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Table of Contents

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C.  20549

 

FORM 10-Q

 

(Mark one)

 

x      QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended September 30, 2011

 

o         TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from                    to                   

 

Commission file number   0-5576

 

SPHERIX INCORPORATED

(Exact name of Registrant as specified in its charter)

 

Delaware

 

52-0849320

(State or other jurisdiction of incorporation or organization)

 

(I.R.S. Employer Identification No.)

 

6430 Rockledge Drive, Suite 503, Bethesda, MD 20817

(Address of principal executive offices)

 

301-897-2540

(Registrant’s telephone number, including area code)

 

Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  Yes x  No o

 

Indicate by check mark whether the Registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit and post such files.)  Yes x  No o

 

Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company.  See definition of  “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

 

Large Accelerated Filer o

 

Accelerated Filer o

 

 

 

Non-accelerated Filer o

 

Smaller Reporting Company x

 

Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).  Yes o  No x

 

Indicate the number of shares outstanding of each of the Registrant’s classes of Common Stock, as of the latest practicable date.

 

Class

 

Outstanding as of November 10, 2011

Common Stock, $0.01 par value

 

3,094,961 shares

 

 

 



Table of Contents

 

Spherix Incorporated

 


 

Form 10-Q

For the Quarter Ended September 30, 2011

 

Index

 

 

 

Page No.

 

 

 

Part I. Financial Information

 

 

 

 

Item 1.

Financial Statements (Unaudited)

 

 

 

 

 

Condensed Consolidated Statements of Operations for the three-month and nine-month periods ended September 30, 2011 and 2010

3

 

 

 

 

Condensed Consolidated Balance Sheets as of September 30, 2011 and December 31, 2010

4

 

 

 

 

Condensed Consolidated Statements of Cash Flows for the nine-month periods ended September 30, 2011 and 2010

5

 

 

 

 

Notes to the Condensed Consolidated Financial Statements

6

 

 

 

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

11

 

 

 

Item 4.

Controls and Procedures

15

 

 

 

Part II. Other Information

 

 

 

 

Item 1A.

Risk Factors

16

 

 

 

Item 6.

Exhibits

16

 

 

 

Signatures

17

 

2



Table of Contents

 

Spherix Incorporated

 


 

Part I.  Financial Information

 

Item 1.        Financial Statements

 

Condensed Consolidated Statements of Operations

(Unaudited)

 

 

 

Three Months Ended Sept. 30,

 

Nine Months Ended Sept. 30,

 

 

 

2011

 

2010

 

2011

 

2010

 

 

 

 

 

 

 

 

 

 

 

Revenue

 

$

198,464

 

$

368,838

 

$

690,817

 

$

1,028,268

 

 

 

 

 

 

 

 

 

 

 

Operating expenses

 

 

 

 

 

 

 

 

 

Direct costs

 

(87,399

)

(121,841

)

(336,714

)

(353,740

)

Research and development expense

 

(371,327

)

(1,453,987

)

(1,131,329

)

(4,310,471

)

Selling, general and administrative expense

 

(653,651

)

(933,507

)

(2,271,369

)

(3,214,257

)

Total operating expenses

 

(1,112,377

)

(2,509,335

)

(3,739,412

)

(7,878,468

)

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(913,913

)

(2,140,497

)

(3,048,595

)

(6,850,200

)

Interest income

 

595

 

1,054

 

2,680

 

5,270

 

Other income

 

 

 

53,007

 

 

Gain on settlement of obligations

 

 

 

845,000

 

 

Loss before taxes

 

(913,318

)

(2,139,443

)

(2,147,908

)

(6,844,930

)

 

 

 

 

 

 

 

 

 

 

Income tax expense

 

 

 

(14,485

)

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(913,318

)

$

(2,139,443

)

$

(2,162,393

)

$

(6,844,930

)

 

 

 

 

 

 

 

 

 

 

Net loss per share, basic

 

(0.36

)

(1.25

)

(0.86

)

(3.99

)

Net loss per share, diluted

 

(0.36

)

(1.25

)

(0.86

)

(3.99

)

 

 

 

 

 

 

 

 

 

 

Weighted average shares outstanding, basic

 

2,562,488

 

1,715,065

 

2,524,541

 

1,715,065

 

Weighted average shares outstanding, diluted

 

2,562,488

 

1,715,065

 

2,524,541

 

1,715,065

 

 

See accompanying notes to financial statements.

 

3



Table of Contents

 

Spherix Incorporated

 


 

Condensed Consolidated Balance Sheets

 

 

 

Sept. 30, 2011
(Unaudited)

 

December 31,
 2010

 

ASSETS

 

 

 

 

 

Current assets

 

 

 

 

 

Cash and cash equivalents

 

$

5,022,165

 

$

5,575,310

 

Trade accounts receivable, net of allowance of $8,174 and $65,000

 

167,045

 

285,859

 

Grants receivable

 

 

270,128

 

Other receivables

 

81,975

 

74,110

 

Prepaid research expenses

 

211,934

 

464,322

 

Prepaid expenses and other assets

 

3,140

 

155,261

 

Total current assets

 

5,486,259

 

6,824,990

 

 

 

 

 

 

 

