JUNIPER PHARMACEUTICALS INC - FORM 10-Q/A

Attached files

Attached files

Stock widget

Investing forum

JUNIPER PHARMACEUTICALS INC Reports

Table of Contents

Table of Contents

Table of Contents

Table of Contents

Table of Contents

Table of Contents

Table of Contents

Table of Contents

Table of Contents

Table of Contents

Table of Contents

Table of Contents

Table of Contents

Table of Contents

Table of Contents

Table of Contents

Table of Contents

Table of Contents

Table of Contents

Table of Contents

Table of Contents

Table of Contents

Table of Contents

Table of Contents

Table of Contents

Table of Contents

Table of Contents

Table of Contents

Table of Contents

Table of Contents

Table of Contents

Table of Contents

Table of Contents

file	filename
EXCEL - IDEA: XBRL DOCUMENT - JUNIPER PHARMACEUTICALS INC	Financial_Report.xls
EX-32.1 - EX-32.1 - JUNIPER PHARMACEUTICALS INC	d681125dex321.htm
EX-31.1 - EX-31.1 - JUNIPER PHARMACEUTICALS INC	d681125dex311.htm
EX-32.2 - EX-32.2 - JUNIPER PHARMACEUTICALS INC	d681125dex322.htm
EX-31.2 - EX-31.2 - JUNIPER PHARMACEUTICALS INC	d681125dex312.htm

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q/A

(Amendment No. 1)

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

For the quarterly period ended September 30, 2013

¨	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 1-10352

COLUMBIA LABORATORIES, INC.

(Exact name of Registrant as specified in its charter)


Delaware		59-2758596
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

4 Liberty Square Boston, Massachusetts		02109
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (617) 639-1500

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities 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 ¨

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 ¨

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 the definitions of “large accelerated filer,” “accelerated filer” and “small reporting company” in Rule 12b-2 of the Exchange Act.

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

The number of shares outstanding of the registrant’s common stock as of November 1, 2013: 12,009,545.

EXPLANATORY NOTE

Columbia Laboratories Inc. (herein referred to as “Columbia”, the “Company”, “we”, “us” or “our”) is filing this Amendment No. 1 on Form 10-Q/A (the “Amendment”) to our Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2013 (the “Original Form 10-Q”) filed with the Securities and Exchange Commission (the “Commission”) on November 7, 2013 (the “Original Filing Date”) to restate the unaudited interim consolidated financial statements for the three- and nine-month periods ended September 30, 2013 that were included in our Original Form 10-Q (the “Original Financial Statements”) and amend certain other related items (as described below).

Description of the Restatement

The Company currently has 621,275 warrants outstanding that are classified as a liability with an exercise price of $12.16 and an expiration date of April 30, 2015. Management estimates the fair value of the common stock warrant liability quarterly by using the Black-Scholes option pricing model, which is based on our stock price at the measurement date, exercise price of the warrants, risk-free rate and historical volatility.

Following a review of our Original Financial Statements, we discovered a calculation error related to our common stock warrant expense, which resulted in the overstatement of this expense for the three- and nine-month periods ended September 30, 2013, and affected, among other things, our reported net (loss) income and net (loss) income per common share (basic and diluted).

The restatement of our Original Financial Statements (the “Restatement”) has resulted in the following corrections to our Original Financial Statements:

•

A $4.9 million favorable adjustment to net (loss) income, a non-cash item, which does not affect the Company’s reported cash balances or operating income;

•

Net income of $1.7 million for the three month period ended September 30, 2013;

•

Net income of $5.6 million for the nine month period ended September 30, 2013;

•

Basic and diluted net income per common share of $0.15 and $0.11, respectively, for the three month period ended September 30, 2013;

•

Basic and diluted net income per common share of $0.51 and $0.46, respectively, for the nine month period ended September 30, 2013; and

•

Common stock warrant liability of $0.7 million reflected on our consolidated balance sheet as of September 30, 2013.

Items Amended in this Amendment

This Amendment amends and restates the following items of our Original Form 10-Q:

•

Part I — Item 1. Financial Statements (unaudited)

•

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

•

Part I — Item 4. Controls and Procedures

•

Part II — Item 6. Exhibits

In accordance with applicable Commission rules, this Amendment includes new certifications as required by Rule 12b-15 under the Securities Exchange Act of 1934, as amended, from our Principal Executive Officer and Principal Financial Officer dated as of the date of filing of this Amendment.

Except for the items noted above, no other information included in the Original Filing is being amended or updated by this Amendment. This Amendment continues to describe the conditions as of the Original Filing Date, and, except as contained herein, we have not updated or modified the disclosures contained in the Original Form 10-Q. Accordingly, this Amendment should be read in conjunction with our filings made with the Commission subsequent to the filing of the Original Form 10-Q.

Columbia Laboratories, Inc. and Subsidiaries

Table of Contents


		Page
Part I — Financial Information
Item 1.	Financial Statements (unaudited)
	Consolidated Balance Sheets as of September 30, 2013 (As Restated) and December 31, 2012		4
	Consolidated Statements of Operations for the three and nine month periods ended September 30, 2013 (As Restated) and 2012		5
	Consolidated Statements of Comprehensive (Loss) Income for the three and nine month periods ended September 30, 2013 (As Restated) and 2012		6
	Consolidated Statements of Cash Flows for the nine month periods ended September 30, 2013 (As Restated) and 2012		7
	Notes to Consolidated Financial Statements (unaudited)		8
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations		19
Item 4.	Controls and Procedures		30

Part II — Other Information
Item 6.	Exhibits		32

Signatures			33

Columbia Laboratories, Inc. and Subsidiaries

Consolidated Balance Sheets


	September 30, 2013			December 31, 2012
	(As Restated) (Unaudited)
Assets
Current assets:
Cash and cash equivalents	$	18,817,057		$	13,204,067
Short-term investments		—			15,433,967
Accounts receivable, net		6,848,148			1,159,145
Amounts due from related parties		900,000			2,194,491
Inventories		1,994,454			2,626,606
Prepaid expenses and other current assets		2,808,954			1,284,279

Total current assets		31,368,613			35,902,555
Property and equipment, net		12,726,893			927,227
Goodwill and intangibles, net		15,560,287			—
Other assets		124,903			38,882

Total assets	$	59,780,696		$	36,868,664

Liabilities and Shareholders’ Equity
Current liabilities:
Accounts payable	$	2,556,163		$	1,435,660
Accrued expenses		3,158,638			2,216,524
Deferred revenue		599,787			93,750
Notes payable		243,347			—

Total current liabilities		6,557,935			3,745,934
Deferred revenue, net of current portion		2,323,584			33,526
Notes payable, net of current portion		3,730,411			—
Common stock warrant liability		696,065			1,173,747

Total liabilities		13,307,995			4,953,207

Commitments and contingencies
Contingently redeemable series C preferred stock, 550 shares issued and outstanding (liquidation preference of $550,000)		550,000			550,000

Shareholders’ equity:
Preferred stock, $.01 par value; 1,000,000 shares authorized
Series B convertible preferred stock, 130 shares issued and outstanding (liquidation preference of $13,000)		1			1
Series E convertible preferred stock, 22,740 shares issued and outstanding (liquidation preference of $2,274,000)		227			227
Common stock $.01 par value; 150,000,000 shares authorized; 12,020,442 issued at September 30, 2013 and 10,942,973 issued at December 31, 2012		120,204			109,430
Additional paid-in capital		287,885,380			279,463,439
Treasury stock (at cost), 10,897 shares at September 30, 2013, and 4,556 shares at December 31, 2012		(156,074	)		(125,381	)
Accumulated deficit		(242,748,816	)		(248,365,480	)
Accumulated other comprehensive income		821,779			283,221

Total shareholders’ equity		45,922,701			31,365,457

Total liabilities and shareholders’ equity	$	59,780,696		$	36,868,664

The accompanying notes are an integral part of these consolidated financial statements.

Columbia Laboratories, Inc. and Subsidiaries

Consolidated Statements of Operations

(Unaudited)


	Three Months Ended September 30,					Nine Months Ended September 30,
	2013		2012			2013			2012
	(As Restated)					(As Restated)
Revenues
Product revenues	$	5,456,152	$	4,193,999		$	17,848,180		$	12,511,277
Product revenues from related party		—		1,426,890			—			3,590,073
Royalties		107,218		112,770			284,011			299,800
Royalties from related party		887,553		904,839			2,524,466			2,232,397
Other revenues		674,769		34,540			762,577			103,568

Total revenues		7,125,692		6,673,038			21,419,234			18,737,115
Cost of revenues		3,238,215		1,889,749			8,910,550			6,392,248
Cost of revenues from related party		—		1,297,043			—			3,263,376

Total cost of revenues		3,238,215		3,186,792			8,910,550			9,655,624
Gross profit		3,887,477		3,486,246			12,508,684			9,081,491
Operating expenses
Sales and marketing		78,777		—			78,777			—
Research and development (net of reimbursement from related party of $3,092 and $435,199 for the three and nine months ended September 30, 2012, respectively)		—		143,795			—			856,545
Acquisition related expenses		947,202		—			1,439,946			—
General and administrative		1,594,223		1,901,880			5,881,636			6,376,561

Total operating expenses		2,620,202		2,045,675			7,400,359			7,233,106
Income from operations		1,267,275		1,440,571			5,108,325			1,848,385

Interest income		641		35,880			95,996			158,625
Change in fair value of stock warrants		427,656		(1,065,498	)		477,682			5,399,569
Other income (expense), net		25,195		(19,882	)		(57,165	)		(115,629	)

Income before income taxes		1,720,767		391,071			5,624,838			7,290,950
Provision for income taxes		2,624		2,342			8,174			5,018

Net income	$	1,718,143	$	388,729		$	5,616,664		$	7,285,932

Basic net income per common share	$	0.15	$	0.04		$	0.51		$	0.67

Diluted net income per common share	$	0.11	$	0.04		$	0.46		$	0.17

Basic weighted average common shares outstanding		11,137,780		10,916,358			10,994,382			10,913,844

Diluted weighted average common shares outstanding		11,293,029		11,067,853			11,148,275			11,056,421

The accompanying notes are an integral part of these consolidated financial statements.

