United Therapeutics Corporation
UNITED THERAPEUTICS Corp (Form: 10-Q, Received: 04/28/2015 06:10:00)

Table of Contents

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

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

 

For the quarterly period ended March 31, 2015

 

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 0-26301

 

United Therapeutics Corporation

(Exact Name of Registrant as Specified in Its Charter)

 

Delaware

 

52-1984749

(State or Other Jurisdiction of

 

(I.R.S. Employer

Incorporation or Organization)

 

Identification No.)

 

 

 

1040 Spring Street, Silver Spring, MD

 

20910

(Address of Principal Executive Offices)

 

(Zip Code)

 

(301) 608-9292

(Registrant’s Telephone Number, Including Area Code)

 

 

(Former Name, Former Address and Former Fiscal Year, If Changed Since Last Report)

 

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  o

 

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

 

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

 

Large accelerated filer x

 

Accelerated filer o

 

 

 

Non-accelerated filer o

 

Smaller reporting company o

(do not check if a smaller reporting company)

 

 

 

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

 

The number of shares outstanding of the issuer’s common stock, par value $.01 per share, as of April 21, 2015 was 46,260,939.

 

 

 



Table of Contents

 

INDEX

 

 

 

Page

 

 

 

Part I.

FINANCIAL INFORMATION (UNAUDITED)

3

 

 

 

Item 1.

Consolidated Financial Statements

3

 

 

 

 

Consolidated Balance Sheets

3

 

 

 

 

Consolidated Statements of Operations

4

 

 

 

 

Consolidated Statements of Comprehensive (Loss) Income

5

 

 

 

 

Consolidated Statements of Cash Flows

6

 

 

 

 

Notes to Consolidated Financial Statements

7

 

 

 

Item 2.

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

21

 

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

34

 

 

 

Item 4.

Controls and Procedures

35

 

 

 

Part II.

OTHER INFORMATION

36

 

 

 

Item 1.

Legal Proceedings

36

 

 

 

Item 1A.

Risk Factors

36

 

 

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

53

 

 

 

Item 6.

Exhibits

53

 

 

 

SIGNATURES

 

54

 

2



Table of Contents

 

PART I. FINANCIAL INFORMATION

Item 1. Consolidated Financial Statements

 

UNITED THERAPEUTICS CORPORATION

CONSOLIDATED BALANCE SHEETS

(In thousands, except share data)

 

 

 

March 31,
 2015

 

December 31,
 2014

 

 

 

(Unaudited)

 

 

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

426,509

 

$

397,697

 

Marketable investments

 

230,356

 

297,842

 

Accounts receivable, net of allowance of none for 2015 and 2014

 

156,153

 

162,287

 

Inventories, net

 

72,465

 

66,927

 

Other current assets

 

108,608

 

49,444

 

Total current assets

 

994,091

 

974,197

 

Marketable investments

 

116,493

 

122,658

 

Goodwill and other intangibles, net

 

29,135

 

29,465

 

Property, plant and equipment, net

 

474,680

 

478,421

 

Deferred tax assets, net

 

182,716

 

181,721

 

Other assets

 

97,499

 

97,948

 

Total assets

 

$

1,894,614

 

$

1,884,410

 

 

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable and accrued expenses

 

$

90,130

 

$

85,382

 

Convertible notes

 

115,222

 

126,414

 

Share tracking awards plan

 

392,432

 

282,101

 

Other current liabilities

 

48,964

 

10,413

 

Total current liabilities

 

646,748

 

504,310

 

Other liabilities

 

135,812

 

114,526

 

Total liabilities

 

782,560

 

618,836

 

Commitments and contingencies:

 

 

 

 

 

Temporary equity

 

20,431

 

23,218

 

Stockholders’ equity:

 

 

 

 

 

Preferred stock, par value $.01, 10,000,000 shares authorized, no shares issued

 

 

 

Series A junior participating preferred stock, par value $.01, 100,000 shares authorized, no shares issued

 

 

 

Common stock, par value $.01, 245,000,000 shares authorized, 66,453,471 and 65,988,561 shares issued, and 46,370,058 and 47,107,709 shares outstanding at March 31, 2015 and December 31, 2014, respectively

 

665

 

660

 

Additional paid-in capital

 

1,426,998

 

1,376,141

 

Accumulated other comprehensive loss

 

(21,643

)

(16,734

)

Treasury stock, 20,083,413 and 18,880,852 shares at March 31, 2015 and December 31, 2014, respectively

 

(1,365,870

)

(1,185,825

)

Retained earnings

 

1,051,473

 

1,068,114

 

Total stockholders’ equity

 

1,091,623

 

1,242,356

 

Total liabilities and stockholders’ equity

 

$

1,894,614

 

$

1,884,410

 

 

See accompanying notes to consolidated financial statements.

 

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Table of Contents

 

UNITED THERAPEUTICS CORPORATION

CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share data)

 

 

 

Three Months Ended
March 31,

 

 

 

2015

 

2014

 

 

 

(Unaudited)

 

Revenues:

 

 

 

 

 

Net product sales

 

$

325,917

 

$

284,553

 

Other

 

1,587

 

4,850

 

Total revenues

 

327,504

 

289,403

 

Operating expenses:

 

 

 

 

 

Research and development

 

110,212

 

12,448

 

Selling, general and administrative

 

211,340

 

30,215

 

Cost of product sales

 

20,778

 

30,600

 

Total operating expenses

 

342,330

 

73,263

 

Operating (loss) income

 

(14,826

)

216,140

 

Other (expense) income:

 

 

 

 

 

Interest expense

 

(2,059

)

(4,610

)

Other, net

 

93

 

1,686

 

Total other expense, net

 

(1,966

)

(2,924

)

(Loss) income before income taxes

 

(16,792

)

213,216

 

Income tax benefit (expense)

 

151

 

(75,692

)

Net (loss) income

 

$

(16,641

)

$

137,524

 

Net (loss) income per common share:

 

 

 

 

 

Basic

 

$

(0.36

)

$

2.73

 

Diluted

 

$

(0.36

)

$

2.43

 

Weighted average number of common shares outstanding:

 

 

 

 

 

Basic

 

46,707

 

50,402

 

Diluted

 

46,707

 

56,657

 

 

See accompanying notes to consolidated financial statements.

 

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Table of Contents

 

UNITED THERAPEUTICS CORPORATION

CONSOLIDATED STATEMENTS OF COMPREHENSIVE (LOSS) INCOME

(In thousands)

 

 

 

Three Months Ended
March 31,

 

 

 

2015

 

2014

 

 

 

(Unaudited)

 

Net (loss) income

 

$

(16,641

)

$

137,524

 

Other comprehensive loss:

 

 

 

 

 

Foreign currency translation loss

 

(3,117

)

(477

)

Defined benefit pension plan:

 

 

 

 

 

Prior service cost arising during period, net of tax

 

 

(2,415

)

Actuarial (loss) gain arising during period, net of tax

 

(2,110

)

221

 

Less: amortization of actuarial loss and prior service cost included in net periodic pension cost, net of tax

 

333

 

226

 

Total defined benefit pension plan, net

 

(1,777

)

(1,968

)

Unrealized loss on available-for-sale securities, net of tax

 

(15

)

(13

)

Other comprehensive loss, net of tax

 

(4,909

)

(2,458

)

Comprehensive (loss) income

 

$

(21,550

)

$

135,066

 

 

See accompanying notes to consolidated financial statements.

 

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UNITED THERAPEUTICS CORPORATION

CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

 

 

 

Three Months Ended
March 31,

 

 

 

2015

 

2014

 

 

 

(Unaudited)

 

Cash flows from operating activities:

 

 

 

 

 

Net (loss) income

 

$

(16,641

)

$

137,524

 

Adjustments to reconcile net (loss) income to net cash provided by operating activities:

 

 

 

 

 

Depreciation and amortization

 

8,330

 

7,565

 

Share-based compensation expense (benefit)

 

234,530

 

(60,723

)

Amortization of debt discount and debt issue costs

 

2,005

 

3,265

 

Amortization of discount or premium on investments

 

994

 

1,604

 

Other

 

(1,843

)

658

 

Excess tax benefits from share-based compensation

 

(8,725

)

(5,606

)

Changes in operating assets and liabilities:

 

 

 

 

 

Accounts receivable

 

6,134

 

(5,913

)

Inventories

 

(1,371

)

(4,799

)

Accounts payable and accrued expenses

 

4,747

 

11,724

 

Other assets and liabilities

 

(119,209

)

25,298

 

Net cash provided by operating activities

 

108,951

 

110,597

 

 

 

 

 

 

 

Cash flows from investing activities:

 

 

 

 

 

Purchases of property, plant and equipment

 

(3,980

)

(18,676

)

Purchases of held-to-maturity investments

 

(24,262

)

(110,070

)

Maturities of held-to-maturity investments

 

96,697

 

235,125

 

Net cash provided by investing activities

 

68,455

 

106,379

 

 

 

 

 

 

 

Cash flows from financing activities:

 

 

 

 

 

Principal payments of debt

 

(13,975

)

 

Payments to repurchase common stock

 

(152,286

)

(97,633

)

Proceeds from the exercise of stock options

 

10,132

 

8,376

 

Issuance of stock under employee stock purchase plan

 

1,927

 

1,734

 

Excess tax benefits from share-based compensation

 

8,725

 

5,606

 

Net cash used in financing activities

 

(145,477

)

(81,917

)

 

 

 

 

 

 

Effect of exchange rate changes on cash and cash equivalents

 

(3,117

)

(154

)

Net increase in cash and cash equivalents

 

28,812

 

134,905

 

Cash and cash equivalents, beginning of period

 

397,697

 

278,889

 

Cash and cash equivalents, end of period

 

$

426,509

 

$

413,794

 

 

 

 

 

 

 

Supplemental schedule of cash flow information:

 

 

 

 

 

Cash paid for interest

 

$

682

 

$

1,971

 

Cash paid for income taxes

 

$

16,173

 

$

66,803

 

Non-cash investing activities and financing activities:

 

 

 

 

 

Non-cash additions to property, plant and equipment

 

$

355

 

$

6,907

 

Issuance of common stock upon conversion of convertible notes

 

$

27,759

 

$

 

 

See accompanying notes to consolidated financial statements.

 

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UNITED THERAPEUTICS CORPORATION

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

March 31, 2015

(UNAUDITED)

 

1. Organization and Business Description

 

United Therapeutics Corporation is a biotechnology company focused on the development and commercialization of innovative products to address the unmet medical needs of patients with chronic and life-threatening conditions. As used in these notes to the consolidated financial statements, unless the context otherwise requires, the terms “we”, “us”, “our”, and similar terms refer to United Therapeutics Corporation and its consolidated subsidiaries.

 

We have approval from the United States Food and Drug Administration (FDA) to market the following therapies: Remodulin ®  (treprostinil) Injection (Remodulin), Tyvaso ®  (treprostinil) Inhalation Solution (Tyvaso), Adcirca ®  (tadalafil) Tablets (Adcirca), Orenitram ®  (treprostinil) Extended-Release Tablets (Orenitram) and Unituxin TM  (dinutuximab) Injection (formerly called ch14.18) (Unituxin). Remodulin has also been approved for distribution in various countries outside the United States. We commenced commercial sales of Orenitram during the second quarter of 2014. We expect to commence sales of Unituxin during the second half of 2015.

