ITEM 1. Financial Statements
POSITRON CORPORATION AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(In thousands, except share data)
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2014
|
|
|
2013
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
374
|
|
|
$
|
1,744
|
|
Accounts receivable, less allowance for doubtful accounts of $171 and $141
|
|
|
214
|
|
|
|
247
|
|
Inventories, less reserve of $444
|
|
|
535
|
|
|
|
547
|
|
Prepaid expenses
|
|
|
9
|
|
|
|
35
|
|
Total current assets
|
|
|
1,132
|
|
|
|
2,573
|
|
|
|
|
|
|
|
|
|
|
Property and equipment, less accumulated depreciation of $577 and $503
|
|
|
979
|
|
|
|
1,044
|
|
Intangible assets
|
|
|
9
|
|
|
|
10
|
|
Other assets
|
|
|
219
|
|
|
|
255
|
|
Total assets
|
|
$
|
2,339
|
|
|
$
|
3,882
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ DEFICIT
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable, trade and accrued liabilities
|
|
$
|
960
|
|
|
$
|
1,401
|
|
Customer deposits
|
|
|
-
|
|
|
|
658
|
|
Unearned revenue
|
|
|
24
|
|
|
|
45
|
|
Advances from related parties
|
|
|
665
|
|
|
|
1,035
|
|
Notes payable – current portion
|
|
|
519
|
|
|
|
98
|
|
Convertible debentures, less debt discount of $663 and $1,328
|
|
|
1,896
|
|
|
|
4,452
|
|
Embedded conversion derivative liabilities
|
|
|
2,623
|
|
|
|
6,968
|
|
Total current liabilities
|
|
|
6,687
|
|
|
|
14,657
|
|
|
|
|
|
|
|
|
|
|
Notes payable – noncurrent portion
|
|
|
-
|
|
|
|
466
|
|
Total liabilities
|
|
|
6,687
|
|
|
|
15,123
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ deficit:
|
|
|
|
|
|
|
|
|
Series A preferred stock: $1.00 par value; 8% cumulative, convertible, redeemable; 7,900,000 shares authorized; 447,652 shares issued and outstanding.
|
|
|
448
|
|
|
|
448
|
|
Series B preferred stock: $1.00 par value; convertible, redeemable; 9,000,000 shares authorized; 3,036,487 and 3,056,487 shares issued and outstanding
|
|
|
2,730
|
|
|
|
2,750
|
|
Series S preferred stock: $1.00 par value; convertible, redeemable; 100,000 shares authorized; 75,000 and 100,000 shares issued and outstanding
|
|
|
75
|
|
|
|
100
|
|
Series H preferred stock: $0.01 par value; convertible, redeemable; 15,000,000 shares authorized; 0 and 12,500,000 shares issued and outstanding
|
|
|
-
|
|
|
|
125
|
|
Common stock: $0.0001 in 2014 and $0.01 in 2013par value; 6,000,000,000 shares authorized; 4,077,294,923 and 1,452,548,262 shares issued and outstanding
|
|
|
408
|
|
|
|
14,208
|
|
Additional paid-in capital
|
|
|
116,500
|
|
|
|
94,575
|
|
Accumulated deficit
|
|
|
(124,494
|
)
|
|
|
(123,432
|
)
|
Treasury stock: 60,156 shares at cost
|
|
|
(15
|
)
|
|
|
(15
|
)
|
Total stockholders’ deficit
|
|
|
(4,348
|
)
|
|
|
(11,241
|
)
|
Total liabilities and stockholders’ deficit
|
|
$
|
2,339
|
|
|
$
|
3,882
|
|
See accompanying notes to consolidated financial
statements
POSITRON CORPORATION AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
(Unaudited)
|
|
Three Months Ended
|
|
|
Six Months Ended
|
|
|
|
June 30, 2014
|
|
|
June 30, 2013
|
|
|
June 30, 2014
|
|
|
June 30, 2013
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales:
|
|
$
|
355
|
|
|
$
|
432
|
|
|
$
|
811
|
|
|
$
|
803
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs of sales:
|
|
|
310
|
|
|
|
418
|
|
|
|
738
|
|
|
|
664
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit
|
|
|
45
|
|
|
|
14
|
|
|
|
73
|
|
|
|
139
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative
|
|
|
590
|
|
|
|
446
|
|
|
|
1,155
|
|
|
|
1,012
|
|
Research and development
|
|
|
120
|
|
|
|
107
|
|
|
|
222
|
|
|
|
335
|
|
Selling and marketing
|
|
|
42
|
|
|
|
119
|
|
|
|
88
|
|
|
|
218
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
752
|
|
|
|
672
|
|
|
|
1,465
|
|
|
|
1,565
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(707
|
)
|
|
|
(658
|
)
|
|
|
(1,392
|
)
|
|
|
(1,426
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense
|
|
|
(734
|
)
|
|
|
(491
|
)
|
|
|
(1,130
|
)
|
|
|
(984
|
)
|
Derivative gain (loss)
|
|
|
518
|
|
|
|
61
|
|
|
|
738
|
|
|
|
123
|
|
Other income (expenses)
|
|
|
722
|
|
|
|
-
|
|
|
|
722
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense)
|
|
|
506
|
|
|
|
(430
|
)
|
|
|
330
|
|
|
|
(861
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes
|
|
|
(201
|
)
|
|
|
(1,088
|
)
|
|
|
(1,062
|
)
|
|
|
(2,287
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income taxes
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss and comprehensive loss
|
|
$
|
(201
|
)
|
|
$
|
(1,088
|
)
|
|
$
|
(1,062
|
)
|
|
$
|
(2,287
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per common share
|
|
$
|
(0.00
|
)
|
|
$
|
(0.00
|
)
|
|
$
|
(0.00
|
)
|
|
$
|
(0.00
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted weighted average shares outstanding
|
|
|
3,452,521
|
|
|
|
1,452,425
|
|
|
|
2,458,059
|
|
|
|
1,452,177
|
|
See accompanying notes to consolidated financial
statements
POSITRON CORPORATION AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
|
|
Six Months Ended
|
|
|
|
June 30, 2014
|
|
|
June 30, 2013
|
|
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(1,062
|
)
|
|
$
|
(2,287
|
)
|
Adjustment to reconcile net loss to net cash used in operating activities
|
|
|
|
|
|
|
|
|
Increase in allowance for doubtful accounts
|
|
|
30
|
|
|
|
-
|
|
Depreciation and amortization
|
|
|
74
|
|
|
|
80
|
|
Stock based compensation
|
|
|
-
|
|
|
|
88
|
|
Derivative (gain)
|
|
|
(738
|
)
|
|
|
(123
|
)
|
Common stock issued for services
|
|
|
35
|
|
|
|
5
|
|
Accretion of debt discount
|
|
|
1,098
|
|
|
|
899
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
3
|
|
|
|
(68
|
)
|
Inventories
|
|
|
12
|
|
|
|
54
|
|
Prepaid expenses and other assets
|
|
|
62
|
|
|
|
1
|
|
Accounts payable, trade and accrued liabilities
|
|
|
(215
|
)
|
|
|
(38
|
)
|
Customer deposits
|
|
|
(658
|
)
|
|
|
(42
|
)
|
Unearned revenue
|
|
|
(21
|
)
|
|
|
(31
|
)
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(1,380
|
)
|
|
|
(1,462
|
)
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
Purchase of property and equipment
|
|
|
(8
|
)
|
|
|
(2
|
)
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities
|
|
|
(8
|
)
|
|
|
(2
|
)
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
Payments on note payable
|
|
|
(45
|
)
|
|
|
(94
|
)
|
Noninterest bearing advances
|
|
|
-
|
|
|
|
935
|
|
Payment of noninterest bearing advances
|
|
|
(370
|
)
|
|
|
-
|
|
Series H preferred stock issued
|
|
|
-
|
|
|
|
750
|
|
Proceeds from convertible debt
|
|
|
433
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
18
|
|
|
|
1,607
|
|
|
|
|
|
|
|
|
|
|
Net decrease in cash and cash equivalents
|
|
|
(1,370
|
)
|
|
|
127
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, beginning of period
|
|
|
1,744
|
|
|
|
243
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of period
|
|
$
|
374
|
|
|
$
|
370
|
|
|
|
|
|
|
|
|
|
|
Supplemental cash flow information:
|
|
|
|
|
|
|
|
|
Conversion of convertible debentures, accrued interest and derivative liability to common stock
|
|
$
|
7,920
|
|
|
$
|
-
|
|
Conversion of Series B shares to common stock
|
|
$
|
20
|
|
|
$
|
-
|
|
Conversion of Series S shares to common stock
|
|
$
|
25
|
|
|
$
|
-
|
|
Conversion of Series H shares to common stock
|
|
$
|
125
|
|
|
$
|
-
|
|
Equipment under capital lease
|
|
$
|
-
|
|
|
$
|
16
|
|
Debt discount / increase in derivative liability
|
|
$
|
433
|
|
|
$
|
-
|
|
See accompanying notes to consolidated financial
statements
POSITRON CORPORATION AND SUBSIDIARIES
SELECTED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1.
