SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Peabody Energy Corporation – BTU

NEW YORK, Nov. 16, 2020 (GLOBE NEWSWIRE) — Pomerantz LLP is investigating claims on behalf of investors of Peabody Energy Corporation (“Peabody” or the “Company”) (NYSE: BTU).   Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext. 7980.

The investigation concerns whether Peabody and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. 



[Click here for information about joining the class action]

On September 28, 2018, a fire occurred at Peabody’s North Goonyella coal mine in Central Queensland, Australia, forcing Peabody to suspend its operations indefinitely.  On this news, Peabody’s stock price fell $5.54 per share, or 15.3%, to close at $35.64 per share on September 28, 2018. 

On February 6, 2019, Peabody disclosed that contrary to the Company’s previous statements, production at the North Goonyella would not resume in 2019, but was instead targeted to begin to ramp in the early months of 2020.  On this news, Peabody’s stock price fell $3.80 per share, or 10.6%, to close at $32.05 per share on February 6, 2019. 

On May 1, 2019, Peabody reported that it had received a directive from the Queensland Mines Inspectorate (“QMI”) which could lead to further delays and necessitate a reevaluation of the Company’s reentry plan for the mine.  On this news, Peabody’s stock price fell $1.61 per share, or 5.6%, to close at $27.16 per share on May 1, 2019. 

On July 31, 2019, Peabody reported additional delays to the reentry of North Goonyella, explaining that QMI’s requirements had resulted in a slower rate of progress than Peabody’s initial plan had contemplated.  As a results, Peabody suspended its 2020 production guidance at the mine and informed investors that it was reevaluating its entire reentry plan.  On this news, Peabody’s stock price fell $1.06 per share, or 4.8%, to close at $21.06 per share on July 31, 2019.

On August 9, 2019, QMI released preliminary investigative findings indicating that Peabody had deficient safety systems in place at its North Goonyella mine and that the Company was not cooperating fully with QMI’s investigation.  On this news, Peabody’s stock price fell $0.37 per share, or 2%, to close at $18.13 per share on August 9, 2019. 

Finally, on October 29, 2019, Peabody disclosed that QMI was placing stringent restrictions on restarting operations at the North Goonyella mine, forcing Peabody to drastically adjust its reentry plan, ultimately announcing that there would be a delay of at least three years before any meaningful coal could be produced at the North Goonyella mine.  On this news, Peabody’s stock price fell $3.56 per share, or 22.19%, to close at $12.48 per share on October 29, 2019.

The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com.

CONTACT:
Robert S. Willoughby
Pomerantz LLP
[email protected]
888-476-6529 ext. 7980



Greenlane Reports Record Core Business Revenue in Q3 2020

Core Revenue Expands 36% to $32.3 million Compared to Q3 2019

Sales of Greenlane Brands Grew Approximately 65% to $5.6 million Compared to Q3 2019

Implements Further G&A Expense Reductions to Achieve Annualized Savings of Approximately $5.0 million

Strong Balance Sheet Includes $40.0 million in Cash to Support Expansion Initiatives

BOCA RATON, Fla., Nov. 16, 2020 (GLOBE NEWSWIRE) — Greenlane Holdings, Inc. (“Greenlane” or “the Company”) (Nasdaq: GNLN), one of the largest global sellers of premium cannabis accessories and specialty vaporization products, today reported financial results for the third quarter ended September 30, 2020.

Third Quarter 2020 Highlig
hts

  • Net sales of the Company’s Greenlane Brands grew approximately 65% to $5.6 million in Q3 2020 compared to $3.4 million in Q3 2019;
  • Core revenue (defined as non-nicotine revenue) grew 36% to $32.3 million in Q3 2020, compared to $23.8 million in Q3 2019;
  • Total revenue grew 10% to approximately $35.8 million in Q3 2020 compared to $32.4 million in Q2 2020;
  • Excluding the impact of certain inventory adjustments which incurred in the quarter, gross profit would have been $7.3 million or 20.4% of net sales, a 610 basis point year over year improvement in gross profit percentage as compared to Q3 2019;
  • Expanded management team through key hires to support Greenlane sales and marketing efforts in North America and Europe;
  • Launched a first-of-its-kind line of responsibly sourced, precision-manufactured, pre-rolled cones made from organically-sourced paper exclusively processed in France and sealed with 100% natural Arabic gum;
  • Obtained the exclusive right to expand the availability of Marley Naturals Accessories to specialty locations in Europe, Central and South America, and the Caribbean;

Management Commentary

“During the third quarter, with the help of our new senior leadership team, we acted on several key initiatives related to our go forward category emphasis, organizational structure, and related staffing levels. Building on the success we’ve achieved in growing Greenlane brands and non-nicotine sales year over year by 65% and 36%, respectively, we’ve taken additional decisive steps to de-emphasize certain product lines, invest in our fastest growing and highest margin opportunities, and further reduced our headcount by 4.5%,” said Aaron LoCascio, Greenlane’s Chairman and Chief Executive Officer. “While this has had an impact on our Q3 financials, we believe these decisions have positioned Greenlane to return to near-term profitability and long term success.”

Mr. LoCascio added, “We are building a comprehensive suite of high-quality, Greenlane branded products which will enable us to capture more of the margin on each product we sell. At the same time, we continue to work very closely with our brand partners to launch innovative new products into the market leveraging our best-in-class global distribution platform. I remain very encouraged that we are on track to enter 2021 on a solid footing, returning to positive adjusted EBITDA in the first quarter as a result of the changes we have implemented.”

Q3 2020 Financial Summary

Net sales were $35.8 million in the third quarter of 2020 (“Q3 2020”), compared to $44.9 million for the third quarter of 2019 (“Q3 2019”), a decrease of $9.1 million or 20.3%. The change in revenue is largely attributable to the execution of Greenlane’s business transformation initiative, whereby the Company has deliberately moved away from low-margin nicotine sales, to focus on higher-margin products. On a sequential basis, Q3 2020 net sales increased 10% from $32.4 million in the second quarter of 2020 (“Q2 2020”).

Sales of nicotine products decreased to approximately $3.5 million in Q3 2020, from approximately $21.1 million in Q3 2019. Isolating for the impact of declining consumer demand for nicotine products on Greenlane’s total sales, Q3 2020 core revenue grew 36% to $32.3 million compared to $23.8 million in Q3 2019.

Net sales of Greenlane branded products grew to approximately $5.6 million, representing 15.5% of total revenue in the third quarter of 2020, as compared to approximately $3.4 million in the third quarter of 2019, or 7.5% of total revenue.

As of the fourth quarter of 2020, Greenlane has fully transitioned to a more streamlined and centralized model with fewer, but larger, highly automated distribution facilities. We believe these changes will greatly improve the scalability of the Company’s business model.