 

2. Basis of Presentation

 

The accompanying unaudited consolidated financial statements have been prepared in accordance with the rules and regulations of the United States Securities and Exchange Commission (SEC) for interim financial information. Accordingly, they do not include all of the information required by United States generally accepted accounting principles (GAAP) for complete financial statements. These consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the accompanying notes to the consolidated financial statements contained in our Annual Report on Form 10-K for the year ended December 31, 2014, as filed with the SEC on February 24, 2015.

 

In our management’s opinion, the accompanying consolidated financial statements contain all adjustments, including normal, recurring adjustments, necessary to fairly present our financial position as of March 31, 2015, statements of operations, comprehensive (loss) income and cash flows for the three-month periods ended March 31, 2015 and March 31, 2014. Interim results are not necessarily indicative of results for an entire year. In the operating section of our statement of cash flows, we reclassified the prior period amount within “current and deferred income tax expense” to “other assets and liabilities” to conform with the current year presentation.

 

Recently Issued Accounting Standards

 

In May 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers (ASU 2014-09). ASU 2014-09 will eliminate transaction-specific and industry-specific revenue recognition guidance under current GAAP and replace it with a principle-based approach for determining revenue recognition. ASU 2014-09 will require that companies recognize revenue based on the value of transferred goods or services as they occur in the contract. ASU 2014-09 also will require additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. ASU 2014-09 is effective for annual reporting periods beginning after December 15, 2016. Early adoption is not permitted. ASU 2014-09 allows for either full retrospective or modified retrospective adoption. We are evaluating the transition method we will elect and the effects of the adoption of this ASU on our financial statements.

 

In April 2015, the FASB issued ASU No. 2015-03, Simplifying the Presentation of Debt Issuance Costs (ASU 2015-03), which requires that debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct deduction from the carrying amount of that debt liability, consistent with debt discounts. ASU 2015-03 requires retrospective

 

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adoption and will be effective for us beginning in our first quarter of 2016. Early adoption is permitted. We do not expect the adoption of ASU 2015-03 to have a material impact on our financial statements.

 

3. Inventories

 

Inventories are stated at the lower of cost (first-in, first-out method) or market (current replacement cost) and consist of the following, net of reserves (in thousands):

 

 

 

March 31,
 2015

 

December 31,
 2014

 

Raw materials

 

$

20,369

 

$

21,317

 

Work-in-progress

 

21,952

 

15,994

 

Finished goods

 

30,144

 

29,616

 

Total inventories

 

$

72,465

 

$

66,927

 

 

4. Fair Value Measurements

 

We account for certain assets and liabilities at fair value and rank these assets within a fair value hierarchy (Level 1, Level 2 or Level 3).  Our other current assets and our current liabilities have fair values that approximate their carrying values.  Assets and liabilities subject to fair value measurements are as follows (in thousands):

 

 

 

As of March 31, 2015

 

 

 

Level 1

 

Level 2

 

Level 3

 

Balance

 

Assets

 

 

 

 

 

 

 

 

 

Money market funds(1)

 

$

341,677

 

$

 

$

 

$

341,677

 

Federally-sponsored and corporate debt securities(2)

 

 

347,352

 

 

347,352

 

Total assets

 

$

341,677

 

$

347,352

 

$

 

$

689,029

 

Liabilities

 

 

 

 

 

 

 

 

 

Convertible notes due 2016(3)

 

$

437,912

 

$

 

$

 

$

437,912

 

Contingent consideration(4)

 

 

 

11,309

 

11,309

 

Total liabilities

 

$

437,912

 

$

 

$

11,309

 

$

449,221

 

 

 

 

As of December 31, 2014

 

 

 

Level 1

 

Level 2

 

Level 3

 

Balance

 

Assets

 

 

 

 

 

 

 

 

 

Money market funds(1)

 

$

298,416

 

$

 

$

 

$

298,416

 

Federally-sponsored and corporate debt securities(2)

 

 

420,731

 

 

420,731

 

Total assets

 

$

298,416

 

$

420,731

 

$

 

$

719,147

 

Liabilities

 

 

 

 

 

 

 

 

 

Convertible notes due 2016(3)

 

$

388,153

 

$

 

$

 

$

388,153

 

Contingent consideration(4)

 

 

 

11,502

 

11,502

 

Total liabilities

 

$

388,153

 

$

 

$

11,502

 

$

399,655

 

 

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(1)          Included in cash and cash equivalents on the accompanying consolidated balance sheets.

 

(2)          Included in current and non-current marketable investments on the accompanying consolidated balance sheets. The fair value of these securities is principally measured or corroborated by trade data for identical securities in which related trading activity is not sufficiently frequent to be considered a Level 1 input or comparable securities that are more actively traded. See also Note 5— Investments Marketable Investments—Held-to-Maturity Investments to these consolidated financial statements.

 

(3)          Included in convertible notes on the accompanying consolidated balance sheets. The fair value of our Convertible Notes is estimated using Level 1 observable inputs since our Convertible Notes are trading with sufficient frequency such that we believe related pricing can be used as the primary basis for measuring their fair value. As of March 31, 2015 and December 31, 2014, the fair value of the Convertible Notes was substantially higher than their book value. This was primarily due to the excess conversion value of the notes compared to the notes’ par value, and the fact that any such excess would be paid in shares of our common stock.

 

(4)          Included in other liabilities on the accompanying consolidated balance sheets. The fair value of contingent consideration has been estimated using probability weighted discounted cash flow models (DCF). The DCFs incorporate Level 3 inputs including estimated discount rates that we believe market participants would consider relevant in pricing and the projected timing and amount of cash flows, which are estimated and developed, in part, based on the requirements specific to each acquisition agreement. We analyze and evaluate these fair value measurements quarterly to determine whether valuation inputs continue to be relevant and appropriate or whether current period developments warrant adjustments to valuation inputs and related measurements. Any increases or decreases in discount rates would have an inverse impact on the corresponding fair value, while increases or decreases in expected cash flows would result in corresponding increases or decreases in fair value. As of both March 31, 2015 and December 31, 2014, the cost of debt and weighted average cost of capital used to discount projected cash flows relating to our contingent consideration ranged from 6.1 percent to 15.5 percent, respectively.

 

A reconciliation of the beginning and ending balances of Level 3 liabilities for the three-month period ended March 31, 2015 is presented below (in thousands):

 

 

 

Contingent
Consideration

 

Balance, January 1, 2015—Asset (Liability)

 

$

(11,502

)

Transfers into Level 3

 

 

Transfers out of Level 3

 

 

Total gains/(losses) realized/unrealized:

 

 

 

Included in earnings

 

 

Included in other comprehensive income

 

193

 

Purchases

 

 

Sales

 

 

Issuances

 

 

Settlements

 

 

Balance March 31, 2015—Asset (Liability)

 

$

(11,309

)

Amount of total gains/(losses) for the three-month period ended March 31, 2015 included in earnings that are attributable to the change in unrealized gains or losses related to outstanding liabilities

 

$

 

 

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Table of Contents

 

Fair Value of Financial Instruments

 

The carrying amounts of cash and cash equivalents, accounts receivable, accounts payable, and accrued expenses approximate fair value because of their short maturities. The fair values of our marketable investments and our Convertible Notes are reported above within the fair value hierarchy. Refer to Note 9— Debt .

 

5. Investments

 

Marketable Investments

 

Held-to-Maturity Investments

 

Marketable investments classified as held-to-maturity consist of the following (in thousands):

 

As of March 31, 2015

 

Amortized
Cost

 

Gross
Unrealized
Gains

 

Gross
Unrealized
Losses

 

Fair
Value

 

Government-sponsored enterprises

 

$

112,319

 

$

83

 

$

(1

)

$

112,401

 

Corporate notes and bonds

 

234,530

 

428

 

(7

)

234,951

 

Total

 

$

346,849

 

$

511

 

$

(8

)

$

347,352

 

Reported under the following captions on the consolidated balance sheet:

 

 

 

 

 

 

 

 

 

Current marketable investments

 

$

230,356

 

 

 

 

 

 

 

Noncurrent marketable investments

 

116,493

 

 

 

 

 

 

 

 

 

$

346,849

 

 

 

 

 

 

 

 

As of December 31, 2014

 

Amortized
Cost

 

Gross
Unrealized
Gains

 

Gross
Unrealized
Losses

 

Fair
Value

 

Government-sponsored enterprises

 

$

127,212

 

$

118

 

$

(39

)

$

127,291

 

Corporate notes and bonds

 

293,288

 

260

 

(108

)

293,440

 

Total

 

$

420,500

 

$

378

 

$

(147

)

$

420,731

 

Reported under the following captions on the consolidated balance sheet:

 

 

 

 

 

 

 

 

 

Current marketable investments

 

$

297,842

 

 

 

 

 

 

 

Noncurrent marketable investments

 

122,658

 

 

 

 

 

 

 

 

 

$

420,500

 

 

 

 

 

 

 

 

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The following table summarizes gross unrealized losses and the length of time marketable investments have been in a continuous unrealized loss position (in thousands):

 

 

 

As of March 31, 2015

 

As of December 31, 2014

 

 

 

Fair
Value

 

Gross
Unrealized
Loss

 

Fair
Value

 

Gross
Unrealized
Loss

 

Government-sponsored enterprises:

 

 

 

 

 

 

 

 

 

Continuous unrealized loss position less than one year

 

$

5,404

 

$

(1

)

$

15,293

 

$

(39

)

Continuous unrealized loss position greater than one year

 

 

 

 

 

 

 

5,404

 

(1

)

15,293

 

(39

)

Corporate notes and bonds:

 

 

 

 

 

 

 

 

 

Continuous unrealized loss position less than one year

 

15,998

 

(4

)

86,824

 

(97

)

Continuous unrealized loss position greater than one year

 

3,249

 

(3

)

3,443

 

(11

)

 

 

19,247

 

(7

)

90,267

 

(108

)

Total

 

$

24,651

 

$

(8

)

$

105,560

 

$

(147

)

 

We attribute gross unrealized losses pertaining to our held-to-maturity securities as of March 31, 2015 and December 31, 2014 to the variability in related market interest rates. We do not intend to sell these securities, nor is it more likely than not that we will be required to sell them prior to the end of their contractual terms. Furthermore, we do not believe that these securities expose us to undue market risk or counterparty credit risk. As such, we do not consider these securities to be other than temporarily impaired.