Property and equipment, net of of accumulated depreciation of $248,642 and $197,971

 

108,342

 

154,161

 

Patents, net of accumulated amortization of $2,044 and $50,725

 

102

 

2,296

 

Deposit

 

35,625

 

35,625

 

Total assets

 

$

5,630,328

 

$

7,017,072

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities

 

 

 

 

 

Accounts payable and accrued expenses

 

$

250,383

 

$

1,211,561

 

Accrued salaries and benefits

 

432,052

 

563,706

 

Deferred revenue

 

68,442

 

170,641

 

Total current liabilities

 

750,877

 

1,945,908

 

 

 

 

 

 

 

Deferred compensation

 

 

550,000

 

Deferred rent

 

56,276

 

80,945

 

Total liabilities

 

807,153

 

2,576,853

 

 

 

 

 

 

 

Commitments and contingencies

 

 

 

 

 

 

 

 

 

Stockholders’ equity

 

 

 

 

 

Preferred stock, $0.01 par value, 2,000,000 shares authorized; 5,250 series B issued and 1 outstanding at September 30, 2011 and December 31, 2010

 

 

 

Common stock, $0.01 par value, 5,000,000 shares authorized; 2,570,531 and 2,143,631 issued, 2,562,488 and 2,135,588 outstanding at September 30, 2011 and December 31, 2010, respectively

 

25,705

 

21,436

 

Paid-in capital in excess of par value

 

41,109,894

 

38,568,814

 

Treasury stock, 8,043 shares, at cost at September 30, 2011 and December 31, 2010

 

(464,786

)

(464,786

)

Accumulated deficit

 

(35,847,638

)

(33,685,245

)

Total stockholders’ equity

 

4,823,175

 

4,440,219

 

Total liabilities and stockholders’ equity

 

$

5,630,328

 

$

7,017,072

 

 

See accompanying notes to financial statements.

 

4



Table of Contents

 

Spherix Incorporated

 


 

Condensed Consolidated Statements of Cash Flows

(Unaudited)

 

 

 

Nine Months Ended Sept. 30,

 

 

 

2011

 

2010

 

Cash flows from operating activities

 

 

 

 

 

Net loss

 

$

(2,162,393

)

$

(6,844,930

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

Gain on settlement of obligation

 

(845,000

)

 

Depreciation and amortization

 

52,865

 

58,542

 

Recovery of bad debt

 

(13,525

)

 

Bad debt expense

 

8,174

 

40,000

 

Stock-based compensation

 

 

37,084

 

Changes in assets and liabilities:

 

 

 

 

 

Receivables

 

386,428

 

(148,937

)

Prepaid expenses and other assets

 

404,509

 

165,401

 

Accounts payable and accrued expenses

 

(492,832

)

45,469

 

Deferred rent

 

(24,669

)

(21,300

)

Deferred compensation

 

(305,000

)

(30,000

)

Deferred revenue

 

(102,199

)

164,498

 

Net cash used in operating activities

 

(3,093,642

)

(6,534,173

)

 

 

 

 

 

 

Cash flow from investing activities

 

 

 

 

 

Proceeds from the maturity of short-term investments

 

 

375,003

 

Purchase of property and equipment

 

(4,852

)

 

Net cash (used in) provided by investing activities

 

(4,852

)

375,003

 

 

 

 

 

 

 

Cash flow from financing activities

 

 

 

 

 

Proceeds from issuance of common stock, net

 

2,545,349

 

 

Net cash provided by financing activities

 

2,545,349

 

 

 

 

 

 

 

 

Net decrease in cash and cash equivalents

 

(553,145

)

(6,159,170

)

Cash and cash equivalents, beginning of period

 

5,575,310

 

9,026,002

 

Cash and cash equivalents, end of period

 

$

5,022,165

 

$

2,866,832

 

 

See accompanying notes to financial statements.

 

5



Table of Contents

 

Spherix Incorporated

 


 

Notes to the Condensed Consolidated Financial Statements

(Unaudited)

 

1.                          Basis of Presentation

 

The accompanying condensed consolidated financial statements of the Company are unaudited and do not include all of the information and disclosures generally required for annual financial statements.  In the opinion of management, the statements contain all material adjustments (consisting of normal recurring accruals) necessary to present fairly the Company’s financial position as of September 30, 2011, the results of its operations for the three-month and nine-month periods ended September 30, 2011 and 2010, and its cash flows for the nine-month periods ended September 30, 2011 and 2010.  This report should be read in conjunction with the Company’s Annual Report on Form 10-K, which does contain the complete information and disclosure, for the year ended December 31, 2010.

 

The Company operates via two principal segments, Biospherics and Health Sciences.  Biospherics seeks to develop proprietary products for commercial application.  Health Sciences provides technical and regulatory consulting services to biotechnology and pharmaceutical companies, as well as providing technical support for the Biospherics segment.

 

The Company has created two wholly-owned subsidiaries, Biospherics Incorporated and Spherix Consulting, Inc., for its two operating segments.  The Company’s Health Sciences contracts are in the name of Spherix Consulting, Inc. and the Company’s patents are in the name of Biospherics Incorporated.  Spherix Incorporated provides management, strategic guidance, business development, marketing and other services to its subsidiaries.

