SUPERNUS PHARMACEUTICALS, INC. - Quarter Report: 2014 March (Form 10-Q)

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UNITED STATES

 SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 10-Q

 

(Mark One)

 

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

 

For the quarterly period ended March 31, 2014

 

OR

 

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

 

For the transition period from              to              

 

Commission File Number: 0-50440

 

SUPERNUS PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

 

(301) 838-2500

(Registrant’s telephone number, including area code)

 

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the 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.  x Yes  o No

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Website, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).  x Yes  o 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 definition of “large accelerated filer,” “accelerated filer,” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

 

 

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

 

The number of outstanding shares of the registrant’s common stock, par value $0.001 per share, as of the close of business on April 30, 2014 was 42,046,458.

 

 

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SUPERNUS PHARMACEUTICALS, INC.

FORM 10-Q — QUARTERLY REPORT

FOR THE QUARTERLY PERIOD ENDED March 31, 2014

 

TABLE OF CONTENTS

 

		Page No.
PART I — FINANCIAL INFORMATION
	Item 1. Financial Statements
	Consolidated Balance Sheets as of March 31, 2014 (Unaudited) and December 31, 2013	1
	Consolidated Statements of Operations for the three month periods ended March 31, 2014 and 2013 (Unaudited)	2
	Consolidated Statements of Comprehensive Loss for the three month periods ended March 31, 2014 and 2013 (Unaudited)	3
	Consolidated Statements of Cash Flows for the three month periods ended March 31, 2014 and 2013 (Unaudited)	4
	Notes to Consolidated Financial Statements (Unaudited)	5
	Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations	13
	Item 3. Quantitative and Qualitative Disclosures about Market Risk	19
	Item 4. Controls and Procedures	19
PART II — OTHER INFORMATION
	Item 1. Legal Proceedings	20
	Item 1A. Risk Factors	20
	Item 2. Unregistered Sales of Equity Securities and Use of Proceeds	20
	Item 3. Defaults Upon Senior Securities	20
	Item 4. Mine Safety Disclosures	20
	Item 5. Other Information	20
	Item 6. Exhibits	21
SIGNATURES		22

 

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PART I — FINANCIAL INFORMATION

 

Supernus Pharmaceuticals, Inc.

Consolidated Balance Sheets

(in thousands, except share amounts)

 

		March 31,			December 31,
		2014			2013
		(unaudited)
Assets
Current assets:
Cash and cash equivalents		$	12,252		$	32,980
Marketable securities		46,615			49,211
Accounts receivable, net		9,725			5,054
Interest receivable		636			483
Inventories		7,957			7,152
Prepaid expenses and other current assets		2,559			2,052
Deferred financing costs, current		185			229
Total current assets		79,929			97,161
Property and equipment, net		2,648			2,554
Intangible assets, net		2,157			1,158
Long term marketable securities		11,662			8,756
Other non-current assets		360			361
Deferred financing costs, long-term		764			1,005
Total assets		$	97,520		$	110,995
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable and accrued expenses		$	14,658		$	18,314
Deferred product revenue, net		12,271			7,882
Deferred licensing revenue		173			204
Total current liabilities		27,102			26,400
Deferred licensing revenue, net of current portion		1,381			1,417
Convertible notes, net of discount		28,358			34,393
Other non-current liabilities		2,101			2,677
Derivative liabilities		9,565			12,644
Total liabilities		68,507			77,531
Stockholders’ equity:
Common stock, $0.001 par value, 130,000,000 shares authorized at March 31, 2014 and December 31, 2013; 42,046,083 and 39,983,437 shares issued and outstanding at March 31, 2014 and December 31, 2013, respectively		42			40
Additional paid-in capital		223,041			211,952
Accumulated other comprehensive income		1			—
Accumulated deficit		(194,071		)	(178,528		)
Total stockholders’ equity		29,013			33,464
Total liabilities and stockholders’ equity		$	97,520		$	110,995

 

See accompanying notes.

 

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Supernus Pharmaceuticals, Inc.

Consolidated Statements of Operations

(in thousands, except share and per share data)

 

		Three Months ended March 31,
		2014			2013
		(unaudited)
Revenue
Net product sales		$	8,995		$	—
Licensing revenue		86			147
Total revenue		9,081			147
Costs and expenses
Cost of product sales		494			—
Research and development		4,482			4,522
Selling, general and administrative		17,527			13,533
Total costs and expenses		22,503			18,055
Operating loss		(13,422		)	(17,908		)
Other income (expense)
Interest income		102			52
Interest expense		(1,207		)	(727		)
Changes in fair value of derivative liabilities		677			80
Loss on extinguishment of debt		(1,693		)	—
Other income		—			89
Total other expense		(2,121		)	(506		)
Net loss		$	(15,543	)	$	(18,414	)
Loss per common share:
Basic and diluted		$	(0.38	)	$	(0.60	)
Weighted-average number of common shares:
Basic and diluted		41,129,055			30,875,424

 

See accompanying notes.