 

The following table summarizes the contractual maturities of held-to-maturity marketable investments (in thousands):

 

 

 

March 31, 2015

 

 

 

Amortized
Cost

 

Fair
Value

 

Due in less than one year

 

$

230,356

 

$

230,554

 

Due in one to two years

 

116,493

 

116,798

 

Due in three to five years

 

 

 

Due after five years

 

 

 

Total

 

$

346,849

 

$

347,352

 

 

Investments Held at Cost

 

As of March 31, 2015, we maintain in the aggregate, non-controlling equity investments of $83.0 million in privately-held corporations, including a $50.0 million investment in the preferred stock of Synthetic Genomics Inc. (SGI), which we purchased in May 2014. We account for these investments under the cost method since we do not have the ability to exercise significant influence over these companies and their fair values are not readily determinable. The fair value of these investments has not been estimated at March 31, 2015, as we have not identified any events or developments indicating that their carrying amounts may be impaired. We include these investments within other assets on our accompanying consolidated balance sheets.

 

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6. Goodwill and Other Intangible Assets

 

Goodwill and other intangible assets comprise the following (in thousands):

 

 

 

As of March 31, 2015

 

As of December 31, 2014

 

 

 

Gross

 

Accumulated
Amortization

 

Net

 

Gross

 

Accumulated
Amortization

 

Net

 

Goodwill

 

$

10,264

 

$

 

$

10,264

 

$

10,264

 

$

 

$

10,264

 

Other intangible assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

Technology, patents and trade names

 

6,494

 

(4,307

)

2,187

 

6,494

 

(4,100

)

2,394

 

In-process, research and development

 

15,500

 

 

15,500

 

15,500

 

 

15,500

 

Customer relationships and non-compete agreements

 

4,369

 

(3,185

)

1,184

 

4,369

 

(3,062

)

1,307

 

Contract-based

 

1,270

 

(1,270

)

 

1,270

 

(1,270

)

 

Total

 

$

37,897

 

$

(8,762

)

$

29,135

 

$

37,897

 

$

(8,432

)

$

29,465

 

 

7. Supplemental Executive Retirement Plan

 

We maintain the United Therapeutics Corporation Supplemental Executive Retirement Plan (SERP) to provide retirement benefits to certain senior members of our management team. To help fund our expected obligations under the SERP, we maintain the United Therapeutics Corporation Supplemental Executive Retirement Plan Rabbi Trust Document (Rabbi Trust). The balance in the Rabbi Trust was $5.1 million as of March 31, 2015 and December 31, 2014 and is included under “Cash and cash equivalents” on our consolidated balance sheets. The Rabbi Trust is irrevocable and SERP participants have no preferred claim on, nor any beneficial ownership interest in, any assets of the Rabbi Trust.

 

8. Share Tracking Award Plans

 

We maintain the United Therapeutics Corporation Share Tracking Awards Plan, adopted in June 2008 (2008 STAP) and the United Therapeutics Corporation 2011 Share Tracking Awards Plan, adopted in March 2011 (2011 STAP). We refer to the 2008 STAP and the 2011 STAP collectively as the “STAP” and awards granted and/or outstanding under either of these plans as “STAP awards.” STAP awards convey the right to receive in cash an amount equal to the appreciation of our common stock, which is measured as the increase in the closing price of our common stock between the dates of grant and exercise. STAP awards generally vest in equal increments on each anniversary of the grant date over a four-year period and expire on the tenth anniversary of the date of grant.

 

The aggregate STAP liability balance was $460.3 million and $322.7 million at March 31, 2015 and December 31, 2014, respectively, of which $67.9 million and $40.6 million, respectively, have been classified as non-current liabilities under the caption “other liabilities” on our consolidated balance sheets based on their vesting terms.

 

Estimating the fair value of STAP awards requires the use of certain inputs that can materially impact the determination of fair value and the amount of compensation expense (benefit) we recognize. Inputs used in estimating fair value include the price of our common stock, the expected volatility of the price of our common stock, the risk-free interest rate, the expected

 

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term of STAP awards, the expected forfeiture rate and the expected dividend yield. The fair value of the STAP awards is measured each financial reporting period because the awards are settled in cash.

 

The table below includes the assumptions used to measure the fair value of STAP awards:

 

 

 

March 31,
 2015

 

March 31,
 2014

 

Expected volatility

 

34.2%

 

32.9%

 

Risk-free interest rate

 

1.1%

 

1.4%

 

Expected term of awards (in years)

 

4.4   

 

4.1   

 

Expected forfeiture rate

 

9.5%

 

9.9%

 

Expected dividend yield

 

0.0%

 

0.0%

 

 

A summary of the activity and status of STAP awards is presented below:

 

 

 

Number of
Awards

 

Weighted-
Average
Exercise
Price

 

Weighted
Average
Remaining
Contractual
Term
(in Years)

 

Aggregate
Intrinsic
Value
(in Thousands)

 

Outstanding at January 1, 2015

 

7,716,424

 

$

62.59

 

 

 

 

 

Granted

 

1,644,388

 

159.51

 

 

 

 

 

Exercised

 

(1,004,188

)

56.41

 

 

 

 

 

Forfeited

 

(37,956

)

88.30

 

 

 

 

 

Outstanding at March 31, 2015

 

8,318,668

 

$

82.38

 

7.8

 

$

749,197

 

Exercisable at March 31, 2015

 

3,198,513

 

$

62.43

 

6.6

 

$

351,883

 

Expected to vest at March 31, 2015

 

4,624,500

 

$

95.20

 

8.7

 

$

357,208

 

 

The weighted average grant-date fair value of STAP awards granted during the three-month periods ended March 31, 2015 and March 31, 2014 was $58.43 and $33.96, respectively.

 

Share-based compensation expense (benefit) recognized in connection with the STAP is as follows (in thousands):

 

 

 

Three Months Ended 
March 31,

 

 

 

2015

 

2014

 

Research and development

 

$

74,909

 

$

(26,674

)

Selling, general and administrative

 

149,715

 

(31,972

)

Cost of product sales

 

9,595

 

(2,309

)

Share-based compensation expense (benefit) before taxes

 

234,219

 

(60,955

)

Related income tax (expense) benefit

 

(89,237

)

21,334

 

Share-based compensation expense (benefit), net of taxes

 

$

144,982

 

$

(39,621

)

Share-based compensation expense (benefit) capitalized as part of inventory

 

$

2,315

 

$

(265

)

 

Cash paid to settle STAP awards exercised during the three-month periods ended March 31, 2015 and March 31, 2014 was $98.5 million and $20.5 million, respectively.

 

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9. Debt

 

Line of Credit

 

In September 2013, we entered into a credit agreement with Wells Fargo Bank, National Association (Wells Fargo) providing us a $75.0 million revolving loan facility, which may be increased by up to an additional $75.0 million provided certain conditions are met. At our option, amounts borrowed under this credit agreement bear interest at either the one-month LIBOR rate plus a 0.50 percent margin, or a fluctuating base rate excluding any margin. In addition, we are subject to a monthly commitment fee of 0.06 percent per annum on the average daily unused balance of the facility. In July 2014, we extended the term of this credit agreement to September 30, 2015. Amounts borrowed under the credit agreement are secured by certain of our marketable investments. As of March 31, 2015, we had no outstanding balance on the facility. This credit agreement does not contain any financial covenants.

 

Convertible Notes Due 2016

 

In October 2011, we issued $250.0 million in aggregate principal value 1.0 percent Convertible Senior Notes due September 15, 2016 (Convertible Notes). The Convertible Notes are unsecured, unsubordinated debt obligations that rank equally with all of our other unsecured and unsubordinated indebtedness. We pay interest semi-annually on March 15 and September 15 of each year. The initial conversion price is $47.69 per share and the number of underlying shares used to determine the aggregate consideration upon conversion is approximately 5.2 million shares.

 

At March 31, 2015, the aggregate conversion value of the Convertible Notes exceeded their par value by $326.4 million using a conversion price of $172.44, the closing price of our common stock on March 31, 2015.

 

During the three-month period ended March 31, 2015, we settled conversion requests representing $14.0 million in principal value of our Convertible Notes. We paid $14.0 million in principal and issued 193,000 shares of our common stock during the settlement process. We received 193,000 shares of our common stock under our note hedge from Deutsche Bank AG London (DB London) which we placed into our treasury stock account. We recognized a $513,000 extinguishment loss with the settlement of these conversions. As of March 31, 2015, there are 2.6 million underlying shares representing the aggregate consideration upon future conversions on the outstanding Convertible Notes.

 

During March 2015, we received conversion requests representing $89.4 million in principal value of our Convertible Notes. These conversion requests will be settled in the second quarter of 2015. Based on our stock price as of March 31, 2015, we expect that the full $89.4 million of principal will be paid in cash to the converting note holders, and that we will be required to issue shares of our common stock. We expect to receive an equal number of shares of our common stock under our note hedge with DB London and to recognize an estimated $2.9 million extinguishment loss upon settlement of these conversions.

 

Interest expense incurred in connection with our Convertible Notes consisted of the following (in thousands):

 

 

 

Three Months Ended 
March 31,

 

 

 

2015

 

2014

 

Contractual coupon rate of interest

 

$

244

 

$

625

 

Discount amortization

 

1,598

 

2,894

 

Interest expense—convertible notes

 

$

1,842

 

$

3,519

 

 

Components comprising the carrying value of the Convertible Notes include the following (in thousands):

 

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March 31,
 2015

 

December 31,
 2014

 

Principal balance

 

$

124,771

 

$

138,750

 

Discount, net of accumulated amortization of $19,364 and $19,819

 

(9,549

)

(12,336

)

Carrying amount

 

$

115,222

 

$

126,414

 

 

10. Temporary Equity

 

Temporary equity includes securities that: (1) have redemption features that are outside our control; (2) are not classified as an asset or liability; (3) are excluded from permanent stockholders’ equity; and (4) are not mandatorily redeemable. Amounts included in temporary equity relate to securities that are redeemable at a fixed or determinable price.

 

Components comprising the carrying value of temporary equity include the following (in thousands):

 

 

 

March 31,
 2015

 

December 31,
 2014

 

Reclassification of Equity Component(1)

 

$

9,549

 

$

12,336

 

Common stock subject to repurchase(2)

 

10,882

 

10,882

 

Total

 

$

20,431

 

$

23,218

 

 


(1)          Represents the reclassification of the Equity Component equal to the unamortized debt discount of our Convertible Notes as of March 31, 2015 and December 31, 2014, respectively, from additional paid-in capital to temporary equity as our Convertible Notes were convertible at the election of their holders as noted above in Note 9— Debt Convertible Notes Due 2016 .

 

(2)          In connection with our amended 2007 agreement with Toray Industries Inc. (Toray), we issued 400,000 shares of our common stock and provided Toray the right to request that we repurchase the shares at a price of $27.21 per share.

 

11. Stockholders’ Equity

 

Earnings Per Common Share

 

Basic earnings per share is computed by dividing net income by the weighted average number of shares of common stock outstanding during the period. Diluted earnings per share is computed by dividing net income by the weighted average number of shares of common stock outstanding during the period, adjusted for the potential dilutive effect of other securities if such securities were converted or exercised.