|
Summary of Significant Accounting Policies
|
For a summary of significant
accounting policies (which have not changed from December 31, 2013), see the Company’s Annual Report on Form 10-K for the
year ended December 31, 2013.
Basis of Presentation
:
The accompanying unaudited interim
financial statements have been prepared in accordance with generally accepted accounting principles and the rules of the U.S. Securities
and Exchange Commission, and should be read in conjunction with the audited financial statements and notes thereto contained in
the Annual Report on Form 10-K for Positron Corporation (the “Registrant” or the “Company”) for the period
ended December 31, 2013. In the opinion of management, all adjustments, consisting of normal recurring adjustments, necessary for
a fair presentation of financial position, results of operations and cash flows for the interim periods presented have been reflected
herein. The results of operations for interim periods are not necessarily indicative of the results to be expected for the full
year. Notes to the financial statements which would substantially duplicate the disclosures contained in the audited financial
statements for the most recent fiscal year ended December 31, 2013, as reported in the Form 10-K, have been omitted.
In preparing the interim unaudited
consolidated financial statements, management was required to make certain estimates and assumptions that affect the reported amounts
of assets, liabilities, revenues, expenses and related disclosures at the financial reporting date and throughout the periods being
reported upon. Certain of the estimates result from judgments that can be subjective and complex and consequently actual results
may differ from these estimates.
All significant intercompany
balances and transactions have been eliminated.
Use of Estimates
:
The preparation of financial
statements in conformity with accounting principles generally accepted in the United States requires management to make estimates
and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities
at the date of the financial statements as well as the reported amount of revenues and expenses during the reporting period. Actual
results could differ from these estimates.
Debt Discount
:
Costs incurred with parties who
are providing long-term financing, which generally include the value of warrants or the fair value of an embedded derivative conversion
feature, are reflected as a debt discount and are amortized over the life of the related debt. The debt discount attributable to
the embedded conversion derivative liability during the six months ended June 30, 2014 and 2013 was $433,000 and $0, respectively.
The Company recorded the accretion of debt discount of $1,098,000 and $899,000 during the six months ended June 30, 2014 and 2013,
respectively. The total unaccreted debt discount at June 30, 2014 was $663,000, compared to $1,328,000 at December 31, 2013.
Fair Value of
Financial Instruments:
The carrying value of cash and
cash equivalents, accounts receivable, prepaids, deposits, accounts payable and accrued liabilities, common stock payable, and
unearned revenue, approximate their fair values because of the short-term nature of these instruments. Management believes
the Company is not exposed to significant interest or credit risks arising from these financial instruments.
Fair value is defined as the
exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous
market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques
used to measure fair value maximize the use of observable inputs and minimize the use of unobservable inputs. The Company utilizes
a fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable.
|
•
|
Level 1 — Quoted prices in active markets for identical assets or liabilities. These are typically obtained from real-time quotes for transactions in active exchange markets involving identical assets.
|
|
|
|
|
•
|
Level 2 — Quoted prices for similar assets and liabilities in active markets; quoted prices included for identical or similar assets and liabilities that are not active; and model-derived valuations in which all significant inputs and significant value drivers are observable in active markets. These are typically obtained from readily-available pricing sources for comparable instruments.
|
|
•
|
Level 3 — Unobservable inputs, where there is little or no market activity for the asset or liability. These inputs reflect the reporting entity’s own beliefs about the assumptions that market participants would use in pricing the asset or liability, based on the best information available in the circumstances.
|
The following table presents
the embedded conversion derivative liability, the Company’s only financial liability measured and recorded at fair value
on the Company’s consolidated balance sheets on a recurring basis and their level within the fair value hierarchy as of June
30, 2014 (in thousands):
|
|
Level 1
|
|
|
Level 2
|
|
|
Level 3
|
|
|
June 30, 2014
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Embedded conversion derivative liability
|
|
$
|
-
|
|
|
$
|
-
|
|
|
$
|
2,623
|
|
|
$
|
2,623
|
|
The following table reconciles,
for the six months ended June 30, 2014, the beginning and ending balances for financial instruments that are recognized at fair
value in the consolidated financial statements (in thousands):
Balance of embedded conversion derivative liability as of December 31, 2013
|
|
$
|
6,968
|
|
Fair value of embedded conversion derivative liabilities at issuance
|
|
|
433
|
|
Gain on fair value adjustments to embedded conversion derivative liability
|
|
|
(738
|
)
|
Reductions in fair value due to conversion of convertible debentures into common stock
|
|
|
(4,040
|
)
|
Balance of embedded conversion derivative liability at June 30, 2014
|
|
$
|
2,623
|
|
The fair value of the conversion
features are calculated at the time of issuance and the Company records a derivative liability for the calculated value using a
Black-Scholes option-pricing model. Changes in the fair value of the derivative liability are recorded in other income (expense)
in the consolidated statements of operations. Upon conversion of the convertible debt to stock, the Company reclassifies the related
embedded conversion derivative liability to paid in capital. Since the fair value of the embedded conversion derivative liability
exceeded the carrying value of the convertible debentures on the issuance date, the convertible debentures were recorded at a full
discount. The Company recognizes expense for accretion of the convertible debentures discount over the term of the notes. The Company
has considered the provisions of ASC 480,
Distinguishing Liabilities from Equity
, as the conversion feature embedded in
each debenture could result in the note principal being converted to a variable number of the Company’s common shares.