In Q3 2020, gross profit was $2.5 million, or 6.9% of net sales, compared to $6.4 million, or 14.3% of net sales in Q3 2019. In the quarter, Greenlane made certain strategic decisions concerning existing inventory levels and go forward product lines. As a result of those decisions the Company recorded write-offs and adjustments of $4.8 million to damaged and obsolete inventory. Excluding the impact of these inventory adjustments, Q3 2020 gross margin would otherwise have been $7.3 million and gross profit margin would otherwise have been 20.4% or 610 basis points higher than Q3 2019 gross profit. Greenlane expects overall gross margin to expand from the current adjusted levels of 20.4% as it executes on its strategic vision with Greenlane Brands at its core.

Salaries, benefits, and payroll taxes in Q3 2020 decreased approximately $1.6 million, or 23.7%, compared to Q3 2019, primarily due to a net decrease in equity-based compensation expense. Q3 2020 general and administrative expenses increased by approximately $5.9 million. This increase was primarily due to a non-recurring loss of approximately $2.2 million related to a portion of an indemnification asset, in addition to other expenses related to the Company’s business transformation initiatives which are expected to generate long term cost savings.

Q3 2020 net loss was $13.8 million, compared to $9.0 million in the same period for the prior year. Adjusted net loss was $6.9 million in Q3 2020 compared to adjusted net loss of $7.5 million for Q3 2019. Adjusted EBITDA loss was $6.3 million in Q3 2020 compared to adjusted EBITDA loss of $3.4 million in Q3 2019. Definitions of adjusted net loss and adjusted EBITDA and reconciliations of such metrics to the nearest GAAP measure are included below.

Cash was $40.0 million and total debt was $8.2 million as of September 30, 2020, compared to $47.8 million and $8.3 million, respectively, as of December 31, 2019. Year to date, cash used in operating activities was $3.8 million, compared to $33.5 million in the prior year, an 89% improvement. Greenlane continues to actively manage its balance sheet to fund the Company’s growth initiatives and potential M&A opportunities.

Conference Call Information

Greenlane will host a conference call Tuesday, November 17, 2020, to discuss these results. Aaron LoCascio, Chief Executive Officer, will host the call starting at 8:30 a.m. Eastern time. A question and answer session will follow management’s presentation.

Date: Tuesday, November 17, 2020
Time: 8:30 a.m. Eastern Time
Dial-In Number: (833) 519-1285
Conference ID: 9693218
Webcast: https://edge.media-server.com/mmc/p/crczypsj 
Replay: (855) 859-2056 or (404) 537-3406
  Available until 11:30 p.m. Eastern Time Thursday, November 26th, 2020

About Greenlane Holdings, Inc.

Greenlane (NASDAQ: GNLN) is the leading global platform for the development and distribution of premium cannabis accessories and lifestyle products. The company operates as a powerful house of brands, third-party brand accelerator, and omni-channel distribution platform. Greenlane serves the global markets with an expansive customer base of more than 7,000 retail locations, including licensed cannabis businesses, smoke shops, and specialty retailers. As a pioneer in the cannabis space, Greenlane is the partner of choice for many of the industry’s leading brands, including PAX Labs, Storz & Bickel (Canopy-owned), Cookies, Grenco Science, and DaVinci. Greenlane also proudly owns and operates a diverse brand portfolio including packaging innovator Pollen Gear™, the K.Haring Glass Collection by Higher Standards, Marley Natural™, and VIBES™ rolling papers. Higher Standards, Greenlane’s flagship brand, offers both a high-end product line and immersive retail experience with groundbreaking stores in both New York City’s Chelsea Market and Malibu, California. Greenlane also owns and operates both Vapor.com and VapoShop.com, two industry-leading, direct-to-consumer e-commerce platforms in North America and Europe respectively. For additional information, please visit: https://gnln.com/.

Presentation of Financial Information

This press release includes historical consolidated results for the periods presented of Greenlane Holdings, LLC, the predecessor of Greenlane Holdings, Inc., for financial reporting purposes. Accordingly, the consolidated financial statements for periods prior to the completion of the IPO on April 23, 2019 have been adjusted to combine the previously separate entities for presentation purposes. Amounts for the period from January 1, 2019 through April 22, 2019 represent the historical operations of Greenlane Holdings, LLC. The amounts for the period from April 23, 2019 through September 30, 2019, and from January 1, 2020 through September 30, 2020 reflect the consolidated operations of Greenlane Holdings, Inc.

Use of Non-GAAP Financial Measures

Greenlane discloses Adjusted Net Loss and Adjusted EBITDA, which are non-GAAP financial measures, because management believes these metrics assist investors and analysts in assessing the Company’s overall operating performance and evaluating how well Greenlane is executing its business strategies. You should not consider Adjusted Net Loss or Adjusted EBITDA as alternatives to net loss determined in accordance with GAAP as indicators of Greenlane’s operating performance. Investors are cautioned that there are material limitations associated with the use of non-GAAP financial measures as an analytical tool. Accordingly, you should not view Adjusted Net Loss or Adjusted EBITDA in isolation or as a substitute, or superior to, financial information prepared and presented in accordance with GAAP. Furthermore, these non-GAAP measures may be different from non-GAAP financial measures used by other companies, limiting their usefulness for comparison purposes.

Adjusted Net Loss and Adjusted EBITDA have limitations as an analytical tool. Some of these limitations are:

  • Although depreciation and amortization are non-cash charges, the assets being depreciated and amortized may have to be replaced in the future and adjusted EBITDA does not reflect capital expenditure requirements for such replacements or for new capital expenditures;
  • Adjusted EBITDA does not include interest expense, which has been a necessary element of the Company’s costs;
  • Adjusted EBITDA does not reflect income tax payments we may be required to make;
  • Adjusted EBITDA and Adjusted Net Loss do not reflect equity-based compensation;
  • Adjusted EBITDA and Adjusted Net Loss do not reflect transaction and other costs which are generally incremental costs that result from an actual or planned transaction;
  • Other companies, including companies in Greenlane’s industry, may calculate adjusted EBITDA and adjusted net loss differently, which reduces its usefulness as a comparative measure.

For more information on Greenlane’s non-GAAP financial measures and a reconciliation of GAAP to non-GAAP financial measures, please see the “Reconciliation of GAAP to Non-GAAP Financial Measures” table in this press release.

Forward Looking Statements

Certain matters within this press release are discussed using forward-looking language as specified in the Private Securities Litigation Reform Act of 1995, and, as such, may involve known and unknown risks, uncertainties and other factors that may cause the actual results or performance to differ from those projected in the forward-looking statements. These forward-looking statements include, among others: comments relating to the current and future performance of the Company’s business; the impact of the ongoing COVID-19 pandemic on the Company’s business; growth in demand for the Company’s products; growth in the market for cannabis and nicotine; the Company’s marketing and commercialization efforts; and the Company’s financial outlook and expectations. For a description of factors that may cause the Company’s actual results or performance to differ from its forward-looking statements, please review the information under the heading “Risk Factors” included in the Company’s most recent Annual Report on Form 10-K for the year ended December 31, 2019 and the Company’s other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. Additional information is also set forth in Greenlane’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to Greenlane on the date hereof. Greenlane undertakes no duty to update this information unless required by law.