Columbia Laboratories, Inc. and Subsidiaries

Consolidated Statements of Comprehensive Income

(Unaudited)


	Three Months Ended September 30,				Nine Months Ended September 30,
	2013		2012		2013			2012
	(As Restated)				(As Restated)
Net income	$	1,718,143	$	388,729	$	5,616,664		$	7,285,932
Other comprehensive income (loss) components:
Foreign currency translation		637,710		3,195		635,778			(247	)
Unrealized gain (loss) on short term investments		—		79,313		(80,223	)		175,201
Reclassification adjustment for gains included in net income		—		—		(16,997	)		—

Comprehensive income	$	2,355,853	$	471,237	$	6,155,222		$	7,460,886

The accompanying notes are an integral part of these consolidated financial statements.

Columbia Laboratories, Inc. and Subsidiaries

Consolidated Statements of Cash Flows

(Unaudited)


	Nine Months Ended September 30,
	2013			2012
	(As Restated)
Operating activities:
Net income	$	5,616,664		$	7,285,932
Reconciliation of net income to net cash provided by operating activities:
Depreciation and amortization		376,530			440,779
Change in fair value of stock warrants		(477,682	)		(5,399,569	)
Provision for sales returns		(26,120	)		(222,764	)
Write-off of inventories		—			867,316
Stock-based compensation expense		338,139			637,487
Gain on short-term investments		(16,997	)		—
Loss on disposal of fixed assets		36,900			6,225
Changes in operating assets and liabilities:
Accounts receivable		(2,026,081	)		(308,865	)
Due from related party		1,294,491			(348,424	)
Inventories		635,400			(938,288	)
Prepaid expenses and other current assets		(547,306	)		164,196
Other non-current assets		(86,016	)		425,408
Accounts payable		95,482			(856,417	)
Accrued expenses		(137,444	)		(397,590	)
Deferred revenue		(160,485	)		(103,406	)

Net cash provided by operating activities		4,915,475			1,252,020
Investing activities:
Purchase of property and equipment		(246,935	)		(985,930	)
Additions to short term investments		—			(179,811	)
Cash paid for acquisition, net of cash received		(14,516,297	)		—
Proceeds from the sale of short-term investments		15,353,744			—

Net cash provided by (used in) investing activities		590,512			(1,165,741	)
Financing activities:
Redemption of series C convertible preferred stock		—			(50,000	)
Proceeds from exercise of stock options		10,263			—
Principal payments on note payable		(7,297	)		—
Dividends paid		(20,625	)		—

Net cash used in financing activities		(17,659	)		(50,000	)
Effect of exchange rate changes on cash and cash equivalents		124,662			35,140

Net increase in cash and cash equivalents		5,612,990			71,419
Cash and cash equivalents, beginning of period		13,204,067			10,114,163

Cash and cash equivalents, end of period	$	18,817,057		$	10,185,582

Supplemental cash flow information
Cash paid for income taxes	$	2,876		$	52,728

Cash paid for interest	$	4,532		$	—

Supplemental noncash financing activities
Common stock issued in connection with the acquisition of Molecular Profiles	$	8,105,700		$	—

The accompanying notes are an integral part of these consolidated financial statements.

Columbia Laboratories, Inc. and Subsidiaries

Notes to Consolidated Financial Statements

(Unaudited)

(As Restated)

(1) Interim Consolidated Financial Statements

The accompanying unaudited interim consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim information and pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) for reporting on Form 10-Q. Accordingly, certain information and footnote disclosures required for complete financial statements are not included herein. It is recommended that these financial statements be read in conjunction with the consolidated financial statements and related notes that appear in the Annual Report on Form 10-K of Columbia Laboratories, Inc. (“Columbia”) for the year ended December 31, 2012 filed with the SEC on March 14, 2013. In the opinion of management, all adjustments (consisting only of normal recurring adjustments) necessary for the fair presentation of the consolidated financial information for the interim periods reported have been made. Results of operations for the nine months ended September 30, 2013 are not necessarily indicative of the results for the year ending December 31, 2013 or any period thereafter.

Reclassifications

Certain amounts in the prior year’s financial statements have been reclassified to conform to the current year’s presentation within the consolidated balance sheets and consolidated statements of cash flows.

Basis of Presentation

On July 26, 2013, Columbia’s Board of Directors set a ratio of 1-for-8 for its previously approved reverse stock split which took effect on August 9, 2013. The reverse stock split was approved by Columbia’s shareholders at its annual meeting of shareholders on May 1, 2013. All share and per share amounts relating to the common stock, stock options and warrants included in the financial statements and accompanying footnotes have been retroactively adjusted for all periods presented to give effect to this reverse stock split, including reclassifying an equal amount to the reduction in par value of common stock to additional paid-in capital. The reverse stock split did not result in a retroactive adjustment to the share amounts for any of the classes of the Company’s preferred stock.

(2) Actavis Transactions

Under a purchase agreement with Actavis, Inc. (“Actavis”, formerly Watson Pharmaceuticals, Inc.), Actavis has agreed to make royalty payments to Columbia of 10% to 20% of annual net sales of certain Progesterone Products provided, however, that royalty rates will be reduced by 50% in a particular country if a generic entry by a third party occurs in such country and certain other circumstances are fulfilled. In addition, if Actavis commercializes a Progesterone Product through a third party outside of the U.S., in lieu of royalties, Columbia will be entitled to 20% of gross profits associated with such commercialization. If Actavis or its affiliates effects a generic entry with respect to a Progesterone Product in a particular country in the circumstances permitted by the Purchase Agreement, in lieu of royalties payable in respect of net sales for such generic product, Columbia will be entitled to 20% of the gross profits associated with the commercialization of such generic product in such country.

Pursuant to the purchase agreement, Columbia and Actavis had also agreed to collaborate with respect to the development of Progesterone Products. Columbia was responsible for the costs of conducting the PREGNANT Study and the preparation, filing and approval process of the related new drug application (or the supplemental new drug application) up to a maximum of $7.0 million. All other development costs incurred in connection with the development collaboration were paid by Actavis. In the three and nine months ended September 30, 2012, Columbia was reimbursed $3,100 and $0.4 million by Actavis, respectively. These reimbursed costs were credited to research and development expense in the consolidated financial statements. There were no research and development expenses incurred for the three and nine months ended September 30, 2013.

As part of the purchase agreement, from the date of the closing of the Actavis Transactions until the second anniversary of the date on which Columbia and Actavis terminate their relationship with respect to the joint development of Progesterone Products, Columbia agreed not to manufacture, develop or commercialize products containing progesterone or any other products for the preterm birth indication, subject to certain exceptions. The joint development collaboration can be terminated by either party on or after July 2, 2015 (five years after the closing of the Actavis Transactions).

(3) Acquisition of Molecular Profiles Limited

On September 12, 2013, Columbia acquired all of the outstanding capital stock of Molecular Profiles Limited (“Molecular Profiles”), a U.K.-based pharmaceutical development services company. The main service lines that have been added to our portfolio as a result of the acquisition include:

•

Formulation, scale-up and clinical trial manufacturing supply service;

•

Advanced physical and chemical analysis; and,

•

Consulting services.

The acquisition expands Columbia’s business model and customer base while diversifying the Company’s revenue streams. With the addition of Molecular Profiles, the Company has broadened its technical expertise in the field of pharmaceutical development and analytical services. As a result of the transaction, former Molecular Profiles stockholders, in the aggregate received for their shares of Molecular Profiles common stock $16.7 million in cash and 1,051,323 shares of Columbia common stock. The total consideration is valued at $24.9 million, based upon the closing price of Columbia’s common stock on September 12, 2013. The goodwill recognized is attributable to expected synergies as the formulation, clinical trial manufacturing and consulting business lines are integrated into Columbia’s business model. The goodwill is deductible for tax purposes. Columbia accounted for this transaction using the acquisition method under the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 805, Business Combinations.

Columbia has retained an independent valuation firm to assess the fair value of the identifiable intangible assets acquired and is currently assessing the fair value of other assets acquired and liabilities assumed and plans to file pro forma financial information with the SEC within the applicable time period. Columbia has preliminarily allocated the purchase price to the net tangible and intangible assets based on their estimated fair values as of September 12, 2013. As such, the assets acquired and liabilities assumed, including intangible assets, presented in the table below are provisional and will be finalized in a later period once the fair value procedures are completed.

The following table summarizes the preliminary purchase price allocation, net of the cash and debt acquired:


Purchase price:
Cash and stock paid	$	24,852,511
Cash acquired		(2,230,514	)
Debt assumed		3,889,486

Purchase price, net	$	26,511,483


Assets (liabilities) acquired:
Accounts receivable	$	3,583,614
Prepaid expenses and other current assets		970,380
Property and equipment		11,690,239
Goodwill		15,201,557
Accounts payable		(999,539	)
Accrued expenses		(1,045,389	)
Deferred revenue		(2,889,379	)

Total	$	26,511,483

Revenue related to Molecular Profiles operations was $0.6 million following the September 12, 2013 acquisition date, and is included in Columbia’s consolidated statements of operations for the three and nine months ended September 30, 2013. As a result of the integration of the operations of Molecular Profiles into Columbia’s operations, disclosure of earnings included in the accompanying consolidated statements of operations since the acquisition date is not practicable.

The following unaudited pro forma condensed consolidated operating results for the three and nine months ended September 30, 2013 and 2012 summarize the combined results of operations for Columbia and Molecular Profiles. The unaudited pro forma consolidated operating results include the business combination accounting effects as if the acquisitions had been completed as of January 1, 2012 (for both the 2013 and 2012 period results). These pro forma amounts are for informational purposes only and are not indicative of the operating results that would have occurred if the transaction had occurred on such date. No effect has been given for synergies, if any, that may be realized through the acquisition.


	Three Months Ended September 30,				Nine Months Ended September 30,
	2013		2012		2013		2012
	(As Restated)				(As Restated)
Revenue	$	9,518,660	$	8,967,687	$	28,267,722	$	23,874,436
Pre-tax income		1,788,533		872,798		5,650,469		7,507,825

For the three and nine months ended September 30, 2013, Columbia recorded $0.9 million and $1.0 million, respectively, in costs associated with the acquisition of Molecular Profiles. These amounts are recorded as operating expenses in the general and administrative line on the consolidated statements of operations.

