Alector to Present at Stifel’s 3rd Annual CNS Day

SOUTH SAN FRANCISCO, Calif., March 25, 2021 (GLOBE NEWSWIRE) — Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, today announced that Shehnaaz Suliman, M.D., MBA, M.Phil., president and chief operating officer of Alector, will participate in a fireside chat at Stifel’s 3rd Annual CNS Day on Thursday, April 1, 2021, at 9:30 a.m. ET.

A live webcast of the fireside chat will be available on the “Events & Presentations” page within the Investors section of the Alector website at http://investors.alector.com. A replay will be available on the Alector website for 30 days following the event.

About Alector

Alector is a clinical stage biotechnology company pioneering immuno-neurology, a novel therapeutic approach for the treatment of neurodegenerative diseases. The Company is developing a broad portfolio of innate immune system programs, designed to functionally repair genetic mutations that cause dysfunction of the brain’s immune system and enable the rejuvenated immune cells to counteract emerging brain pathologies. Immuno-neurology targets immune dysfunction as a root cause of multiple pathologies that are drivers of degenerative brain disorders. The Company’s immuno-neurology product candidates are supported by biomarkers and target genetically defined patient populations in frontotemporal dementia and Alzheimer’s disease. This scientific approach is also the basis for the Company’s immuno-oncology programs. Alector is headquartered in South San Francisco, California. For additional information, please visit www.alector.com.

Contacts

Media:
Erica Jefferson
Vice President, Communications and Public Affairs
Alector, Inc.
301-928-4650
[email protected]

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

or

Investors:
Alector, Inc.
[email protected]



Zealand Pharma to participate in upcoming investor conferences

Company announcement – No. 17 / 2020

Zealand Pharma to participate in upcoming investor conferences

Copenhagen, DK and Boston, MA, U.S.
March 25, 2021 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company focused on the discovery, development and commercialization of innovative peptide-based medicines, today announced that members of its senior management team are scheduled to participate virtually in the following investor conferences in April:

Guggenheim Virtual Healthcare Talks – Genomic Medicines & Rare Disease
Date: Thursday, April 1, 2021
 
20th Annual Virtual Needham Healthcare Conference  
Date: Monday, April 12, 2021  
Presentation: 11:45 a.m. ET/ 4:45 p.m. CET


A live webcast of the Needham event will be available on the “Events & Presentations” page in the Investor section of the Company’s website at https://www.zealandpharma.com/events-presentations. A replay of the webcast will be archived on the Company’s website following the presentation.

# # #

About Zealand Pharma A/S

Zealand Pharma A/S (Nasdaq: ZEAL) (“Zealand”) is a biotechnology company focused on the discovery, development, and commercialization of next generation peptide-based medicines that change the lives of people living with metabolic and gastrointestinal diseases. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market. Zealand’s robust pipeline of investigational medicines includes three candidates in late stage development, and one candidate being reviewed for regulatory approval in the United States. Zealand markets V-Go®, an all-in-one basal-bolus insulin delivery option for people with diabetes. License collaborations with Boehringer Ingelheim and Alexion Pharmaceuticals create opportunity for more patients to potentially benefit from Zealand-invented peptide therapeutics. Zealand was founded in 1998 in Copenhagen, Denmark, and has presence throughout the U.S. that includes key locations in New York, Boston, and Marlborough (MA). For more information about Zealand’s business and activities, please visit http://www.zealandpharma.com.

For further information, please contact:

Zealand Pharma Investor Relations

Claudia Styslinger
Argot Partners
[email protected]

Zealand Pharma Media Relations

David Rosen
Argot Partners
[email protected]



Viridian Therapeutics Reports 2020 Financial Results and Provides Corporate Updates

  • Progressed lead programs VRDN-001 and VRDN-002 towards clinical trials in Thyroid Eye Disease (TED); both IND filings expected by the end of 2021
  • Completed integration and name change to Viridian Therapeutics following October 2020 merger and concurrent financing
  • Ended 2020 with a strong cash position of $127.6 million, and runway into the second half of 2023
  • Strengthened leadership team with the appointment of Dr. Jonathan Violin as CEO and additions of Dr. Barrett Katz as CMO and Dr. Vahe Bedian as Chief Scientist

BOULDER, Colo., March 25, 2021 (GLOBE NEWSWIRE) — Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biopharmaceutical company advancing new treatments for patients suffering from serious diseases but underserved by today’s therapies, today announced financial results for the fourth quarter and year ended December 31, 2020 and provided corporate updates.

“2020 was a transformative year for Viridian. We completed the acquisition of private Viridian Therapeutics and a concurrent financing, revamped our business and added $115.0 million to our balance sheet in the fourth quarter. We have also strengthened our management team and now have multiple product candidates with the potential to become meaningful treatments for patients suffering from TED,” said Jonathan Violin, Ph.D., President and Chief Executive Officer of Viridian. “As we enter 2021, we look forward to reaching important R&D milestones in our TED programs, continuing to build out our team and expanding our pipeline beyond TED.”

Recent Highlights


  • Jonathan Violin, Ph.D. appointed President, CEO and Director
    – Dr. Violin co-founded privately-held Viridian Therapeutics, which was acquired by the Company in October 2020. Dr. Violin also founded and served as CEO of two drug discovery companies, Quellis Biosciences and Dianthus Therapeutics, and co-founded and held several executive positions at Trevena, Inc.