 

On May 6, 2011, the Company effected a one-for-ten reverse split of its common stock.  The Company implemented the reverse stock split under the authority granted to the Board of Directors by the Company’s stockholders at the annual meeting of stockholders held on November 17, 2009, to effect a reverse stock split of the Company’s Common Stock, par value $0.01 per share.  The reverse stock split reduced the number of outstanding shares of Common Stock from 25,624,872 shares to 2,562,488 shares.  All per share amounts and outstanding shares, including all Common Stock equivalents, stock options, equity compensation plans, and warrants, have been retroactively restated in the Financial Statements and in the Notes to the Financial Statements for all periods presented to reflect the reverse stock split.  On the Company’s balance sheet, the aggregate par value of the common stock at December 31, 2010 was retroactively reduced by $85,746 with an off-setting increase to paid-in capital in excess of par.

 

2.                          Liquidity and Capital Resources

 

The Company’s working capital was $4.7 million as of September 30, 2011, compared to working capital of $4.9 million as of December 31, 2010.  The change in working capital consisted principally of (i) $2.5 million received from the sale of equity in January 2011, (ii) $3.1 million used in support of the Company’s operations, and (iii) the relief of a $600,000 purchase obligation in the first quarter.

 

The Company has incurred substantial development costs in its efforts to explore whether D-tagatose is an effective treatment for Type 2 diabetes, including a completed Phase 3 clinical trial and a related Phase 2 Dose Range trial.  We have funded these costs from the cash we received in the 2007 sale of InfoSpherix, and the net proceeds of our equity offerings.

 

Over the next 12 months, the Company expects that it will need to expend between $4 million and $6 million to support our currently planned development operations.  This estimate assumes (i) continuing efforts to sell, license, or obtain a partner for the diabetes drug application, (ii) no further significant expenditures for developing D-tagatose as a drug for diabetes, (iii) continuing development of SPX-106T as a treatment for high triglycerides, (iv) ongoing operation of the Health Sciences segment at the current level of activity, and (v) that we raise additional funds to continue our development efforts beyond this 12-month period.

 

In October 2010, we obtained net proceeds of approximately $4.9 million in a registered offering.  The common stock issued upon the conversion of the Series B convertible preferred stock and the common stock, which may be issued upon the exercise of warrants issued in the offering, have been registered under a Form S-1 registration statement declared effective by the Securities and Exchange Commission (“SEC”) in October 2010.

 

6



Table of Contents

 

In January 2011, the Company obtained net proceeds of approximately $2.5 million in a registered direct offering.  The common stock issued in the offering and the common stock that may be issued upon exercise of warrants issued in the offering have been registered under a Form S-3 registration statement declared effective by the SEC in October 2009.

 

In October 2011, the Company obtained net proceeds of approximately $1.15 million in a private placement.  The Company has agreed to use its best efforts to register under a Form S-3 registration statement the common stock issued in the offering and the common stock that may be issued upon exercise of warrants issued in the offering for resale by the purchasing stockholders.  See the subsequent event footnote, Note 13, for more information.

 

Due to the nature of our business, we will need to raise additional funds on a consistent basis to continue operations and to fully pursue the triglycerides opportunity.  Fundraising will likely require the issuance of additional equity securities, and a purchaser of such securities will likely insist that such securities be registered securities.  NASDAQ rules require stockholder approval for certain stock issuances constituting twenty percent (20%) or more of a company’s issued and outstanding stock.

 

Pursuant to SEC rules, the Company may not be in a position to issue additional shares of its common stock in another registered direct primary offering under a Form S-3 registration statement until February 2012.  Thus, if the Company wishes to conduct another registered direct primary offering before February 2012, it will likely have to do so in whole or in part under a Form S-1 registration statement.

 

The Company cannot be assured that it will be able to attract a purchaser of securities to raise the additional funds it will likely require, that the Company will be able to obtain any required stockholder approval, or that the Company will be able to have additional registered direct primary offerings.  If we reach a point where we are unable to raise needed additional funds to continue our business activities, we will be forced to cease our development activities and dissolve the Company.  In such an event, we will need to satisfy various severance, lease termination and other dissolution-related obligations.

 

3.                          Common Stock and Paid-in Capital in Excess of Par

 

During the nine months ended September 30, 2011, the Company issued shares of common stock as follows:

 

 

 

Preferred Stock

 

Common Stock

 

Paid-in
Capital in

 

 

 

Shares

 

Amount

 

Shares

 

Amount

 

Excess of Par

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, January 1, 2011

 

1

 

$

 

2,143,631

 

$

21,436

 

$

38,568,814

 

 

 

 

 

 

 

 

 

 

Sale of common stock, net of offering costs of $229,501 (1)

 

 

 

426,900

 

4,269

 

2,541,080

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, September 30, 2011

 

1

 

$

 

2,570,531

 

$

25,705

 

$

41,109,894

 

 


(1) The stock issuance is further discussed in Note 2, “Liquidity and Capital Resources”

 

4.                          Concentrations of Credit Risk

 

The Company maintains cash balances at several banks.  Accounts at each institution are insured by the Federal Deposit Insurance Corporation up to $250,000.  At September 30, 2011, the Company’s cash and cash equivalents in excess of the FDIC limits were $4.8 million.  The Company has not experienced any losses in such accounts and believes it is not exposed to any significant risks.