 

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The components of basic and diluted earnings per common share comprised the following (in thousands, except per share amounts):

 

 

 

Three Months Ended 
March 31,

 

 

 

2015

 

2014

 

 

 

 

 

 

 

Net (loss) income (numerator)

 

$

(16,641

)

$

137,524

 

Denominator:

 

 

 

 

 

Weighted average outstanding shares — basic

 

46,707

 

50,402

 

Effect of dilutive securities (1) :

 

 

 

 

 

Convertible notes (2)

 

 

2,798

 

Warrants

 

 

1,780

 

Stock options and employee stock purchase plan

 

 

1,677

 

Weighted average shares — diluted

 

46,707

 

56,657

 

(Loss) earnings per common share:

 

 

 

 

 

Basic

 

$

(0.36

)

$

2.73

 

Diluted

 

$

(0.36

)

$

2.43

 

 

 

 

 

 

 

Stock options, warrants and shares of our common stock issued under our Convertible Notes excluded from calculation (2)

 

5,612

 

9,705

 

 


(1)          Calculated using the treasury stock method.

 

(2)          Certain stock options and warrants were excluded from the computation of diluted earnings per share because their impact would be anti-dilutive. Under our convertible note hedge agreement, we are entitled to receive shares required to be issued to investors upon conversion of our Convertible Notes. Since related shares used to compute dilutive earnings per share would be anti-dilutive, they have been excluded from the calculation above.

 

Stock Option Plan

 

We may grant stock options to employees and non-employees under our equity incentive plan. We estimate the fair value of stock options using the Black-Scholes-Merton valuation model, which requires us to make certain assumptions that can materially impact the estimation of fair value and related compensation expense. These assumptions used to estimate fair value include the expected volatility of our common stock, the risk-free interest rate, the expected term of stock option awards and the expected dividend yield. We did not grant any stock options during the three-month periods ended March 31, 2015 and March 31, 2014. We did not record share-based compensation expense related to employee stock options during the three-month periods ended March 31, 2015 and March 31, 2014.

 

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A summary of the activity and status of employee stock options during the three-month period ended March 31, 2015 is presented below:

 

 

 

Number of
Options

 

Weighted-
Average
Exercise
Price

 

Weighted
Average
Remaining
Contractual
Term
(Years)

 

Aggregate
Intrinsic
Value
(in thousands)

 

Outstanding at January 1, 2015

 

4,054,771

 

$

76.83

 

 

 

 

 

Granted

 

 

 

 

 

 

 

Exercised

 

(250,835

)

40.29

 

 

 

 

 

Forfeited

 

 

 

 

 

 

 

Outstanding and exercisable at March 31, 2015

 

3,803,936

 

$

79.24

 

6.4

 

$

354,509

 

 

Employee and non-employee stock option exercise data is summarized below (dollars in thousands):

 

 

 

Three Months Ended 
March 31,

 

 

 

2015

 

2014

 

Number of options exercised

 

251,835

 

271,242

 

Cash received

 

$

10,132

 

$

8,434

 

 

Employee Stock Purchase Plan

 

In June 2012, our shareholders approved the United Therapeutics Corporation Employee Stock Purchase Plan (ESPP), which has been structured to comply with Section 423 of the Internal Revenue Code. The ESPP provides eligible employees the right to purchase shares of our common stock at a discount through elective accumulated payroll deductions at the end of each offering period. Offering periods occur in consecutive six-month periods commencing in September and March of each year. For the offering period ending March 4, 2015, we issued 20,214 shares of our common stock for $1.9 million in employee contributions. Eligible employees may contribute up to 15 percent of their base salary, subject to certain annual limitations as defined in the ESPP. The purchase price of the shares is equal to the lower of 85 percent of the closing price of our common stock on either the first or last trading day of a given offering period. In addition, the ESPP provides that no eligible employee may purchase more than 4,000 shares during any offering period. The ESPP has a 20-year term and limits the aggregate number of shares that can be issued to 3.0 million.

 

Share-based compensation expense related to the ESPP for the three-month periods ended March 31, 2015 and March 31, 2014 was $310,700 and $231,000, respectively.

 

We estimate the fair value of the shares of our common stock to be purchased under the ESPP using the Black-Scholes-Merton model. Our approach in determining and estimating inputs for the ESPP is similar to the methodology we employ in valuing our STAP awards.

 

Share Repurchases

 

In June 2014, our Board of Directors authorized the repurchase of up to $500.0 million of our common stock in open market or privately negotiated transactions, at our discretion.  This program became effective on August 1, 2014, and will remain open for up to one year.  During the quarter ended March 31, 2015 we acquired 1,009,700 shares of our common stock at an aggregate cost of $152.3 million under this repurchase program.

 

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12. Accumulated Other Comprehensive Loss

 

The following table includes changes in accumulated other comprehensive loss by component, net of tax (in thousands):

 

 

 

Defined
Benefit
Pension
Plan(1)

 

Foreign
Currency
Translation
Losses

 

Unrealized
Gains
(Losses) on
Available-for-
Sale
Securities

 

Total

 

Balance, January 1, 2015

 

$

(6,957

)

$

(9,858

)

$

81

 

$

(16,734

)

Other comprehensive loss before reclassifications

 

(2,110

)

(3,117

)

(15

)

(5,242

)

Amounts reclassified from accumulated other comprehensive loss

 

333

 

 

 

333

 

Net current-period other comprehensive loss

 

(1,777

)

(3,117

)

(15

)

(4,909

)

Balance, March 31, 2015

 

$

(8,734

)

$

(12,975

)

$

66

 

$

(21,643

)

 


(1)          Refer to Note 7— Supplemental Executive Retirement Plan which identifies the captions within our consolidated statement of operations where reclassification adjustments were recognized and their associated tax impact.

 

13. Income Taxes

 

Income tax expense for the three-month periods ended March 31, 2015 and March 31, 2014 is based on the estimated effective tax rate for the entire year. The estimated annual effective tax rate can be subject to adjustment in subsequent quarterly periods if components used in its estimation are updated or revised. The estimated annual effective tax rates as of March 31, 2015 and March 31, 2014 were approximately 38 percent and approximately 35 percent, respectively. Our estimated annual effective tax rate increased as of March 31, 2015 primarily due to an increase in the amount of non-deductible compensation expense during 2015 as compared to 2014.

 

We are subject to federal and state taxation in the United States and various foreign jurisdictions. Currently, our 2010 to 2014 tax years are subject to examination by the Internal Revenue Service and by state taxing authorities.

 

We are unaware of any positions for which it is reasonably possible that the total amounts of unrecognized tax benefits will significantly increase or decrease within the next twelve months.

 

14. Segment Information

 

We currently operate as one operating segment. However, our chief operating decision makers regularly review revenues, cost of product sales and gross profit data as a primary measure of performance for each of our four commercial products.

 

Net revenues, cost of product sales and gross profit for each of our commercial products were as follows (in thousands):

 

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Three Months Ended March 31,

 

 

 

Remodulin

 

Tyvaso

 

Adcirca

 

Orenitram

 

Total

 

2015

 

 

 

 

 

 

 

 

 

 

 

Net revenues

 

$

146,281

 

$

113,380

 

$

45,370

 

$

20,886

 

$

325,917

 

Cost of product sales(1)

 

5,974

 

7,871

 

2,781

 

3,688

 

20,314

 

Gross profit

 

$

140,307

 

$

105,509

 

$

42,589

 

$

17,198

 

$

305,603

 

 

 

 

 

 

 

 

 

 

 

 

 

2014

 

 

 

 

 

 

 

 

 

 

 

Net revenues

 

$

136,106

 

$

107,086

 

$

41,361

 

$

 

$

284,553

 

Cost of product sales(2)

 

13,226

 

14,454

 

2,593

 

327

 

30,600

 

Gross profit

 

$

122,880

 

$

92,632

 

$

38,768

 

$

(327

)

$

253,953

 

 


(1)          Cost of product sales for the three months ended March 31, 2015 excludes costs related to the production of inventory for Unituxin, as this product was not approved by the FDA until March 2015.  We expect to commence sales of Unituxin in the second half of 2015.

 

(2)          Costs of product sales for the three months ended March 31, 2014 includes costs related to the production of inventory for Orenitram as this product was approved by the FDA in December 2013.  Sales of Orenitram commenced in the second quarter of 2014.

 

For the three-month periods ended March 31, 2015 and March 31, 2014, net revenues from our U.S.-based distributors represented 77 percent and 75 percent, respectively, of our total net operating revenues.

 

15. Litigation

 

Department of Health and Human Services Subpoena

 

In December 2013, we received a subpoena from the Office of the Inspector General (OIG) of the Department of Health and Human Services in connection with a civil investigation by the United States Department of Justice, principally represented by the United States Attorney’s Office for the District of Maryland. The subpoena requested documents regarding Remodulin, Tyvaso and Adcirca, including our marketing practices relating to these products. In April 2015, we received notice from the Department of Justice that the government had closed its investigation. The government is not planning any further action.

 

Sandoz Inc.

 

In February 2012, we received a Paragraph IV certification letter (the Original Notice Letter) from Sandoz Inc. (Sandoz) advising that Sandoz had submitted an abbreviated new drug application (ANDA) to the FDA requesting approval to market a generic version of the 10 mg/mL strength of Remodulin. In December 2012, we received notice (the Second Notice Letter) that Sandoz had amended its previously filed ANDA to request additional approval to market generic versions of the 1 mg/mL, 2.5 mg/mL, and 5 mg/mL strengths of Remodulin. In the Original Notice Letter and the Second Notice Letter, Sandoz stated that it intends to market a generic version of Remodulin before the expiration of the following patents relating to Remodulin: U.S.

 

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Patent No. 5,153,222, which expired in October 2014; U.S. Patent No. 6,765,117, which expires in October 2017; and U.S. Patent No. 7,999,007, which expires in March 2029. Each of these patents is listed in the Orange Book.

 

We responded to the Original Notice Letter by filing a lawsuit in March 2012 against Sandoz in the U.S. District Court for the District of New Jersey alleging patent infringement. We responded to the Second Notice Letter by filing an additional lawsuit in January 2013 for patent infringement in the U.S. District Court for the District of New Jersey. Sandoz filed counterclaims in each action alleging that the patents at issue in the litigation are invalid or will not be infringed by the commercial manufacture, use or sale of the proposed product described in Sandoz’s ANDA submission. Shortly before trial, Sandoz withdrew its request to market a generic version of Remodulin before the expiration of U.S. Patent No. 5,153,222, but maintained its request to market a generic version of Remodulin before the expiration of the other two patents. The trial for both lawsuits, limited to U.S. Patent Nos. 6,765,117 and 7,999,007, occurred in May and June 2014 and we received the Court’s decision in August 2014. In that decision, with respect to U.S. Patent No. 6,765,117 the Court both ruled that the patent is valid and enforceable against Sandoz, and enjoined Sandoz from marketing its generic product until the expiration of that patent in October 2017. With respect to U.S. Patent No. 7,999,007, the Court ruled that the patent is valid, but that it would not be infringed by Sandoz’s generic product.

 

Sandoz has appealed the ruling that U.S. Patent No. 6,765,117 is valid and would be infringed, and that U.S. Patent No. 7,999,007 is valid. We have filed a cross-appeal challenging the Court’s ruling that U.S. Patent No. 7,999,007 would not be infringed by Sandoz’s generic version of Remodulin.

