Relay Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Operational Highlights

Advanced two programs, RLY-1971 and RLY-4008, into clinical development, and on track to initiate IND enabling studies with PI3Kα mutant selective inhibitor in 2021

Entered into a global collaboration with Genentech for the development and commercialization of 
RLY-1971

Continued to advance three additional oncology preclinical programs and extended work outside of oncology into genetic diseases with two preclinical programs

$678.1 million in cash, cash equivalents and marketable securities at end of 2020, with the $75 million upfront payment received from Genentech in 2021, expected to fund operations into 2024

CAMBRIDGE, Mass., March 25, 2021 (GLOBE NEWSWIRE) — Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading edge experimental and computational technologies, today reported fourth quarter and full year 2020 financial results and operational highlights.

“2020 was a transformational year for Relay Therapeutics. We successfully advanced multiple programs into the clinic, evolved our platform, expanded our strong team and completed a successful IPO,” said Sanjiv Patel, M.D., president and chief executive officer. “While the last few years were spent validating our approach of combining leading edge experimental and computational techniques to create potentially life-saving therapies for patients, the next chapter will be about extending our platform leadership and delivering meaningful clinical results to support the success of our programs. 2021 will be a critical year of execution as we advance our mission of transforming drug discovery to address some of the most devastating diseases.”

2020 Corporate Highlights

  • Initiated first-in-human clinical studies for RLY-1971 (SHP2 inhibitor) and RLY-4008 (FGFR2 inhibitor)
  • Progressed PI3Kα mutant selective program into late lead optimization
  • Continued to advance three additional precision oncology programs through preclinical development
  • Expanded research efforts into genetic diseases with two preclinical programs
  • Strengthened the balance sheet with $460 million gross proceeds raised in an initial public offering
  • Announced a worldwide license and collaboration agreement with Genentech, Inc., a member of the Roche Group, for the development and commercialization of RLY-1971

2021 Anticipated Milestones

  • Present preclinical data for RLY-4008 at the American Association for Cancer Research (AACR) Annual Meeting 2021
  • Announce initial clinical data for RLY-4008 in the second half of 2021
  • Genentech to initiate RLY-1971 and GDC-6036 (KRAS G12C inhibitor) combination trial
  • Enter IND-enabling studies for PI3Kα mutant selective inhibitor and provide program update

Fourth Quarter and Full Year 2020 Financial Results

Cash, Cash Equivalents and Investments: As of December 31, 2020, cash, cash equivalents and investments totaled approximately $678.1 million, compared to $355.8 million as of December 31, 2019. The Company expects its current cash and cash equivalents, including the $75 million upfront payment received from Genentech in 2021, will be sufficient to fund its current operating plan into 2024.

R&D Expenses: Research and development expenses were $32.1 million for the fourth quarter of 2020, as compared to $22.4 million for the fourth quarter of 2019. This increase was primarily due to $7.4 million of increased employee related costs, including $5.7 million of additional share-based compensation expense, primarily due to increases in our stock price and increased headcount, and $2.3 million in increased clinical trial expenses. Research and development expenses were $99.9 million for the full year 2020, as compared to $70.3 million for the full year 2019.

G&A Expenses: General and administrative expenses were $15.5 million for the fourth quarter of 2020, as compared to $3.4 million for the fourth quarter of 2019. This increase was primarily due to $9.1 million of increased employee related costs, including $7.5 million of additional share-based compensation expense, primarily due to increases in our stock price and increased headcount, as well as $3.0 million of increased general expenses, primarily driven by public company related costs. General and administrative expenses were $38.6 million for the full year 2020, as compared to $13.7 million for the full year 2019.

Net Income/Loss: Net income was $35.3 million for the fourth quarter of 2020, as compared to a net loss of $23.9 million for the fourth quarter of 2019. Net loss was $52.4 million for the full year 2020, or a net loss per share of $5.40, as compared to a net loss of $75.3 million for the full year 2019, or a net loss per share of $21.82.

About Relay Therapeutics

Relay Therapeutics® (Nasdaq: RLAY) is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, Relay Therapeutics aims to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. The Company’s Dynamo™ platform integrates an array of leading-edge experimental and computational approaches to provide a differentiated understanding of protein structure and motion to drug these targets. For more information, please visit www.relaytx.com or follow us on Twitter.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the Company’s strategy, business plans and focus; the progress and timing of updates on the clinical development of the programs across the Company’s portfolio, including the timing of the Company’s first expected data readout for RLY-4008, ability to enter IND-enabling studies for its PI3Kα mutant selective inhibitor program, expected therapeutic benefits of its programs, presentation of additional data at upcoming scientific conferences and other preclinical data in 2021, ability to optimize the impact of collaborations on the Company’s programs, including but not limited to the Company’s collaboration with Genentech and the expected initiation of the RLY-1971 and GDC-6036 (KRAS G12C inhibitor) combination trial, expectations regarding the Company’s use of capital, expenses, future accumulated deficit and other financial results during 2021 and in the future, and the Company’s ability to fund operations through at least 2024. The words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “expect,” “estimate,” “seek,” “predict,” “future,” “project,” “potential,” “continue,” “target” and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

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, including, without limitation, risks associated with: the impact of COVID-19 on countries or regions in which we have operations or do business, as well as on the timing and anticipated results of our clinical trials, strategy and future operations; the delay of any current or planned clinical trials or the development of the Company’s drug candidates; the risk that the results of our clinical trials may not be predictive of future results in connection with future clinical trials; the Company’s ability to successfully demonstrate the safety and efficacy of its drug candidates; the timing and outcome of the Company’s planned interactions with regulatory authorities; and obtaining, maintaining and protecting its intellectual property.  These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Relay Therapeutics’ Annual Report on Form 10-K expected to be filed on or about March 25, 2021, its most recent Quarterly Report on Form 10-Q as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Relay Therapeutics’ views only as of today and should not be relied upon as representing its views as of any subsequent date. Relay Therapeutics explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

Contact:

Pete Rahmer
Senior Vice President, Corporate Affairs and Investor Relations
617-322-0715
[email protected]

Media:
Dan Budwick
1AB
973-271-6085
[email protected]

 
Relay Therapeutics, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
 
    Year Ended

December 31,
    2020     2019  
Revenue:                
License revenue   $ 82,654     $  
Total revenue     82,654        
Operating expenses:                
Research and development expenses     99,862       70,306  
General and administrative expenses     38,588       13,742  
Total operating expenses     138,450       84,048  
Loss from operations     (55,796 )     (84,048 )
Other income (expense):                
Interest income     3,400       8,801  
Other expense     (16 )     (58 )
Total other income (expense), net     3,384       8,743  
Net loss   $ (52,412 )   $ (75,305 )
Deemed dividend resulting from extinguishment upon
   modification of series C preferred stock
    (177,789 )      
Net loss attributable to common stockholders   $ (230,201 )   $ (75,305 )
Net loss attributable to common stockholders per share,
   basic and diluted
  $ (5.40 )   $ (21.82 )
Weighted average shares of common stock, basic and
   diluted
    42,619,582       3,450,500  
Other comprehensive income (loss):                
Unrealized holding gain (loss)     (261 )     325  
Total other comprehensive income (loss)     (261 )     325  
Total comprehensive loss   $ (52,673 )   $ (74,980 )

 
Relay Therapeutics, Inc.
Selected Condensed Consolidated Balance Sheet Data
(In thousands)
 
    December 31,

2020
    December 31,

2019
 
Cash, cash equivalents and investments   $ 678,061     $ 355,816  
Working capital (1)     756,468       348,550  
Total assets     799,829       393,068  
Total liabilities     36,536       35,725  
Convertible preferred stock           537,781  
Total stockholders’ equity (deficit)     763,293       (180,438 )
Restricted cash     878       878  

(1)   Working capital is defined as current assets less current liabilities.



Eyenovia Reports Fourth Quarter and Full Year 2020 Financial Results

Announces MydCombi expected PDUFA date of October 28, 2021

Completes patient enrollment in Phase 3 VISION-1 study evaluating MicroLine for the treatment of presbyopia; topline data on track for Q2

Company to host conference call and webcast today, March 25, at 4:30 pm ET

NEW YORK, March 25, 2021 (GLOBE NEWSWIRE) — Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic company developing a pipeline of advanced therapeutics based on its proprietary microdose array print (MAP™) platform technology, today announced its financial results for the fourth quarter and full year ended December 31, 2020.