 

5.                          Use of Estimates and Assumptions

 

The accompanying condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America.  This requires management to make estimates

 

7



Table of Contents

 

and assumptions that affect certain reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenue and expenses during the period.  Accordingly, actual results could differ from those estimates and assumptions.

 

6.                          New Accounting Pronouncements

 

In December 2010, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2010-29, “Business combinations — disclosure of supplementary pro forma information,” to amend topic ASC 805 “Business Combinations,” by improving disclosure requirements related to the business combinations performed during the year being reported on.  Under the amended guidance, a public entity that presents comparative financial statements must disclose the pro forma revenue and earnings of the combined entity as though the business combination had occurred as of the beginning of the prior annual reporting period.  The adoption of these disclosure rules had no effect on the Company’s financial position, results of operations or cash flows.

 

In May 2011, the FASB issued a new accounting standard on fair value measurements that clarifies the application of existing guidance and disclosure requirements, changes certain fair value measurement principles and requires additional disclosures about fair value measurements.  We are required to adopt this standard in the first quarter of 2012.  We do not expect this adoption to have a material impact on our financial statements.

 

In June 2011, the FASB issued a new accounting standard on the presentation of comprehensive income. The new standard requires the presentation of comprehensive income, the components of net income and the components of other comprehensive income either in a single continuous statement of comprehensive income or in two separate but consecutive statements. The new standard also requires presentation of adjustments for items that are reclassified from other comprehensive income to net income in the statement where the components of net income and the components of other comprehensive income are presented.  We are required to adopt this standard as of the beginning of 2013. We do not expect this adoption to have a material impact on our financial statements.

 

7.                          Fair Value Measurements

 

The Company has elected not to apply the fair value option to measure any of the financial assets and liabilities on its balance sheet not already valued at fair value under other accounting pronouncements. These other financial assets and liabilities are primarily accounts receivable and accounts payable, which are reported at historical value. The fair value of these financial assets and liabilities approximate their fair value because of their short duration.

 

8.                          Net Loss Per Share

 

Basic net loss per common share has been computed by dividing net loss by the weighted-average number of common shares outstanding during the period.  Diluted net loss per common share has been computed by dividing net loss by the weighted-average number of common shares outstanding without an assumed increase in common shares outstanding for common stock equivalents, as common stock equivalents are antidilutive.  At September 30, 2011, none of the Company’s outstanding options, warrants and preferred stock to purchase up to 3,509 shares, 567,574 shares and 80 shares of common stock, respectively, were included in the calculation of diluted earnings per share as the exercise prices were all above the average market price of the Company’s common stock for the period and thus would be antidilutive.  At December 31, 2010, none of the Company’s 2,800 outstanding options and none of the warrants to purchase up to 118,717 shares of common stock were included in the calculation of diluted earnings per share as the exercise prices were all above the average market price of the Company’s common stock for the period and thus would be antidilutive.

 

8



Table of Contents

 

9.                          Accounting for Stock-Based Compensation

 

During the three- and nine-months ended September 30, 2011, the Company had no stock-based compensation expense.  For the three- and nine-months ended September 30, 2010, the Company recognized $0 and $30,000 in stock-based compensation expense relating to stock options awarded in May 2010 and recognized $2,000 and $7,000 relating to restricted stock granted in August 2009, respectively.  At September 30, 2011, all of the outstanding options under the plan were fully vested.

 

A summary of option activity under the Company’s employee stock option plan for the nine months ended September 30, 2011, is presented below:

 

Options

 

Shares

 

Weighted-
Average
Exercise
Price

 

Weighted-
Average
Remaining
Contractual
Term

 

Aggregate
Intrinsic
Value

 

Outstanding at beginning of year

 

6,309

 

$

16.10

 

 

 

 

 

Granted

 

 

$

 

 

 

 

 

Exercised

 

 

$

 

 

 

 

 

Expired or forfeited

 

(2,800

)

$

22.00

 

 

 

 

 

Outstanding at end of period

 

3,509

 

$

11.40

 

3.6

 

$

 

 

 

 

 

 

 

 

 

 

 

Exercisable at September 30, 2011

 

3,509

 

$

11.40

 

3.6

 

$

 

 

10.                   Income Taxes

 

Deferred income taxes are recognized for the tax consequences in future years of differences between the tax bases of assets and liabilities and their financial reporting amounts at each year end, based on enacted tax laws and statutory tax rates applicable to the periods in which the differences are expected to affect taxable income.  A valuation allowance is established based upon periodic assessments made by management to reduce deferred tax assets to the amount expected to be realized.  Income tax expense is the current tax provision for the period and the change during the period in deferred tax assets and liabilities.  The Company’s estimated annual effective tax rate was zero for the first nine months of 2011 and 2010.  The Company’s estimated effective tax rate was zero for the quarters ended September 30, 2011 and September 30, 2010.  However, the effective income tax rate for the nine months ended September 30, 2011 was approximately -0.7% as a result of realizing a discrete item of $15,000 in the first quarter, compared to an effective income tax rate of 0.0% for the nine months ended September 30, 2010.