Media Contact

MATTIO Communications
[email protected]

Investor Contact:

Rob Kelly
Investor Relations, MATTIO Communications
[email protected]
1-416-992-4539



GREENLANE HOLDINGS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except par value per share amounts)

  September 30,

2020
  December 31,

2019
Assets (Unaudited)    
Current assets      
Cash $ 39,993       $ 47,773    
Accounts receivable, net of allowance of $1,324 and $936 at September 30, 2020 and December 31, 2019, respectively 6,438       8,091    
Inventories, net 36,919       43,060    
Vendor deposits 8,775       11,120    
Assets held for sale 1,177          
Other current assets 8,924       4,924    
Total current assets 102,226       114,968    
       
Property and equipment, net 12,392       13,165    
Intangible assets, net 5,930       6,301    
Goodwill 3,128       11,982    
Operating lease right-of-use assets 3,085       4,695    
Other assets 2,053       2,091    
Total assets $ 128,814       $ 153,202    
       
Liabilities and stockholders’ equity      
Current liabilities      
Accounts payable $ 17,963       $ 11,310    
Accrued expenses and other current liabilities 15,956       10,600    
Customer deposits 2,593       3,152    
Current portion of operating leases 725       1,084    
Current portion of finance leases 208       116    
Total current liabilities 37,445       26,262    
       
Notes payable, less current portion and debt issuance costs, net 7,886       8,018    
Operating leases, less current portion 2,708       3,844    
Finance leases, less current portion 277       194    
Other liabilities 1,038       620    
Total long-term liabilities 11,909       12,676    
Total liabilities 49,354       38,938    
       
Commitments and contingencies      
       
Stockholders’ Equity      
Preferred stock, $0.0001 par value, 10,000 shares authorized, none issued and outstanding          
Class A common stock, $0.01 par value per share, 125,000 shares authorized; 13,072 shares issued and outstanding as of September 30, 2020; 9,999 shares issued and 9,812 shares outstanding as of December 31, 2019 131       98    
Class B common stock, $0.0001 par value per share, 10,000 shares authorized; 3,591 and 5,975 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively 1       1    
Class C Common stock, $0.0001 par value per share, 100,000 shares authorized; 76,489 and 77,791,000 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively 8       8    
Additional paid-in capital 39,194       32,108    
Accumulated deficit (20,732 )     (9,727 )  
Accumulated other comprehensive loss (154 )     (72 )  
Total stockholders’ equity attributable to Greenlane Holdings, Inc. 18,448       22,416    
Non-controlling interest 61,012       91,848    
Total stockholders’ equity 79,460       114,264    
Total liabilities and stockholders’ equity $ 128,814       $ 153,202    



GREENLANE HOLDINGS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited)
(in thousands, except per share amounts)

  Three Months Ended

September 30,
  Nine Months Ended

September 30,
  2020   2019   2020   2019
Net sales $ 35,764       $ 44,886       $ 102,032       $ 147,770    
Cost of sales 33,297       38,448       85,419       123,194    
Gross profit 2,467       6,438       16,613       24,576    
Operating expenses:              
Salaries, benefits and payroll taxes 5,010       6,562       17,745       21,673    
General and administrative 10,673       4,751       25,758       15,549    
Goodwill impairment charge             8,996          
Depreciation and amortization 599       650       1,959       1,980    
Total operating expenses 16,282       11,963       54,458       39,202    
Loss from operations (13,815 )     (5,525 )     (37,845 )     (14,626 )  
Other income (expense), net:              
Change in fair value of convertible notes                   (12,063 )  
Interest expense (115 )     (119 )     (335 )     (862 )  
Other income, net 357       7,746       1,483       8,670    
Total other income (expense), net 242       7,627       1,148       (4,255 )  
(Loss) income before income taxes (13,573 )     2,102       (36,697 )     (18,881 )  
Provision for income taxes 220       11,063       147       10,966    
Net loss (13,793 )     (8,961 )     (36,844 )     (29,847 )  
Less: Net loss attributable to non-controlling interest (9,300 )     (2,563 )     (25,839 )     (4,016 )  
Net loss attributable to Greenlane Holdings, Inc. $ (4,493 )     $ (6,398 )     $ (11,005 )     $ (25,831 )  
               
Net loss attributable to Class A common stock per share – basic and diluted $ (0.35 )     $ (0.64 )     $ (0.95 )     $ (0.67 )  
Weighted-average shares of Class A common stock outstanding – basic and diluted 12,798       9,998       11,559       9,998    
               
Other comprehensive income (loss):              
Foreign currency translation adjustments 285       (13 )     130       38    
Unrealized gain (loss) on derivative instrument 35       (310 )     (525 )     (310 )  
Comprehensive loss (13,473 )     (9,284 )     (37,239 )     (30,119 )  
Less: Comprehensive loss attributable to non-controlling interest (9,066 )     (2,809 )     (26,152 )     (4,238 )  
Comprehensive loss attributable to Greenlane Holdings, Inc. $ (4,407 )     $ (6,475 )     $ (11,087 )     $ (25,881 )  



GREENLANE HOLDINGS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)
(in thousands)

  Nine Months Ended

September 30,
  2020   2019
Cash flows from operating activities:      
Net loss (including amounts attributable to non-controlling interest) $ (36,844 )     $ (29,847 )  
Adjustments to reconcile net loss to net cash used in operating activities:      
Depreciation and amortization 1,959       1,980    
Reversal of tax receivable agreement liability       (5,721 )  
Change in deferred tax asset, net       10,879    
Equity-based compensation expense 182       6,083    
Unrealized gain on equity investment       (1,537 )  
Goodwill impairment charge 8,996          
Change in fair value of contingent consideration (719 )        
Change in fair value of convertible notes       12,063    
Change in provision for doubtful accounts 766       91    
Loss on disposal of assets 569          
Loss related to indemnification asset not probable of recovery 2,200          
Other 242       37    
Changes in operating assets and liabilities, net of the effects of acquisitions:      
Decrease in accounts receivable 886       1,396    
Decrease (increase) in inventories 6,140       (15,764 )  
Decrease (increase) in vendor deposits 2,543       (778 )  
Decrease (increase) in deferred offering costs       2,284    
(Increase) in other current assets (6,217 )     (1,720 )  
Increase (decrease) in accounts payable 6,653       (13,182 )  
Increase in accrued expenses 9,558       465    
(Decrease) in customer deposits (670 )     (272 )  
Net cash used in operating activities (3,756 )     (33,543 )  
Cash flows from investing activities:      
Purchase consideration paid for acquisitions, net of cash acquired (1,841 )     (1,283 )  
Purchases of property and equipment, net (1,438 )     (1,268 )  
Purchase of intangible assets (300 )     (58 )  
Investment in equity securities       (500 )  
Net cash used in investing activities (3,579 )     (3,109 )  
Cash flows from financing activities:      
Proceeds from issuance of convertible notes       8,050    
Proceeds from issuance of Class A common stock sold in initial public offering, net of underwriting costs       83,003    
Payment of debt issuance costs – convertible notes       (1,734 )  
Deferred offering costs paid       (3,523 )  
Redemption of Class A and Class B units of Greenlane Holdings, LLC       (3,019 )  
Member distributions       (897 )  
Other (310 )     (187 )  
Net cash (used in) provided by financing activities (310 )     81,693    
Effects of exchange rate changes on cash (135 )     158    
Net (decrease) increase in cash (7,780 )     45,199    
Cash, as of beginning of the period 47,773       7,341    
Cash, as of end of the period $ 39,993       $ 52,540    
       