Fourth Quarter 2020 and Recent Business Highlights

  • U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for the Company’s pupil dilation agent MydCombi™ and subsequently notified the Company that the expected PDUFA date is October 28, 2021.
  • Completed patient enrollment in the Company’s Phase 3 VISION-1 study of MicroLine for the improvement in near vision in patients with presbyopia.
  • Licensed MicroPine, an investigational treatment for the reduction of pediatric myopia progression in children ages 3-12, to Bausch Health for an upfront payment of $10 million, up to $35 million in milestone payments, and royalties ranging from mid-single digit to mid-teen percentages of gross profit on sales in the U.S. and Canada.
  • Established exclusive collaboration and licensing agreement with Arctic Vision to develop and commercialize MicroPine and MicroLine, a Phase 3-ready treatment for presbyopia in Greater China and South Korea, with potential licensing and development payments of up to $41.75 million, and additional royalty or supply payments.
  • Closed a public offering of the Company’s common stock for net proceeds of approximately $12.5 million.

Dr. Sean Ianchulev, Chief Executive Officer and Chief Medical Officer of Eyenovia, commented, “We have made significant progress during 2020 advancing our proprietary clinical programs. Most recently, we announced that the FDA has accepted our NDA for MydCombi, our proprietary fixed combination mydriatic, or pupil dilation agent, for potential use in the over 80 million comprehensive eye exams currently conducted each year in the United States. If approved, not only would MydCombi be the first microdosed ocular therapeutic applied with our proprietary high precision smart delivery system, the Optejet®, but it would transition us into a commercial stage company. We look forward to our PDUFA date on October 28.”

“Previously we announced that the first patient had been dosed in our VISION-1 Phase 3 clinical study evaluating our proprietary pilocarpine formulation, MicroLine, which is also delivered via the Optejet, for the improvement of near vision in patients with presbyopia, an estimated multi-billion-dollar indication. Today, we are pleased to report that we recently completed enrollment in VISION-1 and, as this is a relatively short study, we continue to anticipate topline data in the second quarter of this year. With our second Phase 3 program now initiated, an NDA accepted, and several robust development partnerships with ophthalmologic leaders established, we believe we have significant momentum. We look forward to building on this progress towards multiple potentially value creating milestones ahead,” concluded Dr. Ianchulev.

Fourth Quarter and Full Year 2020 Financial Review

For the fourth quarter of 2020, net loss was approximately $(4.2) million, or $(0.17) per share, compared to a net loss of approximately $(5.2) million, or $(0.31) per share for the fourth quarter of 2019. For the full year ended December 31, 2020, net loss was approximately $(19.8) million, or $(0.94) per share. This compares to a net loss of approximately $(21.2) million, or $(1.47) per share, for the full year of 2019.

Total revenue was approximately $2.0 million for the fourth quarter and full year 2020. The revenue represented a milestone payment from the Company’s previously announced exclusive collaboration and licensing agreement with Arctic Vision. The Company did not generate revenue in 2019.

Research and development expenses totaled approximately $3.4 million for the fourth quarter of 2020, compared to approximately $3.3 million for the same period in 2019. For the full year 2020, research and development expenses decreased approximately 6% to approximately $13.3 million compared to approximately $14.1 million in the prior year.

For the fourth quarter of 2020, general and administrative expenses were approximately $2.1 million compared to approximately $2.0 million for the fourth quarter of 2019, an increase of 5%. For the full year 2020, general and administrative expenses increased 7% to approximately $7.7 million versus approximately $7.2 million for the full year of 2019.

Total operating expenses for the fourth quarter of 2020 were approximately $5.4 million, compared to total operating expenses of approximately $5.3 million for the same period in 2019, an increase of 2%. For the full year 2020, total operating expenses decreased 1% to approximately $21 million compared to $21.3 million for the full year of 2019.

As of December 31, 2020, the Company’s cash and cash equivalents were approximately $28.4 million, compared to $14.2 million as of December 31, 2019.

Conference Call and Webcast

The conference call is scheduled to begin at 4:30 pm ET on Thursday, March 25, 2021. Participants should dial 1-877-407-9039 (United States) or 1-201-689-8470 (International) with the conference code 13716228. A live webcast of the conference call will also be available on the Investor Relations page of the Company’s corporate website at www.eyenovia.com.

The webcast will be archived on Eyenovia’s website for one year.

About Eyenovia, Inc.

Eyenovia, Inc. (NASDAQ: EYEN) is a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP) therapeutics. Eyenovia is currently focused on the late-stage development of microdosed medications for presbyopia, myopia progression and mydriasis. For more Information, visit www.eyenovia.com.

About MicroLine for Presbyopia

MicroLine is a pharmacologic treatment for presbyopia. Presbyopia is the non-preventable, age related hardening of the lens, which causes a gradual loss of the eye’s ability to focus on nearby objects and is estimated to affect nearly 113 million Americans. Current treatment options are typically device-based, such as reading glasses and contact lenses. Pilocarpine ophthalmic solution is known to constrict the pupil and improve near-distance vision by creating an extended depth of focus through its small aperture effect. Eyenovia believes that its administration of pilocarpine using the Company’s high precision microdosing technology could provide a meaningful improvement in near vision while enhancing tolerability and usability.

About MicroPine for Progressive Myopia

MicroPine (atropine ophthalmic solution) is Eyenovia’s investigational, potentially first-in-class topical treatment for the reduction of pediatric myopia progression, also known as nearsightedness, in children ages 3-12. It has been developed for comfort and ease-of-use in children, and its microdose administration is designed to potentially result in low systemic and ocular drug exposure.

About MicroStat (MyCombi™) for Mydriasis

MydCombi is Eyenovia’s first-in-class fixed-combination micro-formulation product (tropicamide 1% – phenylephrine 2.5%) candidate for pharmacologic mydriasis (eye dilation), which is targeted to improve the efficiency of the estimated 80 million office-based comprehensive eye exams performed every year in the United States, as well as the estimated 4 million pharmacologic mydriasis applications for cataract surgery. Developed for use without anesthetic, Eyenovia is developing MicroStat to help improve the efficacy and tolerability of pharmacologic mydriasis.

About Optejet® and Microdose Array Print (MAP™) Therapeutics

Eyenovia’s Optejet microdose formulation and delivery platform for ocular therapeutics uses high-precision piezo-print technology to deliver 6-8 μL of drug, consistent with the capacity of the tear film of the eye. We believe the volume of ophthalmic solution administered with the Optejet is less than 75% of that delivered using conventional eyedroppers, thus reducing overdosing and exposure to drug and preservatives. Eyenovia’s patented microfluidic ejection technology is designed for fast and gentle ocular surface delivery, where solution is dispensed to the ocular surface in approximately 80 milliseconds, beating the ocular blink reflex. Successful use of the Optejet has been demonstrated more than 85% of the time after basic training in a variety of clinical settings compared to 40 – 50% with conventional eyedroppers. Additionally, its smart electronics and mobile e-health technology are designed to track and enhance patient compliance.

Forward-Looking Statements

Except for historical information, all of the statements, expectations and assumptions contained in this press release are forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions, including estimated regulatory review timing, and market opportunities for our product candidates and platform technology. These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may, and are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors discussed from time to time in documents which we file with the U.S. Securities and Exchange Commission. In addition, such statements could be affected by risks and uncertainties related to, among other things: fluctuations in our financial results; volatility and uncertainty in the global economy and financial markets in light of the evolving COVID-19 pandemic; our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; our estimates regarding the potential market opportunity for our product candidates and potential revenue from licensing transactions; reliance on third parties; risks of our and our licensees’ clinical trials, including, but not limited to, the costs, design, initiation and enrollment (which could still be adversely impacted by COVID-19 and resulting social distancing), timing, progress and results of such trials; the potential impacts of COVID-19 on our supply chain; the timing and our and our licensees’ ability to submit applications for, obtain and maintain regulatory approvals for our product candidates; changes in legal, regulatory and legislative environments in the markets in which we operate and the impact of these changes on our ability to obtain regulatory approval for our products; reliance on third parties to develop and commercialize certain of our product candidates; the ability of us and our partners to timely develop, implement and maintain manufacturing, commercialization and marketing capabilities and strategies for certain of our product candidates; the potential advantages of our product candidates and platform technology; the rate and degree of market acceptance and clinical utility of our product candidates; intellectual property risks; our ability to attract and retain key personnel; and our competitive position. Any forward-looking statements speak only as of the date on which they are made, and except as may be required under applicable securities laws, Eyenovia does not undertake any obligation to update any forward-looking statements.

Eyenovia Contact:

Eyenovia, Inc.
John Gandolfo
Chief Financial Officer
[email protected] 

Eyenovia Investor Contact:

Eric Ribner
LifeSci Advisors, LLC
[email protected] 
(646) 751-4363

Eyenovia Media Contact:

Diana Soltesz
Pazanga Health Communications
[email protected] 
(818) 618-5634

EYENOVIA, INC.
         
