at December 31, 2022, resulting in gross assets of $1.7 billion, of which more than $0.5 billion is cash on hand. In addition, by closing the acquisition in 2022, we were able to engage one of the world’s leading accounting and audit firms, Deloitte, to audit the combined December 31, 2022, balance sheet and financial statements. It also gave us the opportunity to engage Grant Thornton to undertake an audit and Sarbanes-Oxley review of the group’s internal controls and procedures.

“I am also delighted with the progress we made with integrating Tingo Mobile into the group during Q4 2022, and in accelerating the expansion of the various businesses. As announced previously, since November 2022 we have signed trade partnerships that are expected to triple Tingo Mobile’s customers by the end of 2023, in addition to expanding our operations into three new countries, launching two new businesses, namely Tingo DMCC and TingoPay, and acquired the highly profitable Tingo Foods business. These significant developments, and their impact in terms of closing the end-to-end seed-to-sale ecosystem, puts us into a very strong position for 2023 and beyond.

“The financial results for Tingo Mobile, and the pro forma consolidated financial information for the group, speak for themselves. Highlights in the pro forma income statement include the 200% growth in gross profit in 2022 to $675 million, and a move from a Net Income Before Tax loss of $47 million in 2021 to a Net Income Before Tax surplus of more than $550 million in 2022. Additionally, we have experienced material growth during the first quarter of 2023, and we expect such growth to continue and accelerate throughout the remainder of the year and beyond.

“Having successfully integrated Tingo Mobile into the group and completed an audit with a world leading accounting firm, we look forward to finally addressing the significant disconnect in our share price and attract a valuation that is reflective of our consolidated earnings. With more than $500 million of cash on our balance sheet, and the launch of the largest food processing plant in Africa set to take place next year, we have an increasing number of options available to us to overcome the share price disconnect. As we continue to evaluate and consider all the options, together with our overall strategy for maximizing shareholder value, we will keep the market apprised and I hope to provide a further update in the coming weeks.”

Dozy Mmobuosi, Founder & CEO of Tingo Mobile and Tingo Foods, added: “My colleagues and I at Tingo Mobile and Tingo Foods are delighted that we are now part of Tingo Group. The completion of the merger on November 30, 2022, represented a major milestone in the history of Tingo Mobile, which my father and I founded some 22 years ago. We are already seeing the benefits of the synergies in the group, and of being part of a Nasdaq listed company, and our shareholders will have noted the considerable progress we have made since the fourth quarter of 2022, with the acceleration of our growth plans and globalization and dollarization strategies.

“We are particularly excited about the completion of the virtuous circle of our agri-fintech eco-system, where we can now deliver on, and profit from, every part of the journey from seed-to-sale. We are also very excited about our diversification, both geographically, including within my home continent of Africa, as well as into other parts of the world and into other sectors, for example, through our B2C and B2B TingoPay business and partnership with Visa.

“As we deliver on our success for the Company and its shareholders, it is of the highest importance to me and the Board of Tingo Group that we equally deliver on our mission and our Environment Social and Governance (“ESG”) goals, as we continue to strive to meaningfully improve global food security and financial inclusion, and also to deliver social and financial upliftment to our customers and, very importantly to me, help make Africa food sustainable.

“With the major steps we have taken in recent months to capitalize on our merger and the Company’s Nasdaq listing, we are confident we can build significantly on the revenue and earnings growth we achieved in 2022 and deliver considerable value to our shareholders.”

2022 Financial Review

• Net revenues for the year ended December 31, 2022, were $146.0 million, compared to $55.7 million in the prior year, an increase of 162%. The increase is mainly attributable to the consolidation of Tingo Mobile from December 1, 2022.
• Gross profit for the full year 2022 was $64.8 million, or 44% of revenues, compared to $9.2 million, or 16% of revenues, in the prior year. The increase is mainly attributable to the consolidation of Tingo Mobile for the month of December, as well as to the growth in the margins of the Company’s insurance agency business.
• Selling & marketing expenses for the year ended December 31, 2022, were $11.1 million as compared to $6.8 million for the year ended December 31, 2021. The increase was due to the consolidation of such costs from Tingo Mobile for the month of December, and an increase in marketing expenses for the Company’s insurance businesses, which is offset in part by a decrease in marketing expenses for the stock trading businesses.
• General and administrative expenses were $58.2 million in the full year 2022, compared to $36.5 million in the full year 2021, which is mainly attributed to the consolidation of such costs from Tingo Mobile for the month of December. General and administrative expenses for the year included $9.6 million of non-recurring transaction expenses and share based payments totalling $6.6 million, representing a decrease in share-based payments of $4.7 million compared to the previous year.
• Operating loss for the for the year ended December 31, 2022, was $11.8 million versus a loss of $37.9 million for the prior year. The decrease in loss from operations is mainly attributable to the consolidation of the profitable operations of Tingo Mobile for the month of December.
• Net loss for the year ended December 31, 2022, was $47.1 million compared to $36.4 million for the year ended December 31, 2021, mainly as a result of an increase in tax expenses relating to the acquisition and consolidation of Tingo Mobile.
• As of December 31, 2022, the Company’s cash and cash equivalents on a consolidated basis was approximately $500.3 million, compared to $96.6 million at December 31, 2021. This reflects an increase of $403.7 million in cash and cash equivalents, which is attributable to the consolidation of Tingo Mobile’s cash balance into the Company.

Fourth Quarter and Full Year 2022 Results Conference Call

Tingo Group CEO, Darren Mercer, Tingo Mobile and Tingo Foods Founder & CEO, Dozy Mmobuosi, and Tingo Group CFO, Kevin Chen, will host the conference call, followed by a question-and-answer period. The conference call will be accompanied by a presentation, which can be viewed during the webcast or accessed via the investor relations section of the Company’s website here.

Questions for the question-and-answer period will be accepted leading up to the call and can be submitted to [email protected].

To access the call, please use the following information:

Date:	Friday March 31, 2023
Time:	8:00 a.m. Eastern time (5:00 a.m. Pacific time)
Dial-in:	1-877-704-4453
International Dial-in:	1-201-389-0920
Conference Code:	13737364
Webcast:	https://viavid.webcasts.com/starthere.jsp?ei=1605988&tp_key=7a46dc5efb

A telephone replay will be available approximately two hours after the call and will run through April 30, 2023, by dialing 1-844-512-2921 from the U.S., or 1-412-317-6671 from international locations, and entering replay pin number: 13737364. The replay can also be viewed through the webcast link above and the presentation utilized during the call will be available in the company’s investor relations section here.

About Tingo Group

Tingo Group, Inc. (NASDAQ: TIO) is a global Fintech and Agri-Fintech group of companies with operations in Africa, Southeast Asia and the Middle East. Tingo Group’s wholly owned subsidiary, Tingo Mobile, is the leading Agri-Fintech company operating in Africa, with a comprehensive portfolio of innovative products, including a ‘device as a service’ smartphone and pre-loaded platform product. As part of its globalization strategy, Tingo Mobile has recently begun to expand internationally and entered into trade partnerships that are contracted to increase the number of subscribed farmers from 9.3 million in 2022 to more than 32 million, providing them with access to services including, among others, the Nwassa ‘seed-to-sale’ marketplace platform, insurance, micro-finance, and mobile phone and data top-up. Tingo Group’s other Tingo business verticals include: TingoPay, a SuperApp in partnership with Visa that offers a wide range of B2C and B2B services including payment services, an e-wallet, foreign exchange and merchant services; Tingo Foods, a food processing business that processes raw foods into finished products such as rice, pasta and noodles; and Tingo DMCC, a commodity trading platform and agricultural commodities export business based out of the Dubai Multi Commodities Center. In addition to its Tingo business verticals, Tingo Group also holds and operates an insurance brokerage platform business in China, with 130+ offices located in China’s cities and major towns; and Magpie Securities, a regulated finance services Fintech business operating out of Hong Kong and Singapore. For more information visit tingogroup.com.

