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Note 2 - Summary of Significant Accounting Policies
9 Months Ended
Sep. 30, 2019
Notes to Financial Statements  
Organization, Consolidation and Presentation of Financial Statements Disclosure and Significant Accounting Policies [Text Block]
2.
Summary of Significant Accounting Policies
 
Recently Adopted Accounting Standards
In
June 2018,
the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU)
2018
-
07,
“Compensation-Stock Compensation (Topic
718
): Improvements to Nonemployee Share-Based Payment Accounting”
, which simplifies the accounting for nonemployee share-based payment transactions. The amendments specify that Topic
718
applies to all share-based payment transactions in which a grantor acquires goods or services to be used or consumed in a grantor’s own operations by issuing share-based payment awards. The Company adopted the standard on
January 1, 2019.
The adoption of this standard did
not
have a material impact on the Company’s financial statements.
 
In
February 2016,
the FASB issued ASU
2016
-
02
Leases
,” which increases transparency and comparability among organizations by recognizing lease assets and lease liabilities on the balance sheet and disclosing key information about leasing arrangements. The Company adopted the standard on
January 1, 2019.
 
The new standard requires lessees to recognize both the right-of-use assets and lease liabilities in the balance sheet for most leases, whereas under previous GAAP only finance lease liabilities (previously referred to as capital leases) were recognized in the balance sheet. In addition, the definition of a lease has been revised which
may
result in changes to the classification of an arrangement as a lease. Under the new standard, an arrangement that conveys the right to control the use of an identified asset by obtaining substantially all of its economic benefits and directing how it is used as a lease, whereas the previous definition focuses on the ability to control the use of the asset or to obtain its output. Quantitative and qualitative disclosures related to the amount, timing and judgements of an entity’s accounting for leases and the related cash flows are expanded. Disclosure requirements apply to both lessees and lessors, whereas previous disclosures related only to lessees. The recognition, measurement, and presentation of expenses and cash flows arising from a lease by a lessee have
not
significantly changed from previous GAAP. Lessor accounting is also largely unchanged.
 
The new standard provides a number of transition practical expedients, which the Company has elected, including:
 
 
A “package of three” expedients that must be taken together and allow entities to (
1
)
not
reassess whether existing contracts contain leases, (
2
) carryforward the existing lease classification, and (
3
)
not
reassess initial direct costs associated with existing leases, and
 
An implementation expedient which allows the requirements of the standard in the period of adoption with
no
restatement of prior periods.
 
The impact of adoption did
not
have a material impact to the Company as of
January 1, 2019
as the Company’s finance leases are immaterial and its operating leases had terms shorter than
one
year.  In
January 2019,
the Company signed an amendment to its lease for office space at its corporate headquarters in Rancho Cordova, CA.  The amendment extended the lease term by
five
years and was accounted for as a modification.  At that time, the Company recorded lease assets and liabilities of
$966,000
and
no
cumulative effect adjustment to retained earnings.
 
Revenue Recognition
Revenue is recognized based on the
five
-step process outlined in Accounting Standards Codification (ASC)
606.
 
The following tables summarize the revenues of the Company’s reportable segments and product lines:
 
   
Three Months Ended September 30, 2019
 
   
Device
Revenue
   
Service
Revenue
   
Other
Revenue
   
Total
Revenue
 
Device Segment:
                               
AXP
  $
2,255,000
    $
51,000
    $
--
    $
2,306,000
 
BioArchive
   
243,000
     
351,000
     
--
     
594,000
 
Manual Disposables
   
212,000
     
--
     
--
     
212,000
 
CAR-TXpress
   
875,000
     
6,000
     
33,000
     
914,000
 
Other
   
--
     
--
     
19,000
     
19,000
 
Total Device Segment
   
3,585,000
     
408,000
     
52,000
     
4,045,000
 
Clinical Development Segment:
                               
Manual Disposables
   
9,000
     
--
     
--
     
9,000
 
Other
   
--
     
4,000
     
--
     
4,000
 
Total Clinical Development
   
9,000
     
4,000
     
--
     
13,000
 
Total
   
3,594,000
     
412,000
     
52,000
    $
4,058,000
 
 
   
