Ideanomics Announces MEG October & Q4 Sales Activity

– A total of 102 units delivered in October

– Units delivered were from the taxi and ride hailing segment

– Orders continue to be received for the fourth quarter

PR Newswire

NEW YORK, Nov. 16, 2020 /PRNewswire/ — Ideanomics (NASDAQ: IDEX) (“Ideanomics” or the “Company”) announces its Mobile Energy Global (MEG) division’s sales activities for the month of October.

For the period starting October 1, 2020, through October 31, 2020, MEG delivered a total of 102 units, all of which were taxi/ride-hailing vehicles. The 340 units that were invoiced during July through September 2020 are still pending expected delivery. During the month of October, China had two major national holidays overlap, which resulted in fewer business days. As a result, it was expected to be a lower delivery volume month.

“As we enter the final months of 2020, our sales efforts are focused on progressing opportunities for larger vehicle orders towards completion, and expanding our deliveries into battery systems and charging piles as part of testing programs with our customers and partners,” said Mr. Alf Poor, CEO of Ideanomics. “As we look to round out Q4 and 2020, our goal is to deliver quarter over quarter growth while building our order book so that we can hit the ground running in 2021.”

About Ideanomics

Ideanomics is a global company focused on the convergence of financial services and industries experiencing technological disruption. Our Mobile Energy Global (MEG) division is a service provider which facilitates the adoption of electric vehicles by commercial fleet operators through offering vehicle procurement, finance and leasing, and energy management solutions under our innovative sales to financing to charging (S2F2C) business model. Ideanomics Capital is focused on disruptive fintech solutions for the financial services industry. Together, MEG and Ideanomics Capital provide our global customers and partners with leading technologies and services designed to improve transparency, efficiency, and accountability, and our shareholders with the opportunity to participate in high-potential, growth industries.

The company is headquartered in New York, NY, with offices in Beijing, Hangzhou, and Qingdao, and operations in the U.S., China, Ukraine, and Malaysia.

Safe Harbor Statement
This press release contains certain statements that may include “forward looking statements”. All statements other than statements of historical fact included herein are “forward-looking statements.” These forward-looking statements are often identified by the use of forward-looking terminology such as “believes,” “expects” or similar expressions, involve known and unknown risks and uncertainties, and include statements regarding our intention to transition our business model to become a next-generation financial technology company, our business strategy and planned product offerings, our intention to phase out our oil trading and consumer electronics businesses, and potential future financial results. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. You should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of risks and uncertainties, such as risks related to: our ability to continue as a going concern; our ability to raise additional financing to meet our business requirements; the transformation of our business model; fluctuations in our operating results; strain to our personnel management, financial systems and other resources as we grow our business; our ability to attract and retain key employees and senior management; competitive pressure; our international operations; and other risks and uncertainties disclosed under the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our most recent Form 10-K and Form 10-Q filed with the Securities and Exchange Commission, and similar disclosures in subsequent reports filed with the SEC, which are available on the SEC website at www.sec.gov. All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these risk factors. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.

Investor Relations and Media Contact

Ideanomics, Inc.
Tony Sklar, SVP of Investor Relations
1441 Broadway, Suite 5116, New York, NY 10018
[email protected]

Valerie Christopherson / Lora Wilson
Global Results Communications (GRC)
+1 949 306 6476
[email protected] 

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SOURCE Ideanomics

Brooks to Participate in the Stephens Annual Investment Virtual Conference 2020

PR Newswire

CHELMSFORD, Mass., Nov. 16, 2020 /PRNewswire/ — Brooks Automation, Inc. (Nasdaq: BRKS) announced today that company management will participate in Stephens Annual Investment Conference 2020 on Thursday, November 19, 2020 which includes a 45-minute webcast beginning at 9:00 a.m. ET.  The live webcast can be accessed through the Brooks investor relations website at www.brooks.investorroom.com/events.  A replay of the webcast will be available following the event.

About Brooks Automation
Brooks (Nasdaq: BRKS) is a leading provider of life science sample-based solutions and semiconductor manufacturing solutions worldwide.  The Company’s Life Sciences business provides a full suite of reliable cold-chain sample management solutions and genomic services across areas such as drug development, clinical research and advanced cell therapies for the industry’s top pharmaceutical, biotech, academic and healthcare institutions globally.  Brooks Life Sciences’ GENEWIZ division is a leading provider of gene sequencing and gene synthesis services.  With over 40 years as a partner to the semiconductor manufacturing industry, Brooks is a provider of industry-leading precision vacuum robotics, integrated automation systems and contamination control solutions to the world’s leading semiconductor chip makers and equipment manufacturers.  Brooks is headquartered in Chelmsford, MA, with operations in North America, Europe and Asia.  For more information, visit www.brooks.com.

INVESTOR CONTACTS:

Mark Namaroff

Director, Investor Relations
Brooks Automation
978.262.2635
[email protected]

Sherry Dinsmore

Brooks Automation
978.262.2400
[email protected]

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SOURCE Brooks Automation

Graybug Vision to Participate in the 32nd Annual Piper Sandler Healthcare Conference

REDWOOD CITY, Calif., Nov. 16, 2020 (GLOBE NEWSWIRE) — Graybug Vision, Inc. (Nasdaq: GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve, today announced that Fred Guerard, PharmD, Chief Executive Officer of Graybug Vision, will participate in a fireside chat in advance of the virtual Piper Sandler Healthcare Conference, being held December 1-3, 2020.

A recording of the fireside chat will be accessible beginning November 23, 2020 by visiting IR Events & Presentations in the Investors and Media section of the company’s website at https://investors.graybug.vision/news-events/events-presentations. The recording will be available on the Graybug website for 14 days following the conference.

About Graybug
Vision

Graybug is a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve. The company’s proprietary ocular delivery technologies are designed to maintain effective drug levels in ocular tissue for six months and potentially longer, improving disease management, reducing healthcare burdens and ultimately delivering better clinical outcomes. Graybug’s lead product candidate, GB-102, a microparticle depot formulation of the pan-vascular endothelial growth factor (VEGF) inhibitor, sunitinib malate, targeting a six-month or longer dosing regimen, inhibits multiple neovascular pathways for the intravitreal treatment of retinal diseases, including wet age-related macular degeneration. Graybug is also using its proprietary technologies to develop GB-401, an injectable depot formulation of a beta-adrenergic blocker prodrug, for primary open-angle glaucoma, with a dosing regimen of once every six months or longer, and GB-103, a longer-acting version of GB-102, designed to maintain therapeutic drug levels in the retinal tissue for 12 months with a single injection. Founded in 2011 on the basis of technology licensed from the Johns Hopkins University School of Medicine, Graybug is headquartered in Redwood City, California. For more information, please visit www.graybug.vision.

Investor Contact

[email protected]

(650) 487-2409

Media Contact

[email protected]

(404) 384-0067



VERB Reports Record-Breaking Digital Revenues in 2020 Third Quarter Financial Results


  • SaaS recurring revenue up 16% sequentially and 55% year over year


  • Six


    c


    onsecutive


    q


    uarters of


    c


    onsistent SaaS


    r


    ecurring


    r


    evenue


    g


    rowth

  • Highest level of quarterly Digital revenue, up 9% sequentially and 28% year over year

  • Completed


    a


    ccretive


    a


    cquisition of SoloFire, a leading platform for healthcare


    and life sciences


    sales enablement

  • VERB platform continues to gain traction and grow user downloads


    – now up to 1.65M

  • verbLIVE now fully integrated with Salesforce platform


    and available on Salesforce AppExchange


    – joint marketing campaign underway

  • Microsoft Outlook integration underway

  • verbTEAMS – a new entrepreneur and small business CRM with verbLIVE launches today

  • Several new hyper growth revenue catalysts


    to be


    revealed


    during scheduled earnings call

NEWPORT BEACH, Calif. and SALT LAKE CITY, Nov. 16, 2020 (GLOBE NEWSWIRE) — VERB Technology Company, Inc. (Nasdaq: VERB) (“VERB” or the “Company”), a leader in interactive video-based sales enablement applications, including interactive livestream ecommerce, webinar, CRM, and marketing applications for entrepreneurs and enterprises, today reported financial and operating results for the three months ended September 30, 2020. 

Management Commentary

“The third quarter continues what has been a tremendously successful 2020 for VERB,” said Rory J. Cutaia, CEO of VERB. “We’ve now delivered six consecutive quarters of SaaS revenue growth and we’re reporting our highest level of quarterly digital revenue to date. Our successful financial results reflect our continued focus on our higher-margin SaaS business applications.

“While our third quarter results demonstrate the continued growth in adoption and deployment of our verbCRM application among large sales enterprises, verbLIVE, our interactive video-based livestream ecommerce and webinar product, continues to draw significant interest, setting the stage for what we expect will be explosive revenue growth throughout 2021.

“We also successfully completed several strategic initiatives during the quarter. We completed the accretive acquisition of SoloFire, which gives us an immediate entry into the lucrative medical and life sciences sales market. We completed the integration of verbLIVE into the Salesforce platform. We also completed the inclusion of verbLIVE in the Salesforce AppExchange marketplace, expanding our distribution channels by making verbLIVE available to all Salesforce users. We significantly increased the number of user downloads both sequentially and year over year, and during today’s earnings call, we will announce several hyper-growth initiatives to drive revenue during the balance of this year and throughout 2021 and beyond,” Mr. Cutaia continued.

Thir
d Quarter
2020
and
Recent
Company
Highlights

  • Completed accretive acquisition of SoloFire, which develops and markets leading SaaS-based sales enablement applications for sales representatives of medical device, diagnostics and life sciences companies. With strong customer relationships and a proven product that increases sales productivity and marketing effectiveness, SoloFire’s natural strategic fit gives VERB an immediate entry into the lucrative medical and life sciences sales market, one of the largest and fastest growing markets for the sales enablement software industry.  
  • SaaS recurring revenue of approx. $1.5 million, up 16% over Q2 and up 55% from third quarter 2019.
  • Total Digital revenue of approx. $1.84 million, up almost 10% over Q2 and up 28% from third quarter 2019.
  • Total Non-Digital revenue of approx. $1.0 million, up almost 5% over Q2.
  • Total combined revenue of approx. $2.9 million, up almost 8% over Q2.
  • Added 16 new client contracts with a guaranteed base value of $834,000 and almost $500,000 in annual recurring revenue.
  • Six consecutive quarters of SaaS revenue growth.
  • On a pro forma basis, total SaaS revenue for the first nine months of 2020 was $4.5 million – up 33% from $3.4 million reported for the same period last year.
  • On a pro forma basis, total Digital revenue for the first nine months of 2020 was $5.7 million – an increase of almost 20% from $4.7 million reported for the same period last year.
  • Total user downloads now at 1.65M, up from approximately 1.49M reported in the second quarter 2020, and up from 720,000 for the same period last year.
  • Added Market America | SHOP.COM to growing roster of clients.
  • Completed the integration of livestream ecommerce application verbLIVE, with the platform of enterprise CRM giant Salesforce.
  • verbLIVE added to Salesforce’s AppExchange Partner Program.
  • Strengthened executive leadership team with appointments of Kym Nelson, Mitch Bledsoe and Julie Holdren.
  • VERB added to the Russell Microcap® Index as part of the 2020 Russell indexes annual reconstitution.
  • In July, VERB closed an underwritten public offering of common stock for gross proceeds of approximately $13.8 million, including full exercise of the underwriter’s over-allotment option to purchase additional shares.
  • Launched Verb For Humanity as part of a continuing and growing commitment to its ESG initiatives.