Disclaimer

The information in this news release includes certain information and statements about management and the Board’s view of future events, expectations, plans and prospects that constitute forward looking statements. These statements are based upon assumptions that are subject to significant risks and uncertainties. Because of these risks and uncertainties and as a result of a variety of factors, the actual results, expectations, achievements or performance may differ materially from those anticipated and indicated by these forward-looking statements. Forward-looking statements in this news release include, but are not limited to, the ability of the Company to implement certain corporate actions, such as security repurchases and the implementation of a special dividend, the expected financial performance of the Company, including Tingo Mobile’s performance, the ability of the Company to recognize benefits associated with its recent acquisitions, the Company’s anticipated future growth strategy, including the expansion of its customer base and operations, and the ability of the Company to close the end-to-end seed-to-sale ecosystem. Any number of factors could cause actual results to differ materially from these forward-looking statements as well as future results. Although the Company believes that the expectations reflected in forward looking statements are reasonable, it can give no assurance that the expectations of any forward-looking statements will prove to be correct. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking statements to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking statements or otherwise.

Investor Relations Contact

Chris Tyson/Larry Holub
949-491-8235
[email protected]
www.mzgroup.us

Tingo Group Contact Information

Email: [email protected]
Phone: (201) 225-0190

TINGO GROUP, Inc.

CONSOLIDATED BALANCE SHEETS

(In Thousands, except Share and Par Value Data)

	December 31, 2022			December 31, 2021
ASSETS
Current assets:
Cash and cash equivalents	$	500,316		$	96,619	*
Trade accounts receivable, net		11,541			17,879
Related party receivables		13,491			5,134
Other current assets		5,828			7,865	*
Total current assets		531,176			127,497
Property and equipment, net		855,125			677
Intangible assets, net		185,407			21,442
Goodwill		101,247			19,788
Right of use assets under operating lease		2,260			1,921
Long-term deposit and other non-current assets		514			824
Deferred tax assets		3,661			1,764
Restricted cash escrow		2,233			2,417
Micronet Ltd. equity method investment		735			1,481
Total long-term assets		1,151,182			50,314
Total assets	$	1,682,358		$	177,811

TINGO GROUP, Inc.

CONSOLIDATED BALANCE SHEETS

(In Thousands, except Share and Par Value Data)

	December 31, 2022			December 31, 2021
LIABILITIES TEMPORARY EQUITY AND EQUITY
Short-term loan	$	460		$	1,657
Trade accounts payable		11,092			14,416
Deposit held on behalf of clients		2,528			3,101
Related party payables		57,506			4
Current operating lease liability		1,215			1,298
Other current liabilities		192,594			4,914
Total current liabilities		265,395			25,390
Long term loan		377			–
Long term operating lease liability		905			691
Deferred tax liabilities		89,597			3,952
Accrued severance pay		50			56
Total long-term liabilities		90,929			4,699
Commitment and Contingencies (Note 18)		–			–
Temporary equity
Preferred stock Series B subject to redemption: $0.001 par value, 33,687.21    shares authorized and 0 shares issued and outstanding as of December 31,    2022 and 2021, respectively.		553,035			–
Stockholders’ Equity:
Preferred stock Series A: $0.001 par value, 2,604.28 shares authorized and 0    shares issued and outstanding as of December 31, 2022 and 2021, respectively.		3			–
Common stock; $0.001 par value, 425,000,000 shares authorized, 157,599,882    and 122,435,576 shares issued and outstanding as of December 31, 2022    and December 31, 2021, respectively		158			122
Additional paid in capital		889,579			220,786
Accumulated other comprehensive loss		4,367			(414	)
Accumulated deficit		(123,463	)		(76,394	)
TINGO GROUP, Inc. stockholders’ equity		770,644			144,100
Non-controlling interests		2,355			3,622
Total stockholders’ equity		772,999			147,722
Total liabilities, temporary equity and stockholders’ equity	$	1,682,358		$	177,811

TINGO GROUP, Inc.

CONSOLIDATED STATEMENTS OF OPERATIONS

(In Thousands, Except Share and Loss Per Share Data)

	Year ended December 31,
	2022			2021
Revenues	$	146,035		$	55,676
Cost of revenues		81,243			46,456
Gross profit		64,792			9,220
Operating expenses:
Research and development		1,689			889
Selling and marketing		11,140			6,814
General and administrative		58,165			36,488
Amortization of intangible assets		5,590			2,925
Total operating expenses		76,584			47,116
Loss from operations		(11,792	)		(37,896	)
Equity in net loss of Micronet		–			(1,934	)
Loss from decrease in holding percentage in former VIE		–			(1,128	)
Other income, net		2,151			1,261
Finance income (expense), net		(750	)		395
Loss before income tax expense (benefit)		(10,391	)		(39,302	)
Income tax expense (benefit)		37,474			(1,791	)
Net loss after provision for income taxes		(47,865	)		(37,511	)
Gain (loss) from equity investment		(746	)		353
Net loss		(48,611	)		(37,158	)
Net loss attributable to non-controlling stockholders		(1,542	)		(730	)
Net loss attributable to TINGO GROUP	$	(47,069	)	$	(36,428	)
Loss per share attributable to TINGO GROUP:
Basic and diluted loss per share	$	(0.36	)	$	(0.32	)
Weighted average common shares outstanding:
Basic and diluted		129,345,764			112,562,199

Non-GAAP Financial Measures

In addition to providing financial measurements based on generally accepted accounting principles in the U.S., or GAAP, we provide additional financial metrics that are not prepared in accordance with GAAP, or non-GAAP financial measures. Management uses non-GAAP financial measures, in addition to GAAP financial measures, to understand and compare operating results across accounting periods, for financial and operational decision making, for planning and forecasting purposes and to evaluate our financial performance.

Management believes that these non-GAAP financial measures reflect our ongoing business in a manner that allows for meaningful comparisons and analysis of trends in our business, as they exclude expenses and gains that are not reflective of our ongoing operating results. Management also believes that these non-GAAP financial measures provide useful information to investors in understanding and evaluating our operating results and future prospects in the same manner as management and in comparing financial results across accounting periods and to those of peer companies.

The non-GAAP financial measures do not replace the presentation of our GAAP financial results and should only be used as a supplement to, not as a substitute for, our financial results presented in accordance with GAAP.

The non-GAAP adjustments, and the basis for excluding them from non-GAAP financial measures, are outlined below:

• Amortization of acquired intangible assets – We are required to amortize the intangible assets, included in our GAAP financial statements, related to the Transaction and the Acquisition. The amount of an acquisition’s purchase price allocated to intangible assets and term of its related amortization are unique to these transactions. The amortization of acquired intangible assets are non-cash charges. We believe that such charges do not reflect our operational performance. Therefore, we exclude amortization of acquired intangible assets to provide investors with a consistent basis for comparing pre- and post-transaction operating results.