Revenue Recognition
:
The Company’s revenues
are currently derived from the sale of medical equipment products, maintenance contracts and service revenues. Revenues from maintenance
contracts are recognized over the term of the contract. Service revenues are recognized upon performance of the services. The Company
recognizes revenues from the sale of medical equipment products when earned. Specifically, revenue is recognized when persuasive
evidence of an arrangement exists, delivery has occurred (or services have been rendered), the price is fixed or determinable,
and collectability is reasonably assured. The Company obtains a signed customer acceptance after installation is complete for the
sale of its Attrius® systems.
In multiple-element arrangements,
revenue is allocated to each element based on their relative selling prices. Relative selling prices are based first on vendor
specific objective evidence (VSOE), then on third-party evidence of selling price (TPE) when VSOE does not exist, and then on estimated
selling price (ESP) when VSOE and TPE do not exist. Because the Company has neither VSOE nor TPE for its products, the allocation
of revenue has been based on the Company’s ESPs. The objective of ESP is to determine the price at which the Company would
transact a sale if the product was sold on a stand-alone basis. The Company determines ESP by considering the facts and circumstances
of the product being sold.
Recent Accounting Pronouncements:
In May 2014, the FASB issued
Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers (ASU 2014-09), which supersedes nearly all existing
revenue recognition guidance under U.S. GAAP. The core principle of ASU 2014-09 is to recognize revenues when promised goods or
services are transferred to customers in an amount that reflects the consideration to which an entity expects to be entitled for
those goods or services. ASU 2014-09 defines a five step process to achieve this core principle and, in doing so, more judgment
and estimates may be required within the revenue recognition process than are required under existing U.S. GAAP.
The standard is effective for
annual periods beginning after December 15, 2016, and interim periods therein, using either of the following transition methods:
(i) a full retrospective approach reflecting the application of the standard in each prior reporting period with the option to
elect certain practical expedients, or (ii) a retrospective approach with the cumulative effect of initially adopting ASU 2014-09
recognized at the date of adoption (which includes additional footnote disclosures). We are currently evaluating the impact
of our pending adoption of ASU 2014-09 on our consolidated financial statements and have not yet determined the method by which
we will adopt the standard in 2017.
Other issued or adopted accounting
pronouncements are not expected to, or did not have, a material impact on our financial position, results of operations or cash
flows.
Since inception, the Company
has expended substantial resources on research and development and sustained losses. Due to the limited number of systems sold
or placed into service each year, revenues have fluctuated significantly from year to year and have not been sufficient to be operationally
profitable. The Company had an accumulated deficit of $124,494,000 and a stockholders’ deficit of $4,348,000 at June 30,
2014. The Company will need to increase sales and apply the research and development advancements to achieve profitability in the
future. The Company will need to resume and increase sales of PET and radiopharmaceutical systems, services, and radioisotope sales
and apply the research and development advancements to achieve profitability in the future. There can be no assurance that the
Company will continue to be successful in selling products.
The Company had cash and cash
equivalents of $374,000 at June 30, 2014. At June 30, 2014, the Company had accounts payable and accrued liabilities of $960,000
and a negative working capital of $5,555,000. Working capital requirements for the upcoming year will reach beyond our current
cash balances. The Company plans to continue to raise funds as required through equity and debt financing to sustain business operations.
These factors raise substantial doubt about the Company’s ability to continue as a going concern.
There can be no assurance that
the Company will be successful in implementing its business plan and ultimately achieving operational profitability. The Company’s
long-term viability as a going concern is dependent on its ability to 1) achieve adequate profitability and cash flows from operations
to sustain its operations, 2) control costs and expand revenues from existing or new business 3) meet current commitments and fund
the continuation of its business operation in the near future and 4) raise additional funds through debt and/or equity financings.
Other assets at June 30, 2014
consisted of $201,000 in deposits paid to our joint venture partner, Neusoft Positron Medical Systems for Attrius® systems
and $18,000 in operating lease deposits. Other assets at December 31, 2013 consisted of $201,000 in deposits paid to our joint
venture partner, Neusoft Positron Medical Systems for Attrius® systems and $54,000 in operating lease deposits.
Inventories at June 30, 2014
and December 31, 2013 consisted of the following (in thousands):
|
|
June 30, 2014
|
|
|
December 31, 2013
|
|
Finished systems
|
|
$
|
13
|
|
|
$
|
24
|
|
Raw materials and service parts
|
|
|
764
|
|
|
|
927
|
|
Work in progress
|
|
|
202
|
|
|
|
40
|
|
|
|
|
979
|
|
|
|
991
|
|
Less: Reserve for obsolete inventory
|
|
|
(444
|
)
|
|
|
(444
|
)
|
|
|
$
|
535
|
|
|
$
|
547
|
|
Inventories are stated at the
lower of cost or market. Cost is determined using the first-in, first-out (FIFO) method of inventory valuation. The
Company evaluated the reserve as of June 30, 2014 and December 31, 2013.
5.
|
Property and Equipment
|
Property and equipment at June
30, 2014 and December 31, 2013 consisted of the following (in thousands):
|
|
June 30, 2014
|
|
|
December 31, 2013
|
|
Buildings
|
|
$
|
500
|
|
|
$
|
500
|
|
Furniture and fixtures
|
|
|
88
|
|
|
|
88
|
|
Leasehold improvements
|
|
|
72
|
|
|
|
72
|
|
Computer equipment
|
|
|
70
|
|
|
|
62
|
|
Research equipment
|
|
|
667
|
|
|
|
667
|
|
Machinery and equipment
|
|
|
158
|
|
|
|
158
|
|
|
|
|
1,555
|
|
|
|
1,547
|
|
Less: Accumulated depreciation
|
|
|
(576
|
)
|
|
|
(503
|
)
|
|
|
$
|
979
|
|
|
$
|
1,044
|
|
6.
|
Accounts Payable and Accrued Liabilities
|
Accounts payable and accrued liabilities at June
30, 2014 and December 31, 2013 consisted of the following (in thousands):
|
|
June 30, 2014
|
|
|
December 31, 2013
|
|
Trade accounts payable
|
|
$
|
745
|
|
|
$
|
849
|
|
Accrued royalties
|
|
|
-
|
|
|
|
87
|
|
Accrued interest
|
|
|
54
|
|
|
|
278
|
|
Sales taxes payable
|
|
|
83
|
|
|
|
89
|
|
Accrued compensation
|
|
|
60
|
|
|
|
70
|
|
Other accrued expenses
|
|
|
18
|
|
|
|
28
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
960
|
|
|
$
|
1,401
|
|
Customer deposits represent
amounts paid to the Company by customers for devices in advance of manufacturing completion and/or shipment of the device to the
customer. Deposit amounts may vary depending on the contract. Included in customer deposits at December 31,
2013 were deposits of approximately $658,000 from a customer that had placed an order in 2007 for five Nuclear Pharm-Assist™
systems. There was no assurance that this customer would fulfill its order for these devices. Management believes it
has fulfilled its responsibilities under the contract and based on current status has recorded these deposits in other income for
the quarter ended June 30, 2014.
Basic loss per common share
is based on the weighted average number of common shares outstanding in each period and earnings adjusted for preferred stock dividend
requirements. Diluted earnings per common share assumes that any dilutive convertible preferred shares outstanding at the beginning
of each period were converted at those dates, with related interest, preferred stock dividend requirements and outstanding common
shares adjusted accordingly. It also assumes that outstanding common shares were increased by shares issuable upon exercise of
those stock options and warrants for which market price exceeds exercise price, less shares which could have been purchased by
the Company with related proceeds. The convertible preferred stock and outstanding stock options and warrants were not included
in the computation of diluted earnings per common share for the three months ended June 30, 2014 and 2013, respectively since it
would have resulted in an antidilutive effect.