Financial Results


Three Months Ended September 30, 2020

  • Total Digital revenue was $1.8 million, an increase of 28% from the same quarter last year and an increase of almost 10% from the prior quarter.
  • Total SaaS recurring revenue (a component of total Digital revenue) was $1.5 million, an increase of 55% from the same period last year and increase of 16% from the prior quarter. SaaS recurring revenue as a percentage of total Digital revenue was 80%, compared with 66% for the same period last year.
  • Total revenue was $2.9 million, in line with revenue for the same period last year, but reflecting the Company’s strategic change in revenue mix with a substantially higher percentage of its revenue, approximately $400,000, coming from its digital applications business.
  • Cost of
    revenue was $1.3 million, a decrease of 12.5% from $1.5 million for the same period last year.
  • Research and development expenses were $2.4 million, almost double the $1.2 million for the same period last year. The increase was attributable to the development of verbLIVE and enhancements to verbCRM and VERB’s core platform to facilitate native integrations with Salesforce, Microsoft, and other channel partners.
  • General and administrative expenses were $6.7 million, approximately double the $3.3 million for the same period last year, reflecting increases in stock-based compensation expense and labor-related costs to support growth, as well as expenses related to the acquisition of SoloFire.
  • Cash totaled $10.7 million as at September 30, 2020, compared with $983,000 at December 31, 2019.

Conference Call
Information

VERB management will hold a conference call on Monday, November 16, 2020, at 5:30 PM Eastern time, to discuss its results in greater detail. A telephonic replay of the conference call is available from 8:30 PM Eastern time on the same day through November 30, 2020.

Live Call:

Date: Monday, November 16, 2020
Time: 5:30 PM Eastern time (2:30 PM Pacific time)
U.S. dial-in number: 1-877-407-4018
International number: 1-201-689-8471

Replay:

Toll-free replay number: 1-844-512-2921
International replay number: 1-412-317-6671
Replay ID: 13712506

The Company filed its Form 10-Q on November 16, 2020 and will file a transcript of the conference call on Form 8-K. These filings can be viewed in the Investor Relations section of VERB’s website.

About VERB

VERB Technology Company, Inc. (Nasdaq: VERB) transforms how businesses attract and engage customers. The Company’s Software-as-a-Service, or SaaS, platform is based on its proprietary interactive video technology, and comprises a suite of sales enablement business software products offered on a subscription basis. Its software applications are available in over 60 countries and in more than 48 languages to large enterprise and small business sales teams that need affordable, easy-to-use, and quick-to-get-results sales tools. Available in both mobile and desktop versions, the applications are offered as a fully integrated suite, as well as on a standalone basis, and include verbCRM (Customer Relationship Management application), verbLEARN (Learning Management System application), and verbLIVE (Interactive Livestream eCommerce and Video Webinar application). The Company has offices in California and Utah. For more information, please visit: www.verb.tech.

FORWARD LOOKING STATEMENTS

This press release contains forward-looking statements that involve risks and uncertainties. These forward-looking statements involve risks and uncertainties. If any of these risks or uncertainties materialize, or if any of our assumptions prove incorrect, our actual results could differ materially from the results expressed or implied by these forward-looking statements. These risks and uncertainties include risks associated with: the COVID-19 pandemic and related public health measures on our business, customers, markets and the worldwide economy; our plans to attract new customers, retain existing customers and increase our annual revenue; the development and delivery of new products, including verbLIVE; our plans and expectations regarding software-as-a-service offerings; our ability to execute on, integrate, and realize the benefits of any acquisitions; fluctuations in our quarterly results of operations and other operating measures; increasing competition; general economic, market and business conditions; and the risks described in the filings that we make with the Securities and Exchange Commission (“SEC”) from time to time, including the risks described under the headings “Risk Factors” and “Management Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K, which was filed with the SEC on May 14, 2020, as amended by Amendment No. 1 on Form 10-K/A to our Annual Report on Form 10-K, which was filed with the SEC on June 4, 2020, and which should be read in conjunction with our financial results and forward-looking statements contained therein, and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, which was filed with the SEC on November 16, 2020, and which should be read in conjunction with our financial results and forward-looking statements contained therein. All forward-looking statements in this press release are based on information available to us as of the date hereof, and we do not assume any obligation to update the forward-looking statements provided to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Investor Relations Contact:

888.504.9929
[email protected]

Media Contact:
855.250.2300, ext.107
[email protected]

                 
                 
Select Unaudited Pro Forma Performance Metrics By Quarter – as Filed
                 
          2019 2020    
  Q1 Q2 Q3 Q4   Q1 Q2 Q3
Total User Downloads 550,620 668,272 717,066 855,859   1,313,467 1,458,934 1,562,378
                 
SaaS Recurring Rev $       786,000 $       858,000 $       953,000 $       995,000 $      3,592,000 $   1,057,000 $   1,274,000 $   1,478,000
Other Digital 273,000 596,000 485,000 344,000 1,698,000 400,000 406,000 360,000
Total Digital Revenue $   1,059,000 $   1,454,000 $   1,438,000 $   1,339,000 $      5,290,000 $   1,457,000 $   1,680,000 $   1,838,000
                 
Welcome Kits & Fulfillment $   2,265,000 $   1,784,000 $   1,164,000 $       965,000 $      6,178,000 $       728,000 $       713,000 $       836,000
Shipping 677,000 495,000 271,000 181,000 1,624,000 169,000 259,000 186,000
Total Non-Digital Revenue $   2,942,000 $   2,279,000 $   1,435,000 $   1,146,000 $      7,802,000 $       897,000 $       972,000 $   1,022,000
                 
Total Combined Revenue  $   4,001,000 $   3,733,000 $   2,873,000 $   2,485,000 $   13,092,000 $   2,354,000 $   2,652,000 $   2,860,000
Digital Revenue as a % of
Total Combined Revenue
  26%   39%   50%   54%       62%   63%   64%



Surgalign Holdings and Aziyo Biologics Announce Expanded Distribution Agreement

Updated agreement expands availability of ViBone® Moldable, a next generation moldable cellular bone matrix product

DEERFIELD, Ill. and SILVER SPRING, Md., Nov. 16, 2020 (GLOBE NEWSWIRE) — Surgalign Holdings, Inc. (Nasdaq: SRGA), a global pure-play spine company focused on advancing spine surgery including through the application of digital technologies to improve patient outcomes, and Aziyo Biologics, Inc. (Nasdaq: AZYO), a commercial-stage regenerative medicine company, today announced an updated distribution agreement and expanded product offering whereby Aziyo will provide ViBone® Moldable to Surgalign for distribution in the U.S. ViBone Moldable joins Surgalign’s orthobiologic solutions to support spinal fusion, which currently include ViBone and other advanced bone graft solutions.

More about
ViBone
Moldable

Similar to ViBone, ViBone Moldable is a next-generation viable cell bone matrix processed using a proprietary method optimized to protect and preserve the health of native bone cells to potentially enhance new bone formation. It contains cancellous bone particles as well as demineralized cortical bone particles and fibers, delivering the necessary components for bone formation (osteoinduction, osteoconduction and osteogenesis) along with excellent handling and cohesive properties.

“We are excited about the addition of ViBone Moldable to Surgalign’s bone grafting solutions to enhance our surgeon customer experience. ViBone Moldable combines Aziyo’s expertise in viable cellular allograft bone matrix processing with handling enhancements for a better operating room experience,” said Terry Rich, President and Chief Executive Officer of Surgalign Holdings. “With this addition, Surgalign continues to focus on delivering innovative solutions for improved patient outcomes.”

“We are delighted to have the opportunity to expand our existing relationship with Surgalign, and to deliver the benefits of ViBone Moldable through their commercial organization,” said Ron Lloyd, President and CEO of Aziyo. “The orthopedic and spinal repair market is estimated to be a $2 billion market opportunity, with 1.5 million annual orthopedic and spinal repair procedures using biologic materials. We are confident that ViBone Moldable will be a great addition to the Surgalign portfolio of viable bone matrices addressing this significant market need.”

About Surgalign Holdings, Inc.

Surgalign Holdings, Inc. is a global medical technology company advancing the science of spine care, focused on delivering innovative solutions that drive superior clinical and economic outcomes. The company is building off a legacy of high quality and differentiated products, and continues to invest in clinically validated innovation to deliver better surgical outcomes and improve patient’s lives. Surgalign markets products throughout the United States and in more than 50 countries worldwide through an expanding network of top independent distributors. Surgalign, a member of AdvaMed, is headquartered in Deerfield, IL, with commercial, innovation and design centers in San Diego, CA, Marquette, MI, and Wurmlingen, Germany. Learn more at www.surgalign.com and connect on LinkedIn and Twitter.

About Aziyo Biologics

Aziyo Biologics is a commercial-stage regenerative medicine company focused on creating the next generation of differentiated products and improving outcomes in patients undergoing surgery, concentrating on patients receiving implantable medical devices. Since its founding in 2015, Aziyo Biologics has created a portfolio of commercial-stage products used in cardiovascular, orthopedic, and reconstructive specialties. For more information, visit www.Aziyo.com.

Forward Looking Statement

This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the addressable market and Surgalign’s and Aziyo’s ability to satisfy this need. These forward-looking statements are based on Surgalign’s and Aziyo’s management’s current expectations, estimates and projections about their industry, their respective management’s beliefs and certain assumptions made by such management. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “will” and variations of such words and similar expressions are intended to identify such forward-looking statements. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in Surgalign’s and Aziyo’s public filings with the U.S. Securities and Exchange Commission including, but not limited to, those described under the section entitled “Risk Factors” of such filings. Any such forward-looking statements speak as of the date of this press release. Actual results may differ materially from the anticipated results reflected in these forward-looking statements. Except as required by applicable law, neither Surgalign nor Aziyo undertake any obligation to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Surgalign Investor Contact:   Aziyo Investor Contact:   Aziyo Media Contact:
Jonathon Singer   Leigh Salvo or Caroline Paul   Courtney Guyer
Investor and Media Contact   Gilmartin Group   Aziyo Biologics, Inc.
[email protected]   [email protected]   [email protected]
+1 224 303 4651        



PLx Pharma Inc. Reports Third Quarter 2020 Results and Provides Business Update

–Announces $18 million private placement–

–Submitted sNDAs for VAZALORE 325 mg and 81 mg doses to FDA end of October–

–On target for third quarter 2021 commercial launch of VAZALORE–

SPARTA, N.J., Nov. 16, 2020 (GLOBE NEWSWIRE) — PLx Pharma Inc. (NASDAQ: PLXP) (“PLx” or the “Company”), a late-stage specialty pharmaceutical company focused on its clinically-validated and patent-protected PLxGuard™ drug delivery platform to provide more effective and safer products, with its lead products VAZALORE™ 325 mg and VAZALORE™ 81 mg (referred to together as “VAZALORE”), announced today certain financial and operational results for the three and nine months ended September 30, 2020.

Highlights of, and certain events subsequent to, the third quarter of 2020 include:

  • Entered into an $18 million private placement with investors led by White Rock Capital Management, L.P. and Level One Partners, LLC;
  • Submitted supplemental New Drug Applications (“sNDAs”) for VAZALORE 325 mg and 81 mg doses to the U.S. Food and Drug Administration (“FDA”) for regulatory approval at the end of October ahead of previously announced timeline; and
  • Targeting commercial launch of both VAZALORE 325 mg and 81 mg doses for the third quarter of 2021, assuming FDA approval, adequate capital funding and no COVID-related delays.