• Stock-based compensation is share based awards granted to certain individuals. They are non-cash and affected by our historical stock prices which are irrelevant to forward-looking analyses and are not necessarily linked to our operational performance.

• Expenses related to the purchase of a business – These expenses relate directly to the purchase of the Tingo Mobile transaction and consist mainly of legal and accounting fees, insurance fees and other consultants. We believe that these expenses do not reflect our operational performance. Therefore, we exclude them to provide investors with a consistent basis for comparing pre- and post-Mobile Business purchase operating results.

• Expenses related to settlement agreement – These expenses relate directly to the settlement agreement with Maxim and Sunrise. More information can be found in the legal proceeding part.

The following table reconciles, for the periods presented, GAAP net loss attributable to TINGO GROUP to non-GAAP net income attributable to TINGO GROUP. and GAAP loss per diluted share attributable to TINGO GROUP to non-GAAP net loss per diluted share attributable to TINGO GROUP.:

	Year ended December 31,
	(Dollars in Thousands, other than share and per share amounts)
	2022			2021
GAAP net loss attributable to TINGO GROUP, Inc.	$	(47,069	)	$	(36,428	)
Amortization of acquired intangible assets		5,590			2,925
Stock-based compensation		6,615			10,580
Expenses related to purchase of a business		9,574			–
One time expenses relates to settlement agreement		143			303
Income tax effect of above non-GAAP adjustments		(1,543	)		(773	)
Total Non-GAAP net loss attributable to TINGO GROUP, Inc.	$	(26,690	)	$	(23,393	)
Non-GAAP net loss per diluted share attributable to TINGO GROUP, Inc.	$	(0.21	)	$	(0.20	)
Weighted average common shares outstanding used in per share calculations		129,345,764			112,562,199
GAAP net loss per diluted share attributable to TINGO GROUP, Inc.	$	(0.36	)	$	(0.32	)
Weighted average common shares outstanding used in per share calculations		129,345,764			112,562,199

Company Plans to Discontinue the Phase 3 Clinical Trial of Reldesemtiv

After Data Monitoring Committee Found No Effect on Primary or Key Secondary Endpoints

Cytokinetics to Host Conference Call and Webcast Today at 8:30 am Eastern Time

SOUTH SAN FRANCISCO, Calif., March 31, 2023 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the Data Monitoring Committee (DMC) for COURAGE-ALS (Clinical Outcomes Using Reldesemtiv on ALSFRS-R in a Global Evaluation in ALS), recently convened to conduct the second planned interim analysis of this Phase 3 clinical trial.

The DMC reviewed unblinded data from COURAGE-ALS and recommended the discontinuation of the clinical trial due to futility, as it found no evidence of effect in patients treated with reldesemtiv relative to placebo on the primary endpoint of change from baseline to 24 weeks in ALSFRS-R or in key secondary endpoints. Given these results, study conduct in COURAGE-ALS will be concluding. In addition, Cytokinetics plans to discontinue treatment with reldesemtiv in all patients including those in the open-label extension study, COURAGE-ALS OLE.

“We are extremely disappointed with this outcome and would like to thank the people with ALS, caregivers, investigators and clinical trial staff for their participation in COURAGE-ALS,” said Robert I. Blum, Cytokinetics’ CEO and President. “Cytokinetics has been committed to the ALS community for more than a decade and recognizes the urgency to bring new potential medicines to the forefront for this grievous disease. In the coming months, we will assess next steps relating to our neuromuscular development programs.”

The second interim analysis was triggered 24 weeks after at least one third of the planned sample size was randomized in COURAGE-ALS. At the interim analysis, approximately 460 patients had been randomized and over 200 had reached the 24-week assessment of the trial endpoints. This interim analysis assessed the primary and key secondary endpoints for potential futility as well as provided for a potential fixed increase in total enrollment, if it had been deemed necessary to augment the statistical power of the trial, or to continue the trial to its conclusion as planned. Cytokinetics intends to notify all regulatory agencies and clinical trial investigators involved in COURAGE-ALS of these interim findings. The full data set from this trial is being analyzed and more details will be presented at an upcoming medical meeting.

Conference Call and Webcast

Cytokinetics will host a conference call today, March 31, 2023 at 8:30 AM Eastern Time that will be simultaneously webcast and can be accessed from the homepage and in the Investors & Media section of Cytokinetics’ website at www.cytokinetics.com. The live audio of the event can also be accessed by telephone by registering in advance at the following link: COURAGE-ALS Update Call. Upon registration, participants will receive a dial-in number and a unique passcode to access the call.

COURAGE-ALS & COURAGE-ALS OLE: Trial Design

COURAGE-ALS was a Phase 3, multi-center, double-blind, randomized, placebo-controlled trial of reldesemtiv designed to enroll approximately 555 patients with ALS. Patients were randomized 2:1 to receive 300 mg of reldesemtiv or matching placebo dosed orally twice daily for 24 weeks, followed by a 24-week period in which all patients received 300 mg of reldesemtiv twice daily. Eligible patients were within the first two years of their first symptom of muscle weakness, had a vital capacity of ≥65% predicted, and a screening ALS Functional Rating Scale – Revised (ALSFRS-R) ≤44. Patients taking stable doses of edaravone and/or riluzole were permitted to enroll, and randomization was stratified accordingly. The primary efficacy endpoint was change from baseline to 24 weeks in ALSFRS-R. Secondary endpoints included combined assessment of ALSFRS-R total score, time to onset of respiratory insufficiency and survival time up to week 24 using a joint rank test; change from baseline to 24 weeks for vital capacity; ALSAQ-40; and bilateral handgrip strength. The trial included two planned unblinded interim analyses conducted by the Data Monitoring Committee. The first interim analysis assessed for futility, 12 weeks after approximately one-third or more of the planned sample size were randomized. The second interim analysis assessed for futility with the option for a fixed increase in total enrollment, if it had been deemed necessary, to augment the statistical power of the trial.

An open-label extension trial, COURAGE-ALS OLE, has enrolled people who completed participation in COURAGE-ALS. In COURAGE-ALS OLE, participants received 300 mg of reldesemtiv dosed orally twice daily for 48 weeks after which they were eligible to transition into the Managed Access Program, a program designed to provide access to reldesemtiv for patients diagnosed with ALS who have completed a prior Cytokinetics clinical trial with reldesemtiv or tirasemtiv.

About

Reldesemtiv

Skeletal muscle contractility is driven by the sarcomere, the fundamental unit of skeletal muscle contraction and a highly ordered cytoskeletal structure composed of several key proteins. Skeletal muscle myosin is the motor protein that converts chemical energy into mechanical force through its interaction with actin. A set of regulatory proteins, which includes tropomyosin and the troponin complex, make the actin-myosin interaction dependent on changes in intracellular calcium levels. Reldesemtiv is an investigational, selective, small molecule fast skeletal muscle troponin activator (FSTA) arising from Cytokinetics’ skeletal muscle contractility program. Reldesemtiv was designed to slow the rate of calcium release from the regulatory troponin complex of fast skeletal muscle fibers, which sensitizes the sarcomere to calcium, leading to an increase in skeletal muscle contractility.