  • Barrett Katz M.D. joined Viridian as Chief Medical Officer (CMO)
    – Dr. Katz is an internationally recognized neuro-ophthalmologist. He comes to Viridian from BridgeBio Pharma, Inc. where he developed therapeutics to treat orphan eye diseases. Prior to BridgeBio, he was CMO at GenSight Biologics where he oversaw early- and late-stage clinical programs.


  • Vahe Bedian, Ph.D. appointed as Chief Scientist
    – Dr. Bedian co-founded privately-held Viridian Therapeutics. Dr. Bedian also co-founded and served as Chief Scientific Officer of Quellis Biosciences and Dianthus Therapeutics. He also previously held leadership positions in therapeutic antibody research and development at AstraZeneca and Pfizer.


  • Changed Company name to Viridian Therapeutics
    –The new name reflects the evolution of the Company and its patient-centric model of innovation.

Development Pipeline Overview and Update

Viridian is developing multiple product candidates to treat patients who suffer from thyroid eye disease (TED), a debilitating auto-immune disease that causes inflammation and fibrosis of the orbit and tissues surrounding the eye which can lead to proptosis, or bulging of the eyes, redness and swelling, double vision, pain, and potential blindness. TED significantly impacts quality of life, imposing a high physical and mental burden on patients. There is currently one Food and Drug Administration (FDA)-approved treatment for TED, which is an intravenously administered monoclonal antibody that targets the insulin-like growth factor-1 receptor (IGF-1R).

Viridian’s most advanced product candidate is VRDN-001, an intravenously administered anti-IGF-1R monoclonal antibody licensed from ImmunoGen, Inc. This antibody had previously been developed in oncology as AVE-1642 and studied in over 100 patients. The pharmacokinetics, pharmacodynamics, safety, and tolerability data from that clinical program has informed the Company’s plans to further evaluate VRDN-001 in TED. Manufacturing is underway and the Company expects to file an IND in the fourth quarter of 2021, with initial proof of concept data in patients expected in the second quarter of 2022.

Viridian’s second product candidate, VRDN-002, is a distinct anti-IGF-1R antibody that incorporates half-life extension technology and is intended for subcutaneous administration. VRDN-002 manufacturing is underway, and the Company expects to file an IND before the end of 2021. The Company expects to initiate clinical development with a Phase 1 single ascending dose trial to explore safety, tolerability, pharmacokinetics, and target engagement of VRDN-002 in healthy volunteers. Data from this trial is expected in mid-year 2022 and the Company expects to initiate the dosing of patients later in 2022.

Viridian is also pursuing multiple hypotheses within the VRDN-003 program that may offer additional improvements to the class of IGF-1R targeted therapeutic antibodies. In addition, the Company continues to advance its efforts beyond IGF-1R and TED and is focused on opportunities that will leverage validated mechanisms, technologies, and modalities to bring new therapeutic options to patients underserved by today’s options. The most advanced of these programs is VRDN-004, a therapeutic antibody program currently in discovery stage. The Company also continues to evaluate other targets and indications for a future VRDN-005 program.

2020 Financial Results

Cash Position and Runway: Cash, cash equivalents and short-term investments were $127.6 million as of December 31, 2020, compared to $30.1 million as of September 30, 2020 and $26.8 million as of December 31, 2019. Viridian believes that its current cash, cash equivalents and short-term investments will be sufficient to fund its operations into the second half of 2023.

Revenue: Revenue was $0.1 million during the fourth quarter and $1.1 million for the year ended December 31, 2020, compared to $0.9 million and $4.5 million, respectively for the comparable periods in 2019. The decrease in revenue was primarily due to a decrease in research and development activities related to legacy microRNA assets that were reimbursable to the Company under a prior collaboration agreement.

Research and Development Expenses: Research and development expenses were $15.3 million for the fourth quarter of 2020 and $28.3 million for the year ended December 31, 2020, compared to $8.4 million and $34.8 million, respectively for the comparable periods in 2019. The increase in research and development expenses during the fourth quarter was primarily attributable to increased license fees related to the Company’s license agreement with Xencor. The year over year decrease in research and development expenses was primarily attributable to a decrease in clinical and related manufacturing development activities primarily associated with the Company’s legacy microRNA programs and decreases in personnel related costs including restructuring charges in 2020. These decreases were partially offset by an increase in licensing fees primarily attributable to the Company’s license agreement with Xencor.

Acquired In-Process Research and Development (IPR&D) Expense: Acquired IPR&D expense was $69.9 million during the fourth quarter of 2020 and for the year ended December 31, 2020. IPR&D expense resulted from the acquisition of private Viridian Therapeutics in October 2020. The acquisition cost allocated to acquired IPR&D with no alternative future use was recorded as expense at the acquisition date. No acquired IPR&D expenses were incurred in 2019.

General and Administrative Expenses: General and administrative expenses were $5.5 million for the fourth quarter of 2020 and $13.3 million for the year ended December 31, 2020, compared to $2.5 million and $11.6 million, respectively for the comparable periods in 2019. The fourth quarter and year over year increases in general and administrative expenses were due primarily to increases in professional and personnel related costs, including consulting and contract labor.

Net Loss: The Company’s net loss was $90.7 million, or $23.07 per share, for the fourth quarter of 2020, and $110.7 million, or $31.13 per share for the year ended December 31, 2020, compared to $10.1 million, or $4.69 per share, for the fourth quarter of 2019 and $41.9 million, or $20.04 per share for the year ended December 31, 2019.