The following table sets forth
the computation of basic and diluted loss per share (in thousands, except per share data):
|
|
Three Months Ended
|
|
|
Six Months Ended
|
|
|
|
June 30, 2014
|
|
|
June 30, 2013
|
|
|
June 30, 2014
|
|
|
June 30, 2013
|
|
Numerator
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss
|
|
$
|
(201
|
)
|
|
$
|
(1,088
|
)
|
|
$
|
(1,062
|
)
|
|
$
|
(2,287
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted earnings per share - weighted average shares outstanding
|
|
|
3,452,521
|
|
|
|
1,452,425
|
|
|
|
2,485,059
|
|
|
|
1,452,177
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted income (loss) per common share
|
|
$
|
(0.00
|
)
|
|
$
|
(0.00
|
)
|
|
$
|
(0.00
|
)
|
|
$
|
(0.00
|
)
|
Anti-dilutive securities (based
on conversions to common shares) not included in net loss per share calculation (in thousands):
|
|
June 30, 2014
|
|
|
December 31, 2013
|
|
Convertible Series A preferred stock
|
|
|
448
|
|
|
|
448
|
|
Convertible Series B preferred stock
|
|
|
303,649
|
|
|
|
424,532
|
|
Convertible Series S preferred stock
|
|
|
750,000
|
|
|
|
1,000,000
|
|
Convertible Series H preferred stock
|
|
|
-
|
|
|
|
482,625
|
|
Stock warrants
|
|
|
122,500
|
|
|
|
208,850
|
|
Convertible debt
|
|
|
1,086,101
|
|
|
|
258,601
|
|
Common stock options
|
|
|
188,600
|
|
|
|
177,600
|
|
Series B preferred stock options
|
|
|
207,000
|
|
|
|
250,000
|
|
During the six months ending
June 30, 2014, the Company issued $433,000 of convertible debentures “(Convertible Debentures”) to certain investors
(“Investors”). The Convertible Debentures do not accrue interest. The debentures mature on December 31, 2014. The Investors
are entitled to convert the accrued interest and principal of the Convertible Debentures into common stock of the Company at a
conversion price equal to 55% of the lowest daily volume weighted average price for the three trading days preceding conversion.
Initial Accounting:
Under the initial accounting,
the Company separated the Convertible Debentures instrument into component parts of the Convertible Debentures and embedded conversion
derivative liability. The Company estimated the fair value of each component as of the date of issuance. The fair value of the
embedded conversion derivative liability exceeded the proceeds from the Convertible Debentures, which resulted in a debt discount
of $433,000. The debt is accreted to interest expense over the life of the Convertible Debentures.
The following is a summary of
the proceeds from the issuance of the Convertible Debentures and the initial accounting of the issuance (in thousands):
Proceeds from convertible debt issuance
|
|
$
|
433
|
|
|
|
|
|
|
Allocation of proceeds to embedded conversion derivative liability
|
|
$
|
433
|
|
During the six months ended June
30, 2014 and 2013, the Company recognized $1,098,000 and $899,000, respectively, of interest expense on the Convertible Debentures.
The 2014 amount includes $306,000 of unaccreted discount at the date of certain conversions.
The follow is a summary of Convertible
Debt (in thousands):
|
|
June 30, 2014
|
|
|
|
|
|
Convertible debentures
|
|
$
|
2,559
|
|
Debt discount
|
|
|
(663
|
)
|
Net convertible debentures
|
|
$
|
1,896
|
|
10.
|
Notes Payable and Advances from Related Parties
|
On January 17, 2012, in connection
with its acquisition of Manhattan Isotopes Technology LLC (“MIT”) the Company assumed from MIT a note payable with
Los Alamos National Bank (“LANB”) in the amount of $700,000. On February 10, 2012, MIT refinanced with LANB the principal
and accrued interest of this note payable with a promissory note of $708,000, maturing on April 2015. The note renews annually.
The monthly payment to LANB on the promissory note is $10,000, with the interest rate of 5.5% at March 31, 2014. The promissory
note is guaranteed by the Company and secured by all assets of the Company. Total interest paid on the promissory note was $17,000
during the six months ended June 30, 2014. The note’s outstanding amount was $506,000 at June 30, 2014.
As of June 30, 2014, the Company
had outstanding advances of $665,000, from their CEO and CFO to help fund operations. The notes are unsecured and non-interest
bearing.
The Company entered into a capital
lease for equipment at interest rate of 7.25%, payable through 2018. The assets and liabilities under the capital lease are recorded
at the present value of the minimum lease payments and are depreciated over their estimated useful lives. The gross amount of assets
held under capital lease at June 30, 2014 and December 31, 2013 was $16,300, respectively, with accumulated depreciation of $1,746
and $1,165, respectively.
Future maturities of notes payable,
advances and capital leases are as follows:
June 30,
|
|
|
|
|
2015
|
|
$
|
1,177,000
|
|
2016
|
|
|
4,000
|
|
2017
|
|
|
3,000
|
|
|
|
|
|
|
Note payable – noncurrent portion, advances and capital leases
|
|
$
|
1,184,000
|
|
11.
|
Stockholders’ Deficit
|
On April 16, 2014 the Company
increased their authorized common shares by 3,000,000,000 and preferred shares by 50,000,000. Par value decreased from $.01 per
share to $.0001 per share.
In April 2014, the Company issued
an aggregate of 2,614,746,661 shares of Common Stock. 2,015,524,440 shares were issued as a result of conversion of convertible
promissory notes in the original aggregate amount of $5,742,450, and aggregate of 2,000,000 shares from the conversion of 20,000
shares of the Company’s Series B Convertible Preferred Stock into Common Stock, 250,000,000 share from the conversion of
25,000 shares of the Company’s Series S Convertible Redeemable Preferred Stock and 347,222,221 shares from the conversion
of 12,500,000 shares of the Company’s Series H Convertible Redeemable Preferred Stock.
On June 25, 2014, the Company
issued 10,000,000 shares of common stock for consulting services, valued at $35,000.
For all of the Company’s
stock-based compensation plans, the fair value of each grant was estimated at the date of grant using the Black-Scholes option-pricing
model. Black-Scholes utilizes assumptions related to volatility, the risk-free interest rate, the dividend yield (which is assumed
to be zero, as the Company has not paid cash dividends to date and does not currently expect to pay cash dividends) and the expected
term of the option. Expected volatilities utilized in the model are based mainly on the historical volatility of the Company’s
stock price over a period commensurate with the expected life of the share option as well as other factors. The risk-free interest
rate is derived from the zero-coupon U.S. government issues with a remaining term equal to the expected life at the time of grant.
For options issued during 2012,
fifty (50) percent of the options vested immediately on the grant date with the remaining fifty (50) percent vesting on January
17, 2013. The company recognized compensation expense of $88,000 during the first quarter of 2013.
13.
|
Related Party Transactions
|
2014
During the period January 1,
2014 through June 30, 2014, the Company repaid $180,000 to its CEO from related advances.
During the period January 1,
2014 through June 30, 2014, the Company repaid $190,000 to its CFO from related advances.
During the period January 1,
2014 through June 30, 2014, the Company converted convertible notes to its CEO in the amount of $1,000,000 to common stock.
During the period January 1,
2014 through June 30, 2014, the Company converted convertible notes to its CFO in the amount of $300,000 to common stock.