(4) Revenue Recognition and Sales Returns Reserves

Revenues include product revenues from sales of Progesterone Products to Actavis and Merck Serono S.A. (“Merck Serono”), royalty revenues (primarily royalty revenues from Actavis on sales of Progesterone Products), and other revenues (primarily service and deferred revenues).

Product revenues are recognized when shipped, except in the case of product shipments to Actavis, which are recognized when received at Actavis’ warehouse. Royalty revenues, based on sales by licensees, are recorded as revenues as those sales are made by the licensees. Service revenues are recognized over the period in which the services are performed and certain multiple-element arrangements are evaluated in accordance with the principles of Accounting Standards update (“ASU”) 2009-13, (Revenue Recognition Topic — Multiple Element Arrangements) and Columbia allocates revenue among the elements based upon each element’s relative fair value.

Sales to Merck Serono for CRINONE^® (progesterone gel) are determined on a country-by-country basis and are the greater of (i) thirty percent (30%) of the net selling price in the country, or (ii) Columbia’s direct manufacturing cost plus 20%. Columbia estimates net selling prices based on historical experience and other current information from Merck Serono; the amounts are reconciled on a quarterly basis when information is received from Merck Serono. Certain quantity discounts apply to annual purchases over 10 million, 20 million, and 30 million units. Columbia accrues an estimated volume discount on a quarterly basis and reconciles it on an annual basis.

Columbia is not responsible for returns on international sales. Sales adjustments for international sales are estimated to recognize changes in foreign exchange rates and changes in market prices that may fluctuate within a year. Columbia is responsible for sales returns for products sold to domestic customers prior to both the Actavis Transactions and the sale in April 2011 of STRIANT^® (testosterone buccal system) to Actient Pharmaceuticals LLC (“Actient”). Revenues from the sale of products to domestic customers were recorded at the time goods were shipped to customers. Except for sales to licensees, Columbia’s return policy allows product to be returned for a period beginning three months prior to the product expiration date and ending twelve months after the product expiration date. Products sold to Merck Serono and Actavis are not returnable to Columbia. Provisions for returns on sales to wholesalers, distributors and retail chain stores were estimated based on a percentage of sales, using such factors as historical sales information, distributor inventory levels and product prescription data, and were recorded as a reduction to sales in the same period as the related sales were recognized. Columbia evaluates its remaining provision for returns on a quarterly basis based on the rate of returns processed and adjusts the provision if its analysis indicates that the provision needs to be adjusted.

An analysis of the reserve for sales returns at September 30, 2013 is as follows:


	Total
Balance — December 31, 2012	$	483,865
Provision:
Related to current period sales		—
Related to prior period sales		(26,120	)

		(26,120	)

Returns:
Related to current period sales		—
Related to prior period sales		(98,855	)

		(98,855	)

Balance — September 30, 2013	$	358,890

(5) Inventories

Columbia states all inventories at the lower of cost or market, determined on a first-in, first-out method. Inventory includes material and overhead and consists of the following:


	September 30, 2013		December 31, 2012
Raw materials	$	289,604	$	685,578
Work in process		989,594		1,308,399
Finished goods		715,256		632,629

Total Inventories	$	1,994,454	$	2,626,606

(6) Goodwill and Other Intangible Assets

Goodwill represents the excess of the purchase price over the fair value of assets acquired and liabilities assumed in a business combination. Columbia does not amortize its goodwill, but instead tests for impairment annually and more frequently whenever events or changes in circumstances indicate that the fair value of the asset may be less than its carrying value of the asset.

Columbia has adopted ASU 2011-08, Intangibles — Goodwill and Other, an amendment to ASC 350, which updates how an entity will evaluate its goodwill for impairment. The guidance provides entities an option to perform a “qualitative” assessment to determine whether further impairment testing is necessary. If further testing is required, the test for impairment continues with the two step process. The first step compares the carrying amount of the reporting unit to its estimated fair value (Step 1). To the extent that the carrying value of the reporting unit exceeds its estimated fair value, a second step is performed, wherein the reporting unit’s carrying value is compared to the implied fair value (Step 2). To the extent that the carrying value exceeds the implied fair value, impairment exists and must be recognized.

Columbia is evaluating the reporting unit structure for it to establish the baseline for goodwill impairment testing in the future. Upon establishment of this baseline, Columbia will perform its annual test for impairment on the first day of the fourth quarter beginning in 2014.

Changes to goodwill during the nine months ended September 30, 2013 were as follows:


	Total
Balance — December 31, 2012	$	—
Molecular Profiles acquisition		15,201,557
Translation adjustment		358,730

Balance — September 30, 2013	$	15,560,287

Columbia is currently evaluating the fair value of assets acquired and liabilities assumed from the Molecular Profiles acquisition, including identifiable intangible assets and their related amortization periods. As such, the $15.6 million in goodwill presented in the table above is provisional and will be finalized in a later period once the fair value procedures are completed.

(7) Debt and other Contractual Obligations

As a part of the Molecular Profiles acquisition, Columbia assumed debt of $3.9 million that Molecular Profiles had entered into to fund the completion and building of a second facility in the United Kingdom. Molecular Profiles entered into a Business Loan Agreement (“Loan Agreement”) covering three loan facilities with Lloyds TSB Bank (“Lloyds”), as administrative agent. Molecular Profiles had withdrawn $3.9 million and as of September 30, 2013 owes $4.0 million due to foreign currency revaluation. The three loan facilities are each repayable by monthly installments, one started repayment in February 2013 and the remaining two commenced in October 2013. All facilities are due for repayment over 15 years from the date of drawdown. Two of the facilities bear interest at 2.45% and 3.05% per annum, respectively. The third facility is a fixed rate agreement bearing interest at 3.52% per annum. The weighted average interest rate for the period from September 12, 2013 to September 30, 2013 was 3.52%. The Loan Agreement is secured by the mortgaged property and an unlimited lien on other assets of Molecular Profiles. The Loan Agreement contains financial covenants that limit the amount of indebtedness Molecular Profiles may incur, requires Molecular Profiles to maintain certain levels of net worth, and restricts Molecular Profile’s ability to materially alter the character of its business. Molecular Profiles is currently in compliance with all of the covenants under the Loan Agreement.

As part of the acquisition of Molecular Profiles, Columbia assumed a $2.5 million obligation under a grant arrangement with the Regional Growth Fund on behalf of the Secretary of State for Business, Innovation, and Skills in the United Kingdom. Molecular Profiles used this grant to fund the building of its second facility, which includes analytical labs, office space, and a manufacturing facility. As a part of the arrangement, Molecular Profiles is required to create and maintain certain full-time equivalent personnel levels through October 2017. As of September 30, 2013, Molecular Profiles is in compliance with the covenants of the arrangement.

The income from the Regional Growth Fund will be recognized on a decelerated basis over the next four years. As of September 30, 2013, the obligation is valued at $2.6 million due to foreign currency revaluation and is recorded in deferred revenue on the consolidated balance sheets. The amount of other income on the obligation that will be recognized provided Molecular Profiles remains in compliance with the covenants will be the following:


Year	Total
Remainder of 2013	$	64,544
2014		322,720
2015		580,896
2016		839,072
2017		774,528


Total	$	2,581,760

(8) Geographic Information

Columbia and its subsidiaries are engaged in one line of business: the development, licensing, manufacturing, advanced analysis, consulting services and sale of pharmaceutical products. Columbia conducts the manufacturing of CRINONE through its Bermuda subsidiary which contracts with various manufacturers located in the United Kingdom and Switzerland to make product for both its international and domestic operations and through its subsidiary in the United Kingdom. Columbia conducts its advanced formulation, analytical and consulting services through its newly acquired subsidiary, Molecular Profiles.

Columbia’s international customer, Merck Serono, sells its products into several countries. Columbia’s primary domestic customer, Actavis, is responsible for the commercialization and sale of Progesterone Products in the United States. The following table shows selected information by geographic area:

Revenues:


	Three Months Ended September 30,				Nine Months Ended September 30,
	2013		2012		2013		2012
United States	$	1,026,022	$	2,598,514	$	2,928,348	$	6,443,375
Switzerland		5,456,152		4,074,524		17,822,060		12,293,740
Other countries		643,518		—		668,826		—

Total	$	7,125,692	$	6,673,038	$	21,419,234	$	18,737,115

Total Assets:


	September 30, 2013		December 31, 2012
United States	$	19,359,366	$	31,898,401
Switzerland		4,088,611		1,189,183
United Kingdom		36,103,352		3,538,446
Other countries		229,367		242,634

Total	$	59,780,696	$	36,868,664

Long-lived Assets:


	September 30, 2013		December 31, 2012
United States	$	354,961	$	171,167
Switzerland		21,966		59,582
United Kingdom		12,473,761		734,280
Other countries		1,108		1,080

	$	12,851,796	$	966,109

The increase in the amount of total assets is due primarily to the Molecular Profiles acquisition. The increase in the amount of long-lived assets is due to the tangible net assets acquired in the Molecular Profiles acquisition. Columbia is currently evaluating the fair value of assets acquired and liabilities assumed.

(9) Net Income Per Common Share

The calculation of basic and diluted income per common and common equivalent share is as follows:


	Three Months Ended September 30,					Nine Months Ended September 30,
	2013			2012		2013			2012
	(As Restated)					(As Restated)
Basic net income per share
Net income	$	1,718,143		$	388,729	$	5,616,664		$	7,285,932
Less: Preferred stock dividends		6,875			—		20,625			—

Net income applicable to common stock	$	1,711,268		$	388,729	$	5,596,039		$	7,285,932

Basic weighted average number of common shares outstanding		11,137,780			10,916,358		10,994,382			10,913,844

Basic net income per share	$	0.15		$	0.04	$	0.51		$	0.67

Diluted net income per share
Net income applicable to common stock	$	1,711,268		$	388,729	$	5,596,039		$	7,285,932
Add: Preferred stock dividends		6,875			—		20,625			—
Less: Fair value of stock warrants for dilutive warrants		(427,656	)		—		(477,682	)		(5,399,569	)

Net income applicable to dilutive common stock	$	1,290,487		$	388,729	$	5,138,982		$	1,886,363

Basic weighted average number of common shares outstanding		11,137,780			10,916,358		10,994,382			10,913,844
Effect of dilutive securities
Dilutive stock awards		12,799			9,045		11,443			127
Dilutive preferred share conversions		142,450			142,450		142,450			142,450

		155,249			151,495		153,893			142,577
Diluted weighted average number of common shares outstanding		11,293,029			11,067,853		11,148,275			11,056,421

Diluted net income per share	$	0.11		$	0.04	$	0.46		$	0.17

Basic net income per share is computed by dividing net income less preferred stock dividends by the weighted-average number of shares of Columbia’s common stock outstanding during the period. The diluted earnings per share calculation gives effect to dilutive options, warrants, convertible preferred stock, and other potential dilutive common stock, including selected restricted shares of common stock outstanding during the period. Diluted income per share is based on the treasury stock method and includes the effect from potential issuance of common stock, such as shares issuable pursuant to the exercise of stock options, assuming the exercise of all in-the-money stock options. Common share equivalents have been excluded where their inclusion would be anti-dilutive. The warrants related to the stock warrant liability were first evaluated on an “as if converted” basis; the change in the fair value of the stock warrants recognized in the periods presented was subtracted from earnings to calculate net income applicable to dilutive common stock. Then, the incremental shares for dilution were determined utilizing the treasury method. Since the average stock price for all periods presented was below the exercise price of the warrants, the calculation under the treasury method resulted in repurchasing more shares than would have been exercised and therefore, the inclusion of these shares were deemed to be anti-dilutive and excluded from the dilutive share calculation.