Supplemental disclosures of cash flow information      
Cash paid for amounts included in the measurement of lease liabilities:      
Operating cash flows for operating leases $ 1,193       $ 547    
Lease liabilities arising from obtaining finance lease assets $ 272       $ 88    
Lease liabilities arising from obtaining operating lease right-of-use assets $ 331       $ 2,973    
Non-cash investing and financing activities:      
Conversion of convertible debt to Class A common stock $       $ 60,313    
Redeemable Class B Units issued for acquisition of a subsidiary, net of issuance costs $       $ 6,664    
Shares of Class A common stock issued for acquisition of Conscious Wholesale $ 1,988       $    
Exchanges of non-controlling interest for Class A common stock $ (4,616 )     $    



GREENLANE HOLDINGS, INC.

RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL MEASURES

(Unaudited)

The reconciliation of our Net Loss to Adjusted Net Loss for each of the periods indicated is as follows:

  Three Months Ended
September 30,
  Nine Months Ended
September 30,

(in thousands)
2020   2019   2020   2019
Net loss $ (13,793 )     $ (8,961 )     $ (36,844 )     $ (29,847 )  
Debt placement costs for convertible notes (1)                   422    
Transition to being a public company (2)                   775    
Equity-based compensation expense (980 )     1,508       182       6,062    
Initial consulting costs related to ERP system implementation (3) 45             153          
Restructuring expenses (4) 495             859          
Due diligence costs related to acquisition target             903          
Goodwill impairment charge             8,996          
Adjustments related to the product rationalization to increase inventory turnover of slow-selling products 3,222             3,222          
Obsolete inventory charges related to management’s strategic initiative (5) 1,137             1,137          
Allowances for uncollectible vendor deposits incurred in connection with management’s strategic initiative (5) 822             822          
Loss related to indemnification asset not probable of recovery 2,200             2,200          
Change in fair value of convertible notes                   12,063    
Adjusted net loss $ (6,852 )     $ (7,453 )     $ (18,370 )     $ (10,525 )  

(1)   Debt placement costs related to the issuance of convertible notes in January 2019.
(2)   Includes certain non-recurring fees and expenses primarily attributable to consulting fees and incremental audit and legal fees incurred in connection with our IPO.
(3)   Includes non-recurring expenses related to the initial project design for our planned ERP system implementation.
(4)   Includes primarily severance payments for employees terminated as part of our transformation plan.
(5)   Includes certain non-recurring charges related to management’s strategic initiative. These adjustments were incurred liquidate inventory on hand and on order, rationalize product offerings, improve inventory turnover of slow-selling products and vacate warehouse space for products with higher margin and marketability.

The reconciliation of our Net Loss to Adjusted EBITDA for each of the periods indicated is as follows:

  Three Months Ended
September 30,
  Nine Months Ended
September 30,

(in thousands)
2020   2019   2020   2019
Net loss $ (13,793 )     $ (8,961 )     $ (36,844 )     $ (29,847 )  
Other income, net (1) (357 )     (7,746 )     (1,483 )     (8,670 )  
Transition to being a public company (2)                   775    
Interest expense 115       119       335       862    
Provision for (benefit from) income taxes 220       11,063       147       10,966    
Depreciation and amortization 599       650       1,959       1,980    
Equity-based compensation expense (980 )     1,508       182       6,062    
Initial consulting costs related to ERP system implementation (3) 45             153          
Restructuring expenses (4) 495             859          
Due diligence costs related to acquisition target             903          
Adjustments related to product rationalization to increase inventory turnover of slow-selling products (5) 3,222             3,222          
One-time early termination fee on operating lease in connection with moving to a centralized distribution center model             262          
Goodwill impairment charge             8,996          
Obsolete inventory charges related to management’s strategic initiative(5) 1,137             1,137          
Allowances for uncollectible vendor deposits incurred in connection with management’s strategic initiative (5) 822             822          
Loss related to indemnification asset not probable of recovery 2,200             2,200          
Change in fair value of convertible notes                   12,063    
Adjusted EBITDA $ (6,275 )     $ (3,367 )     $ (17,150 )     $ (5,809 )  

(1)   Includes rental and interest income, changes in the fair value of contingent consideration, and other miscellaneous income.
(2)   Includes certain non-recurring fees and expenses primarily attributable to consulting fees and incremental audit and legal fees incurred in connection with our IPO.
(3)   Includes non-recurring expenses related to the initial project design for our planned ERP system implementation.
(4)   Includes primarily severance payments for employees terminated as part of our transformation plan.
(5)   Includes certain non-recurring charges related to management’s strategic initiative. These adjustments were incurred liquidate inventory on hand and on order, rationalize product offerings, improve inventory turnover of slow-selling products and vacate warehouse space for products with higher margin and marketability. 



SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in Evolus, Inc. of Class Action Lawsuit and Upcoming Deadline – EOLS

NEW YORK, Nov. 16, 2020 (GLOBE NEWSWIRE) — Pomerantz LLP announces that a class action lawsuit has been filed against certain officers of Evolus, Inc.  (“Evolus” or the “Company”) (NASDAQ: EOLS).   The class action, filed in United States District Court for the Southern District of New York, and docketed under 20-cv-09053, is on behalf of a class consisting of all persons other than Defendants who purchased or otherwise, acquired Evolus securities between February 1, 2019 and July 6, 2020, both dates inclusive (the “Class Period”), seeking to recover damages caused by Defendants’ violation of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.

If you are a shareholder who purchased Evolus securities during the class period, you have until December 15, 2020, to ask the Court to appoint you as Lead Plaintiff for the class.  A copy of the Complaint can be obtained at www.pomerantzlaw.com.   To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased. 



[Click here for information about joining the class action]

Evolus is a Delaware corporation headquartered in Newport Beach, California. The Company operates as a medical aesthetics company, and develops, produces, and markets clinical neurotoxins for the treatment of aesthetic concerns. Evolus’ sole product is Jeuveau™, which is a purified botulinum toxin indicated for the temporary improvement in the appearance of moderate to severe frown lines in adults. As such, Evolus directly competes with Botox®, which is manufactured by Allergan plc and Allergan Inc. (“Allergan”) and distributed by Medytox Inc. (“Medytox”). Botox® has been the gold standard of the industry since its approval by the U.S. Food and Drug Administration (“FDA”) more than two decades ago.