Balance Sheets
     
    December 31,
    2020   2019
    (unaudited)    
         
Assets        
         
Current Assets:        
Cash and cash equivalents $ 28,371,828     $ 14,152,601  
Deferred license costs   1,600,000        
License receivable   2,966,039        
Prepaid expenses and other current assets   453,478       196,680  
         
Total Current Assets   33,391,345       14,349,281  
         
Property and equipment, net   396,380       230,538  
Security deposit     119,035       117,800  
         
Total Assets $ 33,906,760     $ 14,697,619  
         
Liabilities and Stockholders’ Equity      
         
Current Liabilities:      
Accounts payable $ 1,461,665     $ 1,541,358  
Accrued compensation   1,150,672       916,873  
Accrued expenses and other current liabilities   1,480,692       453,430  
Deferred rent – current portion   7,809        
Deferred license fee   14,000,000        
Notes payable – current portion   97,539        
         
Total Current Liabilities   18,198,377       2,911,661  
         
Deferred rent – non-current portion   38,684       45,351  
Notes payable – non-current portion   365,814        
         
Total Liabilities   18,602,875       2,957,012  
         
Commitments and contingencies      
         
Stockholders’ Equity:      
Preferred stock, $0.0001 par value, 6,000,000 shares authorized;      
   0 shares issued and outstanding as of December 31, 2020 and      
   2019, respectively          
Common stock, $0.0001 par value, 90,000,000 shares authorized;      
   24,978,585 and 17,100,726 shares issued and outstanding      
   as of December 31, 2020 and 2019, respectively   2,498       1,710  
Additional paid-in capital   92,742,306       69,409,949  
Accumulated deficit   (77,440,919 )     (57,671,052 )
         
Total Stockholders’ Equity   15,303,885       11,740,607  
         
Total Liabilities and Stockholders’ Equity $ 33,906,760     $ 14,697,619  
         

 

EYENOVIA, INC.
               
Condensed Statements of Operations
               
 
  For the Three Months Ended   For the Years Ended
  December 31,   December 31,
  2020   2019   2020   2019
  (unaudited)   (unaudited)   (unaudited)    
               
               
Operating Income              
Revenue $ 2,000,000     $     $ 2,000,000     $  
Cost of revenue   (800,000 )           (800,000 )      
Gross Profit   1,200,000             1,200,000        
               
Operating Expenses:              
Research and development $ 3,350,521     $ 3,324,335     $ 13,263,817     $ 14,102,449  
General and administrative   2,056,097       1,964,487       7,725,408       7,206,095  
               
Total Operating Expenses   5,406,618       5,288,822       20,989,225       21,308,544  
               
Loss From Operations   (4,206,618 )     (5,288,822 )     (19,789,225 )     (21,308,544 )
               
Other Income (Expense):              
Small Business Administration Economic              
   Injury Disaster Grant               10,000      
Interest expense   (2,065 )           (17,042 )      
Interest income   1,821       47,338       26,400       151,786  
               
Net Loss $ (4,206,862 )   $ (5,241,484 )   $ (19,769,867 )   $ (21,156,758 )
               
Net Loss Per Share              
   – Basic and Diluted $ (0.17 )   $ (0.31 )   $ (0.94 )   $ (1.47 )
               
Weighted Average Number of              
   Common Shares Outstanding              
   – Basic and Diluted   24,891,184       17,100,726       21,054,706       14,349,738  
               

  



Financial Institutions, Inc. Announces Date of 2021 Annual Meeting of Shareholders and Nominations for Board of Directors

WARSAW, N.Y., March 25, 2021 (GLOBE NEWSWIRE) — Financial Institutions, Inc. (NASDAQ:FISI) (the “Company” or “we”), parent company of Five Star Bank (the “Bank”), SDN Insurance Agency, LLC (“SDN”), Courier Capital, LLC (“Courier Capital”) and HNP Capital, LLC (“HNP Capital”), announced today that its Annual Meeting of Shareholders (the “Meeting”) will be held on Wednesday, June 16, 2021 at 10:00 am EDT. Given ongoing public health and safety concerns related to COVID-19, the Meeting will be held virtually through the internet or other electronic means in lieu of an in-person meeting. The record date for the Meeting is Wednesday, April 21, 2021.

The Company also announced that its board of directors nominated Mauricio Riveros and Mark Zupan for election as new directors at the 2021 Meeting. Current directors Dawn Burlew and Robert Latella are nominees for re-election while Karl Anderson Jr. is retiring from the board.

“Karl has served as an invaluable member of our board for the past 15 years,” commented Robert Latella, Chair of the Board. “We have benefitted from his legal and banking experiences and leadership of board committees. We are grateful to Karl for his dedication to our Company and wish him all the best.”

“Mauricio and Mark are exceptional candidates with diverse work and life experiences,” said Susan Holliday, Vice Chair of the Board and Chair of the Nominating and Governance Committee. “They each bring a unique combination of professional and community service to our board, representing incremental skills, experiences and market knowledge that will benefit us in the future.” 

Mr. Riveros, 46, has served as President of LECESSE Construction Services since 2017 and Chief Operating Officer of The Pike Companies since March 15, 2021 (after serving as Chief Innovation Officer since 2014). LECESSE and The Pike Companies are Rochester-based construction firms. Mr. Riveros previously served as President of Riveros Contracting, National Director of Canadian Executive Services Organization and Director of Strategic Planning for the Government of Bolivia. He currently serves on the boards of the following nonprofit organizations: Center for Governmental Research, Roberts Wesleyan College, St. Ann’s Community and YMCA of Greater Rochester.

Mr. Zupan, 61, has been the President of Alfred University, located in Alfred, New York, since 2016. He previously served as Director of the Bradley Policy Center and Olin Professor of Economics and Public Policy (from 2014 to 2016) and as Dean and Professor of Economics and Public Policy (from 2004 to 2014) at the Simon Business School at the University of Rochester. Prior academic roles were held at Eller College of Management at the University of Arizona, Amos Tuck School of Business Administration at Dartmouth College, and the Marshall School of Business at the University of Southern California. Mr. Zupan is a former director of public companies Steuben Trust Company, PAETEC Holdings and Constellation Brands, and he currently serves on the board of the Allegany County Economic Development Committee.

Mr. Anderson has served on several of the board’s committees during his 15-year tenure. He currently serves on the Audit Committee and the Risk Oversight Committee, which he chairs. Mr. Anderson has practiced law in Western New York since 1972 and is currently Of Counsel at the law firm Mullen Associates PLLC. He previously served as President and Chief Executive Officer of Bank of Avoca from 1981 to 2002 when it was acquired by the Company.

About Financial Institutions, Inc.
Financial Institutions, Inc. provides diversified financial services through its subsidiaries Five Star Bank, SDN, Courier Capital and HNP Capital. Five Star Bank provides a wide range of consumer and commercial banking and lending services to individuals, municipalities and businesses through a network of more than 45 offices throughout Western and Central New York State. SDN provides a broad range of insurance services to personal and business clients. Courier Capital and HNP Capital provide customized investment management, investment consulting and retirement plan services to individuals, businesses, institutions, foundations and retirement plans. Financial Institutions, Inc. and its subsidiaries employ approximately 600 individuals. The Company’s stock is listed on the Nasdaq Global Select Market under the symbol FISI. Additional information is available at www.fiiwarsaw.com.

For additional information contact:
Shelly J. Doran
(585) 627-1362 or [email protected]



Histogen Appoints Rochelle Fuhrmann to Board of Directors

SAN DIEGO, March 25, 2021 (GLOBE NEWSWIRE) — Histogen Inc. (NASDAQ: HSTO), a clinical-stage therapeutics company focused on developing potential first-in-class restorative therapeutics that ignite the body’s natural process to repair and maintain healthy biological function has appointed Rochelle Fuhrmann to its Board of Directors and Chairperson of the Audit Committee. In addition, current director Stephen Chang, Ph.D. will be resigning from the Board.

“I am honored and excited to join the Histogen board during this transformational period and I look forward to working with the board and management to build upon the work that has been done to create value for all company stakeholders,” said Ms. Fuhrmann.

Ms. Fuhrmann currently serves as the Vice President Audit and Enterprise Risk Management at Becton Dickinson (BD). In 2016, Ms. Fuhrmann helped establish the BD Foundation, and she presently serves as Treasurer and as a member of its Board of Trustees. She joined BD in July 2015 as Senior Vice President and Chief Financial Officer, BD Life Sciences. Prior to joining the Company, Rochelle held various positions responsible for the management of financial functions including accounting and financial reporting, investor relations, corporate finance, risk management and treasury, primarily in the pharmaceutical industry with companies such as Amneal Pharmaceuticals and Warner Chilcott plc. She previously served as a member of the Board of Directors of Concordia International Corp. and held the position of Audit Committee Chairperson for three years.