Shares Outstanding: As of March 15, 2021, Viridian had 30,886,700 shares of common stock outstanding on an as-converted basis, which included 7,230,651 shares of common stock and 23,656,049 shares of common stock issuable upon the conversion of 354,823 shares of preferred stock.

Conference Call Information

The Viridian Therapeutics management team will host a conference call and webcast today at 4:30 p.m. ET to provide corporate updates and discuss the Company’s financial results for the fourth quarter and year ended December 31, 2020. To access the call, please dial 877-407-0789 (domestic) or 201-689-8562 (international) and provide the passcode 13717079. A live webcast of the call will be available on the Investors section of the Viridian Therapeutics website at www.viridiantherapeutics.com and a replay of this conference call will be available approximately one hour after its completion.

About Viridian Therapeutics, Inc.

Viridian Therapeutics is a biotechnology company advancing new treatments for patients suffering from serious diseases but underserved by today’s therapies. Viridian’s most advanced program, VRDN-001, is an anti-IGF-1R monoclonal antibody in development for thyroid eye disease (TED), a debilitating auto-immune disease that causes inflammation and fibrosis within the orbit of the eye which can cause double vision, pain, and potential blindness. Patients with severe disease often require multiple remedial surgeries to the orbit, eye muscles and eyelids Viridian is based in Boulder, Colorado, and Waltham, Massachusetts. Learn more about Viridian and our programs at www.viridiantherapeutics.com.

Follow us on Twitter @ViridianThera and on LinkedIn.

Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as, but not limited to, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or other similar terms or expressions that concern Viridian’s expectation, strategy, plans and intentions. Forward-looking statements include, without limitation, statements regarding the Company’s expectations and guidance regarding its business plans and objectives for its product candidates, including the therapeutic potential and clinical benefits thereof, and pipeline, projected cash runway, the timing, progress and plans for the Company’s ongoing and future research and clinical development programs, future regulatory interactions, expectations regarding the timing for data, and the timing of the Company’s IND filings for VRDN-001 and VRDN-002. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our clinical results and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. We may not actually achieve the forecasts disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to the effects from the COVID-19 pandemic on the company’s clinical activities, business and operating results; uncertainty and potential delays related to clinical drug development; smaller than anticipated market opportunities for the company’s product candidates; manufacturing risks; competition from other therapies or products; other matters that could affect the sufficiency of existing cash, cash equivalents and short-term investments to fund operations; the company’s future operating results and financial performance; the timing of pre-clinical and clinical trial activities and reporting results from same; and those risks set forth under the caption “Risk Factors” in the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 12, 2020 and other subsequent disclosure documents filed with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither we, nor our affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.

Viridian Contacts:

Investors:

Dan Ferry
LifeSci Advisors
617-430-7576
[email protected]

Media:

Darby Pearson
Verge Scientific Communications
703-587-0831
[email protected]

 
Viridian Therapeutics, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except share and per share data)

(unaudited)
         
    Three Months Ended

December 31,
  Year Ended

December 31,
    2020   2019   2020   2019
Revenue:                
Collaboration revenue   $ 54     $ 837     $ 735     $ 4,308  
Grant revenue       43     315     153  
Total revenue   54     880     1,050     4,461  
Operating expenses:                
Research and development   15,254     8,417     28,304     34,794  
General and administrative   5,537     2,534     13,265     11,646  
Acquired in-process research and development   69,861         69,861      
Total operating expenses   90,652     10,951     111,430     46,440  
Loss from operations   (90,598 )   (10,071 )   (110,380 )   (41,979 )
Other income (expense):                
Interest and other income   36     123     173     941  
Interest and other expense   (180 )   (170 )   (508 )   (835 )
Net loss   (90,742 )   (10,118 )   (110,715 )   (41,873 )
Change in unrealized gain (loss) on investments       (3 )   (8 )   3  
Comprehensive loss   $ (90,742 )   $ (10,121 )   $ (110,723 )   $ (41,870 )
                 
Net loss   $ (90,742 )   $ (10,118 )   $ (110,715 )   $ (41,873 )
Net loss per share, basic and diluted   $ (23.07 )   $ (4.69 )   $ (31.13 )   $ (20.04 )
Weighted-average shares used to compute basic and diluted net loss per share   3,932,917     2,158,695     3,557,065     2,089,094  
                         

 
Viridian Therapeutics, Inc.

Selected Financial Information

Condensed Consolidated Balance Sheet Data

(amounts in thousands)

(unaudited)
   
  December 31,
  2020   2019
       
Cash and cash equivalents $ 45,897     $ 24,846  
Short-term investments $ 81,742     $ 1,999  
Total assets $ 131,255     $ 30,262  
Notes payable, inclusive of current portion $     $ 8,304  
Total liabilities $ 11,218     $ 14,508  
Total stockholders’ equity $ 120,037     $ 15,754  
               



Phunware Reports Full Year 2020 Financial Results

AUSTIN, Texas, March 25, 2021 (GLOBE NEWSWIRE) — Phunware, Inc. (NASDAQ: PHUN) (“Phunware” or “the Company”), a fully-integrated enterprise cloud platform for mobile that provides products, solutions, data and services for brands worldwide, today announced financial results for its full year ended December 31, 2020.