 

11.                   Information by Business Segment

 

Operating segments are components of an enterprise about which separate financial information is available that is evaluated regularly by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance.  The Company operates via two principal segments, Biospherics and Health Sciences.  Biospherics seeks to develop proprietary products for commercial application.  Health Sciences provides technical and regulatory consulting services to biotechnology and pharmaceutical companies, as well as aiding the Biospherics segment.

 

Financial information by business segment for the three and nine months ended September 30, 2011 and 2010 is summarized below:

 

9



Table of Contents

 

 

 

 

 

Three Months Ended Sept. 30,

 

Nine Months Ended Sept. 30,

 

 

 

 

 

2011

 

2010

 

2011

 

2010

 

Revenue

 

Biospherics

 

$

 

$

 

$

 

$

 

 

 

Health Sciences

 

198,000

 

369,000

 

691,000

 

1,028,000

 

 

 

Total revenue

 

$

198,000

 

$

369,000

 

$

691,000

 

$

1,028,000

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating Profit (Loss) and Loss from Operations Before Income Taxes

 

Biospherics

 

$

(407,000

)

$

(1,605,000

)

$

(1,244,000

)

$

(5,079,000

)

 

 

Health Sciences

 

(6,000

)

160,000

 

152,000

 

314,000

 

 

 

General

 

(501,000

)

(695,000

)

(1,957,000

)

(2,085,000

)

 

 

Total operating loss

 

(914,000

)

(2,140,000

)

(3,049,000

)

(6,850,000

)

 

 

Interest income

 

1,000

 

1,000

 

3,000

 

5,000

 

 

 

Other income

 

 

 

53,000

 

 

 

 

Gain on settlement of obligations

 

 

 

845,000

 

 

 

 

Loss from operations before income taxes

 

$

(913,000

)

$

(2,139,000

)

$

(2,148,000

)

$

(6,845,000

)

 

 

 

 

 

Sept. 30,

 

Dec. 31,

 

 

 

 

 

2011

 

2010

 

Identifiable Assets

 

Biospherics

 

$

193,000

 

$

739,000

 

 

 

Health Sciences

 

249,000

 

359,000

 

 

 

General corporate assets

 

5,188,000

 

5,919,000

 

 

 

Total assets

 

$

5,630,000

 

$

7,017,000

 

 

12.                   Gain on Settlement of Obligations

 

Purchase Commitments

 

On January 14, 2011, Biospherics Incorporated filed a Complaint For Injunction Relief And Damages in The United States District Court For The District Of Maryland against Inalco S.p.A. (the “Complaint”).  The Complaint alleged that one of the Company’s D-Tagatose suppliers, Inalco, had breached the 2009 Manufacturing Support and Supply Agreement as Inalco (i) refused to supply D-tagatose previously paid for by Biospherics, (ii) refused to provide a promised bank guarantee, and (iii) shut-down its D-tagatose production facilities.  On March 16, 2011, both parties signed a settlement agreement whereby Inalco agreed to supply Spherix with 8.5 metric tons of D-tagatose, which has been received by Spherix, and both parties have agreed to release each other from any other obligations under the previous agreement.  As a result, the Company recognized a gain on settlement of obligations of $600,000 in March 2011 on the release from its purchase obligation.

 

Related Party Transactions

 

In January 2011, the Company entered into a Letter Agreement with Gilbert V. Levin and M. Karen Levin pursuant to which the Company agreed to make a one time lump sum payment of $450,000 to the Levins in full satisfaction of the Company’s obligation to make a series of continuing payments to the Levins relating to their prior employment by the Company.  The Company’s estimated liability to the Levins prior to the above agreement was approximately $695,000.  The $450,000 lump sum payment was made on January 31, 2011, and the Company recognized the $245,000 difference as a gain on settlement of obligations in January 2011.

 

13.                   Subsequent Events

 

The Company evaluated all events or transactions after September 30, 2011, through the date the financial statements were issued.

 

In October 2011, the Company obtained proceeds of approximately $1.15 million in a private placement, net of placement agency fees of approximately $76,000.  Spherix issued an aggregate of 532,559 shares of common stock at a price of $2.365 per share along with warrants to purchase an additional 532,559 shares of common stock at an exercise price of $2.24 per share. The warrants are exercisable immediately and expire in five years.  The Company has agreed to use its best efforts to register under a Form S-3 registration statement the common stock issued in the offering and the common stock which

 

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may be issued upon exercise of warrants issued in the offering for resale by the purchasing stockholders.

 

In connection with the closing of the October 2011 offering, the Company issued to Rodman & Renshaw, LLC warrants to purchase 15,977 shares of our common stock (at an exercise price of $2.95625 per share).  The estimated fair value of the warrants at the date of grant was $25,000.  The warrants are exercisable at the option of the holder at any time beginning October 28, 2011 through and including October 27, 2016.  These warrants were offered and sold by us in reliance upon exemptions from the registration statement requirements by Section 4(2) of the Securities Act of 1933, as amended, as transactions by an issuer not involving a public offering.

 

Item 2.  Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

The following is intended to update the information contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2010, and presumes that readers have access to, and will have read, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained in such Form 10-K.