The development program for reldesemtiv assessed its potential for the treatment of ALS and includes FORTITUDE-ALS, a completed Phase 2 trial, and COURAGE-ALS, the Phase 3 clinical trial designed to evaluate the effect of treatment with reldesemtiv compared to placebo on measures of disease progression, functional outcomes and survival.

About ALS

Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease that afflicts approximately 27,000 people in the United States and a comparable number of patients in Europe. Approximately 6,300 new cases of ALS are diagnosed each year in the United States. The average life expectancy of a person with ALS is approximately two to four years and only approximately 10 percent of people with ALS survive for more than 10 years. Death is usually due to respiratory failure because of diminished strength in the skeletal muscles responsible for breathing. Few treatment options exist for these patients, resulting in a high unmet need for new therapies to address functional deficits and disease progression.

About Cytokinetics

Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility. Cytokinetics is developing aficamten, a next-in-class cardiac myosin inhibitor, currently the subject of SEQUOIA-HCM, the Phase 3 clinical trial of aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM). Aficamten is also being evaluated in non-obstructive HCM and the company plans to begin a Phase 3 trial later this year. Cytokinetics is also developing omecamtiv mecarbil, a cardiac muscle activator in patients with heart failure. In 2023, Cytokinetics is celebrating its 25-year history of pioneering innovation in muscle biology and related pharmacology focused to diseases of muscle dysfunction and conditions of muscle weakness.

For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on Twitter, LinkedIn, Facebook and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements, express or implied, relating to our future plans for our neuromuscular development programs. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics’ drug candidates that could slow or prevent clinical development or product approval; Cytokinetics’ drug candidates may have adverse side effects or inadequate therapeutic efficacy; the FDA or foreign regulatory agencies may delay or limit Cytokinetics’ ability to conduct clinical trials; Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; standards of care may change, rendering Cytokinetics’ drug candidates obsolete; and competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics’ drug candidates and potential drug candidates may target. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission.

CYTOKINETICS® and the CYTOKINETICS and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.

Contact:
Cytokinetics
Diane Weiser
Senior Vice President, Corporate Communications, Investor Relations
(415) 290-7757

DURHAM, N.C., March 31, 2023 (GLOBE NEWSWIRE) — Bioventus Inc. (Nasdaq: BVS) (“Bioventus” or “the Company”), a global leader in innovations for active healing, today reported financial results for the year ended December 31, 2022.

Q4 Financial Summary & Recent Highlights:

• Net Sales of $125.8 million, down $4.6 million, or (3.5%), year-over-year as reported ((2.9%) constant currency* and down (9.5%) organically* (9.0%) constant currency*)
• Net Loss of $44.9 million, compared to Net Loss of $1.9 million in prior-year period
• Adjusted EBITDA* of $15.2 million, compared to $28.5 million in prior-year period
• Loss per share of Class A common stock of $0.52, compared to $0.01 in prior-year period
• Non-GAAP loss per share* of $0.06, compared to Non-GAAP earnings per share of $0.26 in prior-year period

FY 2022 Financial Summary & Recent Highlights:

• Net Sales of $512.1 million, up $81.2 million, or 18.8%, year-over-year as reported (19.6% constant currency*) and up 0.7% organically* (1.3% constant currency*)
• Net Loss of $213.4 million, compared to Net Income of $9.6 million in prior-year period
• Adjusted EBITDA* of $66.3 million, compared to $80.8 million in prior-year period
• Loss per share of Class A common stock of $2.59, compared to $0.15 in prior-year period
• Non-GAAP earnings per share* of $0.17, compared to $0.75 in prior-year period
• Executed Settlement Agreement on February 28, 2023 that removed $350.0 million of liabilities and a release of future claims related to the CartiHeal Acquisition
• Amended 2019 Credit Agreement on March 31, 2023 to provide covenant relief

“We have significantly improved our liquidity profile with the removal of our CartiHeal obligations and the amendment of our debt agreement to provide covenant flexibility,” commented Ken Reali, Bioventus’ chief executive officer. “Our results reflect additional pressure in our Pain Treatments vertical, primarily due to additional rebate claims previously not billed to us from a private payer, which offset the double-digit growth we are seeing in the Surgical Solutions vertical. Despite recent challenges, we maintain a strong, diversified business with market tailwinds and are focused on improving our execution and regaining investor confidence in 2023.”

Fourth Quarter 2022 Financial Results:

The following table represents net sales by geographic region, and by vertical, for the three months ended December 31, 2022 and 2021, respectively:

	Three Months Ended						Change as Reported							Constant Currency* Change
	December 31, 2022			December 31, 2021			$				%			%
U.S.
Pain Treatments	$	41,891		$	56,189		$	(14,298	)		(25.4	%)
Restorative Therapies		31,739			31,520			219			0.7	%
Surgical Solutions		34,942			27,462			7,480			27.2	%
Total U.S. net sales		108,572			115,171			(6,599	)		(5.7	)%
International
Pain Treatments		6,367			6,549			(182	)		(2.8	)%		5.2	%
Restorative Therapies		6,490			5,245			1,245			23.7	%		31.2	%
Surgical Solutions		4,405			3,449			956			27.7	%		28.4	%
Total International net sales		17,262			15,243			2,019			13.2	%		19.6	%
Total net sales	$	125,834		$	130,414		$	(4,580	)		(3.5	)%		(2.9	)%

Total net sales were $125.8 million compared to $130.4 million for the fourth quarter of 2021, a decrease of $4.6 million, or 3.5%, year-over-year, due to a decline in the Pain Treatments vertical, primarily driven by a decline in price resulting from higher than expected rebate claims, mostly offset with growth within the Surgical Solutions vertical. International net sales for the fourth quarter of 2022 increased 13.2% year-over-year, or 19.6% on a constant currency* basis primarily due to growth within the Surgical Solutions vertical and acquisitions.

Gross profit was $74.2 million, or 59.0% of net sales, compared to $87.8 million, or 67.3% of net sales, for the fourth quarter of 2021, a decrease of $13.6 million year-over-year. Non-GAAP gross profit* was $89.6 million, or 71.2% of net sales, compared to $99.6 million, or 76.3% of net sales, for the fourth quarter of 2021, a decrease of $10.0 million year-over-year.

Operating loss was $25.4 million, compared to operating loss of $3.2 million for the fourth quarter of 2021, a change of $22.3 million, year-over-year. This loss was primarily related to restructuring and compensation related costs as well as an increase in depreciation and amortization due to acquisitions. Operating margin was (20.2%) of net sales, compared to (2.4%) of net sales for the fourth quarter of 2021. Non-GAAP operating income* was $11.8 million, compared to $22.3 million for the fourth quarter of 2021, a decrease of $10.5 million year-over-year. Non-GAAP operating margin* was 9.4% of net sales, compared to 17.1% of net sales for the fourth quarter of 2021.

Net loss was $44.9 million, compared to net loss of $1.9 million for the fourth quarter of 2021, a change of $43.0 million, year-over-year. Non-GAAP net loss* was $9.2 million, compared to Non-GAAP net income of $17.6 million, for the fourth quarter of 2021, a decrease of $26.8 million, year-over-year.

Adjusted EBITDA* was $15.2 million, compared to $28.5 million for the fourth quarter of 2021, a decrease of $13.3 million year-over-year.

Loss per share of Class A common stock was $0.52, compared to $0.01 for the fourth quarter of 2021.