Beginning in February 2019, Evolus embarked on a public campaign to hype the market right before the commercial launch of its sole leading product Jeuveau™. To secure an aggressive growth and rapid influx of revenue, Defendants disseminated dozens of public statements in which they promoted Jeuveau™ as a proprietary formulation of the botulinum toxic type A complex, purportedly developed by Korean bioengineering company Daewoong through years of clinical research and millions of dollars’ worth of investment in research and development. Among other things, Evolus promised investors that it would attain the number two U.S. market position within twenty-four months of launch.

The complaint alleges that throughout the Class Period, Defendants made materially false and/or misleading because they misrepresented and failed to disclose the following adverse facts pertaining to the Company’s business, operations, and prospects, which were known to Defendants or recklessly disregarded by them. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) the real source of botulinum toxin bacterial strain as well as the manufacturing processes used to develop Jeuveau™ originated with and were misappropriated from Medytox; (ii) sufficient evidentiary support existed for the allegations that Evolus misappropriated certain trade secrets relating to the botulin toxin strain and the manufacturing processes for the development of Jeuveau™; (iii) as a result, Evolus faced a real threat of regulatory and/or court action, prohibiting the import, marketing, and sale of Jeuveau™; which in turn (iv) seriously threatened Evolus’ ability to commercialize Jeuveau™ in the U.S. and generate revenue; and (v) any revenues generated from the sale of Jeuveau™ were based on Evolus’ unlawful activities, including the misappropriation of trade secrets and secret manufacturing processes belonging to Allergan and Medytox.

The investing public learned the truth about Jeuveau™ on July 6, 2020, when the U.S. International Trade Commission (“ITC”) issued its Initial Final Determination in a case brought by Allergan and Medytox against Evolus, alleging that Evolus stole certain trade secrets to develop Jeuveau™. Coming as a great surprise to unsuspecting investors, the ITC Judge found that Evolus misappropriated the botulinum toxin strain as well as the manufacturing processes that led to its development and manufacture. Additionally, the ITC Judge recommended a ten-year-long ban on Evolus’ ability to import Jeuveau™ into the U.S. and a ten-year-long cease-and-desist order preventing Evolus from selling Jeuveau™ in the U.S.

This news caused a precipitous and immediate decline in the price of Evolus shares, which fell 37% over the course of two trading days, to close at $3.35 per share on July 8, 2020, on unusually high trading volume. Following the news of the ITC’s Initial Final Determination and the subsequent price drop of Evolus’ common shares, several securities analysts downgraded Evolus’ rating and significantly lowered the Company’s price target.

The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com.

CONTACT:
Robert S. Willoughby
Pomerantz LLP
[email protected]
888-476-6529 ext. 7980



SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Loop Industries, Inc. – LOOP

NEW YORK, Nov. 16, 2020 (GLOBE NEWSWIRE) — Pomerantz LLP is investigating claims on behalf of investors of Loop Industries, Inc. (“Loop” or the “Company”) (NASDAQ: LOOP). Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext. 7980.

The investigation concerns whether Loop and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. 



[Click here for information about joining the class action]

On October 13, 2020, Hindenburg Research (“Hindenburg”) published a report entitled “Loop Industries: Former Employees and Plastics Experts Blow The Whistle On This ‘Recycled’ Smoke And Mirrors Show”. Citing a months-long investigation that “included speaking with multiple former employees, company partners, polymer/plastic experts, and competitors,” the Hindenburg report characterized Loop’s “claimed breakthroughs in PET [polyethylene terephthalate] plastic recycling” as “fiction”. The Hindenburg Report described former employees as “paint[ing] a picture of a chaotic company whose lead scientists are twenty-something ‘liars’ with no relevant work experience other than Loop” and asserted that “[o]ur investigation points to one conclusion: in the words of a former Loop employee, we simply ‘don’t really think they have the technology.’”

On this news, Loop’s stock price fell sharply during intraday trading on October 13, 2020.

The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com.

CONTACT:
Robert S. Willoughby
Pomerantz LLP
[email protected]
888-476-6529 ext. 7980



SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Citigroup Inc. – C

NEW YORK, Nov. 16, 2020 (GLOBE NEWSWIRE) — Pomerantz LLP is investigating claims on behalf of investors of Citigroup Inc. (“Citigroup” or the “Company”) (NYSE: C).   Such investors are advised to contact Robert S. Willoughby at  [email protected] or 888-476-6529, ext. 7980.

The investigation concerns whether Citigroup and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. 



[Click here for information about joining the class action]

On September 14, 2020, reports surfaced that regulators were preparing to reprimand Citi for failing to improve its risk-management systems.  On this news, Citi’s stock price fell $2.85 per share, or 5.59%, to close at $48.15 per share on September 14, 2020. 

Then, on September 14, 2020, post-market, an internal memo sent to Citi employees revealed for the first time the Company’s disregard for adequate internal controls and regulatory compliance.  On this news, Citi’s stock price fell an additional $3.34 per share, or 3.94%, to close $44.81 per share on September 15, 2020. 

Finally, on October 13, 2020, Citi reported earnings for the third quarter of 2020, and disclosed that the Company’s expenses increased during the third quarter by 5%, to $11 billion, due to an increase in costs including a $400 million fine, investments in infrastructure, and other remediation costs related to control deficiencies.  On this news, Citi’s stock price fell another $2.20 per share, or 4.8%, to close at $43.68 per share on October 13, 2020.

The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com.

CONTACT:
Robert S. Willoughby
Pomerantz LLP
[email protected]
888-476-6529 ext. 7980



SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Raytheon Technologies Corporation – RTX

NEW YORK, Nov. 16, 2020 (GLOBE NEWSWIRE) — Pomerantz LLP is investigating claims on behalf of investors of Raytheon Technologies Corporation (“Raytheon or the “Company”) (NYSE: RTX).   Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext. 7980.

The investigation concerns whether Raytheon and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. 



[Click here for information about joining the class action]

On October 27, 2020, Raytheon filed its quarterly report for the third fiscal quarter with the U.S. Securities and Exchange Commission, in which the Company disclosed receipt of a criminal subpoena from the U.S. Department of Justice seeking information and documents in connection with an investigation relating to financial accounting, internal controls over financial reporting, and cost reporting regarding Raytheon’s Missiles & Defense business since 2009. 

On this news, Raytheon’s stock price fell $4.19 per share, or 7.4%, to close at $52.34 per share on October 28, 2020.

The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com.

CONTACT:
Robert S. Willoughby
Pomerantz LLP
[email protected]
888-476-6529 ext. 7980



SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in Celsion Corporation of Class Action Lawsuit and Upcoming Deadline – CLSN

NEW YORK, Nov. 16, 2020 (GLOBE NEWSWIRE) — Pomerantz LLP announces that a class action lawsuit has been filed against certain officers of Celsion Corporation (“Celsion” or the “Company”) (NASDAQ: CLSN).   The class action, filed in United States District Court for the District of New Jersey, and docketed under 20-cv-015228, is on behalf of a class consisting of all persons other than Defendants who purchased or otherwise, acquired Celsion securities between November 2, 2015 and July 10, 2020, both dates inclusive (the “Class Period”), seeking to recover damages caused by Defendants’ violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.