“The submission of our two sNDAs marks a significant milestone for PLx in our efforts to bring VAZALORE, our novel aspirin therapy to market. While VAZALORE is under regulatory review, we will continue our precommercial activities focused on specialists treating vascular disease, retailers and consumers. Our upcoming priorities are to execute our commercial strategy for a successful product launch that will bring this much-needed aspirin alternative to the millions of at-risk patients,” said Natasha Giordano, President and Chief Executive Officer of PLx.

Private Placement

On November 16, 2020, the Company entered into a securities purchase agreement for the sale of units comprised of shares of common stock and a warrant to purchase shares of common stock in a private placement that will result in gross proceeds to the Company of approximately $18 million, before deducting placement agent and other offering expenses, for the issuance of 4,755,373 shares of common stock and warrants to purchase up to an additional 5,230,910 shares of common stock for a per unit price of $3.787. The private placement is expected to close on or prior to November 18, 2020. The warrants will become exercisable on the date of issuance, have an exercise price of $4.31 per share and will expire five years from the date of issuance.

“We are pleased to be leading the financing in support of PLx and VAZALORE, as the Company advances its innovative aspirin product through the regulatory process and prepares for market entry. With management’s extensive experience launching large, commercially successful products, we are confident in PLx’s ability to execute its strategic plan and to take full advantage of the significant market opportunity for VAZALORE,” stated Tom Barton, White Rock Capital Management, L.P.

Third
Quarter 20
20
Financial
Results

The Company recognized no revenue for the three months ended September 30, 2020, compared to revenue of $41,106 for the three months ended September 30, 2019. Revenue in the 2019 period is attributable to work performed under a federal grant from the National Institutes of Health (“NIH”), which came to an end in the second quarter of 2020.

Research and development expense totaled $1.2 million in the three months ended September 30, 2020 and 2019. The expense in the 2020 period includes clinical-related spending for the bioequivalence study combined with pre-validation manufacturing costs. The prior year period included manufacture and packaging costs for the VAZALORE registration batches.

General and administrative expenses totaled $2.0 million in the three months ended September 30, 2020, compared to $2.5 million in the prior year period. The decrease primarily reflects lower compensation-related expenses combined with reduced spending on conferences and related travel due to COVID-19 restrictions.

Other income (expense), net, totaled $61,847 and $5.4 million of net other income in the three months ended September 30, 2020 and 2019, respectively. The decrease is largely attributable to the non-cash change in fair value of warrant liability primarily due to the fluctuation of the price of the Company’s common stock, combined with lower net interest expense, which was impacted by a lower principal debt balance and lower interest rates.

Net loss attributable to common stockholders for the third quarter of 2020 was $3.6 million, or ($0.40) per basic and diluted share, compared to net income of $1.4 million, or $0.09 per share, for the third quarter of 2019. The third quarter of 2020 includes non-cash income of $134,552, or $0.01 per share, related to the change in fair value of warrant liability and $0.5 million, or ($0.05) per share, of Series A and Series B convertible preferred stock dividends. The third quarter of 2019 included non-cash income of $5.5 million, or $0.55 per share, related to the change in the warrant liability and $0.3 million, or ($0.03) per share, for preferred stock dividends related to the Series A convertible preferred stock.

Nine Months Ended September 30
, 2020
Financial Results

For the nine months ended September 30, 2020, revenue was $30,430 compared to $541,571 in the comparable period in 2019. All the revenue recognized is attributable to work performed under an award of an NIH grant, which came to an end in the second quarter of 2020.

Research and development expense decreased to $3.1 million for the nine months ended September 30, 2020, compared to $3.8 million for the first nine months of 2019. The decrease is due to lower manufacturing-related activities for VAZALORE, as the prior year included the manufacture and packaging of the registration batches. The decrease also reflects lower reimbursable grant expenses, as the grant from the NIH came to an end in the second quarter 2020. Higher clinical-related spending, primarily for the bioequivalence study, partially offset this decrease.  

General and administrative expense totaled $6.7 million for the nine months ended September 30, 2020, compared to $7.2 million in the comparable 2019 period. The decrease was due to compensation-related expense and reduced spending on conferences and related travel due to COVID-19 restrictions, offset somewhat by higher spending on pre-launch marketing activities and higher stock compensation expense.

Other income (expense), net was $2.5 million of net other income for the first nine months of 2020, compared to $8.1 million of net other expense for the first nine months of 2019. The difference is largely attributable to the non-cash change in fair value of warrant liability, primarily due to the fluctuation of the price of the Company’s common stock, combined with lower net interest expense due to lower interest rates and a lower principal debt balance.

Net loss attributable to common stockholders for the nine months ended September 30, 2020 was $8.5 million, or ($0.92) per share, compared to net loss attributable to common stockholders of $31.9 million, or ($3.60) per share, for the first nine months of 2019. The first nine months of 2020 included non-cash income of $2.8 million, or $0.31 per share, as a result of a change in the fair value of the warrant liability and $1.2 million of Series A and Series B convertible preferred stock dividends. The first nine months of 2019 included a charge of $13.4 million, or ($1.52) per share, for the beneficial conversion feature and dividends related to the Series A convertible preferred stock. The first nine months of 2019 also included a non-cash charge of $7.6 million, or ($0.86) per share, as a result of a change in the fair value of the warrant liability.

As of September 30, 2020, cash and cash equivalents were $9.1 million.

Conference Call

As previously announced, PLx management will host its third quarter 2020 conference call as follows:

Date: Monday, November 16, 2020
   
Time: 4:30 p.m. ET
   
Toll free (U.S.): (866) 394-2901
   
International: (616) 548-5567
   
Webcast (live and replay): www.plxpharma.com under the ‘Investor Relations’ section.

The archived webcast will be available for 30 days via the aforementioned URL.

About
VAZAL
ORE

VAZALORE 325 mg is an FDA-approved liquid-filled aspirin capsule that provides patients with vascular disease and diabetic patients who are candidates for aspirin therapy with faster, reliable and more predictable platelet inhibition as compared to enteric-coated aspirin, while also reducing the risk of stomach erosions and ulcers, as compared to immediate-release aspirin, common in an acute setting. PLx’s supplemental New Drug Applications for VAZALORE 325 mg and VAZALORE 81 mg doses, submitted in October 2020 to the FDA, are currently under regulatory review.

About PLx Pharma Inc.

PLx Pharma Inc. is a late-stage specialty pharmaceutical company focused on its clinically-validated and patent-protected PLxGuard™ drug delivery platform to provide more effective and safer products. The PLxGuard drug delivery platform works by targeting the release of active pharmaceutical ingredients to various portions of the gastrointestinal (GI) tract. PLx believes this has the potential to improve the absorption of many drugs currently on the market or in development, and to reduce the risk of stomach erosions and ulcers associated with aspirin and ibuprofen, and potentially other drugs.

To learn more about PLx Pharma Inc. and its pipeline, please visit www.plxpharma.com.

Forward-Looking Statements

Any statements made in this press release relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the prospects for commercializing or selling any products or drug candidates are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to PLx may identify forward-looking statements. PLx cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including the failure by PLx to secure and maintain relationships with collaborators; risks relating to clinical trials; risks relating to the commercialization, if any, of PLx’s proposed product candidates (such as marketing, regulatory, product liability, supply, competition, and other risks); dependence on the efforts of third parties; dependence on intellectual property, risks that PLx may lack the financial resources and access to capital to fund proposed operations. Further information on the factors and risks that could affect PLx’s business, financial conditions and results of operations are contained in PLx’s filings with the U.S. Securities and Exchange Commission (“SEC”), which are available at www.sec.gov. Other risks and uncertainties are more fully described in PLx’s Form 10-K for the year ended December 31, 2019 filed with the SEC on March 13, 2020, and in other filings that PLx has made or will make going forward. The forward-looking statements represent PLx’s estimate as of the date hereof only, and PLx specifically disclaims any duty or obligation to update forward-looking statements.

Contact
Investor Relations:
Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E: [email protected]

Source: PLx Pharma Inc.

FINANCIAL TABLES FOLLOW

       
PLx Pharma Inc.
UNAUDITED CONSOLIDATED BALANCE SHEETS
       
  September 30, 2020   December 31, 2019
ASSETS      
CURRENT ASSETS      
Cash and cash equivalents $            9,086,525     $            14,001,304  
Accounts receivable                             –                             18,683  
Inventory, net                   143,380                                  –    
Prepaid expenses and other current assets                   387,801                         263,268  
TOTAL CURRENT ASSETS                9,617,706                    14,283,255  
NON-CURRENT ASSETS      
Property and equipment, net                1,252,434                      1,466,646  
Right of use assets                   402,640                         618,158  
Goodwill                2,061,022                      2,061,022  
Security deposit                     17,035                           73,665  
TOTAL ASSETS $          13,350,837     $            18,502,746  
         
LIABILITIES, SERIES A AND SERIES B CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)      
CURRENT LIABILITIES        
Accounts payable and accrued liabilities $               612,367     $                 928,921  
Accrued bonuses                   718,092                      1,166,821  
Accrued interest                   589,840                           34,964  
Current portion of term loan, net of discount and fees                1,548,865                      3,658,121  
Other current liabilities                   342,175                         304,603  
TOTAL CURRENT LIABILITIES                3,811,339                      6,093,430  
NON-CURRENT LIABILITIES      
Accrued interest, net of current portion                             –                           501,826  
Term loan, net of discount, fees and current portion                             –                           622,265  
Warrant liability                5,442,717                      8,247,679  
Accrued dividends                2,285,920                      1,058,498  
Other liabilities                   146,424                         409,431  
TOTAL LIABILITIES              11,686,400                    16,933,129  
         
Series A convertible preferred stock: $0.001 par value; liquidation value of $17,042,322; 45,000 shares authorized, 15,000  issued and outstanding              13,661,578                    13,661,578  
Series B convertible preferred stock: $0.001 par value; liquidation value of $8,243,598; 25,000 shares authorized, 8,000 and 0 issued and outstanding                7,723,312                                  –    
       
STOCKHOLDERS’ EQUITY (DEFICIT)       
Preferred stock; $0.001 par value; 930,000 shares authorized; none issued and outstanding                             –                                    –    
Common stock; $0.001 par value; 100,000,000 shares authorized; 9,156,260 shares issued and outstanding                        9,156                             9,156  
Additional paid-in capital              74,437,924                    74,837,046  
Accumulated deficit            (94,167,533 )                (86,938,163 )
TOTAL STOCKHOLDERS’ EQUITY (DEFICIT)            (19,720,453 )                (12,091,961 )
TOTAL LIABILITIES, SERIES A AND SERIES B CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT) $          13,350,837     $            18,502,746  
       

 

       
PLx Pharma Inc.
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS
           
  Three Months Ended September 30,   Nine Months Ended September 30,
    2020       2019       2020       2019  
REVENUES:              
Federal grant $     $ 41,106     $ 30,430     $ 541,571  
TOTAL REVENUES         41,106       30,430       541,571  
               