 

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Supernus Pharmaceuticals, Inc.

Consolidated Statements of Comprehensive Loss

(in thousands)

 

		Three Months ended March 31,
		2014			2013
		(unaudited)
Net loss		$	(15,543	)	$	(18,414	)
Other comprehensive income (loss):
Unrealized net gain (loss) on marketable securities		1			(32		)
Other comprehensive income (loss)		1			(32		)
Comprehensive loss		$	(15,542	)	$	(18,446	)

 

See accompanying notes.

 

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Supernus Pharmaceuticals, Inc.

Consolidated Statements of Cash Flows

(in thousands)

 

		Three Months ended March 31,
		2014			2013
		(unaudited)
Cash flows from operating activities
Net loss		$	(15,543	)	$	(18,414	)
Adjustments to reconcile loss to net cash used in operating activities:
Loss on extinguishment of debt		1,693			—
Change in fair value of derivative liabilities		(677		)	(80		)
Unrealized gain (loss) on marketable securities		1			(32		)
Depreciation and amortization		227			162
Amortization of deferred financing costs and debt discount		574			83
Stock-based compensation expense		667			337
Changes in operating assets and liabilities:
Accounts receivable		(4,671		)	(1,650		)
Interest receivable		(153		)	(8		)
Inventory		(805		)	(1,961		)
Prepaid expenses and other assets		(507		)	134
Accounts payable and accrued expenses		(3,656		)	238
Deferred product revenue, net		4,389			3,551
Deferred licensing revenue		(67		)	373
Other non-current liabilities		(576		)	44
Net cash used in operating activities		(19,104		)	(17,223		)
Cash flows from investing activities
Purchases of marketable securities		(9,406		)	(15,643		)
Sales and maturities of marketable securities		9,096			12,866
Purchases of property and equipment, net		(263		)	(372		)
Capitalized patent defense costs		(1,056		)	—
Net cash used in investing activities		(1,629		)	(3,149		)
Cash flows from financing activities
Proceeds from issuance of common stock		6			1,936
Repayment of secured notes payable		—			(2,832		)
Cash settlement of debt to equity conversion		(1		)	—
Financing costs and underwriters discounts		—			(125		)
Net cash provided by (used in) financing activities		5			(1,021		)
Net change in cash and cash equivalents		(20,728		)	(21,393		)
Cash and cash equivalents at beginning of period		32,980			40,302
Cash and cash equivalents at end of period		$	12,252		$	18,909
Supplemental cash flow information:
Cash paid for interest		$	—		$	610
Noncash financial activity:
Conversion of convertible notes		$	10,418		$	—

 

See accompanying notes.

 

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Supernus Pharmaceuticals, Inc.
Notes to Consolidated Financial Statements

For the Three Months Ended March 31, 2014 and 2013
(unaudited)

 

1.  Organization and Business

 

Supernus Pharmaceuticals, Inc. (the Company) is a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, including neurological and psychiatric disorders.  The Company markets two epilepsy products, Oxtellar XR and Trokendi XR, and has several proprietary product candidates in clinical development that address the attention deficit hyperactivity disorder market.

 

2.  Summary of Significant Accounting Policies

 

Basis of Presentation

 

The Company’s unaudited consolidated financial statements include the accounts of Supernus Pharmaceuticals, Inc. and Supernus Europe Ltd. These are collectively referred to herein as “Supernus” or “the Company.” All significant intercompany transactions and balances have been eliminated in consolidation. The Company’s unaudited consolidated financial statements have been prepared in accordance with the requirements of the U.S. Securities and Exchange Commission (SEC) for interim financial information.

 

As permitted under General Accepted Accounting Principles in the United States (U.S. GAAP), certain notes and other information have been omitted from the interim consolidated financial statements presented in this Quarterly Report on Form 10-Q. Therefore, these financial statements should be read in conjunction with the Company’s Annual Report on Form 10-K for the year ended December 31, 2013.

 

In the opinion of management, the consolidated financial statements reflect all adjustments necessary to fairly present the Company’s financial position, results of operations, and cash flows for the periods presented. These adjustments are of a normal recurring nature.  The Company currently operates in one business segment.

 

The results of operations for the three months ended March 31, 2014 are not necessarily indicative of the Company’s future financial results.