Shares to be issued upon the exercise of the outstanding options and warrants, convertible preferred stock and selected restricted shares of common stock excluded from the income per share calculation amounted to 1,590,948 and 1,925,760 for the three months ended September 30, 2013 and 2012, respectively, but were not included in the computation of diluted earnings per share because the awards were anti-dilutive. Shares to be issued upon the exercise of the outstanding options and warrants, convertible preferred stock and selected restricted shares of common stock excluded from the income per share calculation amounted to 1,590,948 and 1,947,819 for the nine months ended September 30, 2013 and 2012, respectively, but were not included in the computation of diluted earnings per share because the awards were anti-dilutive.

(10) Accumulated Other Comprehensive Income

Changes to accumulated other comprehensive income during the nine months ended September 30, 2013 were as follows:


	Unrealized Gain on Marketable Securities, net of tax			Translation Adjustment		Accumulated Other Comprehensive Income
Balance — December 31, 2012	$	97,220		$	186,001	$	283,221
Current period other comprehensive (loss) income		(80,223	)		635,778		555,555
Amounts reclassified from accumulated other comprehensive income		(16,997	)		—		(16,997	)

Balance — September 30, 2013	$	—		$	821,779	$	821,779

(11) Stock-Based Compensation

Columbia recorded stock-based compensation expense of $0.1 million for both the three months ended September 30, 2013 and 2012. Columbia recorded stock-based compensation expense of $0.3 million and $0.6 million for the nine months ended September 30, 2013 and 2012, respectively. Stock-based compensation expense is included in the accompanying consolidated statements of operations as follows:


	Three Months Ended September 30,				Nine Months Ended September 30,
	2013		2012		2013		2012
Cost of revenues	$	4,922	$	4,361	$	9,790	$	14,400
Research and development		—		16,942		—		78,192
General and administrative		60,177		128,203		328,349		544,895

Total	$	65,099	$	149,506	$	338,139	$	637,487

Columbia granted 88,749 and 104,375 stock options during the nine months ended September 30, 2013 and 2012, respectively. Columbia has elected to use the Black-Scholes option pricing model to determine the weighted average fair value of options. The weighted average fair value of the options granted during the nine months ended September 30, 2013 and 2012 was $3.52 and $4.00, respectively, using the following assumptions:


	Nine Months Ended September 30,
	2013	2012
Risk free interest rate	0.71%-0.76%		0.82	%
Expected term	4.75		4.75
Dividend yield	—		—
Expected volatility	96.52%-97.02%		105.72	%

Option-pricing models require the input of various subjective assumptions, including the option’s expected life and the price volatility of the underlying stock. Columbia’s estimated expected stock price volatility is based on its own historical volatility. Columbia’s expected term of options granted in the nine months ended September 30, 2013 and 2012 was derived from the simplified method. The risk-free rate for the expected term of the option is based on the U.S. Treasury yield curve in effect at the time of grant.

Cash received from option exercises was $10,300 during the three and nine months ended September 30, 2013. There were no option exercises in the three and nine months ended September 30, 2012.

(12) Legal Proceedings

Claims and lawsuits may be filed against Columbia from time to time. Although the results of pending claims are always uncertain, Columbia believes that it has adequate reserves or adequate insurance coverage in respect of these claims, but no assurance can be given as to the sufficiency of such reserves or insurance coverage in the event of any unfavorable outcome resulting from such actions.

Between February 1, 2012 and February 6, 2012, two putative securities class action complaints were filed against Columbia and certain of its officers and directors in the United States District Court for the District of New Jersey. These actions were filed under the captions Wright v. Columbia Laboratories, Inc., et al., and Shu v. Columbia Laboratories, Inc., et al and asserted claims under sections 10(b) and 20(a) of the Exchange Act and Rule 10b-5 promulgated under the Exchange Act on behalf of an alleged class of purchasers of the common stock during the period from December 6, 2010 through January 20, 2012. Both actions were consolidated into a single proceeding entitled In re Columbia Laboratories, Inc., Securities Litigation, under which Actavis, Inc., and one of its officers have been added as defendants. The Consolidated Amended Complaint alleged that Columbia and one of its officers and a director omitted to state material facts that they were under a duty to disclose, and made materially false and misleading statements that related to the results of Columbia’s PREGNANT study and the likelihood of approval by the U.S. Food and Drug Administration (“FDA”) of a New Drug Application (“NDA”) to market progesterone vaginal gel 8% for the prevention of preterm birth in women with premature cervical shortening. According to the complaint, these alleged omissions and misleading statements had the effect of artificially inflating the market price of the common stock. The plaintiffs sought unspecified damages on behalf of the putative class and an award of costs and expenses, including attorney’s fees. On June 11, 2013, the Court dismissed the complaint for failure to state a claim upon which relief could be granted, holding that the plaintiffs did not adequately plead facts supporting an inference of an intent to deceive investors. The Court permitted the plaintiffs to file a further amended complaint, and they did so on July 11, 2013. Columbia moved to dismiss the further amended complaint. On October 21, 2013, the Court dismissed the amended complaint. The Court ruled that changes the plaintiffs made to their first amended complaint “still do not create a strong inference that [Columbia] acted with an intent to deceive, manipulate or defraud.” The Court ordered that if the plaintiffs sought to attempt to plead a cognizable action for a third time, they must do so within thirty days and specifically address why the attempt would not be futile. Columbia believes that the amended action is without merit, and intends to defend it vigorously. At this time, it is not possible to determine the likely outcome of, or estimate the liability related to this action, and Columbia has not made any provision for losses in connection with it.

(13) Fair Value of Financial Instruments

U.S. GAAP establishes a framework for measuring fair value and enhances disclosures about fair value measurements. 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 must maximize the use of observable inputs and minimize the use of unobservable inputs. The standard describes the following fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value:

Level 1: Quoted prices in active markets for identical assets or liabilities.

Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

The fair value of cash and cash equivalents are classified as level 1 at September 30, 2013 and December 31, 2012. The fair value of short-term investments is determined based on quoted market prices on the balance sheet date and are classified as a Level 1 investment at December 31, 2012. There we no short-term investments at September 30, 2013.

The estimated fair value of the common stock warrant liability resulting from the October 2009 registered direct offering of 1,362,500 shares of common stock and warrants to purchase 681,250 shares of common stock and is determined by using the Black-Scholes option pricing model based on Columbia’s stock price at the measurement date, exercise price of the warrant, risk-free rate and historical volatility, and is classified as a Level 2 measurement. Columbia recorded income of $0.4 million for the three months ended September 30, 2013 as compared to an expense of $1.1 million for the three months ended September 30, 2012 as a result of the change in stock price. During the nine months ended September 30, 2013 and 2012, Columbia recorded income of $0.5 million and $5.4 million, respectively, as a result of the change in the stock price.

The fair value of accounts receivable and accounts payable approximate their carrying amount.

(14) Related Party Transactions

The table below presents the transactions between the Company and Actavis:


	Three Months Ended September 30,				Nine Months Ended September 30,
	2013		2012		2013		2012
Revenues
Product revenues	$	—	$	1,426,890	$	—	$	3,590,073
Royalties		887,553		904,839		2,524,466		2,232,397

Total revenues	$	887,553	$	2,331,729	$	2,524,466	$	5,822,470

Cost of product revenues
Cost of product revenues		—		1,297,043		—		3,263,376

Gross profit	$	887,553	$	1,034,686	$	2,524,466	$	2,559,094

As of September 30, 2013 and December 31, 2012, amounts due from related party for these sales were $0.9 million and $2.2 million, respectively. There were no amounts due to Actavis as of September 30, 2013 and December 31, 2012.

In the three and nine months ended September 30, 2012, Actavis reimbursed Columbia $3,100 and $0.4 million, respectively, for research and development expenses pursuant to the purchase agreement. There are no further research and development expenses to be reimbursed by Actavis related to the purchase agreement.

(15) Restatement of Financial Statements

The Company’s Board of Directors, based on the recommendation of the Audit Committee of the Company’s Board of Directors and consulation with management, concluded that the previously issued interim consolidated financial statements contained in Form 10-Q for the quarterly period ended September 30, 2013 should no longer be relied upon and must be restated to correct an error related to the valuation of the Company’s common stock warrant liability as of September 30, 2013.

As of September 30, 2013, there were 621,275 warrants outstanding with an exercise price of $12.16 and an expiration date of April 30, 2015 that are classified as liability instruments in the Company’s consolidated balance sheet and are remeasured at fair value each reporting period. Management estimates the fair value of the common stock warrant liability each reporting period using the Black-Scholes option pricing model and input assumptions such as: the Company’s common stock price on the applicable measurement date; the exercise price of the common stock warrants; remaining contractual term; risk-free interest rate; and historical volatility.

Following a review of the Original Financial Statements, the Company discovered a calculation error related to the valuation of the common stock warrant liability as of September 30, 2013 that was previously reported. This error resulted in the overstatement of the common stock warrant liability recorded in the consolidated balance sheet as of September 30, 2013 and overstatement of the associated expense recognized in the consolidated statements of operations for the change in the fair value of the common stock warrant liability recognized for the three and nine month periods ended September 30, 2013.