“This past year was the genesis of an inflection point in our company’s history, as we shifted from a non-recurring, low margin transaction business to a far stickier, more scalable, recurring and high margin SaaS licensing business for our Multiscreen-as-a-Service (“MaaS”) platform,” said Alan S. Knitowski, President, CEO and Co-Founder of Phunware. “In addition to continued enterprise interest in our MaaS Digital Front Door solution for healthcare and our MaaS Smart Workplace solution for corporations, we have resumed conversations with customers from sectors that were hard hit by the pandemic, including the hospitality and real estate verticals. In conjunction with growing our portfolio of direct customers, we intend to expand our footprint globally by amplifying our go-to-market strategy with indirect sales and channel partners, including an anchor distribution partner that will be formally announced during Q2. In parallel, we are excited about the completion of PhunWallet next month as we launch our blockchain ecosystem powered by PhunCoin and PhunToken. We are on schedule to commercialize, scale and monetize this part of our business and look forward to the accelerated global adoption of our blockchain-enabled MaaS Customer Data Platform and MaaS Mobile Loyalty Ecosystem alike.”


Full Year 2020 Summary Financial Highlights

  • Net Revenues for the year totaled $10.0 million
  • Multiscreen-as-a-Service (MaaS) Platform Subscriptions and Services Revenues were $9.1 million
  • Gross Margin was 66.4%
  • Net Loss was ($22.2) million
  • Net Loss per Share was ($0.50)
  • Non-GAAP Adjusted EBITDA Loss was ($8.4) million

“Our executive team continues to proactively attend well-respected financial conferences and meetings with accredited institutional investors in order to bolster our corporate profile within the capital markets,” said Matt Aune, CFO of Phunware. “With a robust cash position as a result of our recently completed institutional financing of approximately $25 million, we now have the financial flexibility to execute both our near-term and long-term operational initiatives.”


Recent Business Highlights


Conference Call Information

Phunware management will host a conference call today (March 25, 2021) at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss its financial results for the full year ended December 31, 2020.

Interested parties may access the conference call by dialing (888) 506-0062 in the United States, or (973) 528-0011 from international locations. The conference call will be broadcast live and available for replay here and via the investor relations section of the Company’s website at investors.phunware.com.

Safe Harbor Clause and Forward-Looking Statements

This press release includes forward-looking statements. All statements other than statements of historical facts contained in this press release, including statements regarding our future results of operations and financial position, business strategy and plans, and our objectives for future operations, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “expose,” “intend,” “may,” “might,” “opportunity,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions that convey uncertainty of future events or outcomes are intended to identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking.

The forward-looking statements contained in this press release are based on our current expectations and beliefs concerning future developments and their potential effects on us. Future developments affecting us may not be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control) and other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors described under the heading “Risk Factors” in our filings with the Securities and Exchange Commission (the “SEC”), including our reports on Forms 10-K, 10-Q, 8-K and other filings that we make with the SEC from time to time. Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. These risks and others described under “Risk Factors” in our SEC filings may not be exhaustive.

By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. We caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and developments in the industry in which we operate may differ materially from those made in or suggested by the forward-looking statements contained in this press release. In addition, even if our results or operations, financial condition and liquidity, and developments in the industry in which we operate are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in subsequent periods.

Disclosure Information

Phunware uses and intends to continue to use its Investor Relations website as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Company’s Investor Relations website, in addition to following the Company’s press releases, SEC filings, public conference calls, presentations and webcasts.

About Phunware, Inc.

Everything You Need to Succeed on Mobile — Transforming Digital Human Experience


Phunware, Inc. (NASDAQ: PHUN)
, is the pioneer of Multiscreen-as-a-Service (MaaS), an award-winning, fully integrated enterprise cloud platform for mobile that provides companies the products, solutions, data and services necessary to engage, manage and monetize their mobile application portfolios and audiences globally at scale. Phunware’s Software Development Kits (SDKs) include location-based services, mobile engagement, content management, messaging, advertising, loyalty (PhunCoin & Phun) and analytics, as well as a mobile application framework of pre-integrated iOS and Android software modules for building in-house or channel-based mobile application and vertical solutions. Phunware helps the world’s most respected brands create category-defining mobile experiences, with more than one billion active devices touching its platform each month. For more information about how Phunware is transforming the way consumers and brands interact with mobile in the virtual and physical worlds, visit https://www.phunware.com, https://www.phuncoin.com, https://www.phuntoken.com, and follow @phunware, @phuncoin and @phuntoken on all social media platforms.

Phunware PR & Media Inquiries:

Email: [email protected]
Phone: (512) 693-4199

Phunware Investor Relations:

Matt Glover and John Yi
Gateway Investor Relations
Email: [email protected]
Phone: (949) 574-3860



Consolidated Balance Sheets

(In thousands, except per share information)