If you are a shareholder who purchased Celsion securities during the class period, you have until December 28, 2020, to ask the Court to appoint you as Lead Plaintiff for the class.  A copy of the Complaint can be obtained at www.pomerantzlaw.com.   To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased. 



[Click here for information about joining the class action]

Celsion is an integrated development clinical stage oncology drug company that focuses on the development and commercialization of directed chemotherapies, DNA-mediated immunotherapy, and RNA-based therapies for the treatment of cancer.

Celsion’s lead product candidate is ThermoDox, a heat-activated liposomal encapsulation of doxorubicin that is in Phase III clinical development for treating primary liver cancer.

In February 2014, Celsion announced that the U.S. Food and Drug Administration (“FDA”) had reviewed and provided clearance for the Company’s planned pivotal, double-blind, placebo-controlled Phase III trial of ThermoDox in combination with radio frequency ablation (“RFA”) in primary liver cancer, also known as hepatocellular carcinoma (“HCC”), called the “OPTIMA Study.” The trial design was purportedly based on a comprehensive analysis of data from the Company’s Phase III HEAT Study, which purportedly demonstrated that treatment with ThermoDox resulted in a 55% improvement in overall survival (“OS”) in a substantial number of HCC patients that received an optimized RFA treatment.  

The OPTIMA Study was expected to enroll 550 patients globally, with up to 100 sites in the U.S., Europe, China and Asia Pacific, to evaluate ThermoDox in combination with RFA. The primary endpoint for the trial was OS, and the statistical plan called for two interim efficacy analyses by an independent Data Monitoring Committee (“DMC”).

The complaint alleges that throughout the Class Period, Defendants made materially false and/or misleading because they misrepresented and failed to disclose the following adverse facts pertaining to the Company’s business, operations, and prospects, which were known to Defendants or recklessly disregarded by them. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) Defendants had significantly overstated the efficacy of ThermoDox; (ii) the foregoing significantly diminished the approval and commercialization prospects for ThermoDox; and (iii) as a result, the Company’s public statements were materially false and misleading at all relevant times.

On July 13, 2020, Celsion announced that “it ha[d] received a recommendation from the independent [DMC] to consider stopping the global Phase III OPTIMA Study of ThermoDox® in combination with [RFA] for the treatment of [HCC], or primary liver cancer.” According to the Company, “[t]he recommendation was made following the second pre-planned interim safety and efficacy analysis by the DMC on July 9, 2020,” which “found that the pre-specified boundary for stopping the trial for futility of 0.900 was crossed with an actual value of 0.903.”

On this news, Celsion’s stock price fell $2.29 per share, or 63.97%, to close at $1.29 per share on July 13, 2020.

The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com.

CONTACT:
Robert S. Willoughby
Pomerantz LLP
[email protected]
888-476-6529 ext. 7980



Results From SOLOIST and SCORED Outcomes Studies Presented at Late-Breaking Science Session of American Heart Association Scientific Sessions and Published in The New England Journal of Medicine

Sotagliflozin Significantly Reduced Total Cardiovascular Deaths, Heart Failure Hospitalization and Urgent Visits, Achieving Primary Endpoint in Both Studies

THE WOODLANDS, Texas, Nov. 16, 2020 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that both the SOLOIST and SCORED Phase 3 studies achieved their primary endpoints by demonstrating statistically significant reductions in total cardiovascular deaths, hospitalizations for heart failure and urgent heart failure visits in patients treated with sotagliflozin as compared with placebo.

In the SOLOIST study, the primary endpoint was achieved with a hazard ratio (HR) of 0.67 (p<0.001) in people with type 2 diabetes and a recent hospitalization for worsening heart failure. In the SCORED study, the primary endpoint was achieved with a hazard ratio of 0.74 (p<0.001) in people with type 2 diabetes and chronic kidney disease with an estimated glomerular filtration rate (eGFR) of 25 to 60 ml/minute per 1.73 m² of body-surface area.

The key results from SOLOIST and SCORED were presented today at the Late-Breaking Science Session of the American Heart Association (AHA) Scientific Sessions 2020 and simultaneously published in The New England Journal of Medicine (NEJM) in two separate articles titled: “Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure” and “Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease.” The articles may be accessed at www.nejm.org.

“Cardiovascular disease continues to be a leading cause of death in people with type 2 diabetes,” said Deepak L. Bhatt, M.D., M.P.H., executive director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital and a professor of medicine at Harvard Medical School and study chair and lead author for the NEJM publications of the SOLOIST and SCORED results. “SOLOIST demonstrates that early, in-hospital initiation of sotagliflozin in patients with worsening heart failure significantly reduces subsequent cardiovascular events, an effect that was consistent across groups with heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF). SCORED demonstrates that sotagliflozin significantly reduces heart failure events in a patient population with stage 3 and 4 chronic kidney disease and cardiovascular risk. Both studies add to the evidence that SGLT2 inhibition should be standard of care in heart failure, and the SCORED data reflecting a reduction in myocardial infarction and stroke and better glucose control in CKD patients suggest potential benefits from the dual SGLT1 and SGLT2 mechanism of this particular agent.”


Key SOLOIST Phase 3 Study Results

SOLOIST was a multi-center, randomized, double-blinded, placebo-controlled Phase 3 study evaluating the cardiovascular efficacy of sotagliflozin versus placebo when added to standard of care in 1,222 patients with type 2 diabetes who had recently been hospitalized for worsening heart failure. The primary endpoint was the total number of events comprised of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure in patients starting treatment with 200 mg sotagliflozin once daily compared with placebo, with dosing initiated either before or within 3 days of hospital discharge.

The first dose of sotagliflozin or placebo was administered prior to hospital discharge in 48.8% of the patients and a median of two days after discharge in 51.2% of the patients, with the benefits of sotagliflozin being consistent between those prespecified subgroups of patients. The initial 200 mg once daily dose of sotagliflozin was increased to 400 mg once daily if unacceptable side effects did not occur.

Treatment with sotagliflozin resulted in a significantly lower total number of cardiovascular deaths, heart failure hospitalizations and urgent visits as compared to placebo. A total of 600 primary endpoint events occurred in the study, with 245 events in the sotagliflozin treated group and 355 events in the placebo group. There were 51.0 primary endpoint events per 100 patient-years in the sotagliflozin treated group as compared to 76.3 events per 100 patient-years in the placebo group (HR=0.67; 95% confidence interval [CI]=0.52 to 0.85; p<0.001). There were 10.6 events of cardiovascular death per 100 patient-years in the sotagliflozin treated group as compared to 12.5 events per 100 patient-years in the placebo group (HR=0.84; 95% CI=0.58 to 1.22; p=0.36).