Non-GAAP earnings per share* was ($0.06), compared to $0.26 for the fourth quarter of 2021.

Full Year 2022 Financial Results:

The following table represents net sales by geographic region, and by vertical, for the years ended December 31, 2022 and 2021, respectively:

	Years Ended						Change as Reported							Constant Currency* Change
	December 31, 2022			December 31, 2021			$				%			%
U.S.
Pain Treatments	$	194,830		$	201,068		$	(6,238	)		(3.1	%)
Restorative Therapies		134,214			103,009			31,205			30.3	%
Surgical Solutions		126,207			83,476			42,731			51.2	%
Total U.S. net sales		455,251			387,553			67,698			17.5	%
International
Pain Treatments		21,495			20,539			956			4.7	%		12.9	%
Restorative Therapies		20,420			18,563			1,857			10.0	%		16.3	%
Surgical Solutions		14,951			4,243			10,708			NM			NM
Total International net sales		56,866			43,345			13,521			31.2	%		39.4	%
Total net sales	$	512,117		$	430,898		$	81,219			18.8	%		19.6	%

Total net sales were $512.1 million compared to $430.9 million for the year ended of 2021, an increase of $81.2 million, or 18.8%, year-over-year, primarily due to acquisitions and volume growth within the Surgical Solutions vertical partially offset with a decline in organic net sales within the Restorative Therapies and Pain Treatments verticals. International net sales for the year ended of 2022 increased 31.2% year-over-year, or 39.4% on a constant currency* basis.

Gross profit was $331.1 million, or 64.6% of net sales, compared to $302.7 million, or 70.3% of net sales, for the year ended of 2021, an increase of $28.4 million, year-over-year. Non-GAAP gross profit* was $382.3 million, or 74.7% of net sales, compared to $334.1 million, or 77.5% of net sales, for the year ended of 2021, an increase of $48.2 million year-over-year.

Operating loss was $251.0 million, compared to operating income of $12.1 million for the year ended of 2021, a change of $263.1 million, year-over-year. This loss was primarily related to a $189.2 million non-cash impairment charge due to the decline in our market capitalization. In addition, restructuring, higher compensation related costs as well as an increase operational costs expenses related to acquisitions contributed to lower operating results. Operating margin was (49.0%) of net sales, compared to 2.8% of net sales for the year ended of 2021. Non-GAAP operating income* was $48.0 million, compared to $85.4 million for the year ended of 2021, a decrease of $37.4 million year-over-year. Non-GAAP operating margin* was 9.4% of net sales, compared to 19.8% of net sales for the year ended of 2021.

Net loss was $213.4 million, compared to net income of $9.6 million for the year ended of 2021, a decrease of $223.0 million year-over-year. Non-GAAP net income* was $7.4 million, compared to $67.1 million, for the year ended of 2021, a decrease of $59.7 million, year-over-year.

Adjusted EBITDA* was $66.3 million, compared to $80.8 million for the year ended of 2021, a decrease of $14.4 million, year-over-year.

Loss per share of Class A common stock was ($2.59), compared to ($0.15) for the year ended of 2021.

Non-GAAP earnings per share* was $0.17, compared to $0.75 for the year ended of 2021.

Balance Sheet:

As of December 31, 2022, the Company had $31.8 million in cash and cash equivalents and $418.1 million in debt obligations, compared to $43.9 million in cash and cash equivalents and $357.7 million in debt obligations as of December 31, 2021.

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.

Fourth Quarter and Fiscal 2022 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 March 31, 2023. Those who would like to participate may dial 1-833-636-0497 (domestic) or +1-412-902-4241 (international) and refer to the Bioventus Inc. conference call.

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 30, 2024.

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 financial guidance (including expected MOTYS Costs) and expected financial performance; our business strategy, position and operations; expected sales trends, opportunities, market position and growth; our integration plans; and expected impacts of the COVID-19 pandemic. 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 our actual results to differ materially from those contemplated in this press release include, but are not limited to, the risk that the material weakness we identified or a new material risk could adversely affect our ability to report our results of operations and financial condition accurately and in a timely manner; we might not be able to continue to fund our operations for at least the next twelve months as a going concern; we might not meet certain of our debt covenants under our Credit Agreement and might be required to repay our indebtedness; we maintain cash at financial institutions, often in balance that exceed federally insured limits; we are subject to securities class action litigation and may be subject to similar or other litigation in the future, which will require significant management time and attention, result in significant legal expenses and may result in unfavorable outcomes; our ability to complete acquisitions or successfully integrate new businesses, products or technologies in a cost-effective and non-disruptive manner; we are highly dependent on a limited number of products; our long-term growth depends on our ability to develop, acquire and commercialize new products, line extensions or expanded indications; we may be unable to successfully commercialize newly developed or acquired products or therapies in the United States; demand for our existing portfolio of products and any new products, line extensions or expanded indications depends on the continued and future acceptance of our products by physicians, patients, third-party payers and others in the medical community; the proposed down classification of non-invasive bone growth stimulators, including our Exogen system, by the U.S. Food and Drug Administration (FDA) could increase future competition for bone growth stimulators and otherwise adversely affect the Company’s sales of Exogen; failure to achieve and maintain adequate levels of coverage and/or reimbursement for our products or future products, the procedures using our products, such as our hyaluronic acid (HA) viscosupplements, or future products we may seek to commercialize; pricing pressure and other competitive factors; governments outside the United States might not provide coverage or reimbursement of our products; we compete and may compete in the future against other companies, some of which have longer operating histories, more established products or greater resources than we do; the reclassification of our HA products from medical devices to drugs in the United States by the FDA could negatively impact our ability to market these products and may require that we conduct costly additional clinical studies to support current or future indications for use of those products; our ability to maintain our competitive position depends on our ability to attract, retain and motivate our senior management team and highly qualified personnel; our failure to properly manage our anticipated growth and strengthen our brands; risks related to product liability claims; fluctuations in demand for our products; issues relating to the supply of our products, potential supply chain disruptions and the increased cost of parts and components used to manufacture our products due to inflation; our reliance on a limited number of third-party manufacturers to manufacture certain of our products; if our facilities are damaged or become inoperable, we will be unable to continue to research, develop and manufacture our products; failure to maintain contractual relationships; security breaches, unauthorized disclosure of information, denial of service attacks or the perception that confidential information in our possession is not secure; failure of key information technology and communications systems, process or sites; risks related to international sales and operations; risks related to our debt and future capital needs; failure to comply with extensive governmental regulation relevant to us and our products; we may be subject to enforcement action if we engage in improper claims submission practices and resulting audits or denials of our claims by government agencies could reduce our net sales or profits; the FDA regulatory process is expensive, time-consuming and uncertain, and the failure to obtain and maintain required regulatory clearances and approvals could prevent us from commercializing our products; if clinical studies of our future products do not produce results necessary to support regulatory clearance or approval in the United States or elsewhere, we will be unable to expand the indications for or commercialize these products; legislative or regulatory reforms; our business may continue to experience adverse impacts as a result of the COVID-19 pandemic; risks related to intellectual property matters; 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, 2021, and subsequent Forms10-Q, such as factors that 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 https://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 balance sheets
As of December 31, 2022 and December 31, 2021
(Amounts in thousands, except share amounts) (unaudited)
	December 31, 2022				December 31, 2021
Assets
Current assets:
Cash and cash equivalents	$	31,814			$	43,933
Restricted cash		23				5,280
Accounts receivable, net		136,645				124,963
Inventory		85,408				61,688
Prepaid and other current assets		18,685				27,239
Total current assets		272,575				263,103
Restricted cash, less current portion		—				50,000
Property and equipment, net		27,647				22,985
Goodwill		13,759				147,623
Intangible assets, net		1,038,724				695,193
Operating lease assets		17,308				17,186
Deferred tax assets		—				481
Investment and other assets		2,636				29,291
Total assets	$	1,372,649			$	1,225,862
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	37,549			$	16,915
Accrued liabilities		111,954				131,473
Accrued equity-based compensation		—				10,875
Current portion of long-term debt		33,056				18,038
Current portion of deferred consideration		117,615				—
Other current liabilities		3,843				3,558
Total current liabilities		304,017				180,859
Long-term debt, less current portion		385,010				339,644
Deferred income taxes		154,001				133,518
Deferred consideration		79,269				—
Contingent consideration		84,682				16,329
Other long-term liabilities		25,338				21,723
Total liabilities		1,032,317				692,073
Stockholders’ Equity:
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 as of December 31, 2022 and December 31, 2021, 62,063,014 and 59,548,504 shares issued and outstanding as of December 31, 2022 and December 31, 2021, respectively		62				59
Class B common stock, $0.001 par value, 50,000,000 shares authorized, 15,786,737 shares issued and outstanding as of December 31, 2022 and December 31, 2021		16				16
Additional paid-in capital		481,919				465,272
Accumulated deficit		(165,306	)			(6,602	)
Accumulated other comprehensive (loss) income		(110	)			179
Total stockholders’ equity attributable to Bioventus Inc.		316,581				458,924
Noncontrolling interest		23,751				74,865
Total stockholders’ equity		340,332				533,789
Total liabilities and stockholders’ equity	$	1,372,649			$	1,225,862