 

Certain statements in this Quarterly Report on Form 10-Q may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are identified by the use of forward-looking words or phrases such as “believes,” “expects,” is or are “expected,” “anticipates,” “anticipated,” “should” and words of similar impact.  These forward-looking statements are based on the Company’s current expectations.  Because forward-looking statements involve risks and uncertainties, the Company’s actual results could differ materially.

 

Overview

 

The Company operates via two segments, Biospherics and Health Sciences.  Biospherics seeks to develop proprietary pharmaceutical products.  Health Sciences provides technical and regulatory consulting services to food, consumer products, biotechnology and pharmaceutical companies, as well as providing technical support to the Biospherics segment.

 

Biospherics is dedicated to development of pharmaceuticals.  Until June 2010, this development was limited to developing D-tagatose as a novel, first-in-class treatment for Type 2 diabetes.  Tagatose, a naturally occurring sugar, is a low-calorie, full-bulk sweetener previously approved by the Food and Drug Administration (“FDA”) as a GRAS (Generally Recognized As Safe) food ingredient.  It is a true sugar that looks, feels, and tastes like table sugar.  During human safety studies supporting food use, we discovered and patented a number of health and medical uses for D-tagatose.

 

In June 2010, the Company announced that it would actively seek a pharma partner to continue the diabetes development and that it would also explore D-tagatose as a potential treatment for high triglycerides, a risk factor for atherosclerosis, myocardial infarction, and stroke.  The Company has begun such exploration and is also evaluating other drug compounds it has licensed from the University of Kentucky.  Recently, the Company has focused its studies on treating high triglycerides with a combination of D-tagatose and one of the licensed drug candidates, which combination is referred to as SPX-106T.  Animal studies of SPX-106T are ongoing and an initial human efficacy study could begin in early to mid 2012.

 

We hold the patents for use of D-tagatose as a treatment for Type 2 diabetes and the license for the pending US and foreign patent filings for SPX-106T in new formulations as a treatment for high blood triglycerides and related dyslipidemias.  We have also filed for patent protection on a D-tagatose and metformin combination.  The use patents for D-tagatose as a treatment for Type 2 diabetes expire in 2012, not including extensions.  The use patent for the new SPX-106 and D-tagatose combination in the United States will last until twenty years after the date of the original PCT filing, as will a patent protection on a D-tagatose and metformin combination.  If D-tagatose is approved for use as a drug by the FDA as a treatment for Type 2 diabetes, we believe we will be eligible for a five-year New Chemical Entity (“NCE”) exclusivity period following FDA approval.  Similar legislation in Europe could provide seven or more years of market exclusivity in the European Union, if approved by the European Medicines Agency (EMA).  If SPX-106 is

 

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approved for use as a drug by the FDA as a treatment for high triglycerides and related dyslipidemias, we believe we will be eligible for a similar five-year New Chemical Entity (“NCE”) exclusivity period following FDA approval, and seven or more years of market exclusivity in the European Union, if approved by the European Medicines Agency (EMA).  The Company is also exploring the possibility of obtaining by license or acquisition other clinical stage compounds/orphan drugs for continued development and commercialization.

 

Results of Operations for the Three and Nine Months Ended September 30, 2011 and 2010

 

Revenue and Direct Costs

 

Health Sciences revenue for the three and nine months ended September 30, 2011, decreased $170,000 (46%) and $337,000 (33%) between years and direct costs decreased $34,000 (28%) and $17,000 (5%) between comparative periods. respectively.  The decrease in revenue is attributable to lower effective rates on 2011 contracts in comparison to 2010 contracts.  This is primarily driven by changing demand in the market for Health Science based consulting services.

 

No substantial revenue is expected from the Biospherics segment until the Company is successful in selling or licensing its technology.

 

Research and Development

 

Research and development expenditures relate solely to the Biospherics segment and consist primarily of salaries and related personnel costs, fees paid to consultants and outside service providers, and other expenses related to our efforts to develop D-tagatose and SPX-106T for future commercialization.  We expense our research and development costs as they are incurred.

 

The clinical trials in the use of D-tagatose for the treatment of Type 2 diabetes was the primary focus of the Biospherics segment during 2010.  Beginning in the fourth quarter of 2010, the Company began shifting the focus of its R&D efforts to the use of SPX-106T in lowering triglyceride and cholesterol levels.  The shift from late stage trials to a pre-clinical trial resulted in a decrease in R&D costs between years; the Company anticipates that R&D cost will begin to increase again with the progression of triglyceride and cholesterol studies.

 

An application for an Investigational New Drug (“IND”) for the D-tagatose and SPX-106 combination drug is being prepared for submission to the US FDA, and a human proof-of-concept trial may begin later in 2012.  Combination therapy is an important tool in many complex disease settings, including cancer, infectious diseases, cardiovascular disease, diabetes and the metabolic syndrome.  Scientific progress has increased understanding of the pathophysiological processes that underlie these and other multifactorial diseases.  This increased knowledge has advanced new therapeutic approaches using combinations of drugs targeted at multiple therapeutic targets to improve treatment response and/or minimize development of drug resistance.  In settings like metabolic syndrome, in which combination therapy may offer significant therapeutic advantages, there is increasing interest in the development of combinations of investigational drugs not previously developed for any purpose.