OPERATING EXPENSES:              
Research and development   1,207,302       1,214,029       3,116,097       3,805,617  
General and administrative   1,981,037       2,503,314       6,681,452       7,180,674  
TOTAL OPERATING EXPENSES   3,188,339       3,717,343       9,797,549       10,986,291  
OPERATING LOSS   (3,188,339 )     (3,676,237 )     (9,767,119 )     (10,444,720 )
               
OTHER INCOME (EXPENSE):              
Interest and other expense, net   (72,705 )     (118,432 )     (267,213 )     (476,084 )
Change in fair value of warrant liability   134,552       5,498,391       2,804,962       (7,581,521 )
TOTAL OTHER INCOME (EXPENSE)   61,847       5,379,959       2,537,749       (8,057,605 )
(LOSS) INCOME BEFORE INCOME TAXES   (3,126,492 )     1,703,722       (7,229,370 )     (18,502,325 )
Income taxes                      
NET (LOSS) INCOME   (3,126,492 )     1,703,722       (7,229,370 )     (18,502,325 )
               
Preferred dividends and beneficial conversion feature   (499,797 )     (311,136 )     (1,227,422 )     (13,433,397 )
NET (LOSS) INCOME ATTRIBUTABLE TO COMMON STOCKHOLDERS $ (3,626,289 )   $ 1,392,586     $ (8,456,792 )   $ (31,935,722 )
               
Net (loss) income per common share – basic $ (0.40 )   $ 0.09     $ (0.92 )   $ (3.60 )
Net (loss) income per common share – diluted $ (0.40 )   $ 0.09     $ (0.92 )   $ (3.60 )
               
Weighted average shares of common shares – basic   9,156,260       8,921,345       9,156,260       8,860,168  
Weighted average shares of common shares – diluted   9,156,260       8,936,255       9,156,260       8,860,168  
               

 



SmileDirectClub Reports Third Quarter 2020 Financial Results

NASHVILLE, Tenn., Nov. 16, 2020 (GLOBE NEWSWIRE) — SmileDirectClub, Inc. (Nasdaq: SDC) today announced its financial results for the third quarter ended September 30, 2020.

Third Quarter 2020 Financial Highlights

  • Third quarter total revenue of $169 million.
  • Third quarter net loss of $(43) million.
  • Third quarter Adjusted EBITDA of $3 million.
  • Third quarter diluted EPS of $(0.11).

Key Operating Metrics

  • Third quarter 2020 unique aligner shipments of 93,301.
  • Average aligner gross sales price (“ASP”) of $1,794 for the third quarter of 2020, compared to $1,788 for the third quarter of 2019.
  • Adjusted EBITDA of $3 million for the third quarter of 2020, compared to $(45) million for the third quarter of 2019, an improvement of 106.7%.

“Our performance in Q3 was continued validation of the strength of our business model, and the power of the competitive moats around our platform. It also demonstrated our continued focus on controlled growth with profitability. We outlined this strategy in the fourth quarter of 2019, and we have been executing against it in the three quarters since,” said SmileDirectClub Chief Executive Officer David Katzman.

SmileDirectClub Chief Financial Officer Kyle Wailes added, “Similar to the second quarter, the flexibility and scalability of our business model served us well, allowing us to make meaningful progress against our growth initiatives, alongside advancements on the cost side driving Adjusted EBITDA profitability one quarter ahead of our plan.”

Business Outlook

The Company remains laser focused on providing the best Club Member experience, while driving controlled and profitable growth. Within the third quarter, the Company made meaningful progress against this plan and the associated future growth drivers; specifically, expanding the core customer acquisition channels, extending the value proposition to the teen demographic, and international expansion. On the cost side, the Company turned AEBITDA profitable one quarter ahead of plan through continued advancement in automating its manufacturing and treatment planning operations, continued discipline around the deployment of marketing and selling dollars, and ongoing cost discipline across the business.

The Company expects to continue to see favorable industry dynamics with broader acceptance of telehealth and specifically teledentistry, minimal penetration against the total addressable market, no real competitor that provides an end-to-end vertically integrated platform for the consumer, and clear aligners gaining share in the overall industry. The Company would expect these dynamics to accrue to more efficient customer acquisition costs, as the Company continues to execute against its 20-30% annualized revenue growth targets.

As the low-cost provider with brand presence and no pricing pressure, and in an increasingly favorable climate for telehealth, the Company is well positioned to continue to gain share in the massively underserved market for clear aligners.

Conference Call Information

SmileDirectClub
Third Quarter 2020 Conference Call Details
   
Date: November 16, 2020
Time: 4:30 p.m. ET (1:30 p.m. PT)
Dial-In:  1-877-407-9208 (domestic) or 1-201-493-6784 (international)
Webcast:  Visit “Events and Presentations” section of the company’s IR page at http://investors.smiledirectclub.com

A replay of the call may be accessed from 7:30 p.m. ET on Monday, November 16, 2020 until 11:59 pm ET on Monday, November 30, 2020 by dialing 1-844-512-2921 (domestic) or 1-412-317-6671 (international) and entering the replay PIN: 13711961. An archived version of the call and a copy of the 2020 third quarter results supplemental earnings presentation will also be available upon completion on the Investor Relations section of SmileDirectClub’s website at investors.smiledirectclub.com.

Forward-Looking Statements

This earnings release contains forward-looking statements. All statements other than statements of historical facts may be forward-looking statements. Forward-looking statements generally relate to future events and include, without limitation, projections, forecasts and estimates about possible or assumed future results of our business, financial condition, liquidity, results of operations, plans, and objectives. Some of these statements may include words such as “expects,” “anticipates,” “believes,” “estimates,” “targets,” “plans,” “potential,” “intends,” “projects,” and “indicates.”

Although they reflect our current, good faith expectations, these forward-looking statements are not a guarantee of future performance, and involve a number of risks, uncertainties, estimates, and assumptions, which are difficult to predict. Some of the factors that may cause actual outcomes and results to differ materially from those expressed in, or implied by, the forward-looking statements include, but are not necessarily limited to: the duration and magnitude of the COVID-19 pandemic and related containment measures; our management of growth; the execution of our business strategies, implementation of new initiatives, and improved efficiency; our sales and marketing efforts; our manufacturing capacity, performance, and cost; our ability to obtain future regulatory approvals; our financial estimates and needs for additional financing; consumer acceptance of and competition for our clear aligners; our relationships with retail partners and insurance carriers; our R&D, commercialization, and other activities and expenditures; the methodologies, models, assumptions, and estimates we use to prepare our financial statements, make business decisions, and manage risks; laws and regulations governing remote healthcare and the practice of dentistry; our relationships with vendors; the security of our operating systems and infrastructure; our risk management framework; our cash and capital needs; our intellectual property position; our exposure to claims and legal proceedings; and other factors described in our filings with the Securities and Exchange Commission, including but not limited to our Annual Report on Form 10-K for the year ended December 31, 2019 and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020.

New risks and uncertainties arise over time, and it is not possible for us to predict all such factors or how they may affect us. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. We are under no duty to update any of these forward-looking statements after the date of this earnings release to conform these statements to actual results or revised expectations. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this earnings release.

About
SmileDirectClub

SmileDirectClub, Inc. (Nasdaq: SDC) (“SmileDirectClub”) is an oral care company and creator of the first MedTech platform for teeth straightening, now also offered directly via dentist and orthodontists’ offices. Through our cutting-edge teledentistry technology and vertically integrated model, we are revolutionizing the oral care industry, from clear aligner therapy to our affordable, premium oral care product line. SmileDirectClub’s mission is to democratize access to a smile each and every person loves by making it affordable and convenient for everyone. SmileDirectClub is headquartered in Nashville, Tennessee and operates in the U.S., Canada, Australia, New Zealand, United Kingdom, Ireland, Germany, Austria, Hong Kong, Singapore and Spain. For more information, please visit SmileDirectClub.com.

Investor Relations:

Alison Sternberg
Vice President, Investor Relations
[email protected]

Media Relations:

Kim Atkinson
Vice President, Communications
[email protected]

SmileDirectClub
, Inc.

Consolidated Balance Sheets

(in thousands)

  September 30,

2020
December 31,

2019
ASSETS    
Cash and cash equivalents $ 373,045     $ 318,458  
Accounts receivable 230,244     239,413  
Inventories 26,101     18,431  
Prepaid and other current assets 15,337     14,186  
Total current assets 644,727     590,488  
Accounts receivable, non-current 71,729     106,315  
Property, plant and equipment, net 183,430     177,543  
Operating lease right-of-use asset 30,564      
Other assets 11,461     11,299  
Total assets $ 941,911     $ 885,645  
LIABILITIES AND PERMANENT EQUITY              
Accounts payable $ 35,863     $ 52,706  
Accrued liabilities 93,308     93,339  
Deferred revenue 51,851     25,435  
Current portion of long-term debt 24,398     35,376  
Other current liabilities 6,452      
Total current liabilities 211,872     206,856  
Long-term debt, net of current portion 391,283     173,150  
Operating lease liabilities, net of current portion 32,038      
Other long-term liabilities 43,400     47,354  
Total liabilities 678,593     427,360  
Commitment and contingencies    
Permanent Equity    
Class A common stock, par value $0.0001 and 113,105,780 shares issued and outstanding at September 30, 2020 and 103,303,674 shares issued and outstanding at December 31, 2019 11     10  
Class B common stock, par value $0.0001 and 272,787,403 shares issued and outstanding at September 30, 2020 and 279,474,505 shares issued and outstanding at December 31, 2019 27     28  
Additional paid-in-capital 479,419     447,866  
Accumulated other comprehensive income (loss) 59     (272 )
Accumulated deficit (183,152 )   (114,513 )
Noncontrolling interest (50,666 )   125,166  
Warrants 17,620      
Total permanent equity 263,318     458,285  
Total liabilities and permanent equity $ 941,911     $ 885,645  
               

SmileDirectClub
, Inc.

Consolidated Statements of Operations

(in thousands, except share and per share amounts)

  Three Months Ended
September 30,
Nine Months Ended
September 30,
  2020 2019 2020 2019
Revenue, net $ 156,459     $ 168,663     $ 434,796     $ 522,529  
Financing revenue 12,042     11,522     37,428     31,185  
Total revenues 168,501     180,185     472,224     553,714  
Cost of revenues 49,760     39,125     158,313     111,363  
Cost of revenues—related parties     2,310         13,652  
Total cost of revenues 49,760     41,435     158,313     125,015  
Gross profit 118,741     138,750     313,911     428,699  
Marketing and selling expenses 66,722     131,263     243,564     340,409  
General and administrative expenses 74,110     389,828     233,828     486,319  
Lease abandonment and impairment of long-lived assets 3,960         28,593      
Other store closure and related costs 1,714         6,190      
Loss from operations (27,765 )   (382,341 )   (198,264 )   (398,029 )
Interest expense 15,555     4,291     29,627     11,607  
Interest expense—related parties             75  
Loss on extinguishment of debt     32     13,781     29,672  
Other (income) expense (1,028 )   421     2,131     500  
Net loss before income tax expense (42,292 )   (387,085 )   (243,803 )   (439,883 )
Income tax expense 1,190     479     1,745     596  
Net loss (43,482 )   (387,564 )   (245,548 )   (440,479 )
Net loss attributable to noncontrolling interest (30,892 )   (299,268 )   (176,909 )   (352,183 )
Net loss attributable to SmileDirectClub, Inc. $ (12,590 )   $ (88,296 )   $ (68,639 )   $ (88,296 )
         
Earnings per share of Class A common stock:        
Basic $ (0.11 )   $ (0.89 )   $ (0.63 )   $ (0.89 )
Diluted $ (0.11 )   $ (0.89 )   $ (0.64 )   $ (0.89 )
         
Weighted average shares outstanding:        
Basic 111,703,080     99,533,877     108,459,488     99,533,877  
Diluted 385,672,677     379,008,382     384,888,849     379,008,382  
                       

SmileDirectClub
, Inc.