As a result, the Company has restated its consolidated balance sheet to reflect the corrected value of the common stock warrant liability as of September 30, 2013 and its consolidated statements of operations to correct the amounts recognized for the change in fair value of common stock warrants for the three and nine month periods ended September 30, 2013. The Company also restated its consolidated statements of comprehensive income (loss) for the three and nine month periods ended September 30, 2013 and the consolidated statement of cash flows for the nine month period ended September 30, 2013 to conform to the changes made in the consolidated balance sheet and statements of operations. As a result of this misstatement, net income was understated by $4.9 million for the three and nine month periods ended September 30, 2013.

This restatement has resulted in certain adjustments to our financial statements which are illustrated in detail below.


	September 30, 2013
	As Previously Reported			Adjustment			As Restated
Consolidated Balance Sheet:
Common stock warrant liability	$	5,568,525		$	(4,872,460	)⁽¹⁾	$	696,065
Total liabilities		18,180,455			(4,872,460	)		13,307,995
Accumulated deficit		(247,621,276	)		4,872,460			(242,748,816	)
Total shareholders’ equity		41,050,241			4,872,460			45,922,701


	Three Months Ended September 30, 2013
	As Previously Reported			Adjustment			As Restated
Consolidated Statement of Operation:
Change in fair value of common stock warrants	$	(4,444,804	)	$	4,872,460		$	427,656
(Loss) income before income taxes		(3,151,693	)		4,872,460			1,720,767
Net (loss) income		(3,154,317	)		4,872,460			1,718,143
Basic net (loss) income per common share	$	(0.28	)	$	0.43		$	0.15
Diluted net (loss) income per common share	$	(0.28	)	$	0.39		$	0.11
Basic weighted average common shares outstanding		11,137,780			—			11,137,780
Diluted weighted average common shares outstanding		11,137,780			155,249	⁽²⁾		11,293,029

Consolidated Statement of Comprehensive (Loss) Income:
Net (loss) income	$	(3,154,317	)	$	4,872,460		$	1,718,143
Comprehensive (loss) income		(2,516,607	)		4,872,460			2,355,853


	Nine Months Ended September 30, 2013
	As Previously Reported			Adjustment			As Restated
Consolidated Statement of Operations:
Change in fair value of common stock warrants	$	(4,394,778	)	$	4,872,460		$	477,682
Income before income taxes		752,378			4,872,460			5,624,838
Net income		744,204			4,872,460			5,616,664
Basic net income per common share	$	0.07		$	0.44		$	0.51
Diluted net income per common share	$	0.07		$	0.39		$	0.46
Basic weighted average common shares outstanding		10,994,382			—			10,994,382
Diluted weighted average common shares outstanding		11,148,275			—			11,148,275

Consolidated Statement of Comprehensive Income:
Net income	$	744,204		$	4,872,460		$	5,616,664
Comprehensive income		1,282,762			4,872,460			6,155,222

Consolidated Statements of Cash Flows Data:
Net income	$	744,204		$	4,872,460		$	5,616,664
Change in fair value of common stock warrants		4,394,778			(4,872,460	)		(477,682	)

(1)	Represents the common stock warrant liability adjustment as of September 30, 2013.

(2)	Represents the effect of dilutive securities change to the diluted weighted average common shares outstanding due to the three months ended September 30, 2013 resulting changing from a net (loss) to a net income.

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

Forward-Looking Information

This Amendment No. 1 to our Quarterly Report on Form 10-Q/A contains forward-looking statements, that involve risk and uncertainties. The words “may,” “will,” “plan,” “believe,” “expect,” “intend,” “anticipate,” “potential,” “should,” “estimate,” “predict,” “project,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those projected in the forward-looking statements.

These forward-looking statements include, among other things, statements about:

•

Successful marketing of CRINONE^® by Actavis and Merck Serono in their respective markets;

•

The anticipated timing of future batch orders of CRINONE from our customers;

•

The successful development by Actavis of a next-generation vaginal Progesterone Product for the U.S. market;

•

Our ability to manufacture our product with minimal difficulties and delays;

•

The availability and pricing of third-party sourced products and materials;

•

Our ability to successfully integrate and strengthen the Molecular Profile business and brand;

•

Our compliance with FDA, MHRA and other governmental regulations applicable to manufacturing facilities, products, and/or business;

•

Our intellectual property portfolio;

•

Our strategy of growing through acquisitions; and,

•

Our estimates regarding expenses, future revenues, and capital requirements.

We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you are cautioned not to place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions, and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in our Annual Report on Form 10-K for the year ended December 31, 2012, particularly in Part 1 — Item 1A and in our other public filings with the Securities and Exchange Commission that could cause actual results or events to differ materially from the forward-looking statements that we make.

You should read this Quarterly Report and the documents that we have filed as exhibits to the Quarterly Report completely and with the understanding that our actual future results may be materially different from what we expect. While we may elect to update forward-looking statements at some point in the future, we do not undertake any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise.

Restatement of Previously Reported Consolidated Financial Information

This Item 2 has been amended and restated to give effect to the restatement of our consolidated financial statements as of and for the three and nine month periods ended September 30, 2013 due to a calculation error related to the valuation of our common stock warrant liability and the expense recognized for the change in the fair value of the common stock warrant liability. See Note 15 to the accompanying interim unaudited consolidated financial statements in Item 1 of this report for additional information.

Company Overview

We are in the business of developing, licensing, manufacturing and selling to our marketing partners pharmaceutical products that utilize proprietary drug delivery technologies to treat various medical conditions. Our focus has been on utilizing our bioadhesive formulations for drug delivery across mucosal membranes, an area where we have a rich heritage and proven capabilities.

On September 12, 2013, we acquired all of the outstanding capital stock of Molecular Profiles Limited (“Molecular Profiles”), a U.K.-based pharmaceutical development services company. The main service lines that have been added to our portfolio as a result of the acquisition include:

•

Formulation, scale-up and clinical trial manufacturing supply service;

•

Advanced physical and chemical analysis; and,

•

Consulting services.

The acquisition expands our business model and customer base while diversifying our revenue stream. With the addition of Molecular Profiles, we have broadened our technical expertise in the field of pharmaceutical development and analytical services. As a result of the transaction, former Molecular Profiles stockholders, in the aggregate, received for their shares of Molecular Profiles common stock $16.7 million in cash and 1,051,323 shares of our common stock. The total consideration is valued at $24.9 million, based upon the closing price of our common stock on September 12, 2013. This acquisition was considered a business acquisition for accounting purposes.

To date, we have developed and brought to market six products: five bioadhesive vaginal gel products that provide patient friendly solutions for infertility, pregnancy support, amenorrhea, and other women’s health conditions, and a testosterone bioadhesive buccal system for male hypogonadism. Our primary product is CRINONE (progesterone gel) which is formulated in a 4% and an 8% solution. We have licensed CRINONE to Merck Serono S.A. (“Merck Serono”), internationally, and to Actavis, Inc. (“Actavis”, formerly Watson Pharmaceuticals, Inc.), in the United States.

Currently, we sell CRINONE 8% to Merck Serono at a price determined on a country-by-country basis that is the greater of (i) thirty percent (30%) of the net selling price in the country, or (ii) our direct manufacturing cost plus 20%. Certain quantity discounts apply to annual purchases over 10 million, 20 million, and 30 million units.

On April 4, 2013, our license and supply agreement with Merck Serono for the sale of CRINONE 8% outside the U.S. was renewed for an additional five year term, extending the expiration date from May 19, 2015, to May 19, 2020.

Under the terms of the amended license and supply agreement, we will continue to sell CRINONE to Merck Serono on a country-by-country basis at the greater of (i) cost plus 20% or (ii) a percentage of Merck Serono’s net selling price. From 2014 through 2020, the percentage of net selling price will convert to a tiered structure. Current volumes will be eligible to receive slightly lower rates than in 2013. As volumes reach higher thresholds, incremental sales will earn a lower percentage of net selling price. These thresholds have been agreed in order to incentivize Merck Serono to continue to develop existing markets and to enter new markets. Additionally, the parties will jointly cooperate to evaluate and implement manufacturing cost reduction measures, with both parties sharing any reductions realized from these initiatives. All other material terms remain substantially as before.

We manufacture and sell product to Actavis at our cost plus 10%; these revenues are recorded within net product revenues from related party. In addition, we receive royalties equal to a minimum of 10% of annual net sales by Actavis for annual net sales up to $150 million, 15% for sales above $150 million but less than $250 million; and 20% for annual net sales of $250 million and over. Due to a build-up of inventory by Actavis in advance of filing for FDA approval of 8% progesterone gel for use in the prevention of preterm birth in women with premature cervical shortening, and Actavis’ decision, in light of the FDA’s denial of both Actavis’ application and subsequent appeal, not to continue development of the proposed indication, Actavis currently has sufficient inventories of CRINONE; therefore we do not expect any material orders for the remainder of 2013. We continue to receive royalties on net sales of CRINONE by Actavis.

Future recurring revenues will be derived from product sales to and royalty streams from our partners, Actavis and Merck Serono and from pharmaceutical development contracts and analytical and consulting services provided through our wholly-owned subsidiary Molecular Profiles. Revenue results are difficult to predict, and any shortfall in revenue or delay in recognizing revenue could cause operating results to vary significantly from quarter to quarter. Because products shipped to our two major customers occur only in full batches, quarterly sales can vary widely and affect comparisons with prior periods and may not correlate to our customers’ in-market sales. Likewise, our revenues from Molecular Profiles are driven by obtaining and retaining our customer contracts and may vary widely from quarter to quarter.

All of our products are manufactured in Europe by third parties on behalf of our foreign subsidiaries who sell the products to our worldwide licensees, and to us, in the case of the products supplied for resale in the United States. Because our foreign subsidiaries recognize these sales and are reduced only by our product manufacturing costs, we have historically shown a profit from our foreign operations.

Workforce Reduction and Corporate Office Relocation

On March 1, 2012, we announced a 42% workforce reduction from 24 employees at December 31, 2011, to 14 employees. We recorded a severance charge of approximately $0.5 million in the nine months ended September 30, 2012. The reduction impacted research and development and general and administrative positions. Our remaining staff focuses its efforts on supporting our customers through existing product supply agreements, assuring compliance with all financial reporting requirements, and executing our strategies to build value for shareholders.