 

We estimate that it will likely take 3 or more years to complete the studies/trials necessary to attract a pharma partner to complete the development and an additional 2-4 years to complete all necessary studies for an NDA filing for D-tagatose or SPX-106T.

 

The Company is seeking to in-license or acquire additional drugs to diversify its pipeline.  Clinical-stage compounds (phase 1 or phase 2) are of particular interest, as are orphan drugs, which can be eligible for accelerated approval processes.

 

The Company’s R&D expenses in 2011 for pre-clinical triglyceride trials were substantially less than the diabetes trials incurred in 2010.  The R&D expenditures for 2010 consisted of both the Phase 3 clinical trial and a related Phase 2 Dose Range study.  For the three and nine months ended September 30, 2011, R&D expenses decreased by $1.1 million (74%) and $3.2 million (74%) between years, respectively, following the completion of the clinical portions of the Phase 3 and Phase 2 diabetes trials in 2010.

 

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As noted, each of the Phase 3 trial to determine efficacy of D-tagatose as a treatment for Type 2 diabetes and the Phase 2 Dose Range trial to evaluate the effectiveness of lower doses of D-tagatose in treating Type 2 diabetes were completed in late 2010.  We are actively seeking a pharma partner to continue the development of D-tagatose as a treatment for Type 2 diabetes, but there is no assurance that we will obtain such a strategic relationship.

 

Selling, General and Administrative

 

Our selling, general and administrative (S,G&A) expenses consist primarily of salaries and related expenses for executive, finance and other administrative personnel, professional fees and other corporate expenses, including facilities-related expenses.  S,G&A expenses for the three and nine months ended September 30, 2011 decreased by $280,000 (30%) and $943,000 (29%) from those of the prior year, respectively.  The decrease between years was primarily attributable to a scaling down of the Company’s business development activities for the use of D-tagatose as a treatment for type 2 diabetes, which included consultants, market research and other related costs.

 

Interest

 

Interest income in 2011 and 2010 was primarily derived from interest earned on the net proceeds of our equity offerings.

 

Other Income

 

In October 2010, the Company was awarded two one-time grants from the U.S. Government under the Patient Protection and Affordable Care Act.  The awards were for the Company’s Diabetes and Triglyceride research.  As a result, in 2011 the Company recognized $53,000 in other income.

 

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Gain on Settlement of Obligations

 

On January 14, 2011, Biospherics Incorporated, a wholly-owned subsidiary of the Company, filed a Complaint For Injunction Relief And Damages in The United States District Court For The District Of Maryland against Inalco S.p.A. (the “Complaint”).  The Complaint alleged that Inalco had breached the 2009 Manufacturing Support and Supply Agreement as Inalco (i) refused to supply D-tagatose previously paid for by Biospherics, (ii) refused to provide a promised bank guarantee, and (iii) shut-down its D-tagatose production facilities.  On March 16, 2011, both parties signed a settlement agreement whereby Inalco agreed to supply Spherix with 8.5 metric tons of D-tagatose, which has been received by Spherix, and both parties have agreed to release each other from any other obligations under the previous agreement.  As a result, the Company recognized a gain of $600,000 in March 2011 on the release from its purchase obligation.

 

In January 2011, the Company entered into a Letter Agreement with Gilbert V. Levin and M. Karen Levin pursuant to which the Company agreed to make a one time lump sum payment of $450,000 to the Levins in full satisfaction of the Company’s obligation to make a series of continuing payments to the Levins relating to their prior employment by the Company.  Per the terms of the agreement, Gilbert V. Levin resigned as a member of the Board of Directors of the Company on January 13, 2011.  The Company’s estimated liability to the Levins at December 31, 2010, and prior to the above agreement was approximately $695,000.  The $450,000 lump sum payment was made on January 31, 2011, and the Company recognized the $245,000 difference as a gain on settlement of obligations in January 2011.

 

Liquidity and Capital Resources, Consolidated

 

The Company’s working capital was $4.7 million as of September 30, 2011, compared to working capital of $4.9 million as of December 31, 2010.  The change in working capital for the three- and nine-months ended September 30, 2011 consisted principally of (i) $2.5 million received from the sale of equity in January 2011, (ii) $3.1 million used in support of the Company’s operations, and (iii) the relief of a $600,000 purchase obligation in the first quarter.

 

The Company has incurred substantial development costs in its efforts to explore whether D-tagatose is an effective treatment for Type 2 diabetes, including a completed Phase 3 clinical trial and a related Phase 2 Dose Range trial.  We have funded these costs from the cash we received in the 2007 sale of InfoSpherix, and the net proceeds of our equity offerings.

 

Over the next 12 months, the Company expects that it will need to expend between $4 million and $6 million to support our currently planned development operations.  This estimate assumes (i) continuing efforts to sell, license, or obtain a partner for the diabetes drug application, (ii) no further significant expenditures for developing D-tagatose as a drug for diabetes, (iii) continuing development of SPX-106 and D-tagatose as a combination drug for treatment of high triglycerides and related dyslipidemias, (iv) ongoing operation of the Health Sciences segment at the current level of activity and (v) that we raise additional funds to continue our development efforts beyond this 12-month period.