 

In July 2014, we received an additional Paragraph IV certification letter (Third Notice Letter) from Sandoz, seeking permission to market and sell its generic version of Remodulin before the expiration of U.S. Patent No. 8,497,393, which expires in December 2028 and is also listed in the Orange Book. We responded to Sandoz’s Third Notice Letter by filing a lawsuit in September 2014 in the U.S. District Court for the District of New Jersey for patent infringement with respect to U.S. Patent No. 8,497,393.

 

We intend to vigorously enforce our intellectual property rights relating to Remodulin.

 

Teva Pharmaceuticals USA, Inc.

 

On July 21, 2014, we received a Paragraph IV certification letter (Teva’s Notice Letter) from Teva Pharmaceuticals USA, Inc. (Teva) advising that Teva had submitted an ANDA to the FDA requesting approval to market a generic version of Remodulin.

 

In Teva’s Notice Letter, Teva states that it intends to market a generic version of Remodulin before the expiration of U.S. Patent Nos. 6,765,117 and 8,497,393, both of which are also the subject of Paragraph IV certifications by Sandoz, as discussed above. Teva’s Notice Letter states that the ANDA contains a Paragraph IV certification alleging that these patents are not valid, not enforceable and/or will not be infringed by the commercial manufacture, use or sale of the proposed product described in Teva’s ANDA submission.

 

We responded to Teva’s Notice Letter by filing a lawsuit in September 2014 against Teva in the U.S. District Court for the District of New Jersey alleging infringement of U.S. Patent Nos. 6,765,117, 7,999,007 and 8,497,393, as well as infringement of U.S. Patent Nos. 8,653,137 and 8,658,694, both of which expire in September 2028. Teva has filed its answer to our complaint, and has also filed a counterclaim alleging that the patents at issue in the litigation are invalid or will not be infringed by the commercial manufacture, use or sale of the proposed product described in Teva’s ANDA submission. We have filed an answer to the counterclaim.

 

Under the Hatch-Waxman Act, the FDA is automatically precluded from approving Teva’s ANDA for up to 30 months from receipt of Teva’s Notice Letter or until the issuance of a U.S. District Court decision that is adverse to us, whichever occurs first.

 

We intend to vigorously enforce our intellectual property rights relating to Remodulin.

 

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Item 2.    MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

The following discussion should be read in conjunction with our Annual Report on Form 10-K for the year ended December 31, 2014, and the consolidated financial statements and accompanying notes included in Part I, Item I of this Quarterly Report on Form 10-Q. The following discussion contains forward-looking statements made pursuant to the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, including the statements listed in the section below entitled Part II, Item 1A—Risk Factors . These statements are based on our beliefs and expectations about future outcomes, and are subject to risks and uncertainties that could cause our actual results to differ materially from anticipated results. Factors that could cause or contribute to such differences include those described in Part II, Item 1A—Risk Factors of this Quarterly Report on Form 10-Q; factors described in our Annual Report on Form 10-K for the year ended December 31, 2014, under the section entitled Part I, Item 1A—Risk Factors—Forward-Looking Statements ; and factors described in other cautionary statements, cautionary language and risk factors set forth in other filings with the Securities and Exchange Commission (SEC). We undertake no obligation to publicly update these forward-looking statements, whether as a result of new information, future events or otherwise.

 

Overview

 

Our key therapeutic products and product candidates include:

 

·                   Prostacyclin analogues (Remodulin ® , Tyvaso ® , Orenitram ®  and esuberaprost, formally called 314d) : stable synthetic forms of prostacyclin, an important molecule produced by the body that has powerful effects on blood vessel health and function;

 

·                   Phosphodiesterase type 5 (PDE-5) inhibitor (Adcirca ® ) : a molecule that acts to inhibit the degradation of cyclic guanosine monophosphate (cyclic GMP) in cells. Cyclic GMP is activated by nitric oxide (NO), a naturally occurring substance in the body that mediates the relaxation of vascular smooth muscle;

 

·                   Monoclonal antibody for oncologic applications (Unituxin TM , formerly called ch14.18) : an antibody that treats cancer by activating the immune system;

 

·                   Glycobiology antiviral agents : a novel class of small, sugar-like molecules that have shown antiviral activity in a range of preclinical settings;

 

·                   Cell-based therapy : a cell-based product known as PLacental eXpanded (PLX) cells we are developing for the treatment of pulmonary hypertension; and

 

·                   Lung transplantation : engineered lungs and lung tissue, which we are developing using xenotransplantation and regenerative medicine technologies, for transplantation in patients suffering from pulmonary arterial hypertension (PAH) and other lung diseases. Through our wholly-owned subsidiary, Lung Biotechnology PBC, we are also developing technologies aimed at improving outcomes for lung transplant recipients and increasing the supply of donor lungs through ex-vivo lung perfusion.

 

We concentrate substantially all of our research and development efforts on the preceding key therapeutic programs.

 

We currently market and sell the following commercial products:

 

·                   Remodulin (treprostinil) Injection (Remodulin). Remodulin, a continuously-infused formulation of the prostacyclin analogue treprostinil, is approved by the United States Food and Drug Administration (FDA) for subcutaneous (under

 

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the skin) and intravenous (in the vein) administration. Remodulin is indicated to diminish symptoms associated with exercise in World Health Organization (WHO) Group 1 PAH patients. Remodulin is also approved for the treatment of patients requiring transition from Flolan ®  (epoprostenol sodium) for Injection. Remodulin has also been approved in various countries outside of the United States.

 

·                   Tyvaso (treprostinil) Inhalation Solution (Tyvaso). Tyvaso, an inhaled formulation of treprostinil, is approved by the FDA to improve exercise ability in WHO Group 1 PAH patients.

 

·                   Orenitram (treprostinil) Extended-Release Tablets (Orenitram). In December 2013, the FDA approved Orenitram, a tablet dosage form of treprostinil, for the treatment of PAH in WHO Group 1 PAH patients to improve exercise capacity. We commenced sales of Orenitram during the second quarter of 2014.

 

·                   Adcirca (tadalafil) Tablets (Adcirca). We acquired exclusive commercialization rights to Adcirca, an oral PAH therapy, in the United States and Puerto Rico from Eli Lilly and Company (Lilly). Adcirca is approved by the FDA to improve exercise ability in WHO Group 1 PAH patients.

 

On March 10, 2015, the FDA approved Unituxin (dinutuximab) Injection (Unituxin), in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy. We expect to commence U.S. sales of Unituxin in the second half of 2015.

 

Revenues

 

Sales of Remodulin, Tyvaso and Adcirca comprise substantially all of our revenues. Despite commencing Orenitram sales during the second quarter of 2014, we remain substantially reliant on sales of Remodulin, Tyvaso and Adcirca as our principal sources of revenue.

 

We have entered into separate, non-exclusive distribution agreements with Accredo Health Group, Inc. (Accredo) and CVS Caremark (Caremark) in the United States, to distribute Remodulin, Tyvaso and Orenitram. We also sell Remodulin to distributors internationally. Under our distribution agreements, we sell each of our treprostinil-based products to these distributors at a transfer price that we establish. We have generally increased the price of Tyvaso by 4.9 percent annually, and the last price increase became effective on January 1, 2015. We have not increased the price of Remodulin since 2010.

 

We sell Adcirca through Lilly’s pharmaceutical wholesaler network at a price determined by Lilly, which Lilly generally increases two or three times per year. Most recently, Lilly increased the price of Adcirca by 9.9 percent effective December 4, 2014.

 

We recognize revenues for the sale of Remodulin, Tyvaso, Orenitram and Adcirca net of estimated rebates, prompt pay discounts, allowances for sales exchanges and returns, and distributor fees.

 

Generic Competition

 

We disclose in Part II, Item 1.—Legal Proceedings of this Quarterly Report on Form 10-Q (and in Note 15 — Litigation , to our consolidated financial statements included with this Quarterly Report on Form 10-Q), that we are engaged in litigation with Sandoz Inc. (Sandoz) and Teva Pharmaceuticals USA, Inc. (Teva), contesting their abbreviated new drug applications (ANDAs) seeking FDA approval to market generic versions of Remodulin before the expiration of certain of our U.S. patents in October 2017, September 2028, December 2028 and March 2029.

 

We intend to vigorously enforce our intellectual property rights relating to Remodulin.  However, there can be no assurance that we will prevail in defending our patent rights, or that additional challenges from other ANDA filers or other challengers will not surface with respect to Remodulin or our other treprostinil-based products. Our existing patents could be invalidated, found unenforceable or found not to cover one or more generic forms of Remodulin, Tyvaso or Orenitram. If any

 

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ANDA filer were to receive approval to sell a generic version of Remodulin, Tyvaso or Orenitram and/or prevail in any patent litigation, the affected product(s) would become subject to increased competition which could reduce our sales.

 

Certain patents for Revatio ® , a PDE-5 inhibitor marketed by Pfizer, Inc. for treatment of PAH, expired in 2012, leading several manufacturers to launch generic formulations of sildenafil citrate, the active ingredient in Revatio. Generic sildenafil’s lower price relative to Adcirca could lead to an erosion of Adcirca’s market share and limit its potential sales. Although we believe Adcirca’s once-daily dosing regimen provides a significant competitive advantage over generic sildenafil’s multiple dosing regimen, we believe that government payers and private insurance companies may favor the use of less expensive generic sildenafil over Adcirca. Thus far, we have not observed any measurable impact of generic sildenafil on sales of Adcirca; however, circumstances could change over time and our revenues could be adversely impacted. The U.S. patent for Adcirca for the treatment of pulmonary hypertension will expire in November 2017.

 

Patent expiration and generic competition for any of our commercial products could have a significant, adverse impact on the magnitude of our revenues, which is inherently difficult to predict. For additional discussion, refer to the risk factor entitled, Our intellectual property rights may not effectively deter competitors from developing competing products that, if successful, could have a material adverse effect on our revenues and profits , contained in Part II Item 1A—Risk Factors  included in this Quarterly Report on Form 10-Q.

 

Operating Expenses

 

Our operating expenses include the following costs:

 

Research and Development

 

Our research and development expenses primarily include costs associated with the research and development of products and post-marketing research commitments. These costs generally include share-based compensation and salary-related expenses for research and development functions, professional fees for preclinical and clinical studies, costs associated with clinical manufacturing, facilities-related expenses and regulatory costs.  Expenses also include costs for third-party arrangements, including upfront fees and milestones paid in connection with license arrangements for therapies under development.

 

Selling, General and Administrative

 

Our selling, general and administrative expenses primarily include costs associated with the commercialization of approved products and general and administrative costs to support our operations. Selling expenses generally include share-based compensation, salary-related expenses, product marketing and sales operations costs, and other costs incurred to support our sales efforts.  General and administrative expenses include our core corporate support functions such as human resources, finance and legal; and other external corporate costs such as insurance, legal fees and other professional services.