 

Accounts Receivable, net

 

Accounts receivable are reported in the consolidated balance sheets at outstanding amounts, less allowances for doubtful accounts and prompt pay discounts. The Company extends credit without requiring collateral. The Company writes off uncollectible receivables when the likelihood of collection is remote. The Company evaluates the collectability of accounts receivable on a regular basis. An allowance, when needed, is based upon various factors including the financial condition and payment history of customers, an overall review of collections experience on other accounts, and economic factors or events expected to affect future collections experience. No accounts have been written off in 2014 or 2013.  No allowance for uncollectible receivables is recorded at March 31, 2014 or December 31, 2013.  The Company has an allowance of $0.1 million for expected prompt-pay discounts as of March 31, 2014 and December 31, 2013.

 

Revenue Recognition on Product Sales

 

Revenue from product sales is recognized when persuasive evidence of an arrangement exists, delivery has occurred and title of the product and associated risk of loss has passed to the customer, the price is fixed or determinable, collection from the customer has been reasonably assured and all performance obligations have been met and returns and allowances can be reasonably estimated. Product sales are recorded net of estimated rebates, chargebacks, discounts, co-pay assistance and other deductions (collectively, “sales deductions”) as well as estimated product returns.

 

Our products are distributed through wholesalers and pharmaceutical distributors. Each of these wholesalers and distributors will take title and ownership of the product upon physical receipt of the product and then distribute our products to pharmacies. Though these distributors will be invoiced concurrent with product shipment, we are unable to recognize revenue upon shipment until such time as we can reasonably estimate and record provisions for sales deductions and product returns utilizing historical information and market research projections.

 

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Oxtellar XR Revenue

 

The Company launched Oxtellar XR on February 4, 2013.   During the fourth quarter of 2013, the Company began to recognize revenue for Oxtellar XR contemporaneously upon shipment of finished product to wholesalers, net of allowances for estimated sales deductions and returns.

 

Trokendi XR Revenue

 

The Company launched Trokendi XR on August 26, 2013.  Through March 31, 2014 the Company recorded shipments to wholesalers as deferred revenue equal to the gross sales price net of known sales deductions. Because we lack the experiential data which would allow us to estimate all remaining sales rebates, allowances and returns,  we must wait until these data become available to the Company in order to recognize revenue upon shipment to wholesalers.

 

Rather than recognize revenue upon shipments to wholesalers, the Company currently recognizes Trokendi XR revenue upon filling prescriptions at pharmacies because prescriptions filled at the pharmacy level have no remaining right of return.  However, because we are still compiling historical data related to our experience with respect to other sales deductions, we cannot reasonably estimate all other sales rebates and allowances, but rather must wait until this data becomes available to the Company.  Because this occurs approximately eight weeks after the close of the quarter, the Company currently delays recognition of revenue until the subsequent fiscal quarter when all the sales deductions are known.

 

With respect to prescriptions which were filled in the fourth quarter, data on rebates and allowances were generally received by the end of the first quarter of 2014. Because of this time lag, the Company could not determine net revenue in a timeframe which would allow reporting fourth quarter net revenue in the Form 10-K filed for the year ended December 31, 2013. Consequently, revenue generated from prescriptions for Trokendi XR filled at the pharmacy level in the fourth quarter are reported in the Company’s first quarter 2014 financial results. We expect to continue to report revenue based on prescriptions filled at the pharmacy level until sufficient experience with rebates and allowances is assembled to allow reporting of revenue based on shipments to wholesalers.

 

The Company believes the compilation of sufficient product specific historical data to reasonably estimate returns, rebates, and allowances for Trokendi XR may be available by the second quarter of 2014, at which time the Company may record revenue based on shipments to wholesalers, rather than on prescriptions filled at the pharmacy level.

 

Milestone Payments

 

Milestone payments on licensing agreements are recognized as revenue when the collaborative partner acknowledges completion of the milestone and substantive effort was necessary to achieve the milestone. Management may recognize revenue contingent upon the achievement of a milestone in its entirety in the period in which the milestone is achieved only if the milestone meets all the criteria to be considered substantive.  The Company recorded no milestone revenue during the three months ended March 31, 2014 and 2013.

 

Recently Issued Accounting Pronouncements

 

We have evaluated all Accounting Standard Updates through the date the unaudited consolidated financial statements were issued and believe the adoption of these will not have a material impact on our results of operations or financial position.

 

3.  Fair Value of Financial Instruments

 

The fair value of an asset or liability should represent the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. Such transactions to sell an asset or transfer a liability are assumed to occur in the principal or most advantageous market for the asset or liability. Accordingly, fair value is determined based on a hypothetical transaction at the measurement date, considered from the perspective of a market participant rather than from a reporting entity’s perspective.