“On behalf of the entire Board of Directors, I want to welcome Rochelle to Histogen,” said David H. Crean, Ph.D., Chairman of the Board of Directors. “Rochelle’s financial and healthcare industry experience will provide us the depth and business acumen required for the company to continue on its growth trajectory as a public company. I also wish to thank Dr. Stephen Chang, who will be stepping down from the Board of Directors, for his many years of service to Histogen”. 

About Histogen Inc.

Histogen Inc. is a clinical-stage therapeutics company focused on developing potential first-in-class restorative therapeutics that ignite the body’s natural process to repair and maintain healthy biological function. Histogen’s innovative technology platform utilizes cell conditioned media and extracellular matrix materials produced by hypoxia-induced multipotent cells. Histogen’s proprietary, reproducible manufacturing process provides targeted solutions across a broad range of therapeutic indications including hair growth, dermal rejuvenation, joint cartilage regeneration and spinal disk repair. For more information, please visit www.histogen.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, we are using forward-looking statements when we discuss Histogen’s future operations and its ability to successfully initiate and complete clinical trials, obtain clinical trial data and achieve regulatory milestones and related timing; the potential that future clinical trials will establish efficacy of Histogen’s product candidates; the nature, strategy and focus of Histogen’s business; the sufficiency of Histogen’s cash resources and ability to achieve value for its stockholders; and the development and commercial potential and potential benefits of any of Histogen’s product candidates. Histogen may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Because such statements deal with future events and are based on Histogen’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of it that could differ materially from those described in or implied by the statements in this press release, including: the uncertainties associated with the clinical development and regulatory approval of Histogen’s product candidates, including potential delays in the commencement, enrollment and completion of clinical trials; the potential that earlier clinical trials and studies of Histogen’s product candidates may not be predictive of future results; risks related to business interruptions, including the outbreak of COVID-19 coronavirus, which could seriously harm Histogen’s financial condition and increase its costs and expenses; and the requirement for additional capital to continue to advance these product candidates, which may not be available on favorable terms or at all. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including those risks discussed in Histogen’s filings with the Securities and Exchange Commission. Except as otherwise required by law, we disclaim any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events, or circumstances or otherwise.

CONTACT:

Susan A. Knudson
Executive Vice President & CFO
Histogen Inc.
[email protected]



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

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


Fourth Quarter 2020 Financial Results Summary

:

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


Full Year 2020 Financial Results Summary:

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

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


Fourth Quarter 2020 and Recent Highlights

:

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

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

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


Presentation & Initial Public Offering:

  • This press release presents historical results, for the periods presented, of Bioventus, LLC, the predecessor of Bioventus Inc. for financial reporting purposes.
  • The financial results of Bioventus Inc. have not been included in this press release as it had no material assets or liabilities and no material business transactions or activities during the periods presented.
  • On February 16, 2021, the Company successfully closed its initial public offering (“IPO”) of common stock at a price to the public of $13.00 per share. The Company issued 9,200,000 shares of Class A common stock, which included 1,200,000 shares sold to the underwriters pursuant to their over-allotment option, and received net proceeds of approximately $111.2 million, after underwriter discounts and commissions.
  • Accordingly, these historical results do not purport to reflect what the results of operations of Bioventus Inc. would have been had the IPO and related transactions occurred prior to such periods. For example, these historical results reference LLC common units and not common stock, and do not reflect the attribution of net income to non-controlling interest or the provision for corporate income taxes on the income attributable to Bioventus Inc. that the Company expects to recognize in future periods.


Fourth Quarter 2020 Financial Results:

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

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

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

Gross profit was $73.5 million, or 74.5% of net sales, compared to $73.4 million, or 75.3% of net sales, for the fourth quarter of 2019, an increase of 0.1%, year-over-year. Non-GAAP gross profit1 was $78.6 million, or 79.7% of net sales, compared to $78.7 million, or 80.7% of net sales, for the fourth quarter of 2019, a decrease of $0.1 million, or 0.1%, year-over-year.

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

Operating income was $5.9 million, compared to $13.7 million for the fourth quarter of 2019, a decrease of $7.8 million, or 57%, year-over-year. Operating margin was 6.0% of net sales, compared to 14% of net sales for the fourth quarter of 2019. Non-GAAP operating income* was $17.0 million, compared to $21.0 million for the fourth quarter of 2019, a decrease of $3.9 million, or 19%, year-over-year. Non-GAAP operating margin1 was 17.3% of net sales, compared to 21.5% of net sales for the fourth quarter of 2019.

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

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

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

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

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

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

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


Full Year 2020 Financial Results

:

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

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

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

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

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

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

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


Full Year 2021 Financial Guidance:


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

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


Fourth Quarter 2020 Earnings Conference Call:

Management will host a conference call to discuss its financial results and provide a business update, with a question and answer session, at 5:00 p.m. Eastern Time on March 25, 2021. Those who would like to participate may dial 844-945-2085 (442-268-1266 for international callers) and provide access code 2158468. A live webcast of the call and any accompanying materials will also be provided on the investor relations section of the Company’s website at https://ir.bioventus.com/.

The webcast will be archived on the Company’s website at https://ir.bioventus.com/ and available for replay until March 25, 2022.

About Bioventus

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

Legal Notice Regarding
Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements concerning our business strategy, position and operations; expected tax treatment, sales trends, opportunities and growth; the ongoing COVID-19 pandemic; the expected benefits and impact of Bioventus’ products, including in certain regions, and biologic drug candidates; and the Company’s financial guidance and expected financial performance. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Factors that could cause actual results to differ materially from those contemplated in this press release include, but are not limited to, statements about the adverse impacts on our business as a result of the COVID-19 pandemic; our dependence on a limited number of products; our ability to develop, acquire and commercialize new products, line extensions or expanded indications; the continued and future acceptance of our existing portfolio of products and any new products, line extensions or expanded indications by physicians, patients, third-party payers and others in the medical community; our ability to differentiate the hyaluronic acid (“HA”) viscosupplementation therapies we own or distribute from alternative therapies for the treatment of osteoarthritic; the proposed down-classification of non-invasive bone growth stimulators, including our Exogen system, by the FDA; our ability to achieve and maintain adequate levels of coverage and/or reimbursement for our products, the procedures using our products, or any future products we may seek to commercialize; our ability to complete acquisitions or successfully integrate new businesses, products or technologies in a cost-effective and non-disruptive manner; competition against other companies; the negative impact on our ability to market our HA products due to the reclassification of HA products from medical devices to drugs in the United States by the FDA; our ability to attract, retain and motivate our senior management and qualified personnel; our ability to continue to research, develop and manufacture our products if our facilities are damaged or become inoperable; failure to comply with the extensive government regulations related to our products and operations; enforcement actions if we engage in improper claims submission practices or in improper marketing or promotion of our products; the FDA regulatory process and our ability to obtain and maintain required regulatory clearances and approvals; failure to comply with the government regulations that apply to our human cells, tissues and cellular or tissue-based products; the clinical studies of any of our future products that do not product results necessary to support regulatory clearance or approval in the United States or elsewhere; and the other risks identified in the Risk Factors section of the Company’s public filings with the Securities and Exchange Commission (“SEC”), including Bioventus’ 424(b)(4) prospectus filed on February 12, 2021 in connection with the Company’s initial public offering, as such factors may be updated from time to time in Bioventus’ other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Bioventus’ website at ir.bioventus.com. Except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection, or forward-looking statement. Actual results may differ materially from those set forth in the forward-looking statements.

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

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

BIOVENTUS LLC
Consolidated statements of cash flows
Years ended December 31, 2020 and 2019
(Amounts in thousands, unaudited)
    2020       2019  
Operating activities:      
Net income $ 14,722     $ 6,298  
Net loss from discontinued operations         1,815  
Net income from continuing operations   14,722       8,113  
Adjustments to reconcile net income to net cash provided by operating activities from continuing operations:          
Depreciation and amortization   28,643       30,316  
Payment of contingent consideration in excess of amount established in purchase accounting         (945 )
Provision for expected credit losses   1,215       2,242  
Profits interest plan, liability-classified and other equity awards compensation   10,103       10,844  
Change in fair value of Equity Participation Rights unit   644       565  
Change in fair value of interest rate swap   1,599        
Deferred income taxes   (511 )     (348 )
Amortization of debt discount and capitalized loan fees, net   543       1,583  
Loss on debt retirement and modification         3,352  
Other, net   (67 )     395  
Changes in operating assets and liabilities:      
Accounts receivable   (3,941 )     (14,909 )
Inventories   (528 )     (1,427 )
Accounts payable and accrued expenses   20,510       6,646  
Other current assets and liabilities   (733 )     (3,882 )
Net cash provided by operating activities from continuing operations   72,199       42,545  
Net cash used in operating activities of discontinued operations   (400 )     (1,832 )
Net cash provided by operating activities   71,799       40,713  
Investing activities:      
Investment and acquisition of distribution rights   (16,579 )     (6,000 )
Acquisition of VIE         430  
Purchase of property and equipment   (4,093 )     (2,342 )
Net cash used in investing activities from continuing operations   (20,672 )     (7,912 )
Net cash provided by investing activities from discontinued operations   172        
Net cash used in investing activities   (20,500 )     (7,912 )
Financing activities:      
Borrowing on revolver   49,000        
Payment on revolver   (49,000 )      
Proceeds from the issuance of long-term debt, net of issuance costs         198,134  
Payments on long-term debt   (10,000 )     (199,500 )
Other financing activities   317       (448 )
Distribution to members   (19,886 )     (9,137 )
Net cash used in financing activities   (29,569 )     (10,951 )
Effect of exchange rate changes on cash   589       (104 )
Net change in cash and cash equivalents   22,319       21,746  
Cash and cash equivalents at the beginning of the period   64,520       42,774  
Cash and cash equivalents at the end of the period $ 86,839     $ 64,520  
       