During the nine months ended September 30, 2013, we relocated our corporate facilities from Livingston, New Jersey to Boston, Massachusetts. On March 15, 2013, we entered into a lease agreement for our new location in Boston. We expect this lease will provide a significant cost saving compared to the lease for our corporate facilities in Livingston, which expired in October 2013. We have completed our process of hiring employees for the Boston office, which is comprised of accounting and finance, operations and other administrative staff. We incurred a charge of $0.6 million for the nine months ended September 30, 2013, related to severance and other relocation costs associated with the elimination of certain positions at the Livingston location. With the relocation now complete, going forward we expect reduced personnel and other related costs associated with our headquarters.

Impact of Restatement on Quarterly Results of Operations.

The Restatement corrected a $4.9 million overstatement of the common stock warrants, liability, resulting in a gain being recorded for the change in fair value of stock warrants of $0.4 million and $0.5 million for the three and nine month periods ended September 30, 2013. A restatement of our previously reported net loss for the three month period ended September 30, 2013, resulted in net income of $1.7 million for such period. A restatement of our previously reported net income for the nine month period ended September 30, 2013, resulted in net income of $5.6 million for such period. We have determined that this Restatement only affects the three and nine months periods ended September 30, 2013 as described and has no impact on any other previously issued unaudited interim consolidated financial statements. The Restatement did not affect our liquidity or capital resources for any interim period. (see Note 15 “Restatement of Unaudited Interim Consolidated Financial Statements”).

Results of Operations

The following tables contain selected statement of operations information, which serves as the basis of the discussion surrounding our results of operations for the three and nine months ended September 30, 2013 and 2012:


	Three Months Ended September 30,
	2013					2012
	(As Restated)
	Amount		As a % of Total Revenues			Amount			As a % of Total Revenues			$ Change			% Change
Product revenues	$	5,456,152		77	%	$	5,620,889			84	%	$	(164,737	)		(3	)%
Royalties		994,771		14			1,017,609			15			(22,838	)		(2	)
Other revenues		674,769		9			34,540			1			640,229			1,854

Total revenues		7,125,692		100			6,673,038			100			452,654			7
Cost of revenues		3,238,215		45			3,186,792			48			51,423			2

Gross profit		3,887,477		55			3,486,246			52			401,231			12
Operating expenses
Sales and marketing		78,777		1			—			—			78,777			100
Research and development (net of reimbursement from related party: $3,092 for the three months ended September 30, 2012)		—		—			143,795			2			(143,795	)		(100	)
Acquisition related expenses		947,202		13			—			—			947,202			100
General and administrative		1,594,223		22			1,901,880			29			(307,657	)		(16	)

Total operating expenses		2,620,202		37			2,045,675			31			574,527			28

Income from operations		1,267,275		18			1,440,571			22			(173,296	)		(12	)
Interest income, net		641		—			35,880			1			(35,239	)		(98	)
Change in fair value of stock warrants		427,656		6			(1,065,498	)		(16	)		1,493,154			140
Other income (expense), net		25,195		—			(19,882	)		—			45,077			227

Income before income taxes		1,720,767		24			391,071			6			1,329,696			340
Provision for income taxes		2,624		—			2,342			—			282			12

Net income	$	1,718,143		24	%	$	388,729			6	%	$	1,329,414			342	%

Revenues


	Three Months Ended September 30,				$ Change			% Change
	2013		2012		$ Change			% Change
Product revenues	$	5,456,152	$	5,620,889	$	(164,737	)		(3	)%
Royalties		994,771		1,017,609		(22,838	)		(2	)
Other revenues		674,769		34,540		640,229			1,854

Total revenues	$	7,125,692	$	6,673,038	$	452,654			7	%

Revenues in the three months ended September 30, 2013 increased by $0.5 million, or 7%, as compared to the three months ended September 30, 2012. The increase was attributable to the following factors:

•

Revenues from the sale of products decreased by approximately $0.2 million, or 3%, from the 2012 period primarily due to the absence of product revenue from Actavis in the three months ended September 30, 2013 as compared with $1.4 million in the three months ended September 30, 2012 due to sufficient inventory on hand at Actavis. This was offset by higher revenues from Merck Serono in the three months ended September 30, 2013 as compared with the three months ended September 30, 2012. Higher revenues from Merck Serono are a result of a 39% increase in volume quarter over quarter.

•

Royalty revenues remained consistent for the three months ended September 30, 2013 as compared to the three months ended September 30, 2012.

•

Other revenues in the three months ended September 30, 2013, primarily consisted of $0.6 million in revenues associated with the acquisition of Molecular Profiles. These revenues are attributable to their formulation, advanced chemical analysis, and consulting services.

Cost of revenues


	Three Months Ended September 30,						$ Change		% Change
	2013			2012			$ Change		% Change
Cost of revenues	$	3,238,215		$	3,186,792		$	51,423		2	%
Cost of revenues (as a percentage of total revenues)		45	%		48	%

Total cost of revenues were $3.2 million for both three months ended September 30, 2013 and 2012. Cost of revenues remained relatively consistent, which is a reflection of increased costs of service associated with the Molecular Profiles revenues generated, offset by a decrease of cost of goods for net product revenues due to a more favorable product mix.

Sales and marketing


	Three Months Ended September 30,						$ Change		% Change
	2013			2012			$ Change		% Change
Sales and marketing	$	78,777		$	—		$	78,777		100	%
Sales and marketing (as a percentage of total revenues)		1	%		—	%

Sales and marketing expenses were generated during the three months ended September 30, 2013. These expenses are attributable to the sales activities of our newly acquired subsidiary, Molecular Profiles, acquired on September 12, 2013.

Research and development


	Three Months Ended September 30,						$ Change			% Change
	2013			2012			$ Change			% Change
Research and development	$	—		$	143,795		$	(143,795	)		(100	)%
Research and development (as a percentage of total revenues)		—	%		2	%

There were no research and development expenses in the three months ended September 30, 2013 because we have eliminated our research and development activities. Research and development expenses of $0.1million in the three months ended September 30, 2012 included costs for product development, clinical development and regulatory fees, which were a combination of internal and third-party costs.

Acquisition related expenses


	Three Months Ended September 30,						$ Change		% Change
	2013			2012			$ Change		% Change
Acquisition related expenses	$	947,202		$	—		$	947,202		100	%
Acquisition related expenses (as a percentage of total revenues)		13	%		—	%

Total acquisition related expenses of $0.9 million for the three months ended September 30, 2013, were costs associated with the Molecular Profiles acquisition.

General and administrative


	Three Months Ended September 30,						$ Change			% Change
	2013			2012			$ Change			% Change
General and administrative	$	1,594,223		$	1,901,880		$	(307,657	)		(16	)%
General and administrative (as a percentage of total revenues)		22	%		29	%

Total general and administrative expenses decreased by $0.3 million to $1.6 million for the three months ended September 30, 2013, compared with $1.9 million for the three months ended September 30, 2012. This decrease is primarily due to lower personnel costs associated with the workforce reduction in January 2013.

Other income and expense


	Three Months Ended September 30,					$ Change			% Change
	2013		2012			$ Change			% Change
	(As Restated)
Interest income, net	$	641	$	35,880		$	(35,239	)		(98	)%
Change in fair value of stock warrants	$	427,656	$	(1,065,498	)	$	1,493,154			140	%
Other income (expense), net	$	25,195	$	(19,882	)	$	45,077			227	%

The decrease in interest income, net primarily relates to the sales of our marketable securities in the second quarter of 2013.

Change in fair value of stock warrants for the three months ended September 30, 2013 was due to $0.4 million of income associated with the fair value of the warrants issued in conjunction with the October 2009 stock issuance and resulted from stabilization of the volatility rate used in our Black-Scholes model as the warrants arrive closer to their expiration date. Change in fair value of stock warrants for the three months ended September 30, 2012 was due to a $1.1 million expense associated with the fair value of the warrants issued in conjunction with the October 2009 stock issuance and resulted from an increase in our stock price during the period.

Other income (expense), net, for the three months ended September 2013 was primarily a result of net foreign currency remeasurement gains related to the strengthening of the euro and the British pound against the U.S. dollar. Other income (expense), net for 2012 related primarily to miscellaneous taxes.

Nine Months Ended September 30, 2013 and September 30, 2012


	Nine Months Ended September 30,
	2013						2012
	(As Restated)
	Amount			As a % of Total Revenues			Amount			As a % of Total Revenues			$ Change			% Change
Product revenues	$	17,848,180			83	%	$	16,101,350			86	%	$	1,746,830			11	%
Royalties		2,808,477			13			2,532,197			13			276,280			11
Other revenues		762,577			4			103,568			1			659,009			636

Total revenues		21,419,234			100			18,737,115			100			2,682,119			14
Cost of revenues		8,910,550			42			9,655,624			52			(745,074	)		(8	)

Gross profit		12,508,684			58			9,081,491			48			3,427,193			38
Operating expenses
Sales and marketing		78,777			—			—			—			78,777			100
Research and development (net of reimbursement from related party: $435,199 for the nine months ended September 30, 2012)		—			—			856,545			5			(856,545	)		(100	)
Acquisition related expenses		1,439,946			7			—			—			1,439,946			100
General and administrative		5,881,636			27			6,376,561			34			(494,925	)		(8	)

Total operating expenses		7,400,359			35			7,233,106			39			167,253			2

Income from operations		5,108,325			24			1,848,385			10			3,259,940			176
Interest income, net		95,996			—			158,625			1			(62,629	)		(39	)
Change in fair value of stock warrants		477,682			2			5,399,569			29			(4,921,887	)		(91	)
Other expense, net		(57,165	)		—			(115,629	)		(1	)		58,464			51

Income before income taxes		5,624,838			26			7,290,950			39			(1,666,112	)		(23	)
Provision for income taxes		8,174			—			5,018			—			3,156			63

Net income	$	5,616,664			26	%	$	7,285,932			39	%	$	(1,669,268	)		(23	)%

Revenues


	Nine Months Ended September 30,				$ Change		% Change
	2013		2012		$ Change		% Change
Product revenues	$	17,848,180	$	16,101,350	$	1,746,830		11	%
Royalties		2,808,477		2,532,197		276,280		11
Other revenues		762,577		103,568		659,009		636

Total revenues	$	21,419,234	$	18,737,115	$	2,682,119		14	%

Revenues in the nine months ended September 30, 2013 increased by $2.7 million, or 14%, as compared to the nine months ended September 30, 2012. The increase in attributable to the following factors:

•

Revenues from the sale of products increased by approximately $1.7 million, or 11%, from the 2012 period. The increase primarily reflects higher revenues over last year from Merck Serono, offset by a decrease in sales from Actavis. Higher revenues from Merck Serono are a result of a 42% increase in volume from the 2012 period to the 2013 period, coupled with shipments to countries with higher net selling prices. There were no product revenues from Actavis in the nine months ended September 30, 2013 as compared with $3.6 million in the nine months ended September 30, 2012.

