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8-K - POLARITYTE, INC.form8-k.htm
EX-99.2 - POLARITYTE, INC.ex99-2.htm

 

Exhibit 99.1

 

 

 

PolarityTE Reports Second Quarter 2020 Results

 

SALT LAKE CITY, August 6, 2020 – PolarityTE, Inc. (Nasdaq: PTE), a biotechnology company developing regenerative tissue products and biomaterials, today reported financial results for the second calendar quarter of 2020. PolarityTE will host a conference call and webcast today, August 6, 2020 at 8:00 a.m. ET.

 

Highlights

 

Total revenues were $2.27 million in Q2:20 compared to $1.33 million in Q2:19
SkinTE revenues were $0.94 million in Q2:20 compared to $0.50 million in Q2:19
Paid Cases were 88 in Q2:20 compared to 46 in Q2:19

 

Financial Results for the Three Months Ended June 30, 2020

 

Total revenue for the three months ended June 30, 2020 was $2.27 million, of which $0.94 million was from sales of SkinTE and $1.32 million from PolarityTE’s contract service operations, which includes $0.71 million from COVID-19 testing services that the Company started providing at the end of May 2020.

 

Research and development expenses for the three months ended June 30, 2020 were approximately $3.16 million versus $4.76 million for the three months ended June 30, 2019. Research and development expenses for the three months ended June 30, 2020 included an expense of $0.40 million from stock-based compensation which is a non-cash charge, versus $1.48 million for the three months ended June 30, 2019.

 

General and administrative expenses for the three months ended June 30, 2020 were $5.21 million versus $15.06 million for the three months ended June 30, 2019. General and administrative expenses for the three months ended June 30, 2020 included $0.14 million of stock-based compensation which is a non-cash charge, versus $6.89 million for the three months ended June 30, 2019.

 

 
 

 

Sales and marketing expenses for the three months ended June 30, 2020 were $2.02 million versus $3.98 million for the three months ended June 30, 2019.

 

Net loss for the three months ended June 30, 2020 was $12.68 million compared with a net loss of $22.79 million for the three months ended June 30, 2019.

 

Cash and Liquidity as of June 30, 2020

 

As of June 30, 2020, our cash, cash equivalents and short-term investments balance was approximately $30.50 million, compared to cash and cash equivalents and short-term investments of $29.24 million at December 31, 2019.

 

Cash used in operating activities for the three-month period ended June 30, 2020 was approximately $11.56 million, or approximately $3.85 million per month on average, 10% lower than the $4.27 million monthly average in the three months ended June 30, 2019 and 17% lower than the $4.62 million monthly average in the three months ended March 31, 2020.

 

The Company believes capital resources will be sufficient to fund its current business plan including related operating expenses and capital expenditure requirements into the second quarter of 2021.

 

Conference Call and Webcast Details

 

The conference call can be accessed by calling 1-888-599-8688 (U.S. and Canada) or +44 (0)330 336 9104 (International), with confirmation code 679989 and referencing “PolarityTE Second Quarter 2020 Earnings Call.” A webcast of the conference call can be accessed by using the link below.

 

Earnings Call Webcast – CLICK HERE

 

A replay of the earnings conference call will be available for 30 days, beginning approximately one hour after the conclusion of the call and can be found by visiting PolarityTE’s website at https://www.polarityte.com/news-media/events or by clicking on the link above.

 

About PolarityTE®

 

PolarityTE is focused on transforming the lives of patients by discovering, designing and developing a range of regenerative tissue products and biomaterials for the fields of medicine, biomedical engineering and material sciences. Rather than manufacturing with synthetic and foreign materials within artificially engineered environments, PolarityTE manufactures products from the patient’s own tissue and uses the patient’s own body to support the regenerative process. From a small piece of healthy autologous tissue, the company creates an easily deployable, dynamic and self-propagating product designed to regenerate the target tissues. PolarityTE’s innovative methods are intended to promote and accelerate growth of the patient’s tissues to undergo a form of effective regenerative healing. Learn more at www.PolarityTE.com – Welcome to the Shift®.

 

Forward Looking Statements

 

Certain statements contained in this release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. They are generally identified by words such as “believes,” “may,” “expects,” “anticipates,” “intend,” “plan,” “will,” “would,” “should” and similar expressions. Readers should not place undue reliance on such forward-looking statements, which are based upon the Company’s beliefs and assumptions as of the date of this release. The Company’s actual results could differ materially due to the impact of the COVID-19 pandemic and FDA regulatory matters, which cannot be predicted, and the risk factors and other items described in more detail in the “Risk Factors” section of the Company’s annual report on Form 10-K, quarterly reports on Form 10-Q, and other filings with the SEC (copies of which may be obtained at www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. The Company specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law. Our actual results could differ materially due to risk factors and other items described in more detail in the “Risk Factors” section of the Company’s Annual Reports and other filings with the SEC (copies of which may be obtained at www.sec.gov).

 

 
 

 

POLARITYTE, the POLARITYTE logo, SKINTE, WHERE SELF REGENERATES SELF and WELCOME TO THE SHIFT are trademarks or registered trademarks of PolarityTE, Inc.