Use of Non-GAAP Financial Measures

International Net Sales Growth on a Constant Currency Basis

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

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

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

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

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

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

We define Non-GAAP Operating Income as operating income, adjusted for the impact of certain cash, non-cash and other items that we do not consider in our evaluation of ongoing operating performance. These items include depreciation and amortization included in the cost of goods sold, amortization in operating expenses, COVID-19 expenses, succession and transition charges, restructuring costs and other non-recurring costs. See the table below for a reconciliation of Operating Income and operating margin to Non-GAAP Operating Income and Non-GAAP Operating Margin.

We define Non-GAAP Net Income Attributable to Common Unit Holders as net income attributable to common unit holders, adjusted for the impact of certain cash, non-cash and other items that we do not consider in our evaluation of ongoing operating performance. These items include depreciation and amortization included in the cost of goods sold, amortization in operating expenses, COVID-19 expense and income, succession and transition charges, losses associated with debt retirement and modification, restructuring costs, and other non-recurring costs. See the table below for a reconciliation of net income attributable to common unit holders to Non-GAAP Net Income Attributable to Common Unit Holders.


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

(a) Includes for the years ended December 31, 2020 and 2019, depreciation and amortization of $21.2 million and $22.4 million in cost of sales and also includes $7.4 million and $7.9 million, respectively, and for the quarters ended December 31, 2020 and 2019, depreciation and amortization of $5.1 million and $5.2 million in cost of sales, and also includes $1.8 million and $2.1 million, respectively, presented in the consolidated statements of operations and comprehensive income (loss), with the balance in research and development.

(b) Represents compensation as well as the change in fair market value resulting from two equity-based compensation plans, the Management Incentive Plan and the Phantom Profits Interest Plan.

(c) Represents income resulting from the Coronavirus Aid, Relief and Economic Security (“CARES”) Act offset by additional cleaning and disinfecting expenses and contract termination fees for canceled events.

(d) Primarily represents costs related to the CEO transition.

(e) Represents costs related to a shift from direct to an indirect distribution model in our International business to improve performance. Various international subsidiaries were dissolved and or merged into other Bioventus LLC entities.

(f) Foreign currency impact represents realized and unrealized gains and losses from fluctuations in foreign currency and is included within other (income) loss in the consolidated statements of operations and comprehensive income (loss).

(g) Represents our share in the losses of CartiHeal for the year and quarter ended December 31, 2020.

(h) Other non-recurring items in 2020 includes settlement and legal costs of $1.9 million with the Office of Inspector General of the U.S. Department of Health and Human Services (“OIG”). The remaining balance in 2020 and the activity in 2019 primarily consists of charges associated with potential strategic transactions, such as potential acquisitions and preparing to become a public company, primarily accounting and legal fees.


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

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

(a) Represents charges with our 2019 debt refinancing that were included in selling, general and administrative expense on the consolidated statements of operations and comprehensive income (loss).

(b) Additional cleaning and disinfecting expenses and contract termination fees for canceled events included in operating expenses.

(c) Represents income resulting from the CARES Act.

(d) Primarily represents costs related to the CEO transition.

(e) Represents costs related to a shift from direct to an indirect distribution model in our International business to improve performance. Various international subsidiaries were dissolved and or merged into other Bioventus LLC entities.

(f) Other non-recurring items in 2020 primarily includes settlement and legal costs of $1.9 million with the OIG.


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

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

(a) Primarily represents costs related to the CEO transition.

(b) Represents costs related to a shift from direct to an indirect distribution model in our International business to improve performance. Various international subsidiaries were dissolved and or merged into other Bioventus LLC entities.

(c) Additional cleaning and disinfecting expenses and contract termination fees for canceled events included in operating expenses.

(d) Other non-recurring items in 2020 primarily includes settlement and legal costs of $1.9 million with the OIG.

 

Reconciliation of Guidance Range for Net Income to Common Shareholders to Non-GAAP Net Income to Common Shareholders for the twelve months ending December 31, 2021
       
       
  2021 Guidance   2021 Guidance
($, thousands) Low   High
Net income attributable to common shareholders   15,349       19,317  
     Plus: Amortization included in cost of goods sold   22,260       21,260  
     Plus: Amortization included in operating expenses   5,323       5,323  
Non-GAAP Net income attributable to common shareholders   42,932       45,900  
       

Reconciliation of Guidance Range for Net Income from continuing operations to Adjusted EBITDA for the twelve months ending December 31, 2021
       
  2021 Guidance   2021 Guidance
($, thousands) Low   High
Net Income from continuing operations   13,958       17,926  
  Depreciation and amortization   30,000       29,000  
  Income tax expense   5,162       6,630  
  Interest expense   3,400       2,900  
  Equity compensation   21,500       22,500  
Other non-recurring costs (a)   5,000       4,000  
Adjusted EBITDA   79,020       82,956  

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



Investor Inquiries:
Mike Piccinino, CFA, IRC
Westwicke/ICR
[email protected]
  
Press and Media Inquiries:
Bioventus
Thomas Hill
[email protected]

FAT BRANDS INC. REPORTS FOURTH QUARTER AND FULL YEAR 2020 FINANCIAL RESULTS

Conference call and webcast today at 5:00 p.m. ET

LOS ANGELES, March 25, 2021 (GLOBE NEWSWIRE) — FAT
(Fresh. Authentic. Tasty.) Brands Inc. (NASDAQ: FAT) (“FAT Brands” or the “Company”) today reported fourth quarter and full year 2020 financial results for the fiscal year ended December 27, 2020.

Andy Wiederhorn, President and CEO of FAT Brands, commented, “We are proud of our franchise partners and employees who have worked incredibly hard and shown impressive versatility throughout this difficult year. We are very hopeful that with the widespread availability of vaccines and accelerated reopening plans in many locations, we will be able to put the COVID-19 pandemic in the rear-view mirror.”

“The fourth quarter proved very productive at FAT Brands and continued our strong rebound during the pandemic. While the initial virus impacts were harsh, this marks another report with improving successive quarterly improvements. Amongst the improving results we have continued to develop our powerful engine for organic growth. We had further new store openings, in addition to more units under construction. We have a solid development pipeline of new franchise locations. And as of today, we have fully integrated Johnny Rockets with plans for the reopening of special venues sometime during the second and third quarters of this year.”

Wiederhorn continued, “We are very excited for the year ahead as we continue our bounce back from the pandemic. In 2021, we will continue to pursue additional accretive acquisition opportunities as well as organic growth of our existing brands.”

“Our existing whole business securitization facility, along with our publicly traded preferred stock and common stock, give us many levers to pull to fund potential acquisitions, reduce our cost of capital further, and drive shareholder value.”

Fiscal Fourth Quarter 2020 Highlights

  • Total revenues improved 24% to $6.5 million compared to the fourth quarter of 2019
  • Excluding revenues attributable to Johnny Rockets which was acquired on September 21, 2020, revenues declined 19% compared to the fourth quarter of 2019, showing sequential improvement compared to a decline in the prior quarter of 39%
    • System-wide sales growth of 46.0% q/q
      • United States sales growth of 25.0% q/q
      • Rest of world sales growth of 119.7% q/q
    • System-wide same-store sales decline of 7.6% q/q
      • United States same-store sales decline of 8.4% q/q
      • Rest of world sales decline of 3.8% q/q
    • 29 new franchised store openings during the fourth quarter 2020
      • Store count as of December 27, 2020: 679 stores system-wide                            

     

  • Net Loss of $7.7 million or $0.64 per share on a basic and fully diluted basis, as compared to net loss of $1.0 million or $0.08 per share on a basic and fully diluted basis in the fourth quarter of 2019
     
  • EBITDA(1) loss of $7.9 million as compared to EBITDA of $726,000 in the fourth quarter of 2019
     
  • Adjusted EBITDA(1) of $1.7 million as compared to $1.8 million in the fourth quarter of 2019. Adjusted EBITDA excludes expenses related to acquisitions, refranchising gain or losses, impairment charges, and certain non-recurring or non-cash items that the Company does not believe directly reflect its core operations and may not be indicative of the Company’s recurring business operations. The reconciliation of EBITDA to Adjusted EBITDA can be found in the accompanying financial tables.