  December 31,

2020
  December 31,

2019
Assets      
Current assets:      
Cash $ 3,940       $ 276    
Accounts receivable, net of allowance for doubtful accounts of $356 and $3,179 at December 31, 2020 and 2019, respectively 664       1,671    
Prepaid expenses and other current assets 304       368    
Total current assets 4,908       2,315    
Property and equipment, net 13       24    
Goodwill 25,900       25,857    
Intangible assets, net 111       253    
Deferred tax asset 537       241    
Restricted cash 91       86    
Other assets 276       276    
Total assets 31,836       29,052    
Liabilities and stockholders’ equity (deficit)      
Current liabilities:      
Accounts payable $ 8,462       $ 10,159    
Accrued expenses 5,353       4,035    
Accrued legal settlement 3,000          
Deferred revenue 2,397       3,360    
PhunCoin deposits 1,202       1,202    
Factored receivables payable       1,077    
Current maturities of long-term debt, net 4,435          
Warrant liability 1,614          
Total current liabilities 26,463       19,833    
Long-term debt 3,762       910    
Long-term debt – related party 195       195    
Deferred tax liability 537       241    
Deferred revenue 2,678       3,764    
Deferred rent 180       83    
Total liabilities 33,815       25,026    
Commitments and contingencies      
Stockholders’ equity (deficit)      
Common stock, $0.0001 par value 6       4    
Additional paid-in capital 144,156       128,008    
Accumulated other comprehensive loss (338 )     (382 )  
Accumulated deficit (145,803 )     (123,604 )  
Total stockholders’ equity (deficit) (1,979 )     4,026    
Total liabilities and stockholders’ equity (deficit) 31,836       29,052    



Consolidated Statements of Operations and Comprehensive Income (Loss)

(In thousands, except per share information)

  Year Ended December 31,
  2020   2019
Net revenues $ 10,001       $ 19,150    
Cost of revenues 3,357       9,020    
Gross profit 6,644       10,130    
Operating expenses:      
Sales and marketing 1,653       2,706    
General and administrative 15,361       15,403    
Research and development 2,628       4,333    
Legal Settlement 4,500          
Total operating expenses 24,142       22,442    
Operating loss (17,498 )     (12,312 )  
Other income (expense):      
Interest expense (3,413 )     (581 )  
Loss on extinguishment of debt (2,158 )        
Fair value adjustment for warrant liabilities 872          
Other income       27    
Total other expense (4,699 )     (554 )  
Loss before taxes (22,197 )     (12,866 )  
Income tax (provision) benefit (2 )     (5 )  
Net loss (22,199 )     (12,871 )  
Cumulative translation adjustment 44       36    
Comprehensive loss $ (22,155 )     $ (12,835 )  
       
Loss per share, basic and diluted $ (0.50 )     $ (0.35 )  
       
Weighted-average common shares used to compute loss per share, basic and diluted 44,269       36,879    



Consolidated Statements of Cash Flows

(In thousands)

  Year Ended December 31,
  2020   2019
Operating activities      
Net loss $ (22,199 )     $ (12,871 )  
Adjustments to reconcile net loss to net cash provided by operating activities:      
Depreciation 11       59    
Amortization of acquired intangibles 142       268    
Amortization of debt discount and deferred financing costs 2,185          
Gain on change in fair value of warrants (872 )        
Loss on sale of digital currencies       4    
Loss on extinguishment of debt 2,158          
Non-cash interest expense 55          
Bad debt (recovery) expense 205       114    
Settlement of accounts payable (453 )        
Stock-based compensation 4,492       1,784    
Deferred income taxes          
Changes in operating assets and liabilities:      
Accounts receivable 796       1,817    
Prepaid expenses and other assets 65       184    
Accounts payable 427       740    
Accrued expenses 1,064       1,133    
Accrued legal settlement 3,000          
Deferred revenue (2,049 )     581    
Net cash used by operating activities (10,973 )     (6,187 )  
       
Investing activities      
Proceeds received from sale of digital currencies       88    
Capital expenditures       (18 )  
Net cash provided by investing activities       70    
       
Financing activities      
Proceeds from borrowings, net of issuance costs 14,815       1,105    
Proceeds from related party bridge loans 560          
Payments on convertible notes (8,418 )        
Payments on related party notes (560 )        
Proceeds from PhunCoin deposits       212    
Net repayments on factoring agreement (1,077 )     (1,357 )  
Proceeds from sales of common stock, net of issuance costs 9,177          
Proceeds from warrant exercises       6,092    
Proceeds from exercise of stock options 99       287    
Series A convertible preferred stock redemptions and dividend payments       (6,240 )  
Net cash provided for financing activities 14,596       99    
       
Effect of exchange rate on cash and restricted cash 46       36    
Net increase (decrease) in cash and restricted cash 3,669       (5,982 )  
Cash and restricted cash at the beginning of the period 362       6,344    
Cash and restricted cash at the end of the period $ 4,031       $ 362    
       
Supplemental disclosure of cash flow information      
Interest paid $ 1,251       $ 603    

  Year Ended December 31,
  2020   2019
Supplemental disclosure of non-cash information      
Issuance of common stock for payment of legal, earned bonus and board of director fees $ 1,283       $ 562    
Issuance of common stock upon partial conversions of Senior Convertible Note $ 2,266       $    
Reacquisition of equity component of Senior Convertible Note $ (1,388 )     $    
Equity classified cash conversion feature of Senior Convertible Note $ 219       $    
Waiver of sponsor promissory note $       $ 1,993    

Non-GAAP Financial Measures and Reconciliation

Adjusted EBITDA should be considered in addition to, not as a substitute for, or superior to, financial measures calculated in accordance with Generally Accepted Accounting Principles in the United States (“GAAP”). It is not a measurement of our financial performance under GAAP and should not be considered as an alternative to net income (loss), as applicable, or any other performance measures derived in accordance with GAAP and may not be comparable to other similarly titled measures of other businesses. Adjusted EBITDA has limitations as an analytical tool and should not be considered in isolation or as a substitute for analysis of our operating results as reported under GAAP. Some of these limitations include: (i) Non-cash compensation is and will remain a key element of our overall long-term incentive compensation package, although we exclude it as an expense when evaluating its ongoing operating performance for a particular period, (ii) Adjusted EBITDA does not reflect the impact of certain charges resulting from matters we consider not to be indicative of ongoing operations, and (iii) other companies in our industry may calculate Adjusted EBITDA differently than we do, limiting their usefulness as comparative measures.