 

CONTACTS

 

Investors:

Rich Haerle

VP, Investor Relations

PolarityTE, Inc.

ir@PolarityTE.com

(385) 315-0697

 

 
 

 

POLARITYTE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

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

 

   June 30, 2020   December 31, 2019 
ASSETS          
Current assets          
Cash and cash equivalents  $30,504   $10,218 
Short-term investments       19,022 
Accounts receivable, net   2,115    1,731 
Inventory   281    252 
Prepaid expenses and other current assets   2,453    1,264 
Total current assets   35,353    32,487 
Property and equipment, net   12,729    14,911 
Operating lease right-of-use assets   3,559    4,590 
Intangible assets, net   636    731 
Goodwill   278    278 
Other assets   599    602 
TOTAL ASSETS  $53,154   $53,599 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current liabilities          
Accounts payable and accrued expenses  $5,050   $7,095 
Other current liabilities   2,644    2,338 
Current portion of long-term notes payable   1,436    528 
Deferred revenue   97    98 
Total current liabilities   9,227    10,059 
Common stock warrant liability   8,736     
Operating lease liabilities   2,192    2,994 
Other long-term liabilities   1,022    1,630 
Long-term notes payable   2,410     
Total liabilities   23,587    14,683 
           
STOCKHOLDERS’ EQUITY          
Preferred stock - 25,000,000 shares authorized, 0 shares issued and outstanding at June 30, 2020 and December 31, 2019        
Common stock – $.001 par value; 250,000,000 shares authorized; 38,496,910 and 27,374,653 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively   38    27 
Additional paid-in capital   490,603    474,174 
Accumulated other comprehensive income       72 
Accumulated deficit   (461,074)   (435,357)
Total stockholders’ equity   29,567    38,916 
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY  $53,154   $53,599 

 

 
 

 

POLARITYTE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

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

 

   For the Three Months Ended   For the Six Months Ended 
   June 30,   June 30, 
   2020   2019   2020   2019 
Net revenues                    
Products  $944   $504   $1,372   $801 
Services   1,322    822    1,827    1,990 
Total net revenues   2,266    1,326    3,199    2,791 
Cost of sales                    
Products   275    342    615    615 
Services   607    254    783    757 
Total cost of sales   882    596    1,398    1,372 
Gross profit   1,384    730    1,801    1,419 
Operating costs and expenses                    
Research and development   3,164    4,764    6,537    10,116 
General and administrative   5,211    15,060    15,816    32,255 
Sales and marketing   2,024    3,981    5,718    7,934 
Restructuring and other charges   2,084        2,536     
Total operating costs and expenses   12,483    23,805    30,607    50,305 
Operating loss   (11,099)   (23,075)   (28,806)   (48,886)
Other income (expenses)                    
Change in fair value of common stock warrant liability   (1,591)       2,941     
Interest (expense) income, net   (65)   29    (77)   99 
Other income, net   78    254    225    422 
Net loss  $(12,677)  $(22,792)  $(25,717)  $(48,365)
Net loss per share, basic and diluted  $(0.33)  $(0.92)  $(0.72)  $(2.09)
Weighted average shares outstanding, basic and diluted   38,428,289    24,768,453    35,724,141    23,190,343 

 

 

 
 

 

POLARITYTE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited, in thousands)

 

  

For the Six Months Ended

June 30,

 
   2020   2019 
CASH FLOWS FROM OPERATING ACTIVITIES          
Net loss  $(25,717)  $(48,365)
Adjustments to reconcile net loss to net cash used in operating activities:          
Stock based compensation expense   3,784    18,907 
Depreciation and amortization   1,549    1,446 
Amortization of intangible assets   95    99 
Amortization of debt discount   13    28 
Change in fair value of common stock warrant liability   (2,941)    
Change in fair value of contingent consideration       (48)
Loss on abandonment of property and equipment   1,529      
Other non-cash adjustments   (21)   30 
Changes in operating assets and liabilities:          
Accounts receivable   (384)   (624)
Inventory   (29)   (26)
Prepaid expenses and other current assets   (1,189)   (486)
Operating lease right-of-use assets   899    791 
Other assets   3    25 
Accounts payable and accrued expenses   (2,109)   (17)
Other current liabilities   9    367 
Deferred revenue   (1)   (126)
Operating lease liabilities   (903)   (670)
Other long-term liabilities       (120)
Net cash used in operating activities   (25,413)   (28,789)
CASH FLOWS FROM INVESTING ACTIVITIES          
Purchase of property and equipment   (1,170)   (2,110)
Purchase of available-for-sale securities   (14,144)   (15,445)
Proceeds from maturities of available-for-sale securities   16,945    9,278 
Proceeds from sale of available-for-sale securities   16,171     
Net cash provided by (used in) investing activities   17,802    (8,277)
CASH FLOWS FROM FINANCING ACTIVITIES          
Net proceeds from the sale of common stock and warrants   24,276    27,948 
Proceeds from stock options exercised   31    529 
Proceeds from ESPP purchase   40    35 
Cash paid for tax withholdings related to net share settlement   (6)   (636)
Payment of contingent consideration liability       (109)
Principal payments on financing leases   (243)   (225)
Proceeds from term note payable and financing arrangements   4,629     
Principal payments on term note payable and financing arrangements   (830)   (262)
Net cash provided by financing activities   27,897    27,280 
Net increase (decrease) in cash and cash equivalents   20,286    (9,786)
Cash and cash equivalents - beginning of period   10,218    55,673 
Cash and cash equivalents - end of period  $30,504   $45,887