Consolidated Statements of Cash Flows

(in thousands)

  Nine Months Ended September 30,
  2020 2019
Operating Activities    
Net loss $ (245,548 )   $ (440,479 )
Adjustments to reconcile net loss to net cash used in operating activities:    
Depreciation and amortization 39,399     16,237  
Deferred loan cost amortization 3,021     1,496  
Equity-based compensation 38,189     332,759  
Loss on extinguishment of debt 13,594     17,693  
Paid in kind interest expense 5,118      
Lease abandonment, impairment of long-lived assets and other store closure and related charges 30,903      
Changes in ROU asset 5,797      
Other non-cash operating activities     1,783  
Changes in operating assets and liabilities:    
Accounts receivable 43,755     (137,509 )
Inventories (8,456 )   (5,852 )
Prepaid and other current assets (2,844 )   (6,205 )
Accounts payable (9,441 )   (4,475 )
Accrued liabilities (8,559 )   45,880  
Due to related parties     (19,177 )
Deferred revenue 26,416     5,834  
Net cash used in operating activities (68,656 )   (192,015 )
Investing Activities    
Purchases of property, equipment, and intangible assets (68,768 )   (66,355 )
Net cash used in investing activities (68,768 )   (66,355 )
Financing Activities    
Payment of IPO related costs (1,155 )   1,285,759  
Proceeds from warrant exercise 922      
Repurchase of Class A shares and related fees     (696,489 )
Repurchase of Class A shares to cover employee tax withholdings (6,976 )   (81,603 )
Settlement of canceled awards —      (2,000 )
Issuance of Class A common stock     6  
Proceeds from HPS Credit Facility and Warrants, net 388,000      
Borrowings on long-term debt 16,807     176,000  
Payments of loan costs (11,784 )   (6,127 )
Principal payments on long-term debt (187,579 )   (159,047 )
Principal payments on related party debt     (24,581 )
Payments on finance leases (7,543 )    
Other 1,319     86  
Net cash provided by financing activities 192,011     492,004  
Increase in cash and cash equivalents 54,587     233,634  
Cash and cash equivalents at beginning of period 318,458     313,929  
Cash and cash equivalents at end of period $ 373,045     $ 547,563  
               

Use of Non-GAAP Financial Measures

This earnings release contains certain non-GAAP financial measures, including adjusted EBITDA (“Adjusted EBITDA”). We provide a reconciliation of this non-GAAP financial measure to the most directly comparable GAAP financial measure below and in our Current Report on Form 8-K announcing our quarterly earnings results, which can be found on the SEC’s website at www.sec.gov and our website at investors.smiledirectclub.com.

We utilize certain non-GAAP financial measures, including Adjusted EBITDA, to evaluate our actual operating performance and for planning and forecasting of future periods.

We define Adjusted EBITDA as net loss plus depreciation and amortization, interest expense, income tax expense, equity-based compensation, impairment of long-lived assets, abandonment and other related charges, and certain other non-operating expenses such as one-time store closure costs associated with our real estate repositioning strategy, severance and other labor costs, and unrealized foreign currency adjustments. We use Adjusted EBITDA when evaluating our performance when we believe that certain items are not indicative of operating performance. Adjusted EBITDA provides useful supplemental information to management regarding our operating performance and we believe it will provide the same to members/stockholders.

We believe that Adjusted EBITDA will provide useful information to members/stockholders about our performance, financial condition, and results of operations for the following reasons: (i) Adjusted EBITDA would be among the measures used by our management team to evaluate our operating performance and make day-to-day operating decisions and (ii) Adjusted EBITDA is frequently used by securities analysts, investors, lenders, and other interested parties as a common performance measure to compare results or estimate valuations across companies in our industry.

Adjusted EBITDA does not have a definition under GAAP, and our definition of Adjusted EBITDA may not be the same as, or comparable to, similarly titled measures used by other companies. Adjusted EBITDA should not be considered in isolation from, or as a substitute for, financial information prepared in accordance with GAAP. A reconciliation of Adjusted EBITDA to net loss, the most directly comparable GAAP financial measure, is set forth below.

SmileDirectClub
, Inc.

Reconciliation of Net Loss to Adjusted EBITDA

(in thousands)

  Three Months Ended
September 30,
Nine Months Ended
September 30,
  2020 2019 2020 2019
  (unaudited)
Net loss $ (43,482 )   $ (387,564 )   $ (245,548 )   $ (440,479 )
Depreciation and amortization 14,042     6,514     39,399     16,237  
Total interest expense 15,555     4,291     29,627     11,682  
Income tax expense 1,190     479     1,745     596  
Lease abandonment and impairment of long-lived assets 3,960         28,593      
Other store closure and related costs 1,714         6,190      
Loss on extinguishment of debt     32     13,781     29,672  
Equity-based compensation 10,972     324,497     38,189     332,759  
IPO related costs     6,146         6,146  
Other non-operating general and administrative (gains) losses (930 )   421     3,775     502  
Adjusted EBITDA $ 3,021     $ (45,184 )   $ (84,249 )   $ (42,885 )
                               

 



Barfresh Provides Third Quarter 2020 Results and Business Update

Third Quarter 2020 Revenue Increased 40% Compared to the Second Quarter of 2020

Company Expects
Fourth Quarter 2020
Revenue Growth and Margin Improvement
Compared to
the Fourth Quarter of 20
19
; First Year-over-Year Increase since Pandemic

LOS ANGELES, Nov. 16, 2020 (GLOBE NEWSWIRE) — Barfresh Food Group, Inc. (the “Company” or “Barfresh”) (OTCQB: BRFH), a manufacturer of frozen, ready-to-blend and ready-to-drink beverages, is providing a business update in conjunction with the filing of its form 10-Q for the third quarter ended September 30, 2020.

Year-to-Date Accomplishments

•  Increased penetration of the education channel:

  • Barfresh introduced its ready-to-drink beverage, Twist & Go™, into the education channel earlier this year and since its launch has expanded its education program to over 470 new school locations throughout multiple states. These schools are across 17 school districts and form a collective student population of over 300,000 students. The Company has already taken orders and began shipping to many of these new locations and expects many more new clients in the near future.

•  Entered into a strategic relationship with Smart Beverage:

  • Smart Beverage will only distribute Barfresh’s full line of beverage products to all of its existing and new customers. Barfresh products will be sold to approximately 1,400 schools once schools reopen and normal school operations resume. In the next twelve months, this relationship is expected to generate approximately $1 million to $2 million on an annual basis in the current Covid-19 environment and $2 million to $3 million annually in a normal operating environment, excluding Covid-19.
  • Smart Beverage will manage, maintain, store, and deliver the equipment needed for Barfresh’s products to their new and replacement accounts. Smart Beverage owns, operates and provides repair support for a wide network of Bunn smoothie machines for their customers with 1,000 existing smoothie machines in operation and 3,000 machines ready for deployment.

•  Launched two new products primarily for school customers:

  • The Company’s Twist & Go™ is a ready-to-drink, bottled fruit and yogurt smoothie line with no sugar added, no preservatives, artificial flavors or colors. Twist & Go™ increases the Company’s growth opportunities in the school channel as it enables Barfresh to expand with entire school districts instead of school by school. The product serves as a complement to the Company’s Bulk Easy Pour product with no customer equipment required.
  • The Company’s WHIRLZ 100% Juice Concentrates are a 5:1 juice concentrate with no added sugars and a good source of Vitamin C. The new 5:1 juice concentrates are stored and delivered ambient, opening up more opportunities for Barfresh to work on strategic distribution partnerships to help accelerate sales within the education channel. WHIRLZ complements the Company’s 1:1 Bulk Easy Pour products used in beverage dispensing equipment. Barfresh has teamed up with Smart Beverage to distribute this high quality product as the Company initially targets elementary and secondary schools across the country.

•  Continued to improve costs:

  • The Company continued to significantly reduce core operating expenses during the third quarter and first nine months of 2020, with a 41% reduction during the third quarter and a 40% year-to-date in general and administrative (G&A) expenses.

Management Comments

Riccardo Delle Coste, the Company’s Chief Executive Officer, stated, “Despite the continued challenges on our business from Covid-19, third quarter 2020 revenue grew 40% compared to the second quarter of 2020. We also remain focused on expanding our penetration within the education channel and implementing strict cost controls. The initial success of new product introductions in schools has helped offset the reduction in revenue from other foodservice accounts and will be additive to our existing product sales once those existing channels start getting back to normal from the Covid-19 effect.”

Mr. Delle Coste continued, “We have continued to drive significant improvement in our expenses with a 40% year-to-date reduction in G&A compared to the prior year and similar improvement expected next year. We are laying the groundwork so that our business is positioned to return to profitable growth and expansion within all our sales channels once normal operations resume with our customers.  We also expect revenue growth and margin enhancement for the fourth quarter of 2020 over the prior year.”

Financial Results

Revenue for the third quarter of 2020 was $708,000, compared to $506,000 in the second quarter of 2020 and $1.6 million in the third quarter of 2019. The incremental increase in revenue is the result of initial and repeat orders for new product offerings in the rapidly expanding school channel. Gross margin for the third quarter of 2020 was 39%, compared to 23% for the second quarter of 2020 and last year’s third quarter gross margin of 54%. The increase in gross margin on an incremental basis was primarily due to second quarter of 2020 expenses related to product mix and the startup expenses for the Company’s new products, Twist & Go and WHIRLZ 100% Juice Concentrates. Offsetting these costs was increased revenue in the third quarter of 2020. The Company expects gross profit margins for the fourth quarter of 2020 to be approximately 40%. Operating loss for the third quarter of 2020 improved to a loss of $836,000 as compared to a loss of $950,000 for the third quarter of 2019. The cost improvement initiatives the Company introduced in 2019 and continued throughout 2020 lowered G&A expenses in the quarter by 41% compared to the third quarter of 2020, but were not enough to offset the decline in net sales due to Covid-19.

As of September 30, 2020, the Company had approximately $2.7 million of cash, and approximately $0.8 million of inventory on its balance sheet.  

The above information is presented in conformity with accounting principles generally accepted in the United States. In order to aid in the understanding of the Company’s business performance, the Company has also presented below certain non-GAAP measures, including EBITDA and Adjusted EBITDA, which are reconciled in the table below to comparable GAAP measures. Management believes that Adjusted EBITDA provides useful information to the investor because it is directly reflective of the cash flow of the Company. The primary factors in reconciling these items are non-cash costs, including stock compensation, stock issued for services, and gain or loss on the sale of derivatives. Adjusted EBITDA is not a recognized measurement under GAAP and should not be considered as an alternative to net income, income from operations or any other performance measure derived in accordance with GAAP, or as an alternative to cash flow from operating activities as a measure of liquidity.

Adjusted EBITDA decreased to a loss of $596,000 for the third quarter of 2020, compared to a loss of $602,000 for the third quarter of 2019. A reconciliation of Adjusted EBITDA to net (loss) is provided below.