 

Cost of Product Sales

 

Our cost of product sales primarily include costs to manufacture and acquire products sold.  These costs generally include share-based compensation and salary-related expenses for manufacturing personnel, commercial distribution and support functions, direct materials and supplies, depreciation, building and overhead expenses and royalty payments under licensing agreements.  Expenses also include the cost to warehouse, transfer and distribute products to customers.

 

We began selling Orenitram during 2014. Typical of the initial commercial activities of a newly-launched product, Orenitram’s cost of product sales as a percentage of its net revenue is significantly higher than that of our other commercial products. We expect that as Orenitram’s revenues increase, its cost of product sales as a percentage of net revenue will decrease to levels similar to our other treprostinil-based commercial products.

 

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Share-Based Compensation

 

As discussed above, our operating expenses, and thus net income, are often materially impacted by the recognition of share-based compensation expense (benefit) associated with awards granted under our share tracking award plans (STAP) and potential stock option grants containing a market or performance condition, as the fair value of these awards varies with the changes in our stock price. The fair values of STAP awards and potential stock option grants are measured using inputs and assumptions under the Black-Scholes-Merton model that can materially impact the amount of compensation expense (benefit) for a given period. We account for STAP awards as liabilities because they are settled in cash. As such, we must re-measure the fair value of outstanding STAP awards at the end of each financial reporting period until the awards are no longer outstanding. Changes in our STAP-related liability resulting from such re-measurements are recorded as adjustments to share-based compensation expense (benefit) and can create substantial volatility within our operating expenses from financial reporting period to period.

 

Through December 31, 2014, we were contractually obligated to award stock options each year to our Chairman and Co-Chief Executive Officer, Dr. Rothblatt, based on a formula tied to the growth (if any) in our market capitalization. These awards were granted at year-end, and vested immediately upon grant. We accrued compensation expense for Dr. Rothblatt’s estimated stock option grant when we determined that it was probable that the performance criteria would be met. Beginning in 2015, Dr. Rothblatt’s long term incentive compensation will be similar to other employees in that she will be eligible for an annual grant of performance-based STAP awards or stock options based on the achievement of our annual corporate milestones, which will vest over a four-year period from the grant date. Accordingly, there will be no share-based compensation expense recorded in calendar year 2015 for Dr. Rothblatt as the annual grant of performance-based STAP awards or stock options will be granted in calendar year 2016, if earned, based upon 2015 performance.

 

Major Research and Development Projects

 

Our major research and development projects focus on: (1) the use of prostacyclin analogues and other therapies, as well as lung transplantation technologies, to treat cardiopulmonary diseases; (2) monoclonal antibodies to treat cancer; and (3) glycobiology antiviral agents to treat infectious diseases.

 

Cardiopulmonary Disease Projects

 

Remodulin Implantable System

 

In 2009, we entered into an agreement with exclusive rights in the United States, United Kingdom, France, Germany, Italy and Japan, with Medtronic, Inc. (Medtronic) to develop its proprietary intravascular infusion catheter to be used with Medtronic’s SynchroMed® II implantable infusion pump and related infusion system components (together referred to as the Remodulin Implantable System) in order to deliver Remodulin for the treatment of PAH. If the Remodulin Implantable System is successful, it could reduce many of the patient burdens and other complications associated with the use of external pumps to administer prostacyclin analogues. With our funding, Medtronic completed the DelIVery clinical trial, in order to study the safety of the Remodulin Implantable System while administering Remodulin. The primary objective was to demonstrate a rate of catheter-related complications below 2.5 per 1,000 patient-days while using the Remodulin Implantable System to deliver Remodulin. In September 2013, Medtronic informed us that this primary objective was met (p<0.0001). In December 2014, Medtronic completed other stability, compatibility and technical assessments of the Remodulin Implantable System, including modifications to its hardware and software, and submitted a premarket approval application (PMA) seeking FDA approval for the catheter and labeling changes. Medtronic received notification that the PMA was accepted for review in January 2015. Medtronic is responsible for responding to any FDA requests for additional information concerning the use of the Remodulin Implantable System with Remodulin. In January 2015, we submitted a supplemental NDA with new labeling requesting FDA

 

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approval to allow the use of Remodulin with the Remodulin Implantable System. The FDA has indicated that our submission will be treated as a new NDA and asked us to resubmit the supplement as a new NDA.

 

In March 2015, the FDA requested that Medtronic amend its PMA for the Remodulin Implantable System to reflect an amendment to the SynchroMed II PMA separately submitted by Medtronic’s neuromodulation business unit, and issued a refuse-to-file letter with respect to our NDA for the Remodulin Implantable System. Medtronic has amended its PMA, and we are working to resubmit our NDA, to address the FDA’s requests. Once the amendment and resubmission have been completed, we anticipate a ten-month review process by FDA.

 

On April 27, 2015, the FDA filed a consent decree against Medtronic requiring the company to stop manufacturing, designing and distributing SynchroMed II implantable infusion pump systems, citing violations of the quality system regulation for medical devices. The consent decree will remain in effect until the FDA has determined that Medtronic has met all the provisions listed in the consent decree.  We are currently assessing the impact of this consent decree on our program to develop the Remodulin Implantable System.

 

Subcutaneous Remodulin Administered via Pre-Filled, Semi-Disposable Pump

 

In December 2014, we entered into an exclusive agreement with DEKA Research & Development Corp. (DEKA) to develop a pre-filled, semi-disposable pump system for subcutaneous delivery of Remodulin. Under the terms of the agreement, we will fund the development costs related to the semi-disposable pump system and will pay product fees and a single-digit royalty to DEKA based on commercial sales of the system and the Remodulin sold for use with the system. Our goal is to be in a position to receive FDA approval for this delivery system by the end of 2018.

 

Tyvaso

 

In connection with Tyvaso’s approval by the FDA, we agreed to a post-marketing requirement (PMR) obligating us to conduct an additional study to continue to assess the safety of Tyvaso. In accordance with our PMR, we are required to complete a long-term observational study in the United States that includes 1,000 patient years of follow-up in patients treated with Tyvaso and 1,000 patient years of follow-up in control patients receiving other PAH treatments, to evaluate the potential association between Tyvaso and oropharyngeal and pulmonary toxicity. We have completed this study and are preparing to submit the results of the study by the FDA’s deadline of June 30, 2015 to meet the PMR. In addition, we are developing further enhancements intended to make the Tyvaso Inhalation System easier to use.

 

Orenitram

 

In December 2013, the FDA approved Orenitram for the treatment of PAH in WHO Group 1 patients to improve exercise capacity. The primary study that supported efficacy of Orenitram was a 12-week monotherapy study (FREEDOM-M) in which PAH patients were not on any approved background therapy.

 

We believe that in order for Orenitram to reach its full commercial potential, we need to complete further studies to support an amendment to Orenitram’s label to indicate that Orenitram delays morbidity and mortality in patients who are on an approved oral background therapy. As such, we are enrolling up to 610 patients in a phase IV clinical trial called FREEDOM-EV, which began in 2012. FREEDOM-EV is a placebo-controlled study of patients who enter the study on an approved background therapy, and one of the two primary endpoints of the study is the time to clinical worsening.

 

We expect to seek approval of Orenitram in Europe upon completion of the FREEDOM-EV study. In 2005, the European Medicines Agency (EMA) announced that Orenitram had been designated an orphan medicinal product for the treatment of PAH. A request for orphan drug designation for Orenitram is pending before the FDA.

 

Esuberaprost (formally called 314d)

 

We have been studying various formulations of beraprost since 2000, under a license agreement with Toray Industries, Inc. (Toray). In July 2012, we completed a phase I safety trial of esuberaprost, a reformulated, single-isomer version of beraprost, and the data suggested that dosing esuberaprost four times a day was safe. We believe that esuberaprost and treprostinil have differing prostacyclin receptor-binding profiles and thus could provide benefits to certain groups of patients with differing sets of safety and efficacy profiles. We also believe that inhaled treprostinil and esuberaprost have complimentary pharmacokinetic and pharmacodynamic profiles, which indicate that they should provide greater efficacy in combination. As a result, in 2013 we began enrolling a phase III study called BEAT ( BE raprost 314d A dd-on to T yvaso) to evaluate the clinical benefit and safety of esuberaprost in combination with Tyvaso for

 

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patients with PAH who show signs of deterioration on inhaled treprostinil or have a less than optimal response to inhaled treprostinil treatment. We intend to enroll 240 patients in the study, which will have a primary endpoint of time to clinical worsening. If we are not successful in securing FDA approval of esuberaprost in combination with Tyvaso following the BEAT study, we expect to terminate our license agreement with Toray.

 

Cell-Based Therapy

 

In 2011, we entered into a license agreement with Pluristem Ltd. (Pluristem) to develop and commercialize a cell-based product for the treatment of PAH using Pluristem’s proprietary cell technology known as PLacental eXpanded (PLX) cells. We commenced a phase I clinical study in Australia in 2013.

 

Lung Transplantation

 

The only reported cure for PAH is a lung transplant. We believe that fewer than 100 PAH patients receive a lung transplant each year due to the shortage of available lungs for transplant and the demand for transplantable lungs in patients with other end-stage pulmonary diseases, such as chronic obstructive pulmonary disease and idiopathic pulmonary fibrosis.

 

In 2011, we acquired all of the outstanding stock of Revivicor, Inc., a company focused on developing genetic biotechnology platforms to provide alternative tissue sources for the treatment of human degenerative disease through tissue and organ xenotransplantation. We are focused on this platform with the goal of providing transplantable lungs for human patients.

 

In May 2014, we completed a $50.0 million preferred stock investment in Synthetic Genomics Inc. (SGI). We also entered into a separate multi-year research and development collaboration agreement with SGI whereby SGI will develop engineered primary pig cells with modified genomes for use in our xenotransplantation program, which is principally focused on lungs. Under this agreement, each party will assume its own research and development costs and SGI may receive royalties and milestone payments from development and commercialization of organs.

 

We are also engaged in preclinical development of several regenerative technologies for creating transplantable lung tissue and whole lungs for patients with end-stage lung disease, as well as other technologies intended to improve outcomes for lung transplant recipients. We are preparing to commence a clinical trial in the United States to study the use of ex-vivo lung perfusion technology originally developed in Canada (where it is already used commercially) to provide extended preservation and assessment of donated lungs that are initially rejected for transplantation. In 2014, we completed the construction of the only laboratory facility in the United States devoted to performing ex-vivo lung perfusion on a fee-for-service basis.

 

From inception to March 31, 2015, we have spent $1.1 billion on all of our current and former cardiopulmonary disease programs.