We compensate for these limitations to Adjusted EBITDA by relying primarily on its GAAP results and using Adjusted EBITDA only for supplemental purposes. Adjusted EBITDA includes adjustments for items that may not occur in future periods. However, we believe these adjustments are appropriate because the amounts recognized can vary significantly from period to period, do not directly relate to the ongoing operations of our business and complicate comparisons of our internal operating results and operating results of other peer companies over time. Each of the normal recurring adjustments and other adjustments described in this paragraph help management with a measure of our operating performance over time by removing items that are not related to day-to-day operations or are non-cash expenses.

Reconciliation of GAAP to Non-GAAP Financial Measures

(In thousands)

  Year Ended December 31,
  2020   2019
Net loss $ (22,199 )     $ (12,871 )  
Add back:  Depreciation and amortization 153       328    
Add back:  Interest expense 3,413       581    
Add back/less:  Income tax (expense) benefit 2       5    
EBITDA (18,631 )     (11,957 )  
Add Back: Stock-based compensation 4,492       1,784    
Add Back: Legal settlement 4,500          
Add Back: Loss on extinguishment of debt 2,158          
Less: Fair value adjustment for warrant liabilities (872 )        
Adjusted EBITDA $ (8,353 )     $ (10,173 )  



Supplemental Information

($ In thousands)

  Year Ended December 31,   Change
  2020   2019   Amount   %
Net Revenue          
Platform subscriptions and services $ 9,108     $ 17,243     $ (8,135 )     (47.2 ) %
Application transaction 893     1,907     (1,014 )     (53.2 ) %
Total revenue $ 10,001     $ 19,150     $ (9,149 )     (47.8 ) %
Platform subscriptions and services as a percentage of total revenue 91.1 %   90.0 %        
Application transactions as a percentage of total revenue 8.9 %   10.0 %        

 



Vivos Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Operational Update

Full Year Revenue Increase of 15%

Management to Host Conference Call Today at 5:00 pm ET

HIGHLANDS RANCH, Colo., March 25, 2021 (GLOBE NEWSWIRE) — Vivos Therapeutics, Inc. (“Vivos” or “the Company”) (NASDAQ: VVOS), a medical technology company focused on developing and commercializing innovative treatments for patients suffering from sleep-disordered breathing, including mild-to-moderate obstructive sleep apnea (OSA), today reported financial results for the fourth quarter and full year ended December 31, 2020.

Financial and Operating Highlights:

  • Revenue was $3.3 million for the fourth quarter of 2020 and increased 15% to $13.1 million for the full year 2020, compared to $3.1 million and $11.4 million for the fourth quarter and full year 2019, respectively;
  • Gross profit was $2.7 million for the fourth quarter of 2020 and $10.4 million for the full year 2020, compared to gross profit of $2.2 million for the fourth quarter of 2019 and gross profit of $8.7 million for the full year 2019;
  • Gross margin was 81% for the fourth quarter of 2020 and 80% for the full year 2020, compared to 72% and 76% for the fourth quarter and full year 2019, respectively;
  • General and administrative expenses were $4.6 million for the fourth quarter of 2020 and $16.1 million for the full year 2020, compared to $4.1 million and $16.2 million for the fourth quarter and full year 2019, respectively;
  • Net loss was $6.2 million for the fourth quarter of 2020 and $12.1 million for the full year 2020, compared to $2.6 million for the fourth quarter of 2019 and $10.8 million for the full year 2019;
    • The $1.3 million additional loss in 2020 was primarily due to a non-cash settlement expense of $3.3 million offset by $1.8 million higher gross profit in 2020
  • Cash and cash equivalents were $18.2 million at December 31, 2020;
  • During 2020, Vivos surpassed 15,000 total cases treated with the Vivos System;
  • In December 2020, Vivos completed its initial public offering for net proceeds of approximately $21.6 million, after deducting underwriter discounts and commissions and offering expenses payable by Vivos;
  • Subsequent to year end:
    • Announced the commercial launch of AireO2, a new patient management software technology;
    • In February, submitted FDA 510(k) application for the Vivos mmRNA oral appliance® with indications to treat mild-to-moderate OSA;
    • Also in February, launched VivoScore™, powered by SleepImage®, a comprehensive home sleep test (HST); and
    • In March, opened the first Pneusomnia center, a clinician-owned, integrated medical-dental sleep center featuring the Vivos System.

“Successfully introducing a disruptive technology like ours takes a passionate mission-driven team, sufficient capital resources, and a little time to execute. Last December, we took a huge step forward with the completion of our IPO which provided the financial resources to execute our go-to-market strategy. Despite a global pandemic that closed dental offices across the U.S. and Canada for extended periods of time, our company still produced strong 2020 revenue results. Our positive financial performance reflects the continued growth of dentists enrolling in our Vivos Integrated Practice (VIP) program coupled with substantially higher appliance sales volume,” said Kirk Huntsman, Vivos Chairman and CEO. “We continue to see a gradual but accelerating recovery from office closures caused by the COVID 19 pandemic with increasing adoption of the Vivos System and related services as more dentists and healthcare providers learn about the compelling advantages of our technology. We also continue to increase awareness of our products and services through our marketing initiatives and our Medical Integration Division that creates strategic alliances within the medical and dental communities. In the near term, we will focus on levering our new VivoScore HST diagnostic product that we believe will assist VIPs in screening and treating more patients with our Vivos System. As we announced a few weeks ago, our VivoScore pilot test demonstrated the potential for 50% of patients who test positive for OSA to enter into Vivos System treatment.”