    (1)EBITDA and Adjusted EBITDA are non-GAAP measures defined below, under “Non-GAAP Measures”. A reconciliation of GAAP net income to EBITDA and adjusted EBITDA is included in the accompanying financial tables.

Summary of Fourth Quarter 2020 Financial Results

Total revenues were $6.5 million in the fourth quarter of 2020 and as compared to $5.2 million in the fourth quarter of 2019. Excluding Johnny Rockets which was acquired on September 21, 2020 as well as advertising revenues, revenues were $3.4 million, down from $4.3 million in the fourth quarter of 2019. The revenue performance overwhelmingly reflects a decline in royalty revenue related to the impact of COVID-19.

Costs and expenses increased to $14.4 million in the fourth quarter of 2020 compared to $5.0 million in the fourth quarter of 2019. These costs and expenses included an impairment charge in 2020 of $5.4 million without comparable activity in the prior year, advertising expenses of $2.9 million in 2020 compared to $1.0 million in 2019 reflecting expenditures in excess of collections recognized in the fourth quarter of 2020, and refranchising losses of $2.0 million in 2020 and $1.1 million in 2019. Total general and administrative expenses were $4.3 million in the fourth quarter of 2020 compared to $3.0 million in the prior period. This increase of $1.3 million was attributed to increases in occupancy costs and legal expenses, additional amortization expense related to the intangible assets of Johnny Rockets, and bad debt expenses related to the COVID-19 global pandemic marginally offset by decreases in travel and entertainment expenses.

Other expense was $2.0 million in the fourth quarter of 2020, compared to other expense of $900,000 in the fourth quarter of 2019, and consisted primarily of net interest expense of $1.6 million in 2020 compared to $1.2 million in the prior period as well as $535,000 of expenses related to the acquisition of Fog Cutter Capital Group Inc in the fourth quarter of 2020 without comparable activity in 2019. The $400,000 increase in net interest expense related primarily to the additional interest expense associated with the $40 million of Series 2020-2 Fixed Rate Asset-Backed Notes sold in September 2020, the proceeds of which were used to fund our acquisition of Johnny Rockets as well as for general corporate purposes.

The combination of the aforementioned revenue and expenses resulted in a net loss of $7.7 million in the fourth quarter of 2020, compared to a net loss of $1.0 million in the fourth quarter of 2019.

Recent Events and Liquidity

On December 24, 2020, the Company completed the acquisition of Fog Cutter Capital Group Inc., a Delaware corporation (“FCCG”), through the merger of FCCG with and into Fog Cutter Acquisition, LLC, a Delaware limited liability company and wholly-owned subsidiary of the Company. The acquisition of FCCG by the Company (the “Merger”) was consummated pursuant to an Agreement and Plan of Merger (the “Merger Agreement”), dated December 10, 2020, by and among the Company, FCCG, Merger Sub and Fog Cutter Holdings, LLC, a Delaware limited liability company. The Company undertook the Merger primarily to simplify its corporate structure and eliminate limitations that restrict the Company’s ability to issue additional Common Stock for acquisitions and capital raising. FCCG holds a substantial amount of net operating loss carryforwards (“NOLs”), which could only be made available to the Company as long as FCCG owned at least 80% of FAT Brands. With the Merger, the NOLs will be held directly by the Company, which will then have greater flexibility in managing its capital structure. In addition, after the Merger, the Company will no longer be required to compensate FCCG for utilizing its NOLs under the Tax Sharing Agreement between the Company and FCCG.

During the fourth quarter of 2020, the Company repurchased 232,663 warrants to purchase shares of the Company’s common stock with an exercise price of $5.00 per share for $420,000.

Key Financial Definitions

New store openings – The number of new store openings reflects the number of stores opened during a particular reporting period. The total number of new stores per reporting period and the timing of stores openings has, and will continue to have, an impact on our results.

Same-store sales growth – Same-store sales growth reflects the change in year-over-year sales for the comparable store base, which we define as the number of stores open and in the FAT Brands system for at least one full fiscal year. For stores that were temporarily closed, sales in the current and prior period are adjusted accordingly. Given our focused marketing efforts and public excitement surrounding each opening, new stores often experience an initial start-up period with considerably higher than average sales volumes, which subsequently decrease to stabilized levels after three to six months. Additionally, when we acquire a brand, it may take several months to integrate fully each location of said brand into the FAT Brands platform. Thus, we do not include stores in the comparable base until they have been open and in the FAT Brands system for at least one full fiscal year. For 2020, the comparable store base does not include Elevation Burger and Johnny Rockets stores as we did not own the brands for the full year of 2019.

System-wide sales growth – System wide sales growth reflects the percentage change in sales in any given fiscal period compared to the prior fiscal period for all stores in that brand only when the brand is owned by FAT Brands. Because of acquisitions, new store openings and store closures, the stores open throughout both fiscal periods being compared may be different from period to period.

Conference Call and Webcast

FAT Brands will host a conference call and webcast to discuss its fiscal fourth quarter and full year 2020 financial results today at 5:00 PM ET. Hosting the conference call and webcast will be Andy Wiederhorn, President and Chief Executive Officer, and Rebecca Hershinger, Chief Financial Officer.

The conference call can be accessed live over the phone by dialing 1-877-705-6003. A replay will be available after the call until Thursday, April 1, 2021, and can be accessed by dialing 1-844-512-2921. The passcode is 13717932. The webcast will be available at www.fatbrands.com under the “Investors” section and will be archived on the site shortly after the call has concluded.

About FAT (Fresh. Authentic. Tasty.) Brands

FAT Brands Inc. (NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets and develops fast casual and casual dining restaurant concepts around the world. The Company currently owns nine restaurant brands: Fatburger, Johnny Rockets, Buffalo’s Cafe, Buffalo’s Express, Hurricane Grill & Wings, Elevation Burger, Yalla Mediterranean and Ponderosa and Bonanza Steakhouses, and franchises over 700 units worldwide. For more information, please visit www.fatbrands.com.


Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the future financial and operating results of the Company, our future acquisitions, and the effects on our business of the current novel coronavirus pandemic (“COVID-19”). Forward-looking statements generally use words such as “expect,” “foresee,” “anticipate,” “believe,” “project,” “should,” “estimate,” “will,” “plans,” “forecast,” and similar expressions, and reflect our expectations concerning the future. It is possible that our future performance may differ materially from current expectations expressed in these forward-looking statements. Forward-looking statements are subject to significant business, economic and competitive risks, uncertainties and contingencies including, but not limited to, uncertainties surrounding the severity, duration and effects of the COVID-19 pandemic, many of which are difficult to predict and beyond our control, which could cause our actual results to differ materially from the results expressed or implied in such forward-looking statements. We refer you to the documents we file from time to time with the Securities and Exchange Commission, such as our reports on Form 10-K, Form 10-Q and Form 8-K, for a discussion of these and other risks and uncertainties that could cause our actual results to differ materially from our current expectations and from the forward-looking statements contained in this press release. We undertake no obligation to update any forward-looking statement to reflect events or circumstances occurring after the date of this press release.


Non-GAAP Measures (Unaudited)

This press release includes the non-GAAP financial measure of EBITDA and Adjusted EBITDA.

EBITDA is defined as earnings before interest, taxes, depreciation and amortization. We use the term EBITDA, as opposed to income from operations, as it is widely used by analysts, investors and other interested parties to evaluate companies in our industry. We believe that EBITDA is an appropriate measure of operating performance because it eliminates the impact of expenses that do not relate to business performance. EBITDA is not a measure of our financial performance or liquidity that is determined in accordance with generally accepted accounting principles (“GAAP”), and should not be considered as an alternative to net income (loss) as a measure of financial performance or cash flows from operations as measures of liquidity, or any other performance measure derived in accordance with GAAP.

Adjusted EBITDA is defined as EBITDA (as defined above), excluding expenses related to acquisitions, refranchising gain or losses, impairment charges, and certain non-recurring or non-cash items that the Company does not believe directly reflect its core operations and may not be indicative of the Company’s recurring business operations.

A reconciliation of net income presented in accordance with GAAP to EBITDA and adjusted EBITDA is set forth in the tables below.