BIOVENTUS INC.
Consolidated statements of operations and comprehensive (loss) income
(Amounts in thousands, except share and per share data, unaudited)
	Three Months Ended (2)								Year Ended
	December 31, 2022				December 31, 2021				December 31, 2022				December 31, 2021
Net sales	$	125,834			$	130,414			$	512,117			$	430,898
Cost of sales (including depreciation and amortization of $15,389 and $8,980, $45,622, $26,471 respectively)		51,645				42,646				181,037				128,192
Gross profit		74,189				87,768				331,080				302,706
Selling, general and administrative expense		77,668				80,881				332,606				254,253
Research and development expense		6,807				7,103				25,941				19,039
Restructuring costs		4,620				689				6,779				2,487
Change in fair value of contingent consideration		2,768				(463	)			6,452				829
Depreciation and amortization		7,761				2,708				21,153				8,363
Impairment of goodwill		—				—				189,197				—
Impairment of variable interest entity assets		—				—				—				5,674
Operating (loss) income		(25,435	)			(3,150	)			(251,048	)			12,061
Interest expense, net		14,873				960				25,795				1,112
Other expense (income)		9,406				508				(12,944	)			3,329
Other expense		24,279				1,468				12,851				4,441
(Loss) income before income taxes		(49,714	)			(4,618	)			(263,899	)			7,620
Income tax benefit		(4,841	)			(2,725	)			(50,508	)			(1,966	)
Net (loss) income		(44,873	)			(1,893	)			(213,391	)			9,586
Loss attributable to noncontrolling interest		12,943				1,529				54,687				9,789
Net (loss) income attributable to Bioventus Inc.	$	(31,930	)		$	(364	)		$	(158,704	)		$	19,375
Net (loss) income	$	(44,873	)		$	(1,893	)		$	(213,391	)		$	9,586
Other comprehensive (loss) income, net of tax
Change in prior service cost and unrecognized gain (loss) for defined benefit plan adjustment		133				60				133				60
Change in foreign currency translation adjustments		1,411				(399	)			(501	)			(1,318	)
Comprehensive (loss) income		(43,329	)			(2,232	)			(213,759	)			8,328
Comprehensive loss attributable to noncontrolling interest		12,629				1,300				54,766				9,789
Comprehensive (loss) income attributable to Bioventus Inc.	$	(30,700	)		$	(932	)		$	(158,993	)		$	18,117
Loss per share of Class A common stock(1):
Basic and Diluted	$	(0.52	)		$	(0.01	)		$	(2.59	)		$	(0.15	)
Weighted-average shares of Class A common stock   outstanding(1):
Basic and diluted		61,931,586				54,733,783				61,389,107				45,472,483
(1) Per share information for the year ended December 31, 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 December 31, 2021, the period following Bioventus Inc.’s initial public offering (IPO) and related transactions completed in connection with the IPO as described in the Company’s SEC filings.
(2) The three months ended December 31, 2022 and 2021 covered the periods beginning October 2, 2022 and October 3, 2021, respectively.

BIOVENTUS INC.
Consolidated condensed statements of cash flows
(Amounts in thousands, unaudited)
	Three Months Ended								Year Ended
	December 31, 2022				December 31, 2021				December 31, 2022				December 31, 2021
Operating activities:
Net (loss) income	$	(44,873	)		$	(1,893	)		$	(213,391	)		$	9,586
Adjustments to reconcile net (loss) income to net cash from operating activities:
Depreciation and amortization		23,160				11,690				66,803				34,875
Equity-based compensation		3,432				6,109				17,585				(4,512	)
Change in fair value of contingent consideration		2,768				(463	)			6,452				829
Change in fair value of Equity Participation Rights		—				—				—				(2,774	)
Change in fair value of interest rate swap		22				(1,339	)			(6,396	)			(2,730	)
Revaluation gain on previously held equity interest in CartiHeal		—				—				(23,709	)			—
Impairment of goodwill and asset impairment charges		10,285				—				199,482				—
Impairments related to variable interest entity		—				—				—				7,043
Loss on debt retirement and modification		—				2,162				—				2,162
Deferred income taxes		(5,638	)			(8,053	)			(52,792	)			(9,756	)
Unrealized (gain) loss on foreign currency fluctuations		(1,543	)			(752	)			1,383				472
Other, net		1,538				804				5,578				1,073
Changes in working capital		16,093				4,852				(14,532	)			(13,277	)
Net cash from operating activities		5,244				13,117				(13,537	)			22,991
Investing activities:
Acquisitions, net of cash acquired		—				(216,080	)			(104,841	)			(262,870	)
Purchase of property and equipment		(3,403	)			(2,802	)			(10,042	)			(7,370	)
Investments and acquisition of distribution rights		—				(2,396	)			(1,478	)			(13,520	)
Other		—				—				(75	)			—
Net cash from investing activities		(3,403	)			(221,278	)			(116,436	)			(283,760	)
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		1,083				886				5,822				1,633
Registration fees for Class A common stock to purchase Misonix		—				(1,838	)			—				(1,838	)
Tax withholdings on equity-based compensation		—				—				(3,352	)			—
Borrowing on revolver		—				20,000				25,000				20,000
Payment on revolver		—				(20,000	)			(25,000	)			(20,000	)
Proceeds from the issuance of long-term debt, net of issuance costs		—				257,453				79,659				257,453
Payments on long-term debt		(6,510	)			(80,000	)			(20,038	)			(91,250	)
Distributions to members		—				(184	)			—				(367	)
Other, net		(11	)			(9	)			(15	)			(37	)
Net cash from financing activities		(5,438	)			176,308				62,076				273,371
Effect of exchange rate changes on cash		1,052				149				521				(228	)
Net change in cash, cash equivalents and restricted cash		(2,545	)			(31,704	)			(67,376	)			12,374
Cash, cash equivalents and restricted cash at the beginning of the period		34,382				130,917				99,213				86,839
Cash, cash equivalents and restricted cash at the end of the period	$	31,837			$	99,213			$	31,837			$	99,213

Use of Non-GAAP Financial Measures

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’s 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 GAAP financial measures, allow 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 Expenses, Non-GAAP R&D, 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 Expenses, Non-GAAP R&D, 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 GAAP financial reporting, because we believe these measures are useful indicators of our operating performance. We revised our prior year presentation of our Non-GAAP measures to condense the adjustments in order to simplify the presentation. Prior periods have been recast to conform to the current periods.