On June 25, 2014, the CEO converted
10,000,000 shares of Series H preferred stock to 277,777,777 shares of common stock.
On June 25, 2014, the CFO converted
2,500,000 shares of Series H preferred stock to 69,444,444 shares of common stock.
2013
During the period January 1,
2013 through June 30, 2013, the Company accepted various non-interest bearing $865,000 advances from its CEO. At the time, the
Company issued no shares or warrants in connection with this transaction.
During the period January 1,
2013 through June 30, 2013, the Company accepted various non-interest bearing $500,000 advances from its CFO. At the time, the
Company issued no shares or warrants in connection with this transaction.
On April 11, 2013, the Company
converted certain advances from its CEO and CFO in the amounts of $500,000 and $250,000, respectively, into Series H preferred
shares.
Lease Agreements:
On April 19, 2010, the Company
entered into an operating lease agreement with a third party for warehousing and office space in Niagara, New York. The lease expires
in May 2014, with an option to renew for an additional three years. Monthly rent is $1,800. The Company is currently negotiating
an extension.
On July 7, 2011, the Company
entered into an operating lease with a third party for space for medical device assembly and warehousing at a building in Fishers,
Indiana. The Company is required to make payments of $5,083 each month from December 1, 2011 through November 13, 2013, and $5,287
from December 1, 2013 through November 30, 2016. The amount of leased space at this location is approximately 9,761 square
feet.
On December 5, 2011, MIT entered
into an operating lease with a third party for space for warehousing at a building in Lubbock, Texas. The Company will be required
to make payments of $1,475 each month from month to month.
Litigation:
On June 8, 2012, the owner of
the radiopharmaceutical manufacturing facility the Company formerly leased in Crown Point, Indiana commenced an action to recover
the use of the premises and the remaining rent due under the lease. On November 14, 2012, the owner was awarded a judgment against
the Company in the amount of $85,525 plus interest at the rate of 8%. The Company and the owner agreed to monthly payments in the
minimum amount of $5,000 until the judgment is paid in its entirety.
In May, 2013, the Company was
served with a First Amended Complaint in an action commenced against its CEO and principal shareholder. The plaintiff in the action
is seeking to enforce a judgment against the CEO and principal shareholder and is seeking to have the Company’s Westmont,
Illinois offices, which it purchased from the CEO, reconveyed. The CEO and the principal shareholder have disputed the basis of
the judgment and the Company has denied the allegations in the Complaint and is defending the action. The action is currently in
the discovery stage.
We have aggregated our operations
into two reportable segments based upon product lines, manufacturing processes, marketing and management of our businesses: medical
equipment and radiopharmaceuticals. Our business segments operate in the nuclear medicine industry. The Company’s
medical equipment segment is currently generating all revenues and the majority of all expenses as the radiopharmaceuticals segment
is still in the development phase.
We evaluate a segment’s
performance based primarily upon operating income before corporate expenses.
Corporate assets consist primarily
of cash but also include plant and equipment associated with our headquarters. These items (and income and expenses related
to these items) are not allocated to the segments. Unallocated income/expenses include interest income, interest expense, debt
extinguishment and refinancing costs and other (expense) income and certain expenses which are not considered related to either
segment, but are instead considered general corporate expenses.
The following table represents
sales, operating loss and total assets attributable to these business segments for the periods indicated (in thousands):
|
|
Three Months Ended
|
|
|
Six Months Ended
|
|
|
|
June 30, 2014
|
|
|
June 30, 2013
|
|
|
June 30, 2014
|
|
|
June 30, 2013
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Sales:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Medical equipment
|
|
$
|
355
|
|
|
$
|
432
|
|
|
$
|
811
|
|
|
$
|
803
|
|
Radiopharmaceuticals
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Total sales
|
|
$
|
355
|
|
|
$
|
412
|
|
|
$
|
811
|
|
|
$
|
803
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Medical equipment
|
|
$
|
(547
|
)
|
|
$
|
(498
|
)
|
|
$
|
(1,028
|
)
|
|
$
|
(1,078
|
)
|
Radiopharmaceuticals
|
|
|
(160
|
)
|
|
|
(160
|
)
|
|
|
(364
|
)
|
|
|
(348
|
)
|
Unallocated
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Total operating loss
|
|
$
|
(707
|
)
|
|
$
|
(658
|
)
|
|
$
|
(1,392
|
)
|
|
$
|
(1,426
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Medical equipment
|
|
|
|
|
|
|
|
|
|
$
|
1,878
|
|
|
$
|
3,373
|
|
Radiopharmaceuticals
|
|
|
|
|
|
|
|
|
|
|
461
|
|
|
|
509
|
|
Unallocated
|
|
|
|
|
|
|
|
|
|
|
-
|
|
|
|
-
|
|
Total Assets
|
|
|
|
|
|
|
|
|
|
$
|
2,339
|
|
|
$
|
2,685
|
|
Management has evaluated all
events that occurred through the date of these financials were issued to determine if they must be reported. The Management of
the Company determined that the following subsequent events were required to be disclosed:
In July 2014, the Company issued 13,400,000 shares of Common
Stock upon the conversion and cancelation of 134,000 shares of the Company’s Series B Convertible Preferred Stock.
On August 11, 2014, the
Company accepted a subscription from an investor in the amount of $1,000,000 for 333,333,333 shares of Common Stock. These
shares have not been issued as of August 14, 2014.
Also on August 11, 2014, the
Company’s CEO converted $300,000 of a convertible note in the principal amount of $400,000 into 100,000,000 shares of the
Company’s Common Stock. On August 11, 2014, the Company’s CFO converted $50,000 of a convertible note in the principal
amount of $50,000 into 16,666,666 shares of the Company’s Common Stock. These
shares have not been issued as of August 14, 2014.
ITEM 2 Management’s Discussion
and Analysis of Financial Condition and Results of Operations
Forwarding Looking Statements
The information in this report
contains forward-looking statements. All statements other than statements of historical fact made in this report are forward looking.
In particular, the statements herein regarding industry prospects and future results of operations or financial position are forward-looking
statements. These forward-looking statements can be identified by the use of words such as “believes,” “estimates,”
“could,” “possibly,” “probably,” anticipates,” “projects,” “expects,”
“may,” “will,” or “should,” or other variations or similar words. No assurances can be given
that the future results anticipated by the forward-looking statements will be achieved. Forward-looking statements reflect management’s
current expectations and are inherently uncertain. Our actual results may differ significantly from management’s expectations.
Although these forward-looking
statements reflect the good faith judgment of our management, such statements can only be based upon facts and factors currently
known to us. Forward-looking statements are inherently subject to risks and uncertainties, many of which are beyond our control.
As a result, our actual results could differ materially from those anticipated in these forward-looking statements as a result
of various factors, including those set forth below under the caption “Risk Factors.” You should not unduly rely
on these forward-looking statements, which speak only as of the date on which they were made. They give our expectations regarding
the future but are not guarantees. We undertake no obligation to update publicly or revise any forward-looking statements, whether
as a result of new information, future events or otherwise, unless required by law.
The following discussion should
be read in conjunction with the information contained in the consolidated financial statements of the Company and the notes thereto
appearing elsewhere herein and in conjunction with the Management’s Discussion and Analysis of Financial Condition and Results
of Operations set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2013 (the “Annual
Report”). Readers should carefully review the risk factors disclosed in the Annual Report and other documents filed
by the Company with the U.S. Securities and Exchange Commission (the “SEC”).