•

Royalty revenues increased by $0.3 million, or 11%, to $2.8 million for the nine months ended September 30, 2013 as compared to $2.5 million for the nine months ended September 30, 2012. This is a result of higher revenues earned by Actavis on sales of Progesterone Products.

•

Other revenues in the nine months ended September 30, 2013, primarily consisted of $0.6 million in revenues associated with the acquisition of Molecular Profiles. These revenues are attributable to their formulation, advanced chemical analysis and consulting services. The remaining revenues are due to amounts of deferred revenue that were recognized during both periods.

Cost of revenues


	Nine Months Ended September 30,						$ Change			% Change
	2013			2012			$ Change			% Change
Cost of revenues	$	8,910,550		$	9,655,624		$	(745,074	)		(8	)%
Cost of revenues (as a percentage of total revenues)		42	%		52	%

Total cost of revenues decreased $0.7 million, or 8%, to $8.9 million for the nine months ended September 30, 2013, as compared to $9.7 million for the nine months ended September 30, 2012. This decrease was primarily a result of the absence of product sales to Actavis during the nine months ended September 30, 2013 as compared to $3.6 million of sales for the nine months ended September 30, 2012, partially offset by increased revenues from Merck Serono as well as revenues from our newly acquired subsidiary Molecular Profiles. Total cost of revenues decreased as a percentage of total revenues to 42% for the nine months ended September 30, 2013 from 52% for the nine months ended September 30, 2012, primarily due to a more favorable sales mix.

Sales and marketing


	Nine Months Ended September 30,						$ Change		% Change
	2013			2012			$ Change		% Change
Sales and marketing	$	78,777		$	—		$	78,777		100	%
Sales and marketing (as a percentage of total revenues)		—	%		—	%

Sales and marketing expenses were generated during the nine months ended September 30, 2013. These expenses are attributable to the sales activities of our newly acquired subsidiary, Molecular Profiles, acquired on September 12, 2013.

Research and development


	Nine Months Ended September 30,						$ Change			% Change
	2013			2012			$ Change			% Change
Research and development	$	—		$	856,545		$	(856,545	)		(100	)%
Research and development (as a percentage of total revenues)		—	%		5	%

There were no research and development expenses in the nine months ended September 30, 2013, as compared to $0.9 million in the nine months ended September 30, 2012, because we have eliminated our research and development activities. Research and development expenses in the nine months ended September 30, 2012 included costs for product development, clinical development and regulatory fees, which were a combination of internal and third-party costs.

Acquisition related expenses


	Nine Months Ended September 30,						$ Change		% Change
	2013			2012			$ Change		% Change
Acquisition related expenses	$	1,439,946		$	—		$	1,439,946		100	%
Acquisition related expenses (as a percentage of total revenues)		7	%		—	%

Total acquisition related expenses of $1.4 million in the nine months ended September 30, 2013, were costs associated with the Molecular Profiles acquisition and a failed transaction in the first quarter of 2013.

General and administrative


	Nine Months Ended September 30,						$ Change			% Change
	2013			2012			$ Change			% Change
General and administrative	$	5,881,636		$	6,376,561		$	(494,925	)		(8	)%
General and administrative (as a percentage of total revenues)		27	%		34	%

Total general and administrative expenses decreased by $0.5 million to $5.9 million for the nine months ended September 30, 2013, compared with $6.4 million for the nine months ended September 30, 2012. General and administrative expenses for the nine months ended September 30, 2013 decreased primarily due to lower personnel costs of $0.4 million associated with our workforce reduction in January 2013.

Other income and expense


	Nine Months Ended September 30,						$ Change			% Change
	2013			2012			$ Change			% Change
	(As Restated)
Interest income, net	$	95,996		$	158,625		$	(62,629	)		(39	)%
Change in fair value of stock warrants		477,682			5,399,569			(4,921,887	)		(91	)%
Other expense, net		(57,165	)		(115,629	)		58,464			51	%

The decrease in interest income, net primarily relates to an overall decrease of interest-bearing securities due to the sales of our marketable securities in the nine months ended September 30, 2013.

Change in fair value of stock warrants for the nine months ended September 30, 2013 was due to income of $0.5 million, associated with the fair value of the warrants issued in conjunction with the October 2009 stock issuance and resulted from stabilization of the volatility rate used in our Black-Scholes model as the warrants arrive closer to their expiration date. Change in fair value of stock warrants for the nine months ended September 30, 2012 was due to $5.4 million of income, associated with the fair value of the warrants issued in conjunction with the October 2009 stock issuance and resulted from a decrease in our stock price during the period.

Other expense, net, for the nine months ended September 2013 and 2012 was primarily a result of less net foreign currency remeasurement losses related to the strengthening of the euro and the British pound against the U.S. dollar.

Impact of Restatement on Quarterly Results of Operations.

The Restatement corrected a $4.9 million overstatement of the change in fair value of common stock warrants, resulting in a gain being recorded for the change in fair value of stock warrants of $0.4 million and $0.5 million for the three and nine month periods ended September 30, 2013. A restatement of our previously reported net loss for the three month period ended September 30, 2013, resulted in net income of $1.7 million for such period. A restatement of our previously reported net income for the nine month period ended September 30, 2013, resulted in net income of $5.6 million for such period. We have determined that this Restatement only affects the three and nine months periods ended September 30, 2013 as described and has no impact on any other previously issued unaudited interim consolidated financial statements. The Restatement did not affect our liquidity or capital resources for any interim period. (see Note 15 “Restatement of Unaudited Interim Consolidated Financial Statements”).

Liquidity and Capital Resources

We require cash to pay our operating expenses, fund working capital needs, make capital expenditures and fund acquisitions. We have funded our operations through cash generated from our operations.

On September 12, 2013, we acquired all of the outstanding capital stock of Molecular Profiles. As a result of the transaction, former Molecular Profiles stockholders, in the aggregate, received for their shares of Molecular Profiles common stock $16.7 million in cash and 1,051,323 shares of our common stock. The total consideration is valued at $24.9 million, based upon the closing price of our common stock on September 12, 2013.

As a part of the acquisition, we assumed debt of $3.9 million that Molecular Profiles had entered into to fund the completion and building of a second facility in the United Kingdom. Molecular Profiles entered into a Business Loan Agreement (“Loan Agreement”) covering three loan facilities with Lloyds TSB Bank (“Lloyds”), as administrative agent. Molecular Profiles had withdrawn $3.9 million and as of September 30, 2013 owes $4.0 million due to foreign currency revaluation. The three loan facilities are each repayable by monthly installments; one started repayment in February 2013 and the remaining two commenced in October 2013. All facilities are due for repayment over 15 years from the date of drawdown. Two of the facilities bear interest at 2.45% and 3.05% per annum, respectively. The third facility is a fixed rate agreement bearing interest at 3.52% per annum. The weighted average interest rate for the period from September 12, 2013 to September 30, 2013 was 3.52%. The Loan Agreement is secured by the mortgaged property and an unlimited debenture lien on other assets of Molecular Profiles. The Loan Agreement contains financial covenants that limit the amount of indebtedness we may incur, requires us to maintain certain levels of net worth, and restricts our ability to materially alter the character of the business. We are currently in compliance with all of the covenants under the Loan Agreement.

As part of the acquisition of Molecular Profiles, we assumed a $2.5 million obligation under a grant arrangement with the Regional Growth Fund on behalf of the Secretary of State for Business, Innovation, and Skills in the United Kingdom. Molecular Profiles used this grant to fund the building of their second facility, which includes analytical labs, office space, and a manufacturing facility. As a part of the arrangement, Molecular Profiles is required to create and maintain certain full-time equivalent personnel levels through October 2017. As of September 30, 2013, Molecular Profiles is in compliance with the covenants of the arrangement.

The income from the Regional Growth Fund will be recognized on a decelerated basis over the next four years. As of September 30, 2013, the obligation is valued at $2.6 million due to foreign currency revaluation and is recorded as deferred revenue on the consolidated balance sheets. The amount of other income on the obligation that will be recognized provided Molecular Profiles remains in compliance with the covenants will be the following:


Year	Total
Remainder of 2013	$	64,544
2014		322,720
2015		580,896
2016		839,072
2017		774,528


Total	$	2,581,760

At September 30, 2013, our cash and cash equivalents were $18.8 million. Our cash and cash equivalents are highly liquid investments with original maturities of 90 days or less at date of purchase and consist of cash in operating accounts and investments in money market funds.

Our future capital requirements depend on a number of factors, including the rate of market acceptance of our current and future products and the resources we devote to developing and supporting our products. Our capital expenditures decreased for the nine months ended September 30, 2013, as compared to the nine months ended September 30, 2012, primarily as a result of completing, during 2012, the addition of increased manufacturing capacity to ensure our ability to meet Actavis’ forecasts for the anticipated launch of progesterone vaginal gel 8% for preterm birth in women with premature cervical shortening and facility improvements to ensure compliant manufacturing operations. We expect our capital expenditures to increase for the remainder of 2013 due to the acquisition of Molecular Profiles, but still remain under the 2012 levels.

As of September 30, 2013, we had outstanding exercisable options and warrants that, if exercised, would result in approximately $20.0 million of additional capital and would cause the number of shares outstanding to increase; however, the cashless exercise feature of certain warrants may result in no cash to us. Options and warrants outstanding at September 30, 2013 were 279,151 and 1,236,682, respectively; however, there can be no assurance that any such options or warrants will be exercised. There was no aggregate intrinsic value of exercisable options and warrants for the periods ended September 30, 2013 and September 30, 2012.