 

In October 2010, we obtained net proceeds of approximately $4.9 million in a registered direct offering.  The common stock issued upon the conversion of the Series B convertible preferred stock and common stock, which may be issued upon the exercise of warrants issued in the offering, have been registered under a Form S-1 registration statement declared effective by the SEC in October 2010.

 

In January 2011, the Company obtained net proceeds of approximately $2.5 million in a registered direct offering.  The common stock issued in the offering and the common stock that may be issued upon exercise of warrants issued in the offering have been registered under a Form S-3 registration statement declared effective by the SEC in October 2009.

 

In October 2011, the Company obtained net proceeds of approximately $1.15 million in a private placement.  The Company has agreed to use its best efforts to register under a Form S-3 registration statement the common stock issued in the offering and the common stock that may be issued upon exercise of warrants issued in the offering for resale by the purchasing stockholders.

 

Due to the nature of our business, we will need to raise additional funds on a consistent basis to continue operations and to fully pursue the triglycerides opportunity.  Fundraising will likely require the issuance of additional

 

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equity securities and a purchaser of such securities will likely insist that such securities be registered securities. NASDAQ rules require stockholder approval for certain stock issuances constituting twenty percent (20%) or more of a company’s issued and outstanding stock.

 

Pursuant to SEC rules, the Company may not be in a position to issue additional shares of its common stock in another registered direct primary offering under a Form S-3 registration statement until February 2012.  Thus, if the Company wishes to conduct another registered direct primary offering before February 2012, it will likely have to do so in whole or in part under a Form S-1 registration statement.

 

The Company cannot be assured that it will be able to attract a purchaser of securities to raise the additional funds it will likely require, that the Company will be able to obtain any required stockholder approval, or that the Company will be able to have additional registered direct primary offerings.  If we reach a point where we are unable to raise needed additional funds to continue our business activities, we will be forced to cease our development activities and dissolve the Company.  In such an event, we will need to satisfy various severance, lease termination and other dissolution-related obligations.

 

Item 4.  Controls and Procedures

 

Inherent Limitations on the Effectiveness of Controls

 

Management, including our Chief Executive Officer and Chief Financial Officer, do not expect that our disclosure controls and procedures will prevent all errors and fraud.  In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable, not absolute, assurance of achieving the desired control objectives.  Further, the design of a control system must reflect the fact that there are resource constraints, and management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.  Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected.  These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake.  Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management’s override of the control.  The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.  Over time, controls may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate.  Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

 

Disclosure Controls and Procedures

 

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our Exchange Act reports, such as this report on Form 10-Q, is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. These controls and procedures are based closely on the definition of “disclosure controls and procedures” in Rule 13a-15(e) promulgated under the Exchange Act.  Rules adopted by the SEC require that we present the conclusions of the Chief Executive Officer and Chief Financial Officer about the effectiveness of our disclosure controls and procedures as of the end of the period covered by this report.

 

The Company carried out an evaluation, under the supervision and with the participation of the Company’s management, including the Company’s Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of the Company’s disclosure controls and procedures to provide reasonable assurance of achieving their objective pursuant to Exchange Act Rule 13a-14.  Based upon that evaluation, the Chief Executive Officer and Chief Financial Officer concluded that the Company’s disclosure controls and procedures are effective at a reasonable assurance level, as of September 30, 2011.

 

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Changes in Internal Controls over Financial Reporting

 

There were no changes in the Company’s internal control over financial reporting during the period covered by this quarterly report that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

 

Part II.  Other Information

 

Item 1A.              Risk Factors

 

In addition to the other information set forth in this report, you should carefully consider the factors discussed in Part I, “Item 1A Risk Factors” in our Form 10-K for the year ending December 31, 2010, which could materially affect our business, financial condition, and results of operations.  The risks described in our Form 10-K are not the only risks facing our Company.  Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition and/or operating results.

 

Item 6.                       Exhibits

 

31.1

Certification of Chief Executive Officer of Spherix Incorporated pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

 

31.2

Certification of Chief Financial Officer of Spherix Incorporated pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

 

32.1

Certification of Chief Executive Officer of Spherix Incorporated pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

 

32.2

Certification of Chief Financial Officer of Spherix Incorporated pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

 

101.1

XBRL Instance Document

 

 

101.2

XBRL Taxonomy Extension Schema Document

 

 

101.3

XBRL Taxonomy Extension Calculation Linkbase Document

 

 

101.4

XBRL Taxonomy Extension Definition Linkbase Document

 

 

101.5

XBRL Taxonomy Extension Label Linkbase Document

 

 

101.6

XBRL Taxonomy Extension Presentation Linkbase Document

 

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Signatures

 

Pursuant to the requirements of the Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 

 

 

 

Spherix Incorporated

 

 

 

(Registrant)

 

 

 

 

 

 

 

 

 

 

Date:

November 10, 2011

 

By:

/s/ Claire L. Kruger

 

 

 

 

Claire L. Kruger

 

 

 

 

Chief Executive Officer and Chief Operating Officer

 

 

 

 

 

 

 

 

 

 

Date:

November 10, 2011

 

By:

/s/ Robert L. Clayton

 

 

 

 

Robert L. Clayton, CPA

 

 

 

 

Chief Financial Officer and Treasurer

 

17