 

The Company reports assets and liabilities that are measured at fair value using a three-level fair value hierarchy that prioritizes the inputs used to measure fair value. This hierarchy maximizes the use of observable inputs and minimizes the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows:

 

·                  Level 1 — Inputs are unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.

 

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·                  Level 2 — Inputs are quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability (interest rates, yield curves, etc.) and inputs that are derived principally from or corroborated by observable market data by correlation or other means (market corroborated inputs).

 

·                  Level 3 — Unobservable inputs that reflect the Company’s own assumptions, based on the best information available, including the Company’s own data.

 

In accordance with the fair value hierarchy described above, the following tables show the fair value of the Company’s financial assets and liabilities that are required to be measured at fair value, in thousands:

 

					Fair Value Measurements at
					March 31, 2014
					(unaudited)
								Significant
		Total Carrying			Quoted Prices			Other			Significant
		Value at			in Active			Observable			Unobservable
		March 31,			Markets			Inputs			Inputs
		2014			(Level 1)			(Level 2)			(Level 3)
Assets:
Cash and cash equivalents		$	12,252		12,252			—			—
Marketable securities		46,615			—			46,615			—
Long term marketable securities		11,662			—			11,662			—
Marketable securities - restricted (SERP)		305			—			305			—
Total assets at fair value		$	70,834		$	12,252		$	58,582		$	—
Liabilities:
Derivative liabilities		$	9,565		$	—		$	—		$	9,565

 

					Fair Value Measurements at
					December 31, 2013
								Significant
		Total Carrying			Quoted Prices			Other			Significant
		Value at			in Active			Observable			Unobservable
		December 31,			Markets			Inputs			Inputs
		2013			(Level 1)			(Level 2)			(Level 3)
Assets:
Cash and cash equivalents		$	32,980		$	32,980		$	—		$	—
Marketable securities		49,211			—			49,211			—
Long term marketable securities		8,756			—			8,756			—
Marketable securities - restricted (SERP)		305			—			305			—
Total assets at fair value		$	91,252		$	32,980		$	58,272		$	—
Liabilities:
Derivative liabilities		$	12,644		$	—		$	—		$	12,644

 

The fair value of the restricted marketable securities is included within other non-current assets in the consolidated balance sheets.

 

The Company’s Level 1 assets include money market funds and U.S. Treasury and government agency debt securities with quoted prices in active markets.

 

Level 2 assets include mutual funds in which the SERP (Supplemental Executive Retirement Plan) assets are invested, commercial paper and investment grade corporate bonds and other fixed income securities. Level 2 securities are valued using third-party pricing sources that apply applicable inputs and other relevant data into their models to estimate fair value.

 

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Level 3 liabilities include the fair market value of the interest make-whole liability associated with the Company’s 7.50% Convertible Senior Secured Notes due 2017, or the Notes, and the outstanding warrants to purchase Common Stock, which are recorded as derivative liabilities. The fair value of the common stock warrant liability was calculated using a Monte-Carlo simulation with a Black-Scholes model with the following assumptions as of March 31, 2014:

 

Exercise Price		$4 - $5 per share
Volatility		55%
Stock Price as of March 31, 2014		$8.94 per share
Term		6.3 - 7.8 years
Dividend Yield		0.0%
Risk-Free Rate		2.32% - 2.51%

 

The fair value of the interest make-whole liability of the Notes was calculated using a binomial-lattice model with the following key assumptions as of March 31, 2014:

 

Volatility		45%
Stock Price as of March 31, 2014		$8.94 per share
Credit Spread		1187 bps
Term		3.1 years
Dividend Yield		0.0%

 

Significant changes to these assumptions would result in increases/decreases to the fair value of the derivative liabilities.

 

Changes in the fair value of the warrants and the interest make-whole liability are recognized as a component of Other Income (Expense) in the Consolidated Statements of Operations. The following table presents information about the Company’s Level 3 liabilities as of December 31, 2013 and March 31, 2014 that are included in the Non-Current Liabilities section of the Consolidated Balance Sheets, in thousands:

 

		Three Months ended
		March 31, 2014
		(unaudited)
Balance at December 31, 2013		$	12,644
Changes in fair value of derivative liabilities included in earnings		(677		)
Reduction due to conversion of debt to equity		(2,402		)
Balance at March 31, 2014		$	9,565

 

The carrying value, face value and estimated fair value of the Notes was approximately $28.4 million, $40.0 million and $76.0 million, respectively, as of March 31, 2014. The fair value was estimated based on actual trade information as well as quoted prices provided by bond traders, which would be characterized within Level 2 of the fair value hierarchy. This fair value amount gives recognition to the value of the interest make-whole liability and the value of the conversion option. These items have been accounted for as derivative liabilities and additional paid-in-capital, respectively.