We define Adjusted EBITDA as net (loss) income from continuing operations before depreciation and amortization, provision of income taxes and interest expense (income), net, 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 acquisition and related costs, remeasurement gains and losses on investments, impairments on goodwill, restructuring and succession charges, equity compensation expense, equity loss in unconsolidated investments, foreign currency impact, and other items. See the table below for a reconciliation of net (loss) 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 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 Expenses, Non-GAAP R&D, Non-GAAP Operating Margin and Non-GAAP Net Income principally as measures of our operating performance and believes that these non-GAAP financial measures are useful to better understand the long term 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 and related costs in the cost of goods sold. We define Non-GAAP Gross Margin as Non-GAAP Gross Profit divided by net sales. See the table below for a reconciliation of gross profit and gross margin to Non-GAAP Gross Profit and Non-GAAP 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, acquisition and related costs, remeasurement gains and losses on investments, impairments on goodwill, restructuring and succession charges, and other items. Non-GAAP Operating Margin is defined as Non-GAAP Operating Income divided by net sales. See the table below for a reconciliation of operating (loss) 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 depreciation and amortization, acquisition and related costs, remeasurements gains and losses on investments, impairments on goodwill, restructuring and succession charges, and other items. See the table below for a reconciliation of operating expenses to Non-GAAP Operating Expenses.

We define Non-GAAP R&D as research and development, 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 depreciation and amortization, acquisition and related costs, restructuring and succession charges, and other items. See the table below for a reconciliation of operating expenses to Non-GAAP R&D.

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, acquisition and related costs, restructuring and succession charges, other items, and the tax effect of adjusting items. Starting in the fourth quarter of 2021, we revised our presentation of Non-GAAP Net Income to include the income tax effect of adjusting items. The income tax effect was calculated by applying management’s expectation of a long-term normalized effective tax rate to the adjusting items. Prior period presentation has been recast to conform to current period presentation. See the table below for a reconciliation of Net (Loss) 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, acquisition and related costs, restructuring and succession charges, other items, and the tax effect of adjusting items divided by weighted average number of shares of Class A common stock outstanding during the period. Starting in the fourth quarter of 2021, we revised our presentation of Non-GAAP Earnings per Class A share to include the income tax effect of adjusting items. The income tax effect was calculated by applying management’s expectation of a long-term normalized effective tax rate to the adjusting items. Prior period presentation has been recast to conform to current period presentation. See the table below for a reconciliation of loss per Class A share to Non-GAAP Earnings per Class A share.

Net Sales, International Net Sales Growth and Organic Revenue Growth on a Constant Currency Basis

Net Sales, International Net Sales Growth and Organic Revenue Growth on a Constant Currency Basis are non-GAAP measures, which are 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.

Limitations of the Usefulness of Non-GAAP Measures

Non-GAAP financial measures have limitations as an analytical tool and should not be considered in isolation or as a substitute for, or as superior to, the financial information prepared and presented in accordance with GAAP. These measures might exclude certain normal recurring expenses. Therefore, these measures may not provide a complete understanding of the Company’s performance and should be reviewed in conjunction with the GAAP financial measures. Additionally, other companies might define their non-GAAP financial measures differently than we do. Investors are encouraged to review the reconciliation of the non-GAAP measures provided in this press release, including in the tables below, to their most directly comparable GAAP measures.

Reconciliation of Net (Loss) Income to Adjusted EBITDA (unaudited)
	Three Months Ended								Years Ended
($, thousands)	December 31, 2022				December 31, 2021				December 31, 2022				December 31, 2021
Net (loss) income	$	(44,873	)		$	(1,893	)		$	(213,391	)		$	9,586
Interest expense, net		14,873				960				25,795				1,112
Income tax benefit, net		(4,841	)			(2,725	)			(50,508	)			(1,966	)
Depreciation and amortization(a)		23,160				11,690				66,803				34,875
Acquisition and related costs(b)		6,789				8,920				27,081				22,964
Gain on remeasurement of CartiHeal Investment(c)		—				—				(23,709	)			—
Restructuring and succession charges(d)		4,606				1,575				7,453				3,717
Equity compensation(e)		3,432				6,109				17,585				(4,512	)
Equity loss in unconsolidated investments(f)		—				548				1,003				1,868
Foreign currency impact(g)		(872	)			179				250				132
Impairment of goodwill(h)		—				—				189,197				—
Asset impairment charges(i)		10,285				—				10,285				—
Impairments related to variable interest entity(j)		—				—				—				7,043
Other items(k)		2,669				3,124				8,465				5,940
Adjusted EBITDA	$	15,228			$	28,487			$	66,309			$	80,759

(a) 
Includes for the
three months ended December 31, 2022
and
December 31, 2021
and the
years ended
December 31, 2022
and
December 31, 2021
, respectively, depreciation and amortization of
$15,389
,
$8,980
,
$45,622
and
$26,471
in cost of sales and
$7,771
,
$2,710
,
$21,181
and
$8,404
in operating expenses presented in the consolidated statements of operations and
comprehensive (loss) income
.

(b) 
Includes acquisition and integration costs related to completed acquisitions, amortization of inventory step-up associated with acquired entities, and changes in fair value of contingent consideration.

(c) 
Represents the gain on remeasurement of the Company’s equity method investment in CartiHeal based upon the fair value of consideration transferred for the CartiHeal acquisition.

(d) 
Costs incurred were the result of adopting restructuring plans to reduce headcount, reorganize management structure, and to consolidate certain facilities, and costs related to executive transitions.

(e) 
The
year ended
and the three months ended
December 31, 2022
and the
three months ended
December 31, 2021
include compensation expense resulting from awards granted under the Company’s equity-based compensation plans in effect after its IPO. The
year ended
December 31, 2021
also includes the expense and the change in fair value of the liability-classified awards granted under the compensation plans in effect prior to the Company’s IPO.

(f) 
Represents CartiHeal equity investment losses.

(g) 
Includes realized and unrealized gains and losses from fluctuations in foreign currency.

(h) 
Represents a non-cash impairment charge due to the decline in the Company’s market capitalization.

(i) 
Represents asset impairment charges on Trice Medical, Inc.

(j) 
Represents the loss on impairment of Harbor Medtech Inc.’s (Harbor) long-lived assets and the Company’s investment in Harbor.