Nine Months Ended September 30, 2019
 
   
Device
Revenue
   
Service
Revenue
   
Other
Revenue
   
Total
Revenue
 
Device Segment:
                               
AXP
  $
6,550,000
    $
160,000
    $
--
    $
6,710,000
 
BioArchive
   
1,274,000
     
1,117,000
     
--
     
2,391,000
 
Manual Disposables
   
711,000
     
--
     
--
     
711,000
 
CAR-TXpress
   
1,365,000
     
6,000
     
33,000
     
1,404,000
 
Other
   
--
     
--
     
40,000
     
40,000
 
Total Device Segment
   
9,900,000
     
1,283,000
     
73,000
     
11,256,000
 
Clinical Development Segment:
                               
Manual Disposables
   
53,000
     
--
     
--
     
53,000
 
Other
   
5,000
     
11,000
     
--
     
16,000
 
Total Clinical Development
   
58,000
     
11,000
     
--
     
69,000
 
Total
   
9,958,000
     
1,294,000
     
73,000
     
11,325,000
 
 
 
   
Three Months Ended September 30, 2018
 
   
Device
Revenue
   
Service
Revenue
   
Other
Revenue
   
Total
Revenue
 
Device Segment:
                               
AXP
  $
1,396,000
    $
70,000
    $
--
    $
1,466,000
 
BioArchive
   
485,000
     
314,000
     
--
     
799,000
 
Manual Disposables
   
254,000
     
--
     
--
     
254,000
 
CAR-TXpress
   
517,000
     
--
     
--
     
517,000
 
Other
   
--
     
--
     
23,000
     
23,000
 
Total Device Segment
   
2,652,000
     
384,000
     
23,000
     
3,059,000
 
Clinical Development Segment:
                               
Manual Disposables
   
8,000
     
--
     
--
     
8,000
 
Bone Marrow
   
--
     
40,000
     
--
     
40,000
 
Other
   
--
     
6,000
     
--
     
6,000
 
Total Clinical Development
   
8,000
     
46,000
     
--
     
54,000
 
Total
  $
2,660,000
    $
430,000
    $
23,000
    $
3,113,000
 
 
   
Nine Months Ended September 30, 2018
 
   
Device
Revenue
   
Service
Revenue
   
Other
Revenue
   
Total
Revenue
 
Device Segment:
                               
AXP
  $
2,930,000
    $
201,000
    $
--
    $
3,131,000
 
BioArchive
   
1,357,000
     
969,000
     
--
     
2,326,000
 
Manual Disposables
   
716,000
     
--
     
--
     
716,000
 
CAR-TXpress
   
547,000
     
--
     
--
     
547,000
 
Other
   
46,000
     
--
     
56,000
     
102,000
 
Total Device Segment
   
5,596,000
     
1,170,000
     
56,000
     
6,822,000
 
Clinical Development Segment:
                               
Manual Disposables
   
31,000
     
--
     
--
     
31,000
 
Bone Marrow
   
--
     
101,000
     
--
     
101,000
 
Other
   
--
     
30,000
     
--
     
30,000
 
Total Clinical Development
   
31,000
     
131,000
     
--
     
162,000
 
Total
  $
5,627,000
    $
1,301,000
    $
56,000
    $
6,984,000
 
 
Contract Balances
Generally, all sales are contract sales (with either an underlying contract or purchase order). The Company does
not
have any material contract assets. When invoicing occurs prior to revenue recognition a contract liability is recorded (as deferred revenue on the consolidated balance sheet). Revenues recognized during the
three
and
nine
months ended
September 30, 2019
that were included in the beginning balance of deferred revenue were
$50,000
and
$480,000,
respectively. Short term deferred revenues increased from
$485,000
at
December 31, 2018
to
$840,000
at
September 30, 2019.
 