Investors are also advised to
refer to the information in our previous filings with the SEC, especially on Forms 10-K, 10-Q and 8-K, in which we discuss in more
detail various important factors that could cause actual results to differ from expected or historic results. It is not possible
to foresee or identify all such factors. As such, investors should not consider any list of such factors to be an exhaustive
statement of all risks and uncertainties or potentially inaccurate assumptions. As used in this report, the terms “Company,”
“we,” “our,” and “us” refer to Positron Corporation, a Texas corporation.
Overview
Positron Corporation (the “Company”
or “Positron”) a nuclear medicine healthcare company specializing in the field of cardiac Positron Emission Tomography
(PET) imaging. Cardiac PET is the superior method in diagnostic nuclear imaging for the detection of coronary artery disease (CAD).
Positron’s products and
services enable healthcare providers to more accurately diagnose disease and improve patient outcomes, while practicing cost effective
medicine. Positron is the only company that will provide an economical, end-to-end solution for PET myocardial perfusion imaging
through complementary product integration of PET imaging systems, radiopharmaceuticals, and radioisotopes.
The Company believes its unique
proprietary products, market position and vertically integrated strategy will lead to accelerated adoption and growth of the cardiac
PET modality in the U.S. and emerging markets. Through leadership within our field, Positron intends to gain a dominant market
position with strong earnings potential, ultimately becoming a sustained, long-term value creator for industry participants and
our shareholders.
Our mission is to facilitate
the stabilization, security and growth of the cardiac PET industry by providing cardiologists with: an economical, high-quality,
PET imaging system; a reliable supply of radiopharmaceuticals for imaging procedures; and a comprehensive clinical, technical,
support and service program.
Our Products and Key Components
The Company offers a range of
products and services for nuclear imaging community that are discussed below.
PET Imaging Systems: Support
and Service
Attrius® is the only FDA
approved dedicated PET scanner optimized for cardiac imaging. Attrius® was named the “Most Innovative Device of 2010”
by the renowned business research and consulting firm Frost & Sullivan. The Attrius® provides a robust, cardiac specific
imaging software package designed to ensure effortless interpretation for today’s most challenging clinical cases for nuclear
cardiologists. Heart disease specific software includes the ability to monitor therapy, coronary artery overlay display, and open
architecture for new protocol development and customization and motion correction software. The Attrius® is targeted for cardiac
clinics and is designed to meet the performance, budget and space needs of the most demanding cardiologists.
Positron has further advanced
its product portfolio with the addition of Coronary Flow Reserve (CFR) software. The University of Texas Health Science Center
at Houston has received FDA approval for the CFR quantification software, to be used with Positron’s Attrius® PET scanner.
Positron is licensed to distribute and support this software, a clear differentiator in patient diagnosis.
Positron offers a comprehensive
world-class clinical, technical, and service customer care plan, through its PosiStar® customer care services. PosiStar®
includes: 24/7 clinical and service support; uptime guarantees; remote access diagnostic/maintenance; physician interpretation
training; billing training; nurse training; post-install physician over-reads; ICANL approval assistance; 6 months evaluation/assessment;
industry luminary collaboration, etc. PosiStar® is a fee-based service, typically for three to five years.
Radiopharmaceuticals: Manufacturing,
Processing & Distribution
Positron intends to couple a
Sr-82/Rb-82 generator with the Attrius® sales and utilize Positron’s current nuclear cardiology network. Initial efforts
will be focused on North America. This product is a key element of Positron’s strategy to vertically integrate the production
and delivery of a complete cardiac imaging solution: isotope (Sr-82), generator (Rb-82), and imaging system (Attrius®).
PosiRx® is a radiopharmaceutical
system that automates the elution, preparation and dispensing processes for radiopharmaceutical agents used in molecular imaging.
It was created to simplify and control the procedures associated with compounding radiopharmaceuticals. PosiRx® integrates
features that increase productivity while decreasing exposure and costs. Additionally, the PosiRx® assists in compliance with
all current USP-797 and ALARA exposure control requirements for the production of unit dose radiopharmaceuticals.
PosiRx® is the first system
of its kind to offer a complete and comprehensive automated solution, creating a more efficient and economical alternative to the
current pharmacy per dose model. PosiRx® is targeted for clinics and hospitals with average to high SPECT imaging and pharmaceutical
compounding volumes, in the U.S. and abroad. With PosiRx®, Positron intends to exploit possibilities existing in both, PET
and SPECT imaging and pharmaceutical markets for both cardiology and oncology.
Radioisotopes: Production
& Distribution
Positron, through MIT, has registered
its Drug Master File (DMF) for API grade Sr-82 with the FDA. This marks Positron’s entrance into the radioisotope market
with a high demand product as a precursor for PET radiopharmaceuticals. Positron is the only commercial resource in the U.S. that
possesses the practical experience and knowledge in all stages of Sr-82 production and spent generator lifecycle management. Currently,
Positron produces API grade strontium-82 from target material received from its foreign collaborators.
Positron plans to build and operate
a commercial high energy/high current cyclotron (70MeV) within the U.S. The proposed facility will be unique in that it will be
capable of producing isotopes that are either not available or have very limited availability from other commercial sources in
the United States and the world.
The primary isotope to be produced
is Sr-82, that is currently in short supply in the world and is produced in the U.S. only by the Department of Energy (“DOE”)
National Laboratories.
The Company
Positron, a pioneer in cardiac
PET, is well branded in the field of nuclear cardiology. Founded in 1983, Positron has gained significant traction in the industry
based on its imaging technology and strong commitment towards advancing cardiac care. Originally a research & development and
medical device manufacturing company, Positron has expanded and is evolving into a nuclear healthcare company integrating the key
components of the cardiac PET supply chain to provide an end-to-end solution for the cardiac PET market.
The Company believes that our
unique products, market position and vertical integration strategy will stabilize and secure the supply chain, significantly reducing
costs and industry uncertainties, a substantial advantage, leading to further adoption and growth of the cardiac PET modality.
Positron, through the acquisition
of Manhattan Isotope Technology (MIT) in 2012, is the only commercial resource in the U.S. with practical knowledge and experience
in all stages of Sr-82 production and generator lifecycle management. Positron seeks to secure both short and long-term supply
of radioisotopes used in cardiac PET imaging. Currently, the Company is producing Active Pharmaceutical Ingredient (API) grade
Sr-82 at its Lubbock, Texas, facility from strontium received from foreign irradiated source suppliers. The Company intends to
further supplement strontium resources by pursuing additional supply agreements with all domestic and foreign irradiated source
suppliers, requesting increases in production schedules from third party suppliers, and by recycling expired generators. Positron
seeks to secure a long-term North America supply of medical radioisotopes for cardiac PET imaging by building and operating the
world’s largest commercial high-energy/high-current cyclotron (70MeV) within the U.S. This 70 MeV cyclotron will be
at the heart of providing a reliable, dependable, and indigenous supply of radioisotopes, stabilizing and building confidence
in the PET market and nuclear medicine community overall. Securing and delivering a reliable supply of radioisotopes should
also increase the demand for Positron’s complementary products.
The primary isotope to be produced
is Sr-82, which is currently in short supply worldwide and is produced in the United States only by the U.S. Department of Energy
(DOE) National Laboratories in Los Alamos, New Mexico and Brookhaven, New York. Sr-82 is the parent isotope used in the production
of Rb-82 generators for PET myocardial perfusion imaging.