 
Barfresh Food Group Inc.
Condensed Consolidated Statements of Operations (Unaudited)
For the nine months ended September 30, 2020 and 2019
                       
  For the three months ended Sept 30,   For the nine months ended Sept 30,
                       
  2020   2019   2020   2019
                       
Net (loss) $ (878,257 )   $ (528,700 )   $ (2,800,843 )   $ (3,949,878 )
                       
Depreciation and Amortization   138,729       139,738       442,377       496,789  
Interest   61,757       283,709       420,634       929,596  
EBITDA   (677,771 )     (105,253 )     (1,937,832 )     (2,523,493 )
                       
Stock based compensation   45,692       67,185   *   240,216       338,683  
Stock issued for Services   55,000       140,874   **   80,000       351,914  
(Gain)/loss from debt extinguishment               (379,200 )      
(Gain)/Loss on Sale of Derivatives   (19,884 )     (704,798 )     (176,983 )     (790,072 )
Adjusted EBITDA $ (596,963 )   $ (601,992 )   $ (2,173,799 )   $ (2,622,968 )
                       
                       
*Stock based compensation issued to employees
** Stock based payment issued to directors and third party services
             

 

Conference Call

The conference call to discuss these results is scheduled for today, Monday, November 16, 2020, at 1:30 pm Pacific Time (4:30 pm Eastern Time). Listeners can dial (877) 407-4018 in North America, and international listeners can dial (201) 689-8471. Participants from the Company will be Riccardo Delle Coste, CEO; Joseph Cugine, Director; and Raffi Loussararian, Vice President of Finance.

A telephonic playback will be available approximately two hours after the call concludes and will be available through Monday, November 30, 2020. Listeners in North America can dial (844) 512-2921, and international listeners can dial (412) 317-6671. Passcode is 13712059.

Interested parties may also listen to a simultaneous webcast of the conference call by logging onto the Company’s website at www.barfresh.com in the Investors-Presentations section.

About Barfresh Food Group

Barfresh Food Group, Inc. (OTCQB: BRFH) is a developer, manufacturer and distributor of ready-to-blend and ready-to-drink beverages, including smoothies, shakes and frappes, primarily for restaurant chains and the foodservice industry. The company’s proprietary, patented system uses portion-controlled pre-packaged beverage ingredients that deliver freshly made frozen beverages that are quick, cost efficient, better for you and without waste. Barfresh has an exclusive distribution partnership with the leading food distributor in North America. For more information, please visit www.barfresh.com.

Forward Looking Statements

Except for historical information herein, matters set forth in this press release are forward-looking within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including statements about the Company’s commercial progress, success of its strategic relationship(s), and projections of future financial performance. These forward-looking statements are identified by the use of words such as “grow”, “expand”, “anticipate”, “intend”, “estimate”, “believe”, “expect”, “plan”, “should”, “hypothetical”, “potential”, “forecast” and “project”, “continue,” “could,” “may,” “predict,” and “will” and variations of such words and similar expressions are intended to identify such forward-looking statements. All statements, other than statements of historical fact, included in the press release that address activities, events or developments that the Company believes or anticipates will or may occur in the future are forward-looking statements. These statements are based on certain assumptions made based on experience, expected future developments and other factors the Company believes are appropriate under the circumstances. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of the Company. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated or anticipated by such forward-looking statements. Accordingly, you are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made.  The contents of this release should be considered in conjunction with the Company’s recent filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, including any warnings, risk factors and cautionary statements contained therein. Furthermore, the Company expressly disclaims any current intention to update publicly any forward-looking statements after the distribution of this release, whether as a result of new information, future events, changes in assumptions or otherwise.

Investor Relations

John Mills
ICR
646-277-1254
[email protected]

Deirdre Thomson
ICR
646-277-1283
[email protected]



Advantage Solutions Reports Third Quarter 2020 Financial Results and Updates 2020 Outlook

IRVINE, Calif., Nov. 16, 2020 (GLOBE NEWSWIRE) — Advantage Solutions Inc. (NASDAQ: ADV) (“Advantage,” the “Company,” “we” or “our”), the leading provider of outsourced sales and marketing services to consumer goods manufacturers and retailers, today reported financial results for its fiscal third quarter ended September 30, 2020.

“We are excited to begin Advantage’s next chapter as a public company,” said Tanya Domier, Chief Executive Officer of Advantage. “Despite the difficult operating environment brought on by COVID-19, I am pleased with the progress we continue to make in building the business for the long-term. While portions of our business continue to experience temporary headwinds from the pandemic, we’ve never been more important and valuable partners to our clients and customers than we are today. The impact from COVID-19 remained a significant short-term headwind for our business in the third quarter, but we are pleased with improving momentum in the quarter and believe it represents the beginning of a recovery from COVID-19 lows,” Domier commented. “The sequential revenue improvement we saw in the third quarter versus our second quarter was broad-based across both the sales and marketing segments and was primarily driven by the beginning of a recovery in the parts of our business most negatively impacted by COVID-19, as well as by continued strength in the other businesses that have remained critical to clients during the pandemic.”

“Importantly, I’d like to thank our associates. I couldn’t be more proud of the team’s passion and performance during this challenging time. Our associates have worked tirelessly in-stores and at-home to serve clients, customers and communities with critical solutions that help brands and retailers meet today’s evolving needs, providing best-in-class execution and service. We are grateful that we’re able to support communities in need during these trying times by making sure food and essential products from our brand and retailer partners are available to consumers in-store and online,” Domier added.

Third Quarter 2020 Highlights

  • Revenues were $784.3 million for the third quarter of 2020, representing a decline of $197.3 million, or 20.1%, from the same period in 2019, but sequential growth of $142.8 million, or 22.3%, from the second quarter of 2020.
  • Operating income was $88.6 million for the third quarter of 2020, representing growth of $12.0 million, or 15.7%, from the same period in 2019.
  • Net income was $36.7 million for the third quarter of 2020, representing growth of $14.0 million, or 61.5%, from the same period in 2019.
  • Adjusted Net Income was $65.6 million for the third quarter of 2020, representing a decline of $0.2 million, or 0.3%, from the same period in 2019.
  • Adjusted EBITDA was $136.3 million for the third quarter of 2020, representing a decline of $8.6 million, or 5.9%, from the same period in 2019.

Third quarter 2020 revenues declined $197.3 million, or 20.1%, to $784.3 million compared to $981.7 million for the third quarter of 2019. The year-over-year decline in revenue was driven by a $236.1 million decline in the marketing segment, partially offset by $38.7 million of growth in the sales segment. The third quarter’s decline in the marketing segment was primarily the result of the temporary suspension of the Company’s in-store sampling business in response to the COVID-19 pandemic. While in-store sampling programs began to return to stores in the third quarter of 2020, the business is still early in its return to full-operation and remains materially below 2019 levels.

Importantly, however, third quarter revenue of $784.3 million represented a sequential improvement of $142.8 million, or 22.3%, over the second quarter of 2020. This improvement was primarily driven by the beginning of a recovery in business units experiencing temporary headwinds from the COVID-19 pandemic, including the food service and international joint venture operations in the sales segment and the in-store sampling operations in the marketing segment.

Third quarter 2020 operating income grew $12.0 million, or 15.7%, to $88.6 million compared to $76.5 million for the third quarter of 2019. The year-over-year growth in operating income was driven by revenue growth in the sales segment, the benefit from the favorable settlement of lease liability obligations, the change in fair value adjustments related to contingent consideration arrangements from previous acquisitions and the decrease in costs associated with the exit of a previously acquired business, partially offset by the decline in revenues in the marketing segment related to the temporary suspension of in-store sampling programs during the pandemic.

Third quarter 2020 net income grew $14.0 million, or 61.5%, to $36.7 million compared to $22.7 million for the third quarter of 2019. The year-over-year growth in net income was primarily driven by higher operating income and lower interest expense, partially offset by a higher provision for income taxes.

Third quarter 2020 Adjusted Net Income declined $0.2 million, or 0.3%, to $65.6 million compared to $65.8 million for the third quarter of 2019. The year-over-year decline in Adjusted Net Income was primarily driven by the decline in revenues in the marketing segment related to the temporary suspension of in-store sampling programs during the pandemic, partially offset by the decrease in interest expense.

Third quarter 2020 Adjusted EBITDA declined $8.6 million, or 5.9%, to $136.3 million compared to $144.9 million for the third quarter of 2019. The year-over-year decline in Adjusted EBITDA was primarily driven by the declines in the marketing segment related to the temporary suspension of in-store sampling programs during the pandemic, partially offset by growth in the sales segment.

Successful Business Combination
and Balance Sheet
Highlights

Advantage Solutions and Conyers Park II Acquisition Corp. (“Conyers Park”), a publicly traded special purpose acquisition company, successfully completed their business combination on October 28, 2020. Proceeds from the business combination and the related PIPE and debt refinancing transactions were primarily used to repay the existing borrowings of the Company.

As of September 30, 2020, the Company’s cash and cash equivalents balance was $486 million, total debt was $3,331 million and Net Debt was $2,845 million. In connection with the closing of the merger with Conyers Park II, the Company completed its previously announced debt refinancing. Net Debt outstanding was reduced to approximately $2 billion. The post-combination debt capitalization consists primarily of a $400 million new revolving credit facility, under which $100 million was outstanding after the close of the business combination, a $1,325 million new first lien term loan facility, and $775 million of new senior secured notes.

The Class A Common Stock of Advantage Solutions began trading under the ticker symbol “ADV” on the NASDAQ exchange on October 29, 2020. After completion of the business combination, there were 313,425,182 Class A Common shares outstanding. This share count excludes 5,000,000 performance shares issued as part of the business combination that remain subject to vesting upon satisfaction of a market performance condition that has yet to be met and 18,583,333 warrants that carry an $11.50 exercise price.

FY 2020
Outlook

The Company now expects full year 2020 Adjusted EBITDA in the range of $480 to $485 million, an increase from the $475 million it previously provided as part of the business combination investor presentations in connection with the recently completed merger. The increase to forecasted Adjusted EBITDA reflects the expectation that strength in the sales segment continues through the fourth quarter and that the marketing segment continues to gradually recover from COVID-related headwinds. It now expects full year 2020 revenues to decline 16% to 19% versus 2019 revenues of $3,785 million. This slight revision to the forecast revenues is primarily due to a change in the expected mix of marketing revenues that would not impact the Company’s earnings estimates. For the purpose of this 2020 outlook update, the Company assumed the current trends in the business continue as they have for the last several months and there is no significant change to how COVID-19 is currently expected to impact the Company in the fourth quarter.

The Company expects to provide 2021 guidance on its fourth quarter earnings call to be scheduled for early next year.

Conference Call Details

Advantage will host a conference call at 5:00 p.m. ET on November 16 to discuss the third quarter financial performance and business outlook. To participate, please dial (877) 300-8521 within the United States or (412) 317-6026 outside the United States approximately 10 minutes before the scheduled start of the call. The conference ID for the call is 10149859. The conference call will also be accessible, live via audio broadcast, on the Investor Relations section of the Advantage website at https://ir.advantagesolutions.net/

A replay of the conference call will be available online at https://ir.advantagesolutions.net/. In addition, an audio replay of the call will be available for one week following the call and can be accessed by dialing (844) 512-2921 within the United States or (412) 317-6671 outside the United States. The replay ID is 10149859.