Of note, effects on the primary endpoint were consistent among patients suffering from heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF), with a hazard ratio of 0.72 (95% CI=0.56 to 0.94) in patients with a left ventricular ejection fraction (LVEF) of less than 50% and a hazard ratio of 0.48 (95% CI=0.27 to 0.86) in patients with a LVEF of greater than or equal to 50%.

Serious adverse events that led to discontinuation of study drug, as determined by investigators, occurred in 3.0% (n=18) of the patients in the sotagliflozin treated group and in 2.8% (n=17) of the patients in the placebo group. Based on investigator reported events, the most common adverse events of special interest included hypotension (6.0% on sotagliflozin versus 4.6% on placebo), urinary tract infections (4.8% on sotagliflozin versus 5.1% on placebo), acute kidney injury (4.1% on sotagliflozin versus 4.4% on placebo), and diarrhea (6.1% on sotagliflozin versus 3.4% on placebo). Among other adverse events of interest, in SOLOIST, genital mycotic infections (0.8% on sotagliflozin vs. 0.2% on placebo) were infrequent, severe hypoglycemia (1.5% on sotagliflozin vs. 0.3% on placebo) was more common in the sotagliflozin treated group and diabetic ketoacidosis (0.3% on sotagliflozin vs. 0.7% on placebo) was similar between treatment groups.

The SOLOIST study was originally designed with a primary endpoint of the first occurrence of death from cardiovascular causes or hospitalization for heart failure, as determined by independent adjudication, but was modified in connection with the early close out of the study to include urgent heart failure visits and reflect the total number of events, as determined by investigators, in order to enhance the statistical power of the comparison. The specification of the primary endpoint based on total events was implemented without any awareness of the study outcomes or study-group assignments and without information from an interim analysis.

The results for first occurrence of cardiovascular death or hospitalization for heart failure (HR=0.71; 95% CI=0.57 to 0.89; p=0.003) based on investigator reported events were consistent with those of the modified primary endpoint.


Key SCORED Phase 3 Study Results

SCORED was a multi-center, randomized, double-blinded, placebo-controlled Phase 3 study evaluating the cardiovascular efficacy of sotagliflozin versus placebo when added to standard of care in 10,584 patients with type 2 diabetes, chronic kidney disease with eGFR of 25 to 60 ml per minute per 1.73 m² of body-surface area, and risks for cardiovascular disease. The primary endpoint was the total number of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure in patients treated with sotagliflozin compared with placebo. The initial 200 mg once daily dose of sotagliflozin was increased to 400 mg once daily if unacceptable side effects did not occur.

Treatment with sotagliflozin resulted in a significantly lower total number of cardiovascular deaths, heart failure hospitalizations and urgent visits as compared to placebo. A total of 930 primary endpoint events occurred in the study, with 400 events in the sotagliflozin treated group and 530 events in the placebo group. There were 5.6 primary endpoint events per 100 patient-years in the sotagliflozin treated group as compared to 7.5 events per 100 patient-years in the placebo group (HR=0.74; 95% CI=0.63 to 0.88; p<0.001). There were 2.2 events of cardiovascular death per 100 patient-years in the sotagliflozin treated group as compared to 2.4 events per 100 patient-years in the placebo group (HR=0.90; 95% CI=0.73 to 1.12; p=0.35).

Of note, over the course of the study, the data showed an average reduction in hemoglobin A1c of 0.56% in the sotagliflozin treated group as compared to a reduction of 0.25% in the placebo group in patients with severe chronic kidney disease, eGFR less than 30 ml per minute per 1.73 m² of body-surface area (p<0.001). In patients with moderate chronic kidney disease, eGFR greater than or equal to 30 ml per minute per 1.73 m² of body-surface area, the data showed an average reduction in hemoglobin A1c of 0.60% in the sotagliflozin treated group as compared to a reduction of 0.17% in the placebo group (p<0.001).

Serious adverse events that led to discontinuation of study drug, as determined by investigators, occurred in 2.1% (n=112) of the patients in the sotagliflozin treated group and in 1.8% (n=94) of the patients in the placebo group. Based on investigator reported events, the most common adverse events of special interest included urinary tract infections (11.5% on sotagliflozin versus 11.1% on placebo), diarrhea (8.5% on sotagliflozin versus 6.0% on placebo), volume depletion (5.3% on sotagliflozin versus 4.0% on placebo), bone fractures (2.1% on sotagliflozin versus 2.2% on placebo), and genital mycotic infections (2.4% on sotagliflozin versus 0.9% on placebo). Among other adverse events of interest, diabetic ketoacidosis (0.6% on sotagliflozin vs. 0.3% on placebo) was more common in the sotagliflozin treated group and severe hypoglycemia (1.0% on sotagliflozin vs. 1.0% on placebo) was similar between treatment groups.

The SCORED study was originally designed with co-primary endpoints, assessed in time-to-event analyses, of the first occurrence of a major adverse cardiovascular event (defined as death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, or 3-point MACE) and the first occurrence of death from cardiovascular causes or hospitalization for heart failure, as determined by independent adjudication, but were modified in connection with the early close out of the study to include urgent heart failure visits and reflect the total number of events, as determined by investigators, in order to enhance the statistical power of the comparison. The specification of the primary endpoint based on total events was implemented without any awareness of the study outcomes or study-group assignments and without information from an interim analysis.

In a time-to-event analysis, applying the original co-primary endpoints based on investigator reported events, the results for both the first occurrence of a MACE event (HR=0.84; 95% CI=0.72 to 0.99; p=0.035) and the first occurrence of death from cardiovascular causes or hospitalization for heart failure (HR=0.78; 95% CI=0.66 to 0.91; p=0.001) were consistent with those of the modified primary endpoint.

About Sotagliflozin

Discovered using Lexicon’s unique approach to gene science, sotagliflozin is an oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney. Sotagliflozin is approved in the European Union (EU) for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes with a body mass index ≥ 27 kg/m², who could not achieve adequate glycemic control despite optimal insulin therapy, but has not yet been commercially launched.

About Lexicon Pharmaceuticals

Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through its Genome5000™ program, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. Lexicon advanced one of these medicines to market and has a pipeline of promising drug candidates in discovery and clinical and preclinical development in diabetes and metabolism, neuropathic pain and other indications. For additional information, please visit www.lexpharma.com.