 

The carrying amounts of other financial instruments, including accounts receivable, accounts payable and accrued expenses approximate fair value due to their short-term maturities.

 

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Unrestricted marketable securities held by the Company were as follows, in thousands:

 

At March 31, 2014, unaudited:

 

Available for Sale		Amortized  Cost			Gross  Unrealized  Gains			Gross  Unrealized  Losses			Fair Value
Corporate debt securities		$	58,276		$	34		$	(33	)	$	58,277

 

At December 31, 2013:

 

Available for Sale		Amortized  Cost			Gross  Unrealized  Gains			Gross  Unrealized  Losses			Fair Value
Corporate debt securities		$	57,967		$	33		$	(33	)	$	57,967

 

The contractual maturities of the unrestricted marketable securities held by the Company were as follows, in thousands:

 

		March 31,  2014
Less Than 1 Year		$	46,615
1 - 5 Years		11,662
Greater Than 5 Years		—
Total		$	58,277

 

The Company has not experienced any other-than-temporary losses on its marketable securities and restricted marketable securities.  The cost of securities sold is calculated using the specific identification method.

 

4.  Inventories

 

Inventories consist of the following, in thousands:

 

		March 31,			December 31,
		2014			2013
		(unaudited)
Raw materials		$	4,188		$	3,897
Work in process		1,093			1,347
Finished goods		2,676			1,908
Total		$	7,957		$	7,152

 

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5.  Property and Equipment

 

Property and equipment consist of the following, in thousands:

 

		March 31,			December 31,
		2014			2013
		(unaudited)
Computer equipment		$	798		$	798
Software		225			209
Lab equipment and furniture		5,052			4,809
Leasehold improvements		2,333			2,329
		8,408			8,145
Less accumulated depreciation and amortization		(5,760		)	(5,591		)
		$	2,648		$	2,554

 

Depreciation expense on property and equipment was approximately $169,000 for the three months ended March 31, 2014, and $106,000 for the three ended March 31, 2013.

 

6.  Intangible Assets

 

The Company purchased certain patents from Shire Laboratories, Inc. in connection with a 2005 purchase agreement, which is being amortized over the weighted average life of the patents purchased in that transaction.  Patent defense costs have been incurred in connection with a Complaint filed on August 7, 2013 related to patents for Oxtellar XR (see Part II, Item I, Legal Proceedings). The following sets forth the gross carrying amount and related accumulated amortization of these intangible assets, in thousands:

 

				March 31, 2014
				(unaudited)						December 31, 2013
		Weighted-		Gross Carrying			Accumulated			Gross Carrying			Accumulated
		Average Life		Amount			Amortization			Amount			Amortization
Purchased patents		10.0		$	2,292		$	1,896		$	2,292		$	1,838
Patent defense costs(1)				$	1,761		$	—		$	704		$	—

 

(1)           Amortization of capitalized patent defense costs will begin upon successful outcome of the on-going litigation.  Three U.S. patents have been issued covering Oxtellar XR, providing patent protection through 2027.

 

Amortization expense was approximately $57,000 for each of the three months ended March 31, 2014 and 2013. The estimated annual aggregate amortization expense through December 31, 2015 is $229,000.

 

There were no indicators of impairment identified at March 31, 2014 or December 31, 2013.

 

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7.  Accrued Liabilities

 

Accrued liabilities are comprised of the following (and are included within the accounts payable and accrued expenses line item on the consolidated balance sheets), in thousands:

 

		March 31,			December 31,
		2014			2013
		(unaudited)
Accrued clinical trial and clinical supply costs		$	538		$	2,253
Accrued compensation		3,829			5,016
Accrued rebates and allowances		2,817			1,903
Accrued product costs		517			2,503
Accrued sales and marketing expenses		1,540			1,077
Accrued interest		1,251			619
Other accrued liabilities		1,998			1,801
		$	12,490		$	15,172

 

Accrued clinical trial and clinical supply costs consist primarily of investigator fees, contract research organization services, contract manufacturing, pass-through costs and laboratory costs.  Other accrued liabilities consist primarily of professional fees, distribution fees, and miscellaneous accrued expenses.