Supply
Agreement
On
August 30, 2019,
the Company entered into a supply agreement with a global distributor for substantially all
X
-Series® products under the CAR-TXpress™ platform (the “Products”). The agreement has an initial term of
five
years with automatic
two
-year renewal terms, unless terminated by either party in accordance with the terms of the agreement. Pursuant to the agreement, the Company has granted exclusive worldwide distribution rights for
X
-Series products, for the duration of the term, subject to certain geographical and other exceptions. In addition, the Company has granted rights of
first
refusal for the exclusive worldwide distribution of certain future products developed or introduced by the Company relating to cell isolation or cell selection, including any such products substantially related or similar to the Products (the “ROFR Products”). As consideration for the exclusive worldwide distribution rights for the Products and ROFR Products, the Company will receive a
$2,000,000
fee, in addition to any amounts payable throughout the term for the Products and any ROFR Products. The agreement also contains an option, exercisable by the global distributor at any time following
January 1, 2021,
to become the manufacturer for all or any portion of the Products.
 
The agreement contains covenants by the Company to negotiate in good faith regarding price reductions for the Products and, commencing in
2020,
cost reduction efforts with respect to development and manufacture of the Products. Moreover, the agreement contains a most-favored customer provision with respect to the pricing made available for the Products during the term. The agreement contains mutual indemnification provisions, as well as standard warranties with respect to the Products, including that the Products supplied and the services provided (including customer support services for Products sold) be manufactured or performed, as applicable, in a
first
class, workmanlike manner by personnel properly trained.
 
Fair Value Measurements
In accordance with ASC
820,
Fair Value Measurements and Disclosures
,” fair value is defined as the exit price, or the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants as of the measurement date.
 
The guidance also establishes a hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. Observable inputs are inputs that market participants would use in valuing the asset or liability and are developed based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the factors that market participants would use in valuing the asset or liability. The guidance establishes
three
levels of inputs that
may
be used to measure fair value:
 
Level
1:
Quoted market prices in active markets for identical assets or liabilities.
Level
2:
Observable market-based inputs or unobservable inputs that are corroborated by market data.
Level
3:
Unobservable inputs reflecting the reporting entity’s own assumptions.
 
The carrying values of cash and cash equivalents, accounts receivable and accounts payable approximate fair value due to their short duration. The fair value of the Company’s derivative obligation liability is classified as Level
3
within the fair value hierarchy since the valuation model of the derivative obligation is based on unobservable inputs. The impairment of goodwill and intangible assets is a non-recurring Level
3
fair value measurement.
 
Segment Reporting
Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated regularly by the Chief Operating Decision Maker (CODM), or decision-making group, whose function is to allocate resources to and assess the performance of the operating segments. The Company has identified its chief executive officer as the CODM. In determining its reportable segments, the Company considered the markets and the products or services provided to those markets.
 
The Company has
two
reportable business segments:
 
 
The Device Segment, engages in the development and commercialization of automated technologies for cell-based therapeutics and bio-processing. The device division is operated through the Company’s ThermoGenesis Corp. subsidiary.
 
 
The Clinical Development Segment, utilizes autologous stem cell-based therapeutics in the vascular and orthopedic markets through the Company’s TotipotentRX subsidiary in Gurgaon, India.
 
Net Loss per Share
Net loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding plus the pre-funded warrants (as described in Footnote
8
). For the purpose of calculating basic net loss per share, the additional shares of common stock that are issuable upon exercise of the pre-funded warrants have been included since the shares are issuable for a negligible consideration and have
no
vesting or other contingencies associated with them. There were
324,444
pre-funded warrants included in the quarter ended
September 30, 2019
calculation. The calculation of the basic and diluted earnings per share is the same for all periods presented, as the effect of the potential common stock equivalents noted below is anti-dilutive due to the Company’s net loss position for all periods presented. Anti-dilutive securities consisted of the following at
September 30:
 
   
2019
 
2018
Common stock equivalents of convertible promissory notes and accrued interest
   
6,013,667
     
4,626,667
 
Vested Series A warrants
   
40,442
     
40,442
 
Unvested Series A warrants
(1)
   
69,853
     
69,853
 
Warrants – other
   
1,300,091
     
1,319,728
 
Stock options
   
296,029
     
118,830
 
Total
   
7,720,082
     
6,175,520
 
______________
 
(
1
)
The unvested Series A warrants were subject to vesting based upon the amount of funds actually received by the Company in the
second
close of the
August 2015
financing which never occurred. The warrants will remain outstanding but unvested until they expire in
February 2021.
 
Reclassifications
Certain prior period amounts have been reclassified to conform to the current period presentation. The reclassifications did
not
have an impact on net loss as previously reported.