 

Cancer-Related Projects

 

Unituxin (formerly called ch14.18)

 

In 2010, we entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) of the United States National Institutes for Health (NIH) to collaborate on the late-stage development and regulatory approval process for Unituxin for children with high-risk neuroblastoma and patients with other forms of cancer. Unituxin is an antibody that has shown potential in the treatment of neuroblastoma by targeting GD2, a glycolipid on the surface of tumor cells. Under the terms of the CRADA, the NCI completed necessary studies and we developed the ability to produce Unituxin on a commercial scale. Collectively, related NCI-supported studies and our production data were used as the foundation for our marketing authorization application, which the EMA accepted for review in December 2013, and a biologics license application (BLA), which the FDA accepted for review in June 2014. On March 10, 2015, the FDA approved Unituxin, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy. We expect to commence sales of Unituxin in the second half of 2015. We previously received orphan drug designation for Unituxin from both the FDA and the EMA. Orphan designation, coupled with

 

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FDA approval of our BLA, confers an exclusivity period through March 2022, during which the FDA may not approve any application to market the same drug for the same indication, except in limited circumstances. In lieu of a royalty payment to the NCI, we have an ongoing obligation to provide the NCI with Unituxin for its studies free of charge.

 

In conjunction with the BLA approval for Unituxin, the FDA awarded us a Rare Pediatric Priority Review Voucher.  The voucher can be sold (without limitation), and the holder of the voucher can redeem it with a subsequently filed New Drug Application or Biologics License Application, which would require the FDA to meet the review goals for a priority review, as opposed to a standard review.

 

We have spent $127.0 million from inception to March 31, 2015, on all of our current and former cancer programs.

 

Infectious Disease Projects

 

Pursuant to our research agreement with the University of Oxford (Oxford), we have the exclusive right to commercialize a platform of glycobiology antiviral drug candidates in various preclinical stages of testing for the treatment of a wide variety of viruses. Through our research agreement with Oxford, we are also supporting the research of new glycobiology antiviral drug candidates and technologies. We are currently testing many of these compounds in preclinical studies and Oxford continues to synthesize new agents that we may elect to test.

 

In 2011, we were awarded a cost plus fixed fee contract with an aggregate value of up to $45.0 million under a Broad Agency Announcement from the National Institute of Allergy and Infectious Diseases (NIAID) of the NIH for studies directed toward the development of a broad spectrum antiviral drug with a primary indication for dengue and a secondary indication for influenza, based on our glycobiology antiviral platform. There are eight milestone-based options to expand the project and funding under the contract. To date, we have received contract modifications exercising five of these options, increasing total committed contract funding to $28.1 million. We recognize revenue under this contract to the extent of allowable costs incurred, plus a proportionate amount of fees earned. Related revenues are included under the caption Other Revenues on our consolidated statements of operations.

 

We began enrolling a phase I clinical trial of our lead antiviral candidate, an alpha-glucosidase inhibitor called UV-4B, for the treatment of dengue in the third quarter of 2014. In November 2014, the FDA granted orphan drug designation for UV-4B for the treatment of acute dengue illness. We are also performing preclinical studies of UV-4B for the treatment of patients with influenza.

 

From inception to March 31, 2015, we have spent $89.9 million on all of our current and former infectious disease programs.

 

Future Prospects

 

The extent of our future success is dependent on, among other things, how well we achieve the following objectives: (1) in the near term, continued sales growth of our current commercial products by increasing our market share and launching enhancements designed to improve patient care, such as new delivery systems for Remodulin, and growing sales of our recently-launched product, Orenitram; (2) in the medium term, augmenting our near-term product growth through: (a) the successful launch of Orenitram for use in combination with other oral therapies following positive FREEDOM-EV results, and (b) the launch of esuberaprost following positive results of the BEAT study; and (3) in the long term, supplementing our oral, inhaled and infused PAH therapy revenues by introducing transplantable cells, tissues and organs that may prove effective in treating PAH and other end-stage lung diseases.

 

Our ability to achieve these objectives and sustain our growth and profitability will depend on many factors, including among others: (1) the timing and outcome of clinical trials and regulatory approvals for products we develop; (2) the timing of and the degree of success related to the commercial launch of new products; (3) the demand for our products; (4) pricing and reimbursement of our products by public and private health insurance organizations; (5) the competition we face within our industry; (6) our ability to effectively manage our business in an increasingly complex legal and regulatory environment; (7)

 

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our ability to defend against generic competition and challenges to our patents, including the ongoing challenges to our Remodulin patents by two generic drug companies; and (8) the risks identified in Part II, Item 1A—Risk Factors , included in this Quarterly Report on Form 10-Q.

 

We may need to construct additional facilities to support the development and commercialization of our products. For example, the development of broad-spectrum anti-viral drugs, cell therapies and transplantable lungs and lung tissues will require the design and construction of sophisticated facilities that will need to comply with stringent regulatory requirements related to these programs, some of which have not yet been developed or adopted by the relevant government agencies. The extent to which we fully develop any of these facilities will depend on the progress of our pre-clinical and clinical development in various earlier stage programs.

 

We operate in a highly competitive market in which a small number of pharmaceutical companies control a majority share of available PAH therapies. These pharmaceutical companies are well established in the market and possess greater financial, technical and marketing resources than we do. In addition, there are a number of investigational products in late-stage development that, if approved, may erode the market share of our existing commercial therapies and make market acceptance more difficult to achieve for any therapies we attempt to market in the future.

 

Financial Position

 

Cash, cash equivalents and marketable securities at March 31, 2015 and December 31, 2014 (excluding restricted amounts of $5.4 million) were $768.0 million and $812.8 million, respectively.  The decrease of $44.8 million in unrestricted cash, cash equivalents and marketable securities resulted primarily from the use of $152.3 million to repurchase shares of our common stock, offset by $109.0  million of cash generated from operating activities.

 

Other current assets increased by $59.2 million from $49.4 million at December 31, 2014 to $108.6 million at March 31, 2015.  The increase is primarily due to an increase in current deferred tax assets and federal and state tax payments that we will apply against our 2015 annual tax liabilities.

 

The STAP liability (current) increased by $110.3 million, from $282.1 million at December 31, 2014, to $392.4 million at March 31, 2015. The increase of the liability resulted from a 33 percent increase in the price of our common stock during the year, offset partially by exercises and forfeitures of STAP awards.

 

Additional paid-in capital was $1,427.0 million at March 31, 2015, compared to $1,376.1 million at December 31, 2014. The $50.9 million increase in additional paid-in capital primarily consisted of the following components: (1) $18.9 million in proceeds from stock option exercises and related tax benefits; (2) $27.8 million related to the common stock issued in connection with the early conversion of $14.0 million of our Convertible Notes based on the closing price of our common stock on the date the shares were issued; and (3) $1.9 million in proceeds from the issuance of 20,214 shares of our common stock under our employee stock purchase plan.

 

The $180.0 million increase in treasury stock from $1,185.8 million at December 31, 2014 to $1,365.9 million at March 31, 2015, was driven by: (1) our repurchase of approximately 1.0 million shares of our common stock at a cost of $152.3 million during the quarter; and (2) $27.8 million reflecting the receipt of approximately 193,000 shares from our note hedge in connection with the early conversion of $14.0 million of our Convertible Notes based on the closing price of our common stock on the date the shares were received during the three months ended March 31, 2015. Refer to Note 11— Stockholders’ Equity—Share Repurchases and Note 9 —Debt—Convertible Notes Due 2016 to our consolidated financial statements.

 

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Three Months Ended March 31, 2015 and March 31, 2014

 

Revenues

 

The following table sets forth the components of net revenues (dollars in thousands):

 

 

 

Three Months Ended

March 31,

 

Percentage

 

 

 

2015

 

2014

 

Change

 

Cardiopulmonary products:

 

 

 

 

 

 

 

Remodulin

 

$

146,281

 

$

136,106

 

7.5

%

Tyvaso

 

113,380

 

107,086

 

5.9

%

Adcirca

 

45,370

 

41,361

 

9.7

%

Orenitram

 

20,886

 

 

100.0

%

Other

 

1,587

 

4,850

 

(67.3

)%

Total net revenues

 

$

327,504

 

$

289,403

 

13.2

%

 

The growth in product revenues for the three months ended March 31, 2015, compared to the same quarter in 2014, corresponded primarily to the continued increase in the number of patients being treated with our products and the commencement of Orenitram sales. For the three months ended March 31, 2015 and March 31, 2014, approximately 77 percent and 75 percent, respectively, of total net revenues were derived from our U.S.-based specialty pharmaceutical distributors.

 

The tables below include a reconciliation of the accounts associated with estimated rebates, prompt-pay discounts, sales allowances and distributor fees (in thousands):

 

 

 

Three Months Ended March 31, 2015

 

 

 

Rebates

 

Prompt Pay
Discounts

 

Allowance
for Sales
Returns

 

Distributor
Fees

 

Total

 

Balance, January 1, 2015

 

$

31,616

 

$

3,285

 

$

4,028

 

$

557

 

$

39,486

 

Provisions attributed to sales in:

 

 

 

 

 

 

 

 

 

 

 

Current period

 

38,585

 

7,492

 

465

 

2,223

 

48,765

 

Prior periods

 

1,874

 

 

 

(255

)

1,619

 

Payments or credits attributed to sales in:

 

 

 

 

 

 

 

 

 

 

 

Current period

 

(6,532

)

(4,396

)

 

(599

)

(11,527

)

Prior periods

 

(30,790

)

(3,245

)

(289

)

(1,590

)

(35,914

)

Balance, March 31, 2015

 

$

34,753

 

$

3,136

 

$

4,204

 

$

336

 

$

42,429

 

 

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Three Months Ended March 31, 2014

 

 

 

Rebates

 

Prompt Pay
Discounts

 

Allowance
for Sales
Returns

 

Distributor
Fees

 

Total

 

Balance, January 1, 2014

 

$

22,475

 

$

2,500

 

$

2,862

 

$

1,092

 

$

28,929

 

Provisions attributed to sales in:

 

 

 

 

 

 

 

 

 

 

 

Current period

 

26,155

 

6,293

 

357

 

1,988

 

34,793

 

Prior periods

 

6,265

 

 

 

306

 

6,571

 

Payments or credits attributed to sales in:

 

 

 

 

 

 

 

 

 

 

 

Current period

 

(2,795

)

(3,843

)

 

(368

)

(7,006

)

Prior periods

 

(25,198

)

(2,313

)

(159

)

(1,108

)

(28,778

)

Balance, March 31, 2014

 

$

26,902

 

$

2,637

 

$

3,060

 

$

1,910

 

$

34,509

 

 

Research and Development Expense

 

The table below summarizes research and development expense by major project and non-project component (dollars in thousands):

 

 

 

Three Months Ended

 

 

 

 

 

March 31,

 

Percentage

 

 

 

2015

 

2014

 

Change

 

Project and non-project component:

 

 

 

 

 

 

 

Cardiopulmonary

 

$

26,894

 

$

28,288

 

(4.9

)%

Share-based compensation expense (benefit)

 

75,019

 

(26,574

)

382.3

%

Other

 

8,299

 

10,734

 

(22.7

)%

Total research and development expense

 

$

110,212

 

$

12,448

 

785.4

%

 

Share-based compensation. The increase in share-based compensation of $101.6 million for the three months ended March 31, 2015, compared to the same three-month period in 2014, was due to a 33 percent increase in our stock price to $172.44 at March 31, 2015, compared to a 17 percent decrease in our stock price to $94.03 at March 31, 2014, partially offset by expense for certain staff that is now included within selling, general and administrative classification due to a change in their responsibilities in the first quarter of 2015.