 

8.   Convertible Senior Secured Notes

 

The table below summarizes how the issuance of the Notes is reflected in the balance sheet at March 31, 2014, in thousands:

 

Gross proceeds		$	90,000
Initial value of interest make-whole derivative reported as debt discount		(9,270		)
Conversion option reported as debt discount and APIC		(22,336		)
Conversion of debt to equity - principal		(40,492		)
Conversion of debt to equity - debt discount		13,833
Amortization of debt discount		2,658
December 31, 2013 carrying value		34,393
Conversion of debt to equity - principal		(9,467		)
Conversion of debt to equity - debt discount		2,908
Amortization of debt discount		524
March 31, 2014 carrying value		$	28,358

 

During the three month period ended March 31, 2014, approximately $9.5 million of the Notes were presented to the Company for conversion. Accordingly, the Company issued approximately 1.8 million shares of common stock in conversion of the principal amount of the Notes.  The Company issued an additional 0.3 million shares of common stock in settlement of the interest make-whole provision related to the converted Notes.  As a result of the conversions, the Company incurred an approximately $1.7 million loss on extinguishment of debt during the three months ended March 31, 2014.

 

9. Share-Based Payments

 

The Company has adopted the Supernus Pharmaceuticals, Inc. 2012 Equity Incentive Plan (the “2012 Plan”), which is stockholder-approved, and provides for the grant of stock options and certain other awards, including stock appreciation rights (“SAR”), restricted and unrestricted stock, stock units, performance awards, cash awards and other awards that are convertible into or otherwise based on the Company’s common stock, to the Company’s key employees, directors, and consultants and advisors.  The 2012 Plan is administered by the Company’s Board of Directors and provides for the issuance of up to 2,500,000 shares of the Company’s Common Stock. Option awards are granted with an exercise price equal to the estimated fair value of the Company’s Common Stock

 

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at the grant date; those option awards generally vest in four annual installments, starting on the first anniversary of the date of grant and have ten-year contractual terms. The 2012 Plan provides for the issuance of Common Stock of the Company upon the exercise of stock options. Share-based compensation recognized related to the grant of employee and non-employee stock options, SAR, and non-vested stock was as follows, in thousands:

 

		Three Months ended March 31,
		2014			2013
		(unaudited)
Research and development		$	184		$	114
Selling, general and administrative		483			223
Total		$	667		$	337

 

The following table summarizes stock option and SAR activity:

 

							Weighted-
				Weighted-			Average
		Number of		Average			Remaining
		Options and SAR		Exercise Price			Contractual Term
Outstanding, December 31, 2013		1,463,043		$	7.27		8.51
Granted (unaudited)		618,285		$	9.33
Exercised (unaudited)		(2,386	)	$	2.48
Forfeited or expired (unaudited)		(15,034	)	$	8.02
Outstanding, March 31, 2014 (unaudited)		2,063,908		$	7.89		8.73
As of December 31, 2013
Vested and expected to vest		1,425,752		$	7.26		8.50
Exercisable		256,227		$	4.47		6.44
As of March 31, 2014
Vested and expected to vest (unaudited)		2,003,361		$	7.87		8.71
Exercisable (unaudited)		509,444		$	6.18		7.52

 

10. Loss Per Share

 

Basic loss per common share is determined by dividing loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period, without consideration of common stock equivalents. Diluted loss per share is computed by dividing the loss attributable to common stockholders by the weighted-average number of common share equivalents outstanding for the period. The treasury stock method is used to determine the dilutive effect of the Company’s stock option grants, SAR, potential Employee Stock Purchase Plan (ESPP) awards and warrants, and the if-converted method is used to determine the dilutive effect of the Company’s Notes. The following common stock equivalents were excluded in the calculation of diluted loss per share because their effect would be anti-dilutive as applied to the net loss for the periods ending March 31, 2014 and 2013:

 

		Three Months ended March 31,
		2014		2013
Shares Underlying Convertible Senior Secured Notes		7,556,001		—
Warrants to Purchase Common Stock		21,273		15,276
Stock Options, Stock Appreciation Rights, Non-vested Stock Options, and ESPP Awards		356,364		190,418

 

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

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations is intended to help the reader understand the results of operations and financial condition of the Company. The interim financial statements included in this report and this Management’s Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with our audited consolidated financial statements and notes thereto for the year ended December 31, 2013 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 21, 2014.  In addition to historical information, this Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are intended to be covered by the safe harbors created thereby. These forward-looking statements may include declarations regarding the Company’s belief or current expectations of management, such as statements including the words “budgeted,” “anticipate,” “project,” “estimate,” “expect,” “may,” “believe,” “potential,” and similar statements or expressions are intended to be among the statements that are forward-looking statements, as such statements reflect the reality of risk and uncertainty that is inherent in the Company’s business. Actual results may differ materially from those expressed or implied by such forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which are made as of the date this report was filed with the Securities and Exchange Commission. Our actual results and the timing of events could differ materially from those discussed in our forward-looking statements as a result of many factors, including those set forth under the “Risk Factors” section of our Annual Report on Form 10-K and elsewhere in this report as well as in other reports and documents we file with the Securities and Exchange Commission from time to time. Except as required by law, we undertake no obligation to update any forward-looking statements to reflect events or circumstances occurring after the date of this Quarterly Report on Form 10-Q.