With the recent growth of cardiac
PET imaging, the supply of Sr-82 is quickly moving towards capacity within the next one-three years. Annual demands for medical
imaging products, produced by a high-energy cyclotron, are expected to reach $30-35 million over the next few years, with continued
growth estimated at 25-30% per year thereafter.
The DOE lists many isotopes for
medical treatment or diagnostics that are in short supply, some of which can be produced in a high-energy commercial accelerator.
As such isotopes are developed and advance from R&D to clinical trials to commercial use, these isotopes will further expand
their respective markets. Additionally, using secondary targets, a high-energy cyclotron can also produce low-energy isotopes,
in conjunction with, the production of high-energy isotopes, generating additional revenue. The revenue potential and diversity
inherent in this project is considerable.
Positron’s business strategy
is to gain a dominant market share through the vertical integration of such key components: imaging technologies, clinical services,
radiopharmaceutical and radioisotope processing, production, and distribution. Positron creates market efficiencies by integrating
these critical components. Positron intends to maximize market share by offering cost-effective, value added solutions to end-users
that meet the current and future nuclear cardiology market demands.
PET vs. SPECT
There are two main imaging modalities
utilized in nuclear cardiology: Single Photon Emission Computed Tomography, or SPECT, and Positron Emission Tomography, or PET.
In myocardial perfusion imaging,
PET has been proven to be superior in sensitivity and specificity when compared to SPECT, the more commonly utilized modality.
Cardiac PET scans, with Rb-82 Chloride or Nitrogen-13 Ammonia (N-13), result in a lower patient radiation exposure and is capable
of performing superior quantitative measurements such as coronary flow reserve. Cardiac PET imaging has been shown to provide
a 50% reduction in invasive coronary arteriography and coronary artery bypass grafting, leading to a 30% costs savings and improved
clinical outcomes, when compared to SPECT (M.E. Merhige, M.D., et al. Journal Nuclear Medicine 2007; 48: 1069-1076).
The cardiac PET equipment market
is much smaller than SPECT, but has seen significant annual growth of 25-30% during the last decade and is expected to continue
its expansion at 20% average annual growth during the next five years According to Bracco Diagnostics, there were approximately
170 dedicated cardiac PET & PET/CT scanners performing nuclear cardiology within the U.S. in 2014.
Our Market
According to the U.S. Department
of Health and Human Services, there are more than 22,000 cardiovascular diseases specialists in the U.S., and their number will
increase to 31,000 by 2020. This is the target market for our products and services, as well as hospitals in the United States
that performs or could perform nuclear cardiac procedures and want to automate the delivery of radiopharmaceuticals. By adding
complimentary products, we are able to offer customers value added solutions which include low cost molecular imaging devices,
maintenance service, disease specific software, radiopharmaceutical unit doses drawing devices, and, potentially, radiopharmaceuticals
agents for Cardiac Nuclear Medicine.
Cardiac Nuclear medicine helps
in the diagnosis, management and prevention of cardiovascular disease (CVD) in patients. Radiopharmaceuticals are injected into
a patient to provide the most accurate, non-invasive test for identifying narrowed coronary arteries, mild cholesterol build-up
or diffuse coronary vascular disease, conditions that are responsible for almost all heart attacks.
Cardiovascular disease is the
leading cause of death in the United States and constitutes 17% of overall national health expenditures (Forecasting the Future
of Cardiovascular Disease in the United States, American Heart Association, 2011). Direct CVD costs are projected to increase from
$273 Billion, in 2010, to $818 Billion, in 2030; with indirect costs, due to lost productivity, expected to rise from $172 Billion
to $276 Billion by 2030.
Barriers to entry
For many years, one of the major
constraints for adoption of this modality had been the high cost of PET and PET/CT scanners. Many practices and hospitals could
not justify the cost of a new system for cardiac studies. In 2010, Positron received FDA clearance to market and distribute its
dedicated PET system, which is optimized for nuclear cardiology. The Attrius is the only new, cost effective, dedicated PET system
available on the market. Other system manufacturers (GE, Philips, Siemens) offer PET/CT cameras, which have a 200%-300% higher
purchase price; but comparable performance of cardiac studies.
Another more recent issue that
has slowed the growth of nuclear cardiology is the shortage of the key drugs utilized in both SPECT (Mo-99/Tc-99m) and PET imaging
(Sr-82/Rb-82).
The Sr-82 isotope decays to produce
the Rb-82 tracer utilized in cardiac PET studies. Rb-82 is the most commonly used cardiac PET tracer in the United States. The
FDA approved Rb-82 in 1989 for use in the detection of coronary artery disease and the Health Care Financing Administration approved
reimbursement for Rb-82, PET MPI, in 1995 as a first line test in symptomatic patients. Rubidium is uniformly available through
generator production in the U.S. and is used in conjunction with an automatic infusion system.
Over the past five years the
explosive growth of cardiac PET imaging has driven a significant increase in the use of Sr-82/Rb-82 generators. The increasing
demand for Sr-82 is beginning to outpace supply. Until recently, the U.S. Department of Energy had been the only entity in the
United States capable of providing this material. In August of 2012, MIT submitted its DMF with the FDA and has begun production
of API grade strontium-82.
Due to the growing demand and
limited supply, the industry suffered a Sr-82 shortage in January 2011, effecting supply of Rb-82 generators. The same year Bracco
Diagnostics Inc., the sole market supplier of the Rb-82 generator, underwent a voluntary recall of generators, further stunting
industry sales and growth.
Positron is acutely focused on
production of Sr-82. Positron possesses certain resources and technical advantages, unique to MIT, which will increase current
and future strontium supply.
Market Potential
The cardiac PET industry has
an indisputable need for a stable, efficient and economical environment. Through Positron’s leadership and vision to integrate
each key segment of the cardiac PET supply chain, the Company will stimulate growth and increase capacity to meet the needs of
the global cardiac PET market. Positron intends to become the premier product, services, and solutions provider in the nuclear
cardiology industry.
Although the cardiac PET industry
experienced its most challenging years ever, it enabled the Company to aggressively pursue its strategy toward aggregating and
integrating the key components critical in securing the cardiac value chain. Positron is dedicated to lowering the barriers that
have been constricting, or could later constrict, the progress of medical advancements in cardiac PET. Through our efforts to supplement
the supply of key radioisotopes and our ability to offer innovative products and services, management has methodically positioned
Positron to become the industry’s only end-to-end solutions provider. PET is the future of nuclear cardiology.
We believe that Positron is the
only company with the critical components to vertically integrate the fragmented “single source supplier environment”
that exists in the cardiac PET market today and that these initiatives are intended to drive the Company towards consistent profitability
and cash flow.
Results of Operations
Comparison of the Results
of Operations for the Three Months ended
June 30, 2014 and
2013
The Company experienced a net
loss of $201,000 for the three months ended June 30, 2014 compared to a net loss of $1,088,000 for the three months ended June
30, 2013. The decrease in the loss for the current three month period as compared to the same period last year is attributed
primarily to the recognition of certain customer deposits in other income.
Revenues
- Revenues
for the three months ended June 30, 2014 were $355,000 as compared to $432,000 for the three months ended June 30, 2013. Service
and parts revenue was $353,000 and $432,000 for the three months ended June 30, 2014 and 2013, respectively. Sales of PET systems
during 2014 and 2103 have been negatively impacted by shortage of Sr-82/Rb-82 generators supplied to cardiac imaging facilities
by Bracco Diagnostics due to cyclotron maintenance and limited production capacity of the isotope Sr-82.