Huntsman added, “We remain fiercely committed to establishing revenue opportunities from complimentary technologies and services.”

Further information on Vivos’ financial results is included on the attached condensed consolidated balance sheets and statements of operations, and additional explanations of Vivos’ financial performance are provided in the Company’s Annual Report on Form 10-K for the twelve months ended December 31, 2020, which will be filed with the Securities and Exchange Commission (“SEC”). The full 10-K report will be available on the SEC Filings section of the Investor Relations section of Vivos’ website at https://vivoslife.com/investor-relations/.

Business Updates

In December 2020, the Company completed its initial public offering by issuing 4,025,000 common shares at a price of $6.00 per share, for net proceeds of approximately $21.6 million, after deducting underwriter discounts and commissions and offering expenses payable by the Company.

In January 2021, Vivos commercially launched AireO2, a new patient management software technology that will enable healthcare professionals to more effectively diagnose, treat and monitor patients with OSA and its related conditions. Developed in collaboration with Lyon Dental, AireO2 contains features that enhance healthcare professionals’ billing services and more, including practice management systems.

Later in January, the Company established a Clinical Advisory Board to further drive adoption and growth of its next-generation treatments for OSA. Members of Vivos’ Clinical Advisory Board include internationally recognized medical and dental industry veterans, who will work closely with management to drive further commercial success.

In early February 2021, Vivos submitted a 510(k) Class II application to the U.S. Food and Drug Administration (FDA) for its mmRNA oral appliance® with indications to treat mild-to-moderate OSA, sleep-disordered breathing and snoring in adults. Vivos’ mmRNA oral appliance® (modified mandibular Repositioning Nighttime Appliance) is a new version of the Company’s existing mRNA appliance®, which is an FDA-cleared Class II oral appliance. Assuming the mmRNA’s 510(k) Class II approval, Vivos expects to submit an application to a PDAC (Pricing, Data Analysis and Coding) contractor for the mmRNA to be added to the Centers for Medicare and Medicaid Services’ list of approved sleep apnea appliances. The process is expected to take approximately three to six months in total, although no assurances can be given as to the timing and outcome of the FDA’s review of this application.

Later in February, the Company launched VivoScore™, powered by SleepImage®. VivoScore is a comprehensive HST that utilizes proprietary cardiopulmonary coupling technology developed by MyCardio LLC (“SleepImage”). VivoScore consists of a single-sensor ring recorder that works with a mobile phone application and proprietary cloud-based algorithms to evaluate sleep quality and clinically diagnose sleep apnea. The Company anticipates increased revenue from VivoScore due to an expected increase in total patients tested and a corresponding increase in patient enrollment in Vivos System treatment. In arriving at that conclusion, the Company is relying on the results of a recently conducted informal pilot study with 12 independent Vivos-trained dentists, who performed 938 sleep-tests over a three-month period using VivoScore, and other Vivos provider feedback, which may or may not prove reliable on a broader scale.

In February 2021, Vivos (through its Medical Integration Division) opened the first Pneusomnia center, a clinician-owned, integrated medical-dental sleep center featuring the Vivos System. This first Pneusomnia center is located in Del Mar, Calif., and is owned and operated by a diverse group of local physicians led by Dr. Mimi Guarneri, cardiologist, founder and president of The Academy of Integrative Health and Medicine and an award-winning physician and researcher. The Company launched its Medical Integration Division in 2020 to foster an environment where more medical doctors could work directly with dentists (including dentists who participate in the VIP program) for treating sleep disorders in patients. Additionally, new Pneusomnia centers are currently being developed in Colorado, California, New Jersey and Nevada.

Conference Call

The Company will conduct a conference call today, March 25, 2021 at 5:00 p.m. (Eastern Time) to review the results as well as provide an overview of the Company’s recent milestones and growth strategy.

To access the conference call, please dial (877) 451-6152, or for international callers, (201) 389-0879. A replay will be available shortly after the call and can be accessed by dialing (844) 512-2921, or for international callers, (412) 317-6671. The passcode for the live call and the replay is 13717735. The replay will be available until April 8, 2021.

A live webcast of the conference call can be accessed on Vivos’ website at https://vivoslife.com/investor-relations/. An online archive of the webcast will be available on the Company’s website for 30 days following the call.

About Vivos Therapeutics, Inc.

Vivos Therapeutics Inc. (NASDAQ: VVOS) is a medical technology company focused on developing and commercializing innovative treatments for adult patients suffering from sleep-disordered breathing, including obstructive sleep apnea (OSA). The Vivos treatment for mild-to-moderate OSA involves customized oral appliances and protocols called the Vivos System. Vivos believes that its Vivos System oral appliance technology represents the first clinically effective non-surgical, non-invasive, non-pharmaceutical and cost-effective solution for people with mild-to-moderate OSA. Vivos oral appliances have proven effective in over 15,000 patients treated worldwide by more than 1,200 trained dentists. Combining technologies and protocols that alter the size, shape and position of the tissues of a patient’s upper airway, the Vivos System opens airway space and significantly reduce symptoms and conditions associated with mild-to-moderate OSA. The Vivos System has been shown to significantly lower Apnea Hypopnea Index scores and improve other conditions associated with OSA. The Vivos Integrated Practice (VIP) program offers dentists training and other value-added services in connection with using the Vivos System.