On July 26, 2013, our Board of Directors set a ratio of 1-for-8 for its previously approved reverse stock split, which took effect on August 9, 2013. Our reverse stock split was approved by our shareholders at our annual meeting of shareholders on May 1, 2013. All share and per share amounts relating to the common stock, stock options and warrants included in the financial statements and accompanying footnotes have been retroactively adjusted for all periods presented to give effect to this reverse stock split, including reclassifying an equal amount to the reduction in par value of common stock to additional paid-in capital. The reverse stock split did not result in a retroactive adjustment to the share amounts for any of the classes of our preferred stock.

We believe that our current cash and cash equivalents, as well as cash generated from operations, will be sufficient to meet our anticipated cash needs for working capital and capital expenditures for the foreseeable future.

Cash Flows

Net cash provided by operating activities for the nine months ended September 30, 2013 was $4.9 million and resulted primarily from $5.6 million of net income for the period, increased by approximately $0.7 million in depreciation and amortization and stock-based compensation expense and partially offset by $0.5 million from the change in fair value of stock warrants. Net changes in working capital items reduced cash from operating activities by approximately $0.9 million, primarily due to an increase in accounts receivable of $2.0 million associated with increased product shipments offset by a decrease in amounts due from related party totaling $1.3 million primarily related to the absence of product shipments to Actavis during the nine months ended September 30, 2013. Net cash provided by investing activities was $0.6 million for the nine months ended September 30, 2013, which resulted primarily from the proceeds from the sale of short-term investments totaling $15.4 million partially offset by cash paid for the Molecular Profiles acquisition of $14.5 million and the purchase of property and equipment of $0.2 million. Net cash used in financing activities was $18,000 for the nine months ended September 30, 2013,

Net cash provided by operating activities for the nine months ended September 30, 2012 was $1.3 million and resulted primarily from $7.3 million of net income for the period, increased by approximately $1.1 million in depreciation and amortization and stock-based compensation expense as well as $0.9 million related to the write-off of certain inventories, and decreased by $5.4 million for the change in fair value of stock warrants. Net changes in working capital items reduced cash from operating activities by approximately $2.4 million, primarily relating to an increase in inventory of $0.9 million associated with the buildup of inventory to meet Actavis’ forecast requirements as well as a decrease in accounts payable and accrued expenses of $1.3 million. Net cash used in investing activities was for the nine months ended September 30, 2012 was $1.2 million resulting from the purchase of property and equipment of $1.0 million and the purchase of short-term investments of $0.2 million. Net cash used in financing activities was $50,000 for the nine months ended September 30, 2012.

Contractual Obligations, Commercial Commitments and Off-Balance Sheet Arrangements

As a result of the acquisition of Molecular Profiles on September 12, 2013, we have assumed debt totaling $3.9 million which is valued at $4.0 million as of September 30, 2013, due to foreign currency revaluation. Our future contractual obligations include the following:


	Total		1 year or less		1-3 years		3-5 years		More than 5 years
Operating lease obligations	$	274,923	$	103,958	$	170,965	$	—	$	—
Loan agreements		3,973,758		243,347		507,559		538,725		2,684,127

Total	$	4,248,681	$	347,305	$	678,524	$	538,725	$	2,684,127

Critical Accounting Policies and Estimates

The discussion and analysis of our financial condition and results of operations set forth above are based on our financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses. On an ongoing basis, we evaluate our estimates and judgments, including those described in our Annual Report on Form 10-K for the year ended December 31, 2012. We base our estimates on historical experience and on various assumptions that we believe to be reasonable under the circumstances. These estimates and assumptions form the basis for making judgments about the carrying values of assets and liabilities, and the reported amounts of revenues and expenses, that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

The following accounting policies have been updated and adopted as of September 30, 2013:

Revenue Recognition

Multiple-element arrangements are evaluated in accordance with the principles of Accounting Standards update (“ASU”) 2009-13, (Revenue Recognition Topic — Multiple Element Arrangements) and we allocate revenue among the elements based upon each element’s relative fair value.

Goodwill

Goodwill represents the excess of the purchase price over the fair value of assets acquired and liabilities assumed in a business combination. We do not amortize our goodwill, but instead test for impairment annually and more frequently whenever events or changes in circumstances indicate that the fair value of the asset may be less than its carrying value of the asset.

We have adopted ASU 2011-08, Intangibles — Goodwill and Other, and amendment to ASC 350, which updates how an entity will evaluate its goodwill for impairment. The guidance provides entities an option to perform a “qualitative” assessment to determine whether further impairment testing is necessary. If further testing is required, the test for impairment continues with the two step process. The first step compares the carrying amount of the reporting unit to its estimated fair value (Step 1). To the extent that the carrying value of the reporting unit exceeds its estimated fair value, a second step is performed, wherein the reporting unit’s carrying value is compared to the implied fair value (Step 2). To the extent that the carrying value exceeds the implied fair value, impairment exists and must be recognized.

We are evaluating our reporting unit structure to establish the baseline for goodwill impairment testing in the future. Upon establishment of this baseline, we will perform our annual test for impairment on the first day of the fourth quarter beginning in 2014.

The remainder of our critical accounting policies and the related judgments and estimates affecting the preparation of our consolidated financial statements are included in our Annual Report on Form 10-K for the year ended December 31, 2012. There have been no other material changes to our critical accounting policies as of September 30, 2013.

Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

We maintain “disclosure controls and procedures,” as such term is defined in Rule 13a-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that are designed to ensure that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in SEC 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. In designing and evaluating our disclosure controls and procedures, management recognized that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any disclosure controls and procedures 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.

The Company’s management, under the supervision of and with the participation of the Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of the design and operation of the Company’s disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of the end of the period covered by this report. Based on this evaluation, the Chief Executive Officer and Chief Financial Officer concluded that, as of September 30, 2013, the Company’s disclosure controls and procedures were effective.

In connection with the Restatement, management, under the supervision of and with the participation of the Chief Executive Officer and Chief Financial Officer, reevaluated the effectiveness of the Company’s disclosure controls and procedures and has reaffirmed that the Company’s disclosure controls and procedures, was not effective as of September 30, 2013.

Changes in Internal Control over Financial Reporting

While there were no changes in our internal control over financial reporting that occurred during the period covered by this report that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting, the Company is in the process of instituting measures to address a certain material weakness in our internal control over financial reporting that was identified by management in connection with the Restatement.

A “material weakness,” as defined by Rule 12b-2 of the Exchange Act and PCAOB Auditing Standard No. 5, Paragraph A.7, is a deficiency, or combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of the company’s annual or interim financial statements will not be prevented or detected on a timely basis.

The material weakness in internal control over financial reporting identified by management relates to our evaluation of warrant accounting during the third quarter of 2013. Specifically, management determined that there was a calculation error with the number of warrants remaining within a manual spreadsheet. The subsequent review process failed to detect and correct the error.

Management has commenced steps to remediate the material weakness identified above and to implement an enhanced process to review and approve, among other things, the complex calculations associated with the measurement of the fair value of the Company’s outstanding stock warrants, which process will involve more significant staffing of Company personnel and the involvement of the Company’s independent registered accounting firm.

Changes in Internal Control over Financial Reporting

There was no change in our internal control over financial reporting that occurred during the period covered by this Quarterly Report on Form 10-Q that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

Part II — Other Information

Item 6. Exhibits

(a) Exhibits


2.1		Share Purchase Agreement between the sellers listed on schedule 1 thereto, and the Company and Molecular Profiles Limited, dated September 12, 2013 (previously filed as Exhibit 2.1 to the Company’s Current Report on Form 8-K (File No. 001-10352) filed September 18, 2013, is incorporated herein by reference).

3.1		Certificate of Amendment of the Restated Certificate of Incorporation of the Company, dated August 7, 2013 as filed with the Secretary of the State of Delaware on August 7, 2013 (previously filed as Exhibit 3.1 to the Company’s Current Report on Form 8-K filed August 8, 2013, is incorporated herein by reference).

4.1		Specimen Stock Certificate of the Company (previously filed as Exhibit 4.1 to the Company’s Current Report on Form 8-K filed August 8, 2013, is incorporated herein by reference).

10.1		Parent Guarantee of the Company, dated September 12, 2013 (previously filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed September 18, 2013, is incorporated herein by reference).

10.2		Employment Agreement between Dr. Nikin Patel and the Company, dated September 12, 2013 (previously filed as Exhibit 10.2 to the Company’s Current Report on Form 8-K filed September 18, 2013, is incorporated herein by reference).

10.3		Bank Loan Agreement between Molecular Profiles Limited and Lloyds TSB Bank plc, dated January 6, 2012 (previously filed as Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q (File No. 001-10352) filed November 7, 2013, is incorporated herein by reference).

10.4		Amendment letter between Molecular Profiles Limited and Lloyds TSB Bank plc, dated September 16, 2013 (previously filed as Exhibit 10.4 to the Company’s Quarterly Report on Form 10-Q (File No. 001-10352) filed November 7, 2013, is incorporated herein by reference).

31.1*		Rule 13a-14(a)/15d-14(a) Certification of Chief Executive Officer of the Company.

31.2*		Rule 13a-14(a)/15d-14(a) Certification of Chief Financial Officer of the Company.

32.1**		Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

32.2**		Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

101*		The following materials from the Columbia Laboratories, Inc. Quarterly Report on Form 10-Q for the quarter ended September 30, 2013, formatted in XBRL (eXtensible Business Reporting Language): (i) Consolidated Statements of Operations for the three and nine months ended September 30, 2013 and 2012, (ii) Consolidated Balance Sheets at September 30, 2013 and December 31, 2012, (iii) Consolidated Statements of Comprehensive (Loss) Income for the three and nine months ended September 30, 2013 and 2012, (iv) Consolidated Statements of Cash Flows for the nine months ended September 30, 2013 and 2012, and (v) Notes to Consolidated Financial Statements.

*	Filed herewith.

**	Furnished herewith.

Signatures

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

COLUMBIA LABORATORIES, INC.

/s/ Jonathan B. Lloyd Jones

Jonathan B. Lloyd Jones

Vice President, Chief Financial Officer and Treasurer

(Principal Financial and Accounting Officer)

DATE: March 3, 2014

Large accelerated filer

Accelerated filer

Non-accelerated filer

x (Do not check if a smaller reporting company)

Smaller reporting company