Safe Harbor Statement

This press release contains “forward-looking statements,” including statements relating to Lexicon’s
clinical development of sotagliflozin
and the clinical development and therapeutic and commercial potential of sotagliflozin. In addition, this press release also contains forward looking statements relating to Lexicon’s financial position, long term outlook on its business, growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including
the risk that the FDA and other regulatory authorities may not grant regulatory approval of sotagliflozin, and the risk that such regulatory approvals, if granted, may have significant limitations on the approved use of sotagliflozin. As a result, sotagliflozin may never be successfully commercialized. Other risks include
Lexicon’s ability to meet its capital requirements, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of LX9211 and its other potential drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

For Inquiries:

Chas Schultz
Executive Director, Corporate Communications and Investor Relations
Lexicon Pharmaceuticals
(281) 863-3421
[email protected]



SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in Las Vegas Sands Corporation of Class Action Lawsuit and Upcoming Deadline – LVS

NEW YORK, Nov. 16, 2020 (GLOBE NEWSWIRE) — Pomerantz LLP announces that a class action lawsuit has been filed against Las Vegas Sands Corporation (“Las Vegas Sands” or the “Company”) (NYSE: LVS) and certain of its officers. The class action, filed in United States District Court for the District of Nevada, and docketed under 20-cv-01958, is on behalf of a class consisting of all persons other than Defendants who purchased or otherwise, acquired Las Vegas Sands securities between February 27, 2016 and September 15, 2020, both dates inclusive (the “Class Period”), seeking to recover damages caused by Defendants’ violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.

If you are a shareholder who purchased Las Vegas Sands securities during the class period, you have until December 21, 2020, to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased. 



[Click here for information about joining the class action]

Las Vegas Sands was founded in 1988 and is based in Las Vegas, Nevada. The Company, together with its subsidiaries, develops, owns, and operates integrated resorts in Asia and the U.S., which offer various amenities.

Las Vegas Sands’ properties include, among others, the Marina Bay Sands resort in Singapore, which operates a casino.

The Complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) weaknesses existed in Marina Bay Sands’ casino control measures pertaining to fund transfers; (ii) the Marina Bay Sands’ casino was consequently prone to illicit fund transfers that implicated, among other issues, the transfer of customer funds to unauthorized persons and potential breaches in the Company’s anti-money laundering procedures; (iii) the foregoing foreseeably increased the risk of litigation against the Company, as well as investigation and increased oversight by regulatory authorities; (iv) Las Vegas Sands had inadequate disclosure controls and procedures; (v) consequently, all the foregoing issues were untimely disclosed; and (vi) as a result, the Company’s public statements were materially false and misleading at all relevant times.

On July 19, 2020, Bloomberg News reported that Las Vegas Sands had settled a lawsuit brought by a former patron, Wang Xi (“Xi”), meeting his demand for a S$9.1 million ($6.5 million) payment. Xi reportedly sued the Marina Bay Sands casino in 2019 to recover S$9.1 million of his funds that the casino allegedly transferred to other patrons from his casino deposit accounts in 2015 without his approval, which triggered a probe into the casino by local authorities. Bloomberg News also reported that the U.S. Department of Justice (“DOJ”) “is also scrutinizing whether anti-money laundering procedures had been breached in the way the Singapore casino handles high rollers.”

On this news, Las Vegas Sands’ stock price fell $1.41 per share, or 2.9%, to close at $47.28 per share on July 20, 2020.

Then, on September 16, 2020, Bloomberg reported that Marina Bay Sands “has hired a law firm to conduct a new investigation into employee transfers of more than $1 billion in gamblers’ money to third parties[.]” The article quoted the Singapore Casino Regulatory Authority (“CRA”) as stating that “there were weaknesses in [Marina Bay Sands’] casino control measures pertaining to fund transfers[.]”

On this news, Las Vegas Sands’ stock price fell $2.18 per share, or 4.2%, to close at $49.67 per share on September 16, 2020.

The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com.

CONTACT:
Robert S. Willoughby
Pomerantz LLP
[email protected]



SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in Aurora Cannabis, Inc. of Class Action Lawsuit and Upcoming Deadline – ACB

NEW YORK, Nov. 16, 2020 (GLOBE NEWSWIRE) — Pomerantz LLP announces that a class action lawsuit has been filed against certain officers of Aurora Cannabis, Inc.  (“Aurora” or the “Company”) (NYSE: ACB).   The class action, filed in United States District Court for the District of New Jersey, and docketed under 20-cv-13819, is on behalf of a class consisting of all persons other than Defendants who purchased or otherwise, acquired Aurora securities between February 13, 2020, and September 4, 2020, both dates inclusive (the “Class Period”), seeking to recover damages caused by Defendants’ violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.

If you are a shareholder who purchased Aurora securities during the class period, you have until December 1, 2020, to ask the Court to appoint you as Lead Plaintiff for the class.  A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased. 



[Click here for information about joining the class action]

Aurora is headquartered in Edmonton, Canada. The Company produces and distributes medical cannabis products worldwide. It is vertically integrated and horizontally diversified across various segments of the cannabis value chain, including facility engineering and design, cannabis breeding, genetics research, production, derivatives, high value-add product development, home cultivation, wholesale, and retail distribution.

In 2018, the Canadian government approved the Cannabis Act, which legalized and regulated the use of recreational cannabis. In response to the statute’s approval and the corresponding surge of the recreational cannabis industry, Aurora completed a series of acquisitions to expand the Company’s presence and increase its distribution, including the Company’s all-share purchase of the Canadian medical cannabis producer MedReleaf for a total consideration of 3.2 billion Canadian dollars. Like many other companies in the cannabis industry, however, the Company encountered a variety of difficulties as the industry surged, including, inter alia, overproduction, regulatory delays, and competition from the black market.

On February 6, 2020, shortly before the start of the Class Period, Aurora issued a press release announcing, inter alia, a “business transformation plan,” to “better align the business financially with the current realities of the cannabis market in Canada while maintaining a sustainable platform for long-term growth.” Specifically, the press release touted that the plan was “expected to include significant and immediate decreases in selling, general & administrative (“SG&A”) expenses and capital investment plans.”

The complaint alleges that thought the Class Period, Defendants made materially false and/or misleading because they misrepresented and failed to disclose the following adverse facts pertaining to the Company’s business, operations, and prospects, which were known to Defendants or recklessly disregarded by them. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) Aurora had significantly overpaid for previous acquisitions and experienced degradation in certain assets, including its production facilities and inventory; (ii) the Company’s purported “business transformation plan” and cost reset failed to mitigate the foregoing issues; (iii) accordingly, it was foreseeable that the Company would record significant goodwill and asset impairment charges; and (iv) as a result, the Company’s public statements were materially false and misleading at all relevant times.

On September 8, 2020, Aurora issued a press release “announc[ing] an update on its business operations along with certain unaudited preliminary fiscal fourth-quarter 2020 results.” Among other things, Aurora announced that the Company expected to record up to $1.8 billion in goodwill impairment charges in the fourth quarter of 2020. The Company also announced that “previously announced fixed asset impairment charges[ were] now expected to be up to $90 million, due to production facility rationalization, and a charge of approximately $140 million in the carrying value of certain inventory, predominantly trim, in order to align inventory on hand with near term expectations for demand.”

On this news, Aurora’s stock price fell $0.99 per share, or 11.63%, to close at $7.52 per share on September 8, 2020.

The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com.

CONTACT:
Robert S. Willoughby
Pomerantz LLP
[email protected]
888-476-6529 ext. 7980