Investor Relations:

ICR

Ashley DeSimone


[email protected]

646-677-1827

Media Relations:

JConnelly

Erin Mandzik


emandzik@jconnel
ly.com

862-246-9911

###

FAT Brands Inc. Consolidated Statements of Operations Data

    13 weeks ended December 27, 2020      13 weeks ended December 29, 2019     52 weeks ended December 27, 2020     52 weeks ended December 29, 2019  
                         
(in thousands)                                
                                 
Revenues                                
Royalties   $ 4,742     $ 3,831     $ 13,420     $ 14,895  
Franchise fees     559       855       1,130       3,433  
Store opening fees           (399 )            
Advertising fees     1,180       952       3,527       4,111  
Management fees and other income     18       13       41       66  
Total revenues     6,499       5,252       18,118       22,505  
                                 
Costs and expenses                                
General and administrative expenses     4,250       3,015       14,876       12,257  
Impairment of goodwill and intangible assets     5,368             9,295        
Advertising expenses     2,860       952       5,218       4,111  
Refranchising loss     1,958       1,070       3,827       219  
Total costs and expenses     14,436       5,037       33,216       16,587  
                                 
(Loss) income from operations     (7,937 )     215       (15,098 )     5,918  
                                 
Other expense, net                                
Interest expense, net     (1,634 )     (1,173 )     (4,919 )     (6,530 )
Change in fair value of derivative liability                 887        
Loss on extinguishment of debt                 (88 )      
Gain on contingent consideration payable adjustment                 1,680        
Other (expense) income, net     (384 )     262       (1,011 )     104  
Total other expense, net     (2,018 )     (911 )     (3,451 )     (6,426 )
                                 
Loss before income tax (benefit) expense     (9,955 )     (696 )     (18,549 )     (508 )
                                 
Income tax (benefit) expense     (2,284 )     257       (3,689 )     510  
                                 
Net loss   $ (7,671 )   $ (953 )   $ (14,860 )   $ (1,018 )
Basic and diluted loss per share   $ (0.64 )   $ (0.08 )   $ (1.25 )   $ (0.09 )

  
Consolidated Balance Sheet for FAT Brands Inc. as of December 27, 2020

    As of December 27, 2020
     
(in thousands)        
         
Cash and restricted cash   $ 7,211  
Total assets   $ 121,144  
Total liabilities   $ 163,027  
Total stockholders’ deficit   $ (41,883 )

FAT Brands Inc. Consolidated EBITDA and Adjusted EBITDA Reconciliation

    13 weeks ended December 27, 2020     13 weeks ended December 29, 2019     52 weeks ended December 27, 2020     52 weeks ended December 29, 2019  
                         
(in thousands)                                
                                 
Net loss   $ (7,671 )   $ (953 )   $ (14,860 )   $ (1,018 )
Interest expense, net     1,634       1,173       4,919       6,530  
Income tax (benefit) expense     (2,284 )     257       (3,689 )     510  
Depreciation and amortization     409       249       1,172       785  
EBITDA   $ (7,912 )   $ 726     $ (12,458 )   $ 6,807  
Share-based compensation     38       44       99       262  
Non-cash lease expenses     69       17       243       174  
Acquisition costs     535       (46 )     1,168       201  
Refranchising loss     1,958       1,070       3,827       219  
Impairment of goodwill and intangible assets     5,368             9,295        
Advertising expenditures exceeding collections     1,680             1,680        
Change in fair value of derivative liability                 (887 )      
Loss on extinguishment of debt                 88        
Gain on contingent consideration payable adjustment                 (1,680 )      
Adjusted EBITDA   $ 1,736     $ 1,811     $ 1,375     $ 7,663  



Crestwood Announces Private Placement of Common Units by First Reserve

Crestwood Announces Private Placement of Common Units by First Reserve

HOUSTON–(BUSINESS WIRE)–
Crestwood Equity Partners LP (NYSE: CEQP) (“Crestwood”) today announced that Crestwood Gas Services Holdings LLC, a company controlled by an investment fund sponsored by First Reserve, has priced a private placement of six million common units representing limited partner interests of Crestwood for gross proceeds of $132 million. The private placement is expected to close March 30, 2021, subject to customary closing conditions. Crestwood is not selling any common units and will not receive any proceeds from the private placement.

Citigroup acted as sole placement agent for the private placement of common units.

The securities offered in the private placement have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or any state securities laws and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws. This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities described herein.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities and Exchange Act of 1934. The words “expects,” “believes,” “anticipates,” “plans,” “will,” “shall,” “estimates,” and similar expressions identify forward-looking statements, which are generally not historical in nature. Forward-looking statements are subject to risks and uncertainties and are based on the beliefs and assumptions of management, based on information currently available to them. Although Crestwood believes that these forward-looking statements are based on reasonable assumptions, it can give no assurance that any such forward-looking statements will materialize. Important factors that could cause actual results to differ materially from those expressed in or implied from these forward-looking statements include the risks and uncertainties described in Crestwood’s reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its subsequent reports, which are available through the SEC’s EDGAR system at www.sec.gov and on our website. Readers are cautioned not to place undue reliance on forward-looking statements, which reflect management’s view only as of the date made, and Crestwood assumes no obligation to update these forward-looking statements.

Crestwood Equity Partners LP

Investor Contacts

Josh Wannarka, 713-380-3081

[email protected]

Senior Vice President, Investor Relations, ESG & Corporate Communications

Rhianna Disch, 713-380-3006

[email protected]

Director, Investor Relations

Sustainability and Media Contact

Joanne Howard, 832-519-2211

[email protected]

Vice President, Sustainability and Corporate Communications

KEYWORDS: United States North America Texas Kansas

INDUSTRY KEYWORDS: Oil/Gas Energy

MEDIA:

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AAR continues to advance aviation technician development: earned recognition from U.S. Department of Labor and signed MOU with American Association of Port Authority’s ACCELerate Apprenticeship Program

Wood Dale, March 25, 2021 (GLOBE NEWSWIRE) — AAR (NYSE: AIR), a leading aviation services provider to commercial and governments operators, MROs and OEMs worldwide, announces that its EAGLE Career Pathways program for aircraft maintenance technicians (AMTs) has been recognized by the U.S. Department of Labor’s (DOL) Employment and Training Division as a nationally registered apprenticeship. AAR’s program standards were approved by the DOL’s Office of Apprenticeship in Washington, D.C., in February.

In addition, AAR has signed a Memorandum of Understanding (MOU) with the American Association of Port Authority’s (AAPA) ACCELerate Apprenticeships program. The program’s goal is to provide competency-based curriculums, on-the-job training, program development assistance and incentive funding to expand apprenticeship opportunities for careers that drive economic mobility.

“Aviation is a key component of our nation’s transportation, distribution and logistics sector,” said Barbara R. Murray, ACCELerate Executive Director. “Apprenticeship is a proven method for developing a skilled, productive, loyal workforce. We are proud to partner with the nation’s leading aircraft maintenance repair organization to meet talent needs, reduce turnover and create a more diverse workforce.”

“Solving the immediate and long-term projected shortage of AMTs continues to be a key focus area of AAR’s workforce development strategy,” said Brian Sartain, AAR Senior Vice President, Repair and Engineering Services. “This coveted national registered apprenticeship program designation and our partnership with AAPA’s ACCELerate Apprenticeship will make our existing programs like the EAGLE Career Pathway Program even more attractive.”

Launched in 2019, AAR’s EAGLE Career Pathway program is a partnership of 15 organizations and institutions, including community colleges, high schools and youth centers, which are dedicated to growing the aviation maintenance technician pipeline. These organizations are located near AAR’s four U.S.-based aircraft repair stations in Miami, Oklahoma City, Indianapolis and Rockford, Illinois, and its global headquarters near Chicago’s O’Hare International Airport.

For more information about AAR´s EAGLE Career Pathways program, visit https://www.aarcorp.com/eagle-pathway-program/.

# # #

About AAR

AAR is a global aerospace and defense aftermarket solutions company with operations in over 20 countries. Headquartered in the Chicago area, AAR supports commercial and government customers through two operating segments: Aviation Services and Expeditionary Services. AAR’s Aviation Services include Parts Supply; OEM Solutions; Integrated Solutions; and Maintenance, Repair and Overhaul (MRO) Services. AAR’s Expeditionary Services include Mobility Systems operations. Additional information can be found at www.aarcorp.com.