 

Solely for convenience, in this Form 10-Q the trade names are referred to without the TM symbols and the trademark registrations are referred to without the circled R, but such references should not be construed as any indicator that the Company will not assert, to the fullest extent under applicable law, our rights thereto.

 

Overview

 

We are a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system, or CNS, diseases. In 2013, we launched Oxtellar XR (extended-release oxcarbazepine) and Trokendi XR (extended-release topiramate), our two novel treatments for epilepsy.

 

In addition, we are developing multiple product candidates in psychiatry to address the large, unmet clinical need and  market opportunity in the treatment of attention deficit hyperactivity disorder, or ADHD, including impulsive aggression in patients with ADHD.

 

Marketed Products. Oxtellar XR and Trokendi XR are the first once-daily extended release oxcarbazepine and topiramate products, respectively, indicated for epilepsy in the U.S. market. The products are differentiated from the immediate release products by offering once-daily dosing and unique pharmacokinetic profiles that can be very important for patients with epilepsy. A once-daily dosing regimen has been shown to improve compliance allowing patients to more completely benefit from their medications, and the unique smooth and steady pharmacokinetic profiles avoid the blood level fluctuations that are associated with immediate release products and their symptomatic side effects. To date, we have received positive feedback from patients and physicians regarding the benefits of and clinical outcomes they are experiencing with our products, and no new safety signals have arisen.

 

We expect the number of prescriptions filled for Oxtellar XR and Trokendi XR to increase throughout 2014, especially as we complete the expansion of our sales force in the first half of 2014.  Total prescriptions, as reported by IMS Health, or IMS, (aggregating Trokendi XR and Oxtellar XR), grew from 21,110 during the three months ended December 31, 2013 to 30,208 during the three months ended March 31, 2014, an increase of 43.1%.

 

Alternatively, data from Wolters-Kluwer/Symphony show 32,063 prescriptions filled for the three months ended March 31, 2014 representing a growth of 49.5% as compared to the three months ended December 31, 2013, which totaled 21,450 prescriptions filled.

 

We have our own specialty sales force promoting both products in the U.S. market, and we expect this sales force to more than 150 sales representatives by the mid-2014. We have incurred significant losses from operations in 2013 and the first three months of 2014 as part of our investment in and commitment to successful product launches for Oxtellar XR and Trokendi XR as well as expenditures to develop our product candidates.  We expect to continue to experience losses from operations in 2014, although we expect to be cash flow break even by year-end 2014.

 

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We believe our current working capital, along with increased revenues from increasing product sales, will be sufficient to finance the Company through the end of 2014. Beyond year end 2014, we expect the business to be cash flow positive.

 

The Company received a Paragraph IV Notice Letter on June 26, 2013 against two of its Oxtellar XR Orange Book patents from generic drug makers Watson Laboratories, Inc. — Florida (“WLF”).  On August 7, 2013, the Company filed a lawsuit against Actavis, Inc., WLF, Actavis Pharma, Inc., Watson Laboratories, Inc., and Anda, Inc. (collectively “Watson”) alleging infringement of two patents that are listed in the FDA’s Orange Book covering its antiepileptic drug Oxtellar XR. Supernus’s United States Patent Nos. 7,722,898 and 7,910,131 (“the patents-in-suit”) generally cover once-a-day oxcarbazepine formulations and methods of treating seizures using those formulations. We have since listed a third patent, United States Patent No. 8,617,600 issued on December 31, 2013, in the FDA’s Orange Book covering Oxtellar XR.  The Company received a second Paragraph IV Notice Letter on February 20, 2014 against this Orange Book patent from WLF.  On March 28, 2014, the Company filed a second lawsuit against Watson alleging infringement of this patent.  All three patents do not expire until April 13, 2027.  Although these cases are in their early stages, we believe that we will be successful in the defense of our patents.  However, in the event that we are not successful in upholding each of these patents, our future revenue from Oxtellar XR may be adversely affected, which could increase our expected net losses.  (See Part II, Item 1, Legal Proceedings for additional information.)

 

Product Candidates. In addition to our marketed products, we continue to develop our product candidates SPN-810 and SPN-812. We are developing SPN-810 (molindone hydrochloride) as a treatment for impulsive aggression in patients with well controlled ADHD. We completed a Phase IIb trial in 2012 demonstrating both safety and efficacy.  As a result of a September 2013 scientific meeting with the FDA, we are now designing a Phase III protocol which will undergo a Special Protocol Assessment.  We expect patient dosing to commence during 2015.