For more information, visit www.vivoslife.com.

Cautionary Note Regarding Forward-Looking Statements

This press release, the conference call referred to herein, and the statements of the Company’s management made in connection therewith contain “forward-looking statements” (as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended) concerning future events, particularly with respect to the public offering described herein. Words such as “may”, “should”, “expects”, “intends”, “plans”, “believes”, “anticipates”, “hopes”, “estimates” and variations of such words and similar expressions are intended to identify forward-looking statements. These statements involve known and unknown risks and are based upon a number of assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond the Company’s control. Actual results (including the actual results of the Company’s growth strategies, operational plans, results of operations and other matters to be addressed herein and on the conference call) may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, the risk factors described in Vivos’ filings with the Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K for the year ended December 31, 2020. Vivos’ filings can be obtained free of charge on the SEC’s website at www.sec.gov. Except to the extent required by law, Vivos expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Vivos’ expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

Investor Relations Contact:

Edward Loew
Investor Relations Officer
(602) 903-0095
[email protected]

Media Relations Contact:

Caitlin Kasunich / Jenny Robles
KCSA Strategic Communications
(212) 896-1241 / (212) 896-1231
[email protected] / [email protected]

VIVOS THERAPEUTICS, INC. AND SUBSIDIARIES
               
Consolidated Statements of Operations
    Year Ended
    December 31,
    2020     2019
             
Revenue              
Product revenue   $ 4,889,840       $ 4,349,623  
Service revenue     8,176,397         7,043,654  
Total revenue     13,066,237         11,393,277  
Cost of sales (exclusive of depreciation and amortization shown separately below)     2,653,429         2,736,034  
               
Gross profit     10,412,808         8,657,243  
               
Operating expenses              
General and administrative     16,090,049         16,172,505  
Sales and marketing     2,314,023         2,310,743  
Settlement     3,330,679          
Depreciation and amortization     717,865         751,228  
Total operating expenses     22,452,616         19,234,476  
               
Operating loss before interest expense and income taxes     (12,039,808 )       (10,577,233 )
               
Interest expense     (96,681 )       (137,876 )
Loss on sale of business             (60,343 )
Interest income     79,612         21,133  
               
Loss before income taxes     (12,056,877 )       (10,754,319 )
Income tax expense              
               
Net loss     (12,056,877 )       (10,754,319 )
               
Warrant beneficial conversion feature expense     (3,597,585 )        
Preferred stock accretion     (2,333,333 )       (1,000,000 )
               
Net loss attributable to common stockholders   $ (17,987,795 )     $ (11,754,319 )
               
Net loss per share attributable to common stockholders (basic and diluted)   $ (1.40 )     $ (0.95 )
               
Weighted average number of shares of Common Stock outstanding (basic and diluted)     12,869,266         12,331,280  
               

VIVOS THERAPEUTICS, INC. AND SUBSIDIARIES
         
Consolidated Balance Sheets
    December 31,   December 31,
      2020       2019  
         
ASSETS        
         
         
Current assets        
Cash and cash equivalents   $ 18,205,668     $ 469,353  
Accounts receivable, net     1,430,890       871,290  
Current portion of note receivable     84,696       84,696  
Deferred offering costs           263,814  
Prepaid expenses and other current assets     673,061       295,002  
Total current assets     20,394,315       1,984,155  
         
Property and equipment, net     871,597       1,139,501  
Intangible assets, net     270,121       689,151  
Note receivable, net – related party     810,635       785,061  
Goodwill     2,671,434       2,671,434  
Deposits     309,367       282,235  
Total assets   $ 25,327,469     $ 7,551,537  
         
LIABILITIES AND STOCKHOLDER’S EQUITY        
Current liabilities        
Accounts payable   $ 781,364     $ 1,083,422  
Accounts payable – related party     1,500,000        
Accrued expenses     1,736,721       1,353,161  
Contract liability     2,937,992       2,947,565  
Current portion of long-term debt     866,972       3,709,535  
Total current liabilities     7,823,049       9,093,683  
         
Long-term debt     423,095        
Deferred rent     163,966       84,246  
Total liabilities     8,410,110       9,177,929  
         
Commitments and contingencies        
         
Convertible Redeemable Series A Preferred Stock – $0.0001 par value. 50,000,000 shares authorized, none and 730,000 shares issued and outstanding at December 31, 2020 and 2019, respectively           1,316,667  
         
Stockholders’ equity        
Preferred Stock        
Series B, nonvoting – $0.0001 par value, 1,200,000 authorized, none issued and outstanding at December 31, 2020 and 2019, respectively            
Common Stock        
Class A, voting – $0.0001 par value, 200,000,000 shares authorized, 18,209,452 and 12,444,165 issued and outstanding at December 31, 2020 and 2019, respectively     1,821       1,244  
Additional paid-in capital     52,250,266       20,333,548  
Accumulated deficit     (35,334,728 )     (23,277,851 )
Total stockholders’ equity     16,917,359       (2,943,059 )
Total liabilities and stockholders’ equity   $ 25,327,469     $ 7,551,537  
         



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]