(k) 
Other items primarily includes charges associated with strategic transactions, such as potential acquisitions; public company preparation costs, which primarily includes accounting and legal fees; and MOTYS Costs (as defined below). During the second quarter of 2022, prior to obtaining the results from our Phase 2 trial, we elected to discontinue the development of MOTYS, to focus our resources on other priorities, including the integration of our acquisitions and our expanded R&D and product development portfolio we inherited with these acquisitions. We incurred
$1.8 million
and
$4.3 million
during the
three months ended
and
year ended
December 31, 2022
, respectively, and we expect to incur approximately
$5.0 million
to
$6.0 million
exclusively to fulfill our remaining regulatory obligations related to our Phase 2 trial (MOTYS Costs).

Reconciliation of Other Reported GAAP Measures to Non-GAAP Measures
Three Months Ended December 31, 2022	Gross Profit				Operating Expenses (a)			R&D			Operating (Loss)/Income				Net Loss				EPS (j)
Reported GAAP measure	$	74,189			$	92,817		$	6,807		$	(25,435	)		$	(44,873	)		$	(0.52	)
Reported GAAP margin		59.0	%								(20.2		)%
Depreciation and amortization		15,389				7,761			10			23,160				23,160				0.30
Acquisition and related costs(b)		—				6,788			—			6,788				6,789				0.09
Restructuring and succession charges(d)		—				4,606			—			4,606				4,606				0.06
Asset impairment charges(g)		—				—			—			—				10,285				0.13
Other items(h)		—				876			1,793			2,669				2,669				0.03
Tax effect of adjusting items(i)		—				—			—			—				(11,796	)			(0.15	)
Non-GAAP measure	$	89,578			$	72,786		$	5,004		$	11,788			$	(9,160	)		$	(0.06	)
Non-GAAP margin		71.2	%									9.4	%
	Non-GAAP Gross Margin				Non-GAAP Operating Expenses			Non-GAAP R&D			Non-GAAP Operating Income				Non-GAAP Net Income				Adjusted EPS

Three Months Ended December 31, 2021	Gross Profit				Operating Expenses (a)			R&D			Operating (Loss)/Income				Net (Loss)/Income				EPS (j)
Reported GAAP measure	$	87,768			$	83,815		$	7,103		$	(3,150	)		$	(1,893	)		$	(0.01	)
Reported GAAP margin		67.3	%								(2.4		)%
Depreciation and amortization		8,980				2,708			2			11,690				11,690				0.16
Acquisition and related costs(b)		2,804				6,116			—			8,920				8,920				0.12
Restructuring and succession charges(d)		—				1,575			—			1,575				1,575				0.02
Other items(h)		—				3,252			—			3,252				3,124				0.05
Tax effect of adjusting items(i)		—				—			—			—				(5,778	)			(0.08	)
Non-GAAP measure	$	99,552			$	70,164		$	7,101		$	22,287			$	17,638			$	0.26
Non-GAAP margin		76.3	%									17.1	%
	Non-GAAP Gross Margin				Non-GAAP Operating Expenses			Non-GAAP R&D			Non-GAAP Operating Income				Non-GAAP Net Income				Adjusted EPS

Year Ended December 31, 2022	Gross Profit				Operating Expenses (a)			R&D			Operating (Loss)/Income				Net (Loss)/Income				EPS (j)
Reported GAAP measure	$	331,080			$	556,187		$	25,941		$	(251,048	)		$	(213,391	)		$	(2.59	)
Reported GAAP margin		64.6	%								(49.0		)%
Depreciation and amortization		45,622				21,153			28			66,803				66,803				0.87
Acquisition and related costs(b)		5,607				21,474			—			27,081				27,081				0.35
Gain on remeasurement of CartiHeal Investment(c)		—				—			—			—				(23,709	)			(0.31	)
Restructuring and succession charges(d)		—				7,453			—			7,453				7,453				0.10
Impairment of goodwill(e)		—				189,197			—			189,197				189,197				2.45
Asset impairment charges(g)		—				—			—			—				10,285				0.13
Other items(h)		—				4,130			4,335			8,465				8,465				0.11
Tax effect of adjusting items(i)		—				—			—			—				(64,813	)			(0.94	)
Non-GAAP measure	$	382,309			$	312,780		$	21,578		$	47,951			$	7,371			$	0.17
Non-GAAP margin		74.7	%									9.4	%
	Non-GAAP Gross Margin				Non-GAAP Operating Expenses			Non-GAAP R&D			Non-GAAP Operating Income				Non-GAAP Net Income				Adjusted EPS

Year Ended December 31, 2021	Gross Profit				Operating Expenses (a)			R&D			Operating Income				Net Income				EPS (j)
Reported GAAP measure	$	302,706			$	271,606		$	19,039		$	12,061			$	9,586			$	(0.15	)
Reported GAAP margin		70.3	%									2.8	%
Depreciation and amortization		26,471				8,363			41			34,875				34,875				0.59
Acquisition and related costs(b)		4,910				18,054			—			22,964				22,964				0.39
Restructuring and succession charges(d)		—				3,717			—			3,717				3,717				0.06
Impairments related to variable interest entity(f)		—				5,674			—			5,674				7,043				0.02
Other items(h)		—				6,068			—			6,068				5,940				0.10
Tax effect of adjusting items(i)		—				—			—			—				(17,017	)			(0.26	)
Non-GAAP measure	$	334,087			$	229,730		$	18,998		$	85,359			$	67,108			$	0.75
Non-GAAP margin		77.5	%									19.8	%
	Non-GAAP Gross Margin				Non-GAAP Operating Expenses			Non-GAAP R&D			Non-GAAP Operating Income				Non-GAAP Net Income				Adjusted EPS

(a) 
The “Reported GAAP Measure” under the “Operating Expenses” column is a sum of all GAAP operating expense line items, excluding research and development.

(b) 
C
onsi
sts of acquisition related items such as integration costs, amortization of inventory step-up and changes in fair value of contingent consideration.

(c) 
Represents the gain on remeasurement of the Company’s equity method investment in CartiHeal based upon the fair value of consideration transferred for the CartiHeal acquisition.

(d) 
Costs incurred were the result of adopting restructuring plans to reduce headcount, reorganize management structure, and to consolidate certain facilities, and costs related to executive transitions.

(e) 
Represents a non-cash impairment charge due to the decline in the Company’s market capitalization.

(f) 
Represents loss on impairment of Harbor’s long-lived assets and the Company’s investment in Harbor.

(g) 
Represents asset impairment charges on Trice Medical, Inc.

(h) 
Other items primarily includes charges associated with strategic transactions, such as potential acquisitions; public company preparation costs, which primarily includes accounting and legal fees; and MOTYS Costs.

(i) 
Includes
$40.9
million of tax impact related to the impairment of goodwill, and an estimated tax impact of the remaining adjustments to Non-GAAP Net Income, calculated by applying a normalized statutory rate of
24.8%
and
22.8%
to those adjustments
for the three months ended and
years ended
December 31, 2022
and
2021
, respectively. The tax effect on adjustments to EPS is normalized to exclude the effect of the non-controlling ownership interest.

(j) 
Adjustments are pro-rated to exclude the weighted average non-controlling interest ownership of
20.4%
and
23.5%
, respectively, for the
years ended
December 31, 2022
and
2021
.

Investor Inquiries and Media:

Dave Crawford
Bioventus
[email protected]