 

We are developing SPN-812 as a non-stimulant treatment for ADHD. We completed a Phase IIa proof of concept trial for SPN-812 in 2011, demonstrating efficacy versus placebo and we have completed the development of several extended release formulations that are being tested in a multi-dose steady state pharmacokinetic study to select the final product formulation for a Phase IIb trial.  We held a pre-IND (investigational new drug application) meeting with the FDA for the extended release program in June 2013.

 

We expect to incur significant research and development expenses related to the continued development of each of our product candidates.

 

Our partner United Therapeutics announced that the FDA has approved Orenitram (treprostinil).  The launch of this product is expected to occur in 2014, which will trigger a milestone payment of $2.0 million.  We are entitled to receive milestone payments and royalties for use of this formulation in other indications.

 

Critical Accounting Policies and the Use of Estimates

 

The significant accounting policies and basis of presentation for our consolidated financial statements are described in Note 2 “Summary of Significant Accounting Policies”. The preparation of our financial statements in accordance with U.S. generally accepted accounting principles, or GAAP, requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, expenses and the disclosure of contingent assets and liabilities in our financial statements. Actual results could differ from those estimates.

 

We believe the following accounting policies and estimates to be critical:

 

Inventories

 

We carry inventories at the lower of cost or market using the first-in, first-out method.  Inventory values include materials, labor, and other direct and indirect overhead. Inventory is evaluated for impairment through consideration of factors such as net realizable value, obsolescence and expiry. Our inventories have values that do not exceed either replacement cost or net realizable value. We believe Oxtellar XR and Trokendi XR have limited risk of obsolescence or expiry based on current demand, our projection for future demand, and product dating.

 

Revenue Recognition and Deferred Revenue

 

At the present time, the Company records Trokendi XR shipments to wholesalers as deferred revenue; i.e., sales price net of known sales deductions (e.g. prompt pay discounts and other similar charges). As Trokendi XR was launched in the second half of 2013, we lack the experiential data which would allow us to estimate all remaining sales rebates, allowances and returns.  Accordingly, we must wait until these data become available to the Company.  Because this occurs approximately eight weeks after the close of the quarter, the Company currently delays recognition of revenue on Trokendi XR until the subsequent fiscal quarter.  In addition, rather than

 

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recognize revenue upon shipments to wholesalers, the Company currently recognizes Trokendi XR revenue upon filling prescriptions at pharmacies, because prescriptions filled at the pharmacy level have no remaining right of return.

 

We expect to continue to report revenue based on Trokendi XR prescriptions filled at the pharmacy level on a quarter lag basis until sufficient experience with rebates, allowances and net sales deductions is assembled to allow reporting of revenue based on shipments to wholesalers (i.e., contemporaneous basis).  We expect that this may occur by the second quarter of 2014.  We expect to recognize higher levels of revenue during the quarter when the change to contemporaneous recognition becomes effective.

 

The Company recognizes revenue for Oxtellar XR based on shipment to distributors as we have sufficient historical experience to estimate sales deductions, allowances and returns.

 

For a complete description of the Trokendi XR and Oxtellar XR gross revenue and gross to net adjustments see Part I, Item 1, Financial Statements and Supplemental Data, Note 2, Revenue Recognition on Product Sales.

 

Results of Operations

 

Comparison of the Three Months Ended March 31, 2014 and March 31, 2013

 

		Three Months ended March 31,						Increase/
		2014			2013			(decrease)
		(unaudited)
		(in thousands)
Revenues:
Net product sales		$	8,995		$	—		8,995
Licensing revenue		86			147			(61	)
Total revenues		9,081			147
Costs and expenses
Cost of product sales		494			—			494
Research and development		4,482			4,522			(40	)
Selling, general and administrative		17,527			13,533			3,994
Total costs and expenses		22,503			18,055
Operating loss		(13,422		)	(17,908		)
Interest income and other income (expense), net		102			141			(39	)
Interest expense		(1,207		)	(727		)	(480	)
Changes in fair value of derivative liabilities		677			80			597
Loss on extinguishment of debt		(1,693		)	—			(1,693	)
Total other expenses		(2,121		)	(506		)
Net loss		$	(15,543	)	$	(18,414	)

 

Revenues.  Our net product sales of $9.0 million for the three months ended March 31, 2014 are based on $4.9 million of revenue from shipments of Oxtellar XR to distributors, less estimates for discounts, rebates, other sales deductions and returns, and $4.1 million of revenue for Trokendi XR prescriptions filled at the pharmacy level, during the fourth quarter of 2013, net of sales deductions.

 

Shipments of Oxtellar XR during the first quarter of 2014 of $4.9 million increased by $1.0 million, or 25%, as compared to fourth quarter 2013 shipments of $3.9 million.

 

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