About Advantage Solutions

Advantage Solutions is a leading business solutions provider committed to driving growth for consumer goods manufacturers and retailers through winning insights and execution. Advantage’s data and technology-enabled omnichannel solutions — including sales, retail merchandising, business intelligence, digital commerce and a full suite of marketing services — help brands and retailers across a broad range of channels drive consumer demand, increase sales and achieve operating efficiencies. Headquartered in Irvine, California, Advantage has offices throughout North America and a presence in select markets throughout Africa, Asia, Australia and Europe through which it services the global needs of multinational, regional and local manufacturers. For more information, please visit advantagesolutions.net. 

Forward-Looking Statements

Certain statements in this press release may be considered forward-looking statements within the meaning of the federal securities laws, including statements regarding the expected future performance of Advantage’s business. Forward-looking statements generally relate to future events or Advantage’s future financial or operating performance. These forward-looking statements generally are identified by the words “may”, “should”, “expect”, “intend”, “will”, “would”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward looking statements.

Factors that may cause actual results to differ materially from current expectations include, but are not limited to, the COVID-19 pandemic and the measures taken in response thereto; changes to labor laws or wage or job classification regulations, including minimum wage, or other market-driven wage changes; Advantage’s ability to continue to generate significant operating cash flow; client procurement strategies and consolidation of Advantage’s clients’ industries creating pressure on the nature and pricing of its services; consumer goods manufacturers and retailers reviewing and changing their sales, retail, marketing, and technology programs and relationships; Advantage’s ability to successfully develop and maintain relevant omni-channel services for our clients in an evolving industry and to otherwise adapt to significant technological change; Advantage’s ability to effectively remediate material weaknesses and maintain proper and effective internal controls in the future; potential and actual harms to Advantage’s business arising from the Take 5 Matter; Advantage’s substantial indebtedness and our ability to refinance at favorable rates; and other risks and uncertainties set forth in the section titled “Risk Factors” in the definitive proxy statement filed by the Company with the Securities and Exchange Commission (the “SEC”) on October 9, 2020 and in its other filings made from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Advantage assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.

Non-GAAP Financial Measure
s
and Related Information

This press release includes certain financial measures not presented in accordance with generally accepted accounting principles (“GAAP”), including EBITDA for economic interests in investments, Adjusted EBITDA, Adjusted Net income and Net Debt. These are not measures of financial performance in accordance with GAAP and may exclude items that are significant in understanding and assessing the Advantage’s financial results. Therefore, the measures are in addition to, and not a substitute for or superior to, measures of financial performance prepared in accordance with GAAP, and should not be considered in isolation or as an alternative to net income, cash flows from operations or other measures of profitability, liquidity or performance under GAAP. You should be aware that Advantage’s presentation of these measures may not be comparable to similarly-titled measures used by other companies. Reconciliations of historical non-GAAP measures to their most directly comparable GAAP counterparts are included below.

Advantage believes these non-GAAP measures provide useful information to management and investors regarding certain financial and business trends relating to Advantage’s financial condition and results of operations. Advantage believes that the use of Adjusted EBITDA, Adjusted Net Income and Net Debt provides an additional tool for investors to use in evaluating ongoing operating results and trends in and in comparing the Advantage’s financial measures with other similar companies, many of which present similar non-GAAP financial measures to investors. Non-GAAP financial measures are subject to inherent limitations as they reflect the exercise of judgments by management about which expense and income are excluded or included in determining these non-GAAP financial measures. Additionally, other companies may calculate non-GAAP measures differently, or may use other measures to calculate their financial performance, and therefore Advantage’s non-GAAP measures may not be directly comparable to similarly titled measures of other companies.

Adjusted EBITDA means net income (loss) before (i) interest expense, net, (ii) (benefit from) provision for income taxes, (iii) depreciation, (iv) impairment of goodwill and indefinite-lived assets, (v) amortization of intangible assets, (vi) private equity sponsors’ management fees and equity-based compensation expense, (vii) fair value adjustments of contingent consideration related to acquisitions, (viii) acquisition-related expenses, (ix) costs associated with COVID-19, net of benefits received, (x) EBITDA for economic interests in investments, (xi) restructuring expenses, (xii) litigation expenses, (xiii) (Recovery from) loss on Take 5, (xiv) costs associated with the Take 5 Matter and (xv) other adjustments that management believes are helpful in evaluating our operating performance.

Adjusted Net Income means net (loss) income before (i) impairment of goodwill and indefinite-lived assets, (ii) amortization of intangible assets, (iii) private equity sponsors’ management fees and equity-based compensation expense, (iv) fair value adjustments of contingent consideration related to acquisitions, (v) acquisition-related expenses, (vi) costs associated with COVID-19, net of benefits received, (vii) EBITDA for economic interests in investments, (viii) restructuring expenses, (ix) litigation expenses, (x) (Recovery from) loss on Take 5, (xi) costs associated with the Take 5 Matter, (xii) other adjustments that management believes are helpful in evaluating our operating performance, and (xiii) related tax adjustments.

Net Debt represents the sum of current portion of long-term debt and long-term debt, less cash and cash equivalents and debt issuance costs. With respect to Net Debt, cash and cash equivalents are subtracted from the GAAP measure, total debt, because they could be used to reduce the debt obligations.

This press release also includes certain estimates and projections of Adjusted EBITDA, including with respect to expected fourth quarter 2020 results. Due to the high variability and difficulty in making accurate estimates and projections of some of the information excluded from Adjusted EBITDA, together with some of the excluded information not being ascertainable or accessible, Advantage is unable to quantify certain amounts that would be required to be included in the most directly comparable GAAP financial measures without unreasonable effort. Consequently, no disclosure of estimated or projected comparable GAAP measures is included and no reconciliation of such forward-looking non-GAAP financial measures is included.

Reconciliation of GAAP to Non-GAAP Historical Financial Measures

Results of Operations for the Three Months Ended September 30, 2020 and 2019

  Three Months Ended September 30,    
(amounts in thousands) 2020     2019    
                             
Revenues $ 784,345     100.0 %   $ 981,682     100.0 %  
Cost of revenues   625,363     79.7 %     809,243     82.4 %  
Selling, general, and administrative expenses   11,855     1.5 %     38,042     3.9 %  
Depreciation and amortization   58,556     7.5 %     57,872     5.9 %  
Total expenses   695,774     88.7 %     905,157     92.2 %  
Operating income   88,571     11.3 %     76,525     7.8 %  
Interest expense, net   48,243     6.2 %     57,762     5.9 %  
Income (loss) before income taxes   40,328     5.1 %     18,763     1.9 %  
Provision for (benefit from) income taxes   3,623     0.5 %     (3,968 )   (0.4 )%  
Net income (loss) $ 36,705     4.7 %   $ 22,731     2.3 %  
Other Financial Data                            
Adjusted Net Income(1) $ 65,607     8.4 %   $ 65,825     6.7 %  
Adjusted EBITDA(2) $ 136,253     17.4 %   $ 144,862     14.8 %  
                             

(1 ) We present Adjusted Net Income because we use it as a supplemental measure to evaluate the performance of our business in a way that also considers our ability to generate profit without the impact of items that we do not believe are indicative of our operating performance or are unusual or infrequent in nature and aid in the comparability of our performance from period to period. Adjusted Net Income should not be considered as an alternative for our most directly comparable measure presented on a GAAP basis.
   
(2 ) We present Adjusted EBITDA because it is a key operating measure used by us to assess our financial performance. This measure adjusts for items that we believe do not reflect the ongoing operating performance of our business, such as certain noncash items, unusual or infrequent items or items that change from period to period without any material relevance to our operating performance. We evaluate this measure in conjunction with our results according to GAAP because we believe it provides a more complete understanding of factors and trends affecting our business than GAAP measures alone. Furthermore, the agreements governing our indebtedness contain covenants and other tests based on measures substantially similar to Adjusted EBITDA. Adjusted EBITDA should not be considered as an alternative for our most directly comparable measure presented on a GAAP basis.

A reconciliation of net income (loss) to Adjusted Net Income is provided in the following table:

Consolidated Three Months Ended September 30,
  2020     2019  
(in thousands)          
Net income (loss) $ 36,705     $ 22,731  
Less: net income attributable to noncontrolling interests   756       142  
Add:          
Sponsors’ management fee and equity-based compensation expense(a)   1,468       1,968  
Fair value adjustments related to contingent consideration related to acquisitions(b)   (6,184 )     (1,100 )
Acquisition-related expenses(c)   3,683       5,308  
Amortization of intangible assets   47,781       47,633  
Restructuring expenses(e)   (7,635 )     260  
Litigation expenses(f)   (31 )      
Costs associated with COVID-19, net of benefits received(g)   (1,389 )      
Costs associated with the Take 5 Matter(h)   1,219       6,344  
Tax adjustments related to non-GAAP adjustments   (9,254 )     (17,177 )
Adjusted Net Income $ 65,607     $ 65,825  
               

A reconciliation of net income (loss) to Adjusted EBITDA is provided in the following table:

Consolidated Three Months Ended September 30,
  2020     2019  
(in thousands)              
Net income (loss) $ 36,705     $ 22,731  
Add:              
Interest expense, net   48,243       57,762  
(Benefit from) provision for income taxes   3,623       (3,968 )
Depreciation and amortization   58,556       57,872  
Sponsors’ management fee and equity-based compensation expense(a)   1,468       1,968  
Fair value adjustments related to contingent consideration related to acquisitions(b)   (6,184 )     (1,100 )
Acquisition-related expenses(c)   3,683       5,308  
EBITDA for economic interests in investments(d)   (2,005 )     (2,315 )
Restructuring expenses(e)   (7,635 )     260  
Litigation expenses(g)   (31 )      
Costs associated with COVID-19, net of benefits received(f)   (1,389 )      
Costs associated with the Take 5 Matter(h)   1,219       6,344  
Adjusted EBITDA $ 136,253     $ 144,862  

(a)   Represents the management fees and reimbursements for expenses paid to certain of the Advantage Sponsors (or certain of the management companies associated with it or its advisors) pursuant to a management services agreement in the three months ended September 30, 2020 and 2019. Also represents expenses related to (i) equity-based compensation associated with grants of Common Series D Units of Topco made to one of the equity sponsors of Topco, (ii) compensation amounts associated with the Company’s Management Incentive Plan originally scheduled for potential payment March 2022, and (iii) compensation amounts associated with the anniversary payments to Tanya Domier.
(b)   Represents adjustments to the estimated fair value of our contingent consideration liabilities related to our acquisitions, excluding the present value accretion recorded in interest expense, net, for the applicable periods. See Note 6 to our unaudited condensed consolidated financial statements for the three months ended and nine months ended September 30, 2020 and 2019.
(c)   Represents fees and costs associated with activities related to our acquisitions and restructuring activities related to our equity ownership, including professional fees, due diligence and integration activities.
(d)   Represents additions to reflect our proportional share of Adjusted EBITDA related to our equity method investments and reductions to remove the Adjusted EBITDA related to the minority ownership percentage of the entities that we fully consolidate in our financial statements for the three months ended September 30, 2020 and 2019.
(e)   Represents fees and costs associated with various internal reorganization activities among our consolidated entities. The decrease for the three months ended September 30, 2020 relates primarily to the non-cash settlement of lease liabilities. For additional information, refer to Note 10—Commitments and Contingencies of our condensed consolidated financial statements for the three months ended and the nine months ended September 30, 2020.
(f)   Represents (1) costs related to implementation of strategies for workplace safety in response to COVID-19, including employee-relief fund, additional sick pay for front-line associates, medical benefit payments for furloughed associates, and personal protective equipment; and (2) benefits received from government grants for COVID-19 relief.
(g)   Represents legal settlements that are unusual or infrequent costs associated with our operating activities.
(h)   Represents costs associated with investigation and remediation activities related to the Take 5 Matter, primarily, professional fees and other related costs for the three months ended September 30, 2020 and 2019.