Gross Margin
-
Gross margin for the three months ended June 30, 2014 and 2013 was $45,000 and $14,000, respectively. Costs were lower during the
three months ended June 30, 2014 due to reduced operational expenses.
Operating Expenses
-
Operating expenses for the three months ended June 30, 2014 were $752,000 compared to $672,000 for the three months ended
June 30, 2013.
The Company recorded $120,000
in research and development costs during the three months ended June 30, 2014, compared to $107,000 for the three months ended
June 30, 2013. Research and development costs for the three months ended June 30, 2014 included mostly payroll, contract labor
and consulting fees for Attrius® software and the PosiRx® development. In addition, the Company has research and development
costs related to the radiopharmaceutical facility to prepare it for regulatory approvals and production. The Company intends to
continue to support research and development in software, radiopharmaceutical products and automated devices.
Sales and marketing expense for
the three months ended June 30, 2014 and 2013 were $42,000 and $119,000, respectively and were lower in 2014 due to the Company’s
efforts to limit expenditures, primarily related to a reduction in trade shows and salaries.
General and administrative
expense during the three months ended June 30, 2014 were $590,000 as compared to $446,000 for the three months ended June 30,
2013, due to an increase in consulting fees.
Other Income (Expenses)
-
Interest expense was $734,000 for the three months ended June 30, 2014 and includes the $716,000 for the accretion of the
convertible debentures discount and $18,000 for interest payable on the debt. Interest expense was $491,000 for the three months
ended June 30, 2013 and includes the $449,000 for the accretion of convertible debentures discount and $42,000 for interest on
this debt.
During the three months ended
June 30, 2014 and 2013, the Company also recorded derivative gain of $518,000 and $61,000, respectively, in connection with the
embedded conversion derivative liabilities related to convertible debt.
During the three months ended
June 30, 2014, the Company recorded other income of $722,000. This is attributed to the recognition of certain customer deposits in the amount of $658,000 and the extinguishment of certain royalties in the amount
of $64,000.
Net Loss
–
For the three months ended June 30, 2014, the Company had a net loss of approximately $201,000, or $0.00 per share, compared to
a net loss of $1,127,000, or $0.00 per share, for the three months ended June 30, 2013.
Comparison of the Results
of Operations for the Six Months ended
June 30, 2014 and
2013
The Company experienced a net
loss of $1,062,000 for the six months ended June 30, 2014 compared to a net loss of $2,287,000 for the six months ended June 30,
2013. The decrease in the loss in the current six month period as compared to the same period last year is attributed
primarily to the recognition of certain customer deposits in other income.
Revenues
- Revenues
for the six months ended June 30, 2014 were $811,000 as compared to $803,000 for the six months ended June 30, 2013. Service and
parts revenue was $811,000 and $803,000 for the six months ended June 30, 2014 and 2013, respectively. Sales of PET systems during
2014 and 2013 have been negatively impacted by shortage of Sr-82/Rb-82 generators supplied to cardiac imaging facilities by Bracco
Diagnostics due to cyclotron maintenance and limited production capacity of the isotope Sr-82.
Gross Margin
-
Gross margin for the six months ended June 30, 2014 and 2013 was $73,000 and $139,000, respectively. Costs were higher during the
six months ended June 30, 2014 due to an increase in consulting service expenses.
Operating Expenses
-
Operating expenses for the six months ended June 30, 2014 were $1,465,000 compared to $1,565,000 for the six months ended
June 30, 2013.
The Company recorded $222,000
in research and development costs during the six months ended June 30, 2014, compared to $335,000 for the six months ended June
30, 2013. Research and development costs for the six months ended June 30, 2014 included mostly payroll, contract labor and consulting
fees for Attrius® software and PosiRx® development. In addition, the Company has research and development costs related
to the radioisotope production facility to prepare it for regulatory approvals and production. The Company intends to continue
to support research and development in software, radiopharmaceutical products and automated devices. Costs were lower due to the
completion of a prototype system for customer pilot.
Sales and marketing expenses
for the six months ended June 30, 2014 and 2013 were $88,000 and $218,000, respectively and were lower in 2014 due to the Company’s
efforts to limit expenditures, primarily related to a reduction in trade shows and salaries.
General and administrative
expenses during the six months ended June 30, 2014 were $1,155,000 as compared to $1,012,000 for the six months ended June
30, 2013, due to an increase in consulting fees.
Other Income (Expenses)
-
Interest expense was $1,130,000 for the six months ended June 30, 2014 and includes the $1,098,000 for the accretion of the
convertible debentures discount and $32,000 for interest payable on the debt. Interest expense was $984,000 for the six months
ended June 30, 2013 and includes the $899,000 for the accretion of the convertible debentures discount and $85,000 for interest
payable on the debt.
During the six months ended June
30, 2014 and 2013, the Company also recorded derivative gains of $738,000 and $123,000, respectively, in connection with the embedded
conversion derivative liabilities related to convertible debt.
During the six months ended June
30, 2014, the Company recorded other income of $722,000. This is attributed to the recognition of certain customer deposits in the amount of $658,000 and the extinguishment of certain royalties in the amount
of $64,000.
Net Loss
–
For the six months ended June 30, 2014, the Company had a net loss of approximately $1,062,000, or $0.00 per share, compared to
a net loss of $2,287,000, or $0.00 per share, for the three months ended June 30, 2013.
Liquidity and Capital Resources
At June 30, 2014, the Company
had current assets of $1,132,000 and current liabilities of $6,687,000 compared to December 31, 2013 when the Company had current
assets of $2,573,000 and current liabilities of $14,657,000. Total assets at June 30, 2014 were $2,339,000 compared to $3,882,000
at December 31, 2013. Total liabilities were $6,687,000 and $15,123,000 at June 30, 2014 and December 31, 2013, respectively.
Cash and cash equivalents at
June 30, 2014 were $374,000 compared to $1,744,000 at December 31, 2013. Accounts receivable was $214,000 at June 30, 2014 compared
to $247,000 at December 31, 2013.
Current liabilities include accounts
payable and accrued expenses of $960,000 at June 30, 2014.
Net cash used in operating activities
was $1,380,000 and $1,462,000 for the six months ended June 30, 2014 and 2013, respectively
Net cash used in investing activities
were $8,000 and $18,000 for the three months ended June 30, 2014 and 2013, respectively.
Net cash provided by financing
activities was $18,000 and $1,607,000 for the three months ended June 30, 2014 and 2013, respectively.
The Company's ability to achieve
its objectives is dependent on its ability to sustain and enhance its revenue stream and to continue to raise funds through loans,
credit and the private placement of restricted securities until such time as the Company achieves profitability. To date, management
has been successful in raising cash on an as-needed basis for the continued operations of the Company. There is no guarantee that
management will be able to continue to raise needed cash in this fashion.
The report of the Company’s
independent public accountants, which accompanied the financial statements for the year ended December 31, 2013, was qualified
with respect to the ability of the Company to continue as a going concern. If the Company is unable to obtain debt or equity financing
to meet its ongoing cash needs, it may have to limit or disregard portions of its business plans
The Company has no material commitments
for capital expenditures at this time. The Company has no “off balance sheet” source of liquidity arrangements.