This press release contains certain statements relating to future results, which are forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, which reflect management’s expectations about future conditions. Forward-looking statements may also be identified because they contain words such as ‘‘anticipate,’’ ‘‘believe,’’ ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ ‘‘intend,’’ ‘‘likely,’’ ‘‘may,’’ ‘‘might,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘seek,’’ ‘‘should,’’ ‘‘target,’’ ‘‘will,’’ ‘‘would,’’ or similar expressions and the negatives of those terms. These forward-looking statements are based on beliefs of Company management, as well as assumptions and estimates based on information currently available to the Company, and are subject to certain risks and uncertainties that could cause actual results to differ materially from historical results or those anticipated. For a discussion of these and other risks and uncertainties, refer to “Risk Factors” in our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. Should one or more of these risks or uncertainties materialize adversely, or should underlying assumptions or estimates prove incorrect, actual results may vary materially from those described. These events and uncertainties are difficult or impossible to predict accurately and many are beyond the Company’s control. The Company assumes no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements or to reflect the occurrence of anticipated or unanticipated events.



Daniela Pietsch
AAR Corp
+16302275100
[email protected]

Royal Gold Announces Virtual Investor Update on Tuesday, April 20

Royal Gold Announces Virtual Investor Update on Tuesday, April 20

DENVER–(BUSINESS WIRE)–Royal Gold, Inc. (NASDAQ: RGLD) (together with its subsidiaries, “Royal Gold” or the “Company,” “we” or “our”) announced today that management will host a virtual Investor Update to provide an in-depth review and discussion of Royal Gold’s business on Tuesday, April 20, from 9:30 a.m. to 11:30 a.m. ET. Prepared remarks by members of Royal Gold’s management team will be followed by a live question and answer session.

Access to the live event will be available through: Royal Gold Investor Update

Dial-in numbers:

855-209-8260 (U.S.); toll free

855-669-9657 (Canada); toll free

412-542-4106 (International)

A replay of the event will be available on the Royal Gold website under:

www.royalgold.com/investors/events-presentations

Corporate Profile

Royal Gold is a precious metals stream and royalty company engaged in the acquisition and management of precious metal streams, royalties and similar production-based interests. As of December 31, 2020, the Company owned interests on 189 properties on five continents, including interests on 41 producing mines and 17 development stage projects. Royal Gold is publicly traded on the Nasdaq Global Select Market under the symbol “RGLD.” The Company’s website is located at www.royalgold.com

Alistair Baker

Vice President Investor Relations and Business Development

(720) 554-6995

KEYWORDS: Colorado United States North America Canada

INDUSTRY KEYWORDS: Mining/Minerals Natural Resources

MEDIA:

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IntelGenx Reports Fourth Quarter and Full-Year 2020 Financial Results

SAINT-LAURENT, Quebec, March 25, 2021 (GLOBE NEWSWIRE) — IntelGenx Technologies Corp. (TSX V:IGX)(OTCQX:IGXT) (the “Company” or “IntelGenx”) today reported financial results for the fourth quarter and twelve-month periods ended December 31, 2020. All dollar amounts are expressed in U.S. currency, unless otherwise indicated, and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise.


2020 Fourth Quarter Financial Highlights:

  • Revenue was $790,000, compared to $68,000 in the 2019 fourth quarter.
  • Net comprehensive loss was $1.3 million, compared to $2.7 million in the 2019 fourth quarter.
  • Adjusted EBITDA loss was $754,000, compared to $2.1 million in Q4-2019.


2020 Full-Year Financial Highlights:

  • Revenue was $1.5 million, compared to $742,000 in 2019.
  • Net comprehensive loss was $7.1 million, compared to $10.3 million in 2019.
  • Adjusted EBITDA loss was $5.3 million, compared to $8.5 million in 2019.


Recent Developments:

  • Announced a strategic partnership with atai Life Sciences (“atai”), including a proposed equity investment by atai, positioning IntelGenx as a leader within the novel therapeutics field of psychedelics and providing the requisite financial resources to continue to advance its robust portfolio of other innovative pharmaceutical film product candidates towards commercialization.
  • The Company’s wholly owned subsidiary, IntelGex Corp., also received a $2.0 million secured loan from atai, of which $628,000 was used to fully repay the Company’s outstanding credit facilities with the Bank of Montreal.
  • Received a Notice of Allowance for US Patent Application 16/110.737, entitled “Film Dosage Form with Extended Release Mucoadhesive Particle,” covering novel disintegrating oral film formulations designed for the transmucosal absorption of drug, especially tetrahydrocannabinol (THC), which protects its DisinteQTM products.
  • Filed a new provisional patent application at the United States Patent and Trademark Office entitled “High Loading Oral Film Formulation,” which covers the incorporation of high concentrations of active ingredients in products based on its VetaFilm™ proprietary veterinary oral film technology.
  • Announced the appointment of Mr. Tommy Kenny as Vice President, Intellectual Property and Legal Affairs, General Counsel of IntelGenx Corp., the Company’s operating subsidiary.
  • Received its first purchase order from Heritage Cannabis Holdings, recently upsized from 50,000 to 75,000 CBD Filmstrips, pursuant to a definitive supply agreement.

“While we were pleased to see the positive impact of our performance improvement program continuing to be reflected in our financial results, it was the transformative partnership that we entered into with atai subsequent to year-end that truly served to validate our long-term growth strategy,” commented Dr. Horst G. Zerbe, CEO of IntelGenx. “We are confident that this transaction is the best way forward to maximize value for our shareholders, and encourage them to vote “FOR” all related proposals at our Annual Meeting on May 11, 2021.”


Financial Results:

Total revenues for the three-month period ended December 31, 202 amounted to $790,000, an increase of $722,000, or 1,062%, compared to $68,000 for the three-month period ended December 31, 2019. The change is mainly attributable to an increase in revenues from licensing agreements of $671,000 and an increase in R&D revenues of $51,000. Operating costs and expenses were $1.8 million for the fourth quarter of 2020, versus $2.4 million for the corresponding three-month period of 2019. For Q4-2020, the Company had an operating loss of $1.0 million, compared to operating loss of $2.4 million for the comparable period of 2019. Net comprehensive loss was $1.3 million, or $0.01 per basic and diluted share, for the fourth quarter of 2020, compared to net comprehensive loss of $2.7 million, or $0.03 per basic and diluted share, for the comparable period of 2019.

Total revenues for the twelve-month period ended December 31, 2020 amounted to $1.5 million, representing an increase of $802,000, or 108% compared, to $742,000 for the year ended December 31, 2019. Operating costs and expenses were $7.8 million for the full year 2020, versus $10.3 million for the corresponding 12-month period of 2019. For the twelve-month period of 2020, the Company had an operating loss of $973,000, compared to an operating loss of $2.4 million for the comparable period of 2019. Net comprehensive loss was $7.1 million, or $0.07 per basic and diluted share, for the twelve-month period of 2020, compared to net comprehensive loss of $10.3 million, or $0.11 per basic and diluted share, for the comparable period of 2019.

As at December 31, 2020, the Company’s cash and short-term investments totalled $2.2 million, which did not include the $2.0 million secured loan granted to IntelGenx Corp. by atai in March 2021.


Annual Filings:

The Company’s annual report on Form 10-K and financial statements for the year ended December 31, 2012, as well as the 2021 Proxy Statement, will be filed with the United States Securities and Exchange Commission and the Canadian Securities regulatory authorities today, March 25, 2021.  


Conference Call Details:

IntelGenx will host a conference call to discuss these 2020 fourth quarter and full year financial results today at 4:30 p.m. ET. The dial-in number for the conference call is (877) 876-9174 (Canada and the United States) and (785) 424-1669 (International). The call will be also be webcast live and archived on the Company’s website at www.intelgenx.com under “Webcasts” in the Investors section.

About IntelGenx

IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films.

IntelGenx’s superior film technologies, including VersaFilm®, DisinteQ™, VetaFilm™ and transdermal VevaDerm™, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offers significant benefits to patients and physicians for many therapeutic conditions.

IntelGenx’s highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx’s state-of-the-art manufacturing facility offers full service by providing lab-scale to pilot- and commercial-scale production. For more information, visit www.intelgenx.com.

Forward Looking Statements:

This document may contain forward-looking information about IntelGenx’ operating results and business prospects that involve substantial risks and uncertainties. Statements that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, but are not limited to, statements about IntelGenx’ plans, objectives, expectations, strategies, intentions or other characterizations of future events or circumstances and are generally identified by the words “may,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “could,” “would,” and similar expressions. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Because these forward-looking statements are subject to a number of risks and uncertainties, IntelGenx’ actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed under the heading “Risk Factors” in IntelGenx’ annual report on Form 10-K, filed with the United States Securities and Exchange Commission and available at www.sec.gov, and also filed with Canadian securities regulatory authorities at www.sedar.com.

IntelGenx assumes no obligation to update any such forward-looking statements. Each of the TSX Venture Exchange and OTCQB has neither approved nor disapproved the contents of this press release. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Source: IntelGenx Technologies Corp.

For IntelGenx:
Stephen Kilmer
Investor Relations
(514) 331-7440 ext 232
[email protected]

Or

Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
[email protected]