A reconciliation of total debt to Net Debt is provided in the following table:

(in millions) September 30, 2020   Proforma Combined
September 30, 2020
Current portion of long-term debt $ 26.2     $ 13.2  
Long-term debt, net of current portion   3,287.3       2,110.4  
Total Debt   3,313.5       2,123.6  
Less:          
Debt issuance costs   (18.0 )     (79.8 )
Cash and cash equivalents   486.4       151.2  
Total Net Debt
(
i
)
$ 2,845.1     $ 2,052.2  

(i)   We present Net Debt because we believe the non-GAAP measure provides useful information to management and investors regarding certain financial and business trends relating to Advantage’s financial condition and to evaluate changes to the Company’s capital structure and credit quality assessment.

Contacts: 

Dan Morrison
Senior Vice President, Finance & Operations
Advantage Solutions

Helen O’Donnell
Solebury Trout
Managing Director
[email protected] 



Summit Therapeutics Reports Financial Results and Operational Progress for the Third Quarter and Nine Months Ended September 30, 2020

Summit Therapeutics Inc.

(‘Summit’, the ‘Company’ or the ‘Group’)

Summit Therapeutics Reports Financial Results and Operational Progress for the Third Quarter and Nine Months Ended September 30, 2020

Cambridge, MA, November 16, 2020 – Summit Therapeutics Inc. (NASDAQ: SMMT) today reports its financial results and provides an update on its operational progress for the third quarter and nine months ended September 30, 2020.

Ridinilazole for C. difficile Infection (‘CDI’)

  1. As of November 15, 2020, Summit had enrolled a total of 448 patients into its Phase 3 Ri-CoDIFy clinical trials of ridinilazole. Below is a table outlining the enrollment statistics by calendar quarter since the opening of the trials in February 2019.
Quarter Number of Patients Enrolled Cumulative Patients Enrolled
Q1 2019   9   9
Q2 2019   21   30
Q3 2019   43   73
Q4 2019   78   151
Q1 2020   101   252
Q2 2020   73   325
Q3 2020   64   389
Q4 2020*   59*   448

            *Q4 2020 includes quarter to date enrollment through November 15th

  1. Due to the uncertainties surrounding COVID-19, Summit has withdrawn public commentary on the timing of completion of the Phase 3 Ri-CoDIFy clinical trials. The Company plans to publicly update stakeholders quarterly as to enrollment status.
  2. The Ri-CoDIFy clinical trials aim to support application for marketing approval of the precision antibiotic ridinilazole in the United States and other territories and the goal of it being used as a first-line treatment and for reduction of recurrence of CDI by:
    1. testing for superiority over the current standard of care, vancomycin, in the primary endpoint of sustained clinical response at 30 days after treatment has ended;
    2. generating health economic data to support ridinilazole’s commercial launch, when as and if approved by regulatory authorities; and
    3. undertaking microbiome and metabolome analysis that aims to show ridinilazole’s impact on the gut microbiome and bile acids composition
  3. BARDA is supporting the Phase 3 clinical trials and regulatory development of ridinilazole with a financial award of potential funding of up to $72.5 million. As of September 30, 2020, an aggregate of $47.0 million had been received.

Discuva Platform

Enterobacteriaceae

  1. DDS-04 compound series is a new class of precision antibiotics, with new mechanism of action, which is in lead optimization that acts via the novel bacterial target LolCDE with the potential to treat multidrug resistant infections caused by the Gram-negative bacteria Enterobacteriaceae.

Corporate Highlights

  1. Dr. Camilla Graham was promoted to Chief Clinical Affairs Officer in October 2020. An infectious disease specialist, she has practiced since 2001 at Beth Israel Deaconess Medical Center and is on faculty at Harvard Medical School in Boston, MA.  Additionally, she has fourteen years of experience straddling academic medicine and the pharmaceutical industry, including leading the launch of Incevik (hepatitis C) and Kalydeco (cystic fibrosis) as the Global Head of Medical Affairs at Vertex Pharmaceuticals, and advising numerous state and federal government agencies on access to medications on the academic side. Dr. Graham received her MD from Medical College of Pennsylvania, Philadelphia, PA and MPH from Harvard School of Public Health, Boston, MA.
  2. Summit has redomiciled to the United States, effective September 18, 2020.

COVID-19

  1. In light of the ongoing COVID-19 pandemic, Summit’s employees continue to work remotely, enabling the majority of day to day business operations to continue. Summit’s own laboratory facilities have begun to reopen to resume work on key projects; site access by staff is being monitored closely and is limited to ensure the safety of Summit researchers. There continues to be a negative impact on patient enrollment into the Ri-CoDIFy clinical trials.  We are working to implement a number of initiatives and considering alternative courses of action to mitigate the impact of the COVID-19 pandemic on our clinical trials, although there can be no assurance that such actions will be successful.

Financial Highlights

  1. Cash and cash equivalents on September 30, 2020, of $21.3 million compared to $63.8 million at December 31, 2019.
  2. In November 2020, the Company closed a private placement for a fundraising of $50 million through the issuance and sale of shares of common stock to the Company’s Chief Executive Officer and Executive Chairman, Robert W. Duggan, Polar Capital and Dr. Mahkam Zanganeh. 
  3. The Company’s existing cash and cash equivalents, committed external funding and $50.0 million private placement completed in November 2020 are expected to be sufficient to enable the Company to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2021.
  4. Net loss for the nine months ended September 30, 2020, of $39.3 million compared to a net loss of $20.0 million for the nine months ended September 30, 2019.

About C. difficile Infection

Clostridioides difficile, or C. difficile infection (CDI) is a bacterial infection of the colon that produces toxins causing inflammation of the colon and severe watery diarrhea, painful abdominal cramping, nausea, fever and dehydration. CDI can also result in more serious disease complications, including bowel perforation, sepsis and death. CDI represents a serious healthcare issue in hospitals, long-term care homes and in the wider community. Summit estimates that there are over 3 million cases of CDI each year worldwide, based on a meta-analysis of 229 publications with data from 41 countries, published in the Journal of Global Health, June 2019.

About Enterobacteriaceae

Enterobacteriaceae are a family of bacteria responsible for serious infections across a number of conditions including bloodstream infections, urinary tract infections and hospital-acquired pneumonias. Multidrug resistant Enterobacteriaceae are resistant to treatment by most or occasionally all of existent antibiotics. The most difficult to treat among them are the ESBL-producing and the Carbapenem-resistant Enterobacteriaceae which according to the CDC, have collectively caused an estimated 210,500 infections and 10,200 deaths in hospitalized patients in the United States in 2017.

About Summit Therapeutics

Summit Therapeutics, empowered by its Discuva Platform, the Company’s innovative antibiotic discovery engine, supported by BARDA and Carb-X funding, intends to be the leader in patient and physician friendly paradigm shifting antibiotic innovation. Our new mechanism antibiotics are designed to become the patient-friendly, new era standard-of-care, by working in harmony with the human microbiome to treat prospective patients suffering from infectious disease, initially focussing on Clostridioides difficile infections (“CDI”) which is estimated to impact over 3 million patients worldwide annually. Commercialization of ridinilazole for the treatment and the reduction of recurrence of CDI is subject to regulatory approvals. The overriding objective of Summit Therapeutics is to create value for patients, hospital infectious disease care givers, community based infectious disease healthcare providers, as well as healthcare payors around the world.  Currently, Summit’s lead product candidate ridinilazole is engaged in two global phase III trials, Ri-CoDIFy 1 & 2, each enrolling 680 patients vs standard of care (Vancomycin) for the treatment and reduction of recurrence of C. difficile infections.

Summit’s vision and mission is to extend our pipeline through the development of new mechanism, narrow spectrum, microbiome sparing antibiotics targeting C. difficile, Gram-negative Enterobacteriaceae such as Escherichia coli and Klebsiella pneumoniae and other bacterial infections with high unmet medical need.

For more information, visit www.summitplc.com and follow us on Twitter @summitplc. For more information on the Company’s Discuva Platform, visit https://www.summittxinc.com/our-science/discuva-platform.

Contacts Summit Press Office [email protected]

Summit Forward-looking Statements

Any statements in this press release about the Company’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company’s product candidates, the therapeutic potential of the Company’s product candidates, the potential commercialization of the Company’s product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals, the impact of the COVID-19 pandemic on the Company’s operations and clinical trials and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials and the results of such trials, global public health crises, including the coronavirus COVID-19 outbreak, that may affect timing and status of our clinical trials and operations, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, expectations for regulatory approvals, laws and regulations affecting government contracts and funding awards, availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the “Risk Factors” section of filings that the Company makes with the Securities and Exchange Commission. Accordingly, readers should not place undue reliance on forward-looking statements or information. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of this release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND OTHER COMPREHENSIVE LOSS
(Unaudited)
In thousands, except per share data
               
  Three Months Ended September 30,   Nine Months Ended September 30,
  2020   2019   2020   2019
Revenue:              
Licensing agreements $ 181   $ 148   $ 675   $795
Total revenue 181   148   675   795
               
Operating expenses:              
Research and development 14,387   9,951   40,979   32,586
General and administrative 7,460   2,683   13,430   7,917
Impairment 859     859  
Total operating expenses 22,706   12,634   55,268   40,503
               
Other operating income 4,309      6,296      14,949      19,881  
Operating loss (18,216)     (6,190)     (39,644)     (19,827)  
Other (income) expense, net 416   (75)   296   (231)  
Loss before income tax (17,800)     (6,265)     (39,348)     (20,058)  
               
Income tax benefit (expense) 99   (111)   93     13
Net loss   $(17,701)      $(6,376)    $(39,255)   $(20,045)
               
Basic loss per share $ (0.26)   $ (0.20)   $ (0.58)   $ (0.63)
Diluted loss per share $ (0.26)   $ (0.20)   $ (0.58)   $ (0.63)
               
Other comprehensive income/(loss):              
Foreign currency translation adjustment 2,255     (1,255)     (2,312)     (1,299)
Total comprehensive loss   $(15,446)       $(7,631)       $(41,567)     $(21,344)



                      CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION

                                                              (Unaudited)

                                                             In thousands

        September 30, 2020   December 31, 2019
             
Cash and cash equivalents       $ 21,270      $ 63,842   
Total assets       $ 56,865      $ 96,679   
Total liabilities       $ 20,004      $ 19,442   
Total stockholders’ equity       $ 36,861      $ 77,237   

   

         CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS INFORMATION

                                                            (Unaudited)

                                                           In thousands

    Nine months ended
    September 30,
    2020   2019
         
Net cash used in operating activities   $ (40,140)     $ (13,861)  
Net cash used in investing activities   (371)     (358)  
Net cash provided by financing activities       24,504   
Effect of exchange rates in cash and cash equivalents   (2,064)     (787)   
         
Net (decrease) / increase in cash and cash equivalents   $ (42,572)     $ 9,498