 

Selling, General and Administrative Expense

 

The table below summarizes selling, general and administrative expense by major category (dollars in thousands):

 

 

 

Three Months Ended
March 31,

 

Percentage

 

 

 

2015

 

2014

 

Change

 

Category:

 

 

 

 

 

 

 

General and administrative

 

$

37,713

 

$

43,148

 

(12.6

)%

Sales and marketing

 

23,737

 

18,923

 

25.4

%

Share-based compensation expense (benefit)

 

149,890

 

(31,856

)

570.5

%

Total selling, general and administrative expense

 

$

211,340

 

$

30,215

 

599.5

%

 

General and administrative. The decrease in general and administrative expense of $5.4 million for the three months ended March 31, 2015, compared to the same three-month period in 2014, resulted primarily from the following: (1) a $2.9 million decrease in professional and consulting fees, primarily driven by a decrease in legal fees in connection with ongoing legal

 

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matters; and (2) a $7.7 million decrease in grants to non-affiliated, non-profit organizations that provide financial assistance to patients with PAH.  These decreases were partially offset by a $4.3 million increase in salaries and related expenses due to the growth of our operations.

 

Sales and marketing.  The increase in sales and marketing expenses of $4.8 million for the quarter ended March 31, 2015, compared to the same quarter in 2014, was driven by increases in marketing activities, salaries and other compensation-related expenses, as we expanded our sales personnel subsequent to the first quarter of 2014.

 

Share-based compensation. The increase in share-based compensation of $181.7 million for the three months ended March 31, 2015, compared to the same three-month period in 2014, was due to a 33 percent increase in our stock price to $172.44 at March 31, 2015, compared to a 17 percent decrease in our stock price to $94.03 at March 31, 2014, and additional expense for certain staff that was previously included within research and development expense that is now included within the general and administrative classification due to a change in their responsibilities in the first quarter of 2015.

 

Cost of Product Sales

 

The table below summarizes cost of product sales by major category (dollars in thousands):

 

 

 

Three Months Ended

 

 

 

 

 

March 31,

 

Percentage

 

 

 

2015

 

2014

 

Change

 

Category:

 

 

 

 

 

 

 

Cost of product sales

 

$

11,156

 

$

32,893

 

(66.1

)%

Share-based compensation expense (benefit)

 

9,622

 

(2,293

)

519.6

%

Total cost of product sales

 

$

20,778

 

$

30,600

 

(32.1

)%

 

Cost of product sales. The decrease in cost of product sales for the quarter ended March 31, 2015, compared to the same quarter in 2014, was due to the expiration of our royalty payment obligation to GlaxoSmithKline plc in October 2014.  During the three months ended March 31, 2014, we paid GlaxoSmithKline plc $20.0 million in royalties.

 

Share-based compensation. The increase in share-based compensation of $11.9 million for the three months ended March 31, 2015, compared to the same three-month period in 2014, was due to a 33 percent increase in our stock price to $172.44 at March 31, 2015, compared to a 17 percent decrease in our stock price to $94.03 at March 31, 2014.

 

Income Tax Expense

 

The provision for income tax expense is based on an estimated annual effective tax rate that is subject to adjustment in subsequent quarterly periods if components used to estimate the annual effective tax rate are updated or revised. Our estimated annual effective tax rates were approximately 38 percent and approximately 35 percent as of March 31, 2015 and March 31, 2014, respectively.  Our 2015 estimated annual effective tax rate increased as of March 31, 2015 primarily due to an increase in the amount of non-deductible compensation expense estimated for 2015 as compared to 2014.

 

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Liquidity and Capital Resources

 

We have funded our operations principally through sales of our commercial products and, from time-to-time, third-party financing arrangements. We believe that our current liquidity is sufficient to fund ongoing operations and future business plans as we expect demand for our commercial products to continue to grow. Furthermore, our customer base remains stable and we believe it presents minimal credit risk. However, any projections of future cash flows are inherently subject to uncertainty and we may seek other forms of financing.

 

Cash Flows

 

Operating Activities

 

Our operating assets and liabilities consist primarily of accounts receivable, inventories, accounts payable and accrued expenses, which include share-based compensation arrangements. Historically, the combination of revenue growth and profitable operations has resulted in cash flows provided by operations.

 

Net cash provided by operating activities was $109.0 million for the three months ended March 31, 2015, compared to $110.6 million for the three months ended March 31, 2014.  The $1.6 million decrease in cash flows from operations was primarily due to year-over-year changes in the following:

 

(i)              Increase in cash provided by operating activities:

 

·                   $38.1 million increase in product sales, which resulted in higher cash collections; and

 

·                   $50.6 million decrease in cash paid for income taxes. Cash paid for income taxes during the three-month periods ended March 31, 2015 and March 31, 2014 was $16.2 million and $66.8 million, respectively. This decrease in cash paid for income taxes was due to an over-payment of prior year federal and state tax payments that we will apply against our current year tax liabilities.

 

(ii)  Decrease in cash provided by operating activities:

 

·                   $77.9 million increase in cash paid to settle STAP awards. Cash paid to settle STAP awards exercised during the three-month periods ended March 31, 2015 and March 31, 2014 was $98.5 million and $20.5 million, respectively; and

 

·                   $11.0 million increase in net operating assets.

 

Investing Activities

 

Net cash provided by investing activities was $68.5 million for the three months ended March 31, 2015, compared to $106.4 million net cash used in investing activities for the three months ended March 31, 2014. The $37.9 million decrease reflects $72.4 million of cash provided from the net maturities of held-to-maturity investments during the three months ended March 31, 2015, compared to $125.1 million of cash provided from the net maturities of held-to-maturity investments during the same period in 2014.  Due to the funding requirements for our ongoing share repurchase program and the pending settlement of $89.4 million of converting Convertible Notes, we have not been reinvesting the proceeds from our maturing investments.

 

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Financing Activities

 

Net cash used in financing activities was $145.5 million for the three months ended March 31, 2015, compared to $81.9 million for the three months ended March 31, 2014.  The $63.6 million increase reflects an increase of $54.7 million in repurchases of our common stock and $14.0 million of principal payments on our Convertible Notes during the three months ended March 31, 2015, compared to the same three-month period in 2014.

 

Convertible Senior Notes

 

In October 2011, we issued the Convertible Notes with an aggregate principal value of $250.0 million.  Please see Note 9 —Debt , to our consolidated financial statements contained elsewhere in this Quarterly Report on Form 10-Q, for a description of the Convertible Notes.  As of March 31, 2015, the outstanding principal balance of our Convertible Notes was $124.8 million.

 

Between April 22, 2015 and May 6, 2015, we will settle conversion requests representing $89.4 million in principal value of Convertible Notes. In addition, we expect to issue shares of our common stock to the converting note holders, and expect to receive an equivalent number of shares of common stock under our note hedge with Deutsche Bank AG London at the settlement dates, which will be placed into our treasury stock account. We expect to recognize a $2.9 million extinguishment loss with the settlement of these conversions.

 

Line of Credit

 

In September 2013, we entered into a one-year Credit Agreement with Wells Fargo Bank, National Association (Wells Fargo) providing for a $75.0 million revolving loan facility, which may be increased by up to an additional $75.0 million provided certain conditions are met (the 2013 Credit Agreement). In July 2014, we amended the Credit Agreement solely to extend its maturity to September 30, 2015. We use this facility for general corporate purposes. At our option, amounts borrowed under the 2013 Credit Agreement bear interest at either the one-month LIBOR rate plus a 0.50 percent margin, or a fluctuating base rate excluding any margin. In addition, we are subject to a monthly commitment fee at a rate of 0.06 percent per annum based on the average daily unused balance of the facility. Amounts borrowed under the 2013 Credit Agreement are secured by certain of our marketable investments. As of March 31, 2015 and December 31, 2014, we had no outstanding balance on the line of credit.

 

Share Tracking Awards Plans

 

Awards granted under our STAP entitle participants to receive in cash an amount equal to the appreciation in our common stock, which is calculated as the increase in the closing price of our common stock between the grant date and the exercise date. Depending on the future price movements of our common stock, cash requirements associated with the exercise of awards could be significant. At March 31, 2015, the fair value of STAP awards that could potentially be exercised during 2015 was $360.2 million. We review the potential future cash requirements of the STAP program annually. Based on our review, we can modify our operating budgets, the metrics used in determining the number of awards to be granted, or both. We currently have sufficient cash and cash equivalents and borrowing capacity to fund any STAP awards that could be exercised during 2015 and beyond.

 

Share Repurchases

 

From time to time, our Board of Directors may authorize plans to repurchase our common stock. In June 2014, our Board of Directors authorized the repurchase of up to $500.0 million of our common stock. This program became effective on August

 

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1, 2014, and will remain open for up to one year.  During the three-month period ended March 31, 2015, we acquired 1,009,700 shares of our common stock at an aggregate cost of $152.3 million under this program. As of March 31, 2015, we had $242.2 million in remaining repurchase authorization under the repurchase program.

 

We currently have sufficient cash and cash equivalents, borrowing capacity and, if needed, marketable investments, to fund repurchases of our common stock under this program.

 

Summary of Critical Accounting Policies

 

The preparation of our consolidated financial statements in conformity with United States generally accepted accounting principles (GAAP) requires our management to make estimates and assumptions that affect the amounts reported in our consolidated financial statements and accompanying notes. We continually evaluate our estimates and judgments to determine whether they are reasonable, relevant and appropriate. These assumptions are frequently developed from historical data or experience, currently available information and anticipated developments. By their nature, our estimates are subject to an inherent degree of uncertainty; consequently, actual results may differ. We discuss critical accounting policies and estimates that involve a higher degree of judgment and complexity in Part II, Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report on Form 10-K for the year ended December 31, 2014. There have been no material changes to our critical accounting policies and estimates as disclosed in our Annual Report on Form 10-K for the year ended December 31, 2014.

 

Recently Issued Accounting Standards

 

See Note 2 —Basis of Presentation , to our consolidated financial statements for information on our anticipated adoption of recently issued accounting standards.

 

Item 3.     QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

As of March 31, 2015, we have invested $346.8 million in debt securities issued by corporations and federally-sponsored agencies. The market value of these investments varies inversely with changes in current market interest rates. In general, as interest rates increase, the market value of these debt securities would be expected to decrease. Conversely, as interest rates decrease, the market value of these debt securities would be expected to increase. To address market risk, we invest in debt securities that mature within three years and hold these investments to maturity so that they can be redeemed at their stated or face value. At March 31, 2015, our investments had a weighted average stated interest rate of approximately 0.61 percent and a weighted average maturity of approximately 1.0 year. Many of our investments are callable prior to maturity.

 

During sustained periods of instability and uncertainty in the financial markets, we could be exposed to additional investment-related risks that could materially affect the value and liquidity of our investments. In light of these risks, we actively monitor market conditions and developments specific to the securities and security classes we invest in. We believe that we maintain a conservative investment approach in that we invest exclusively in highly rated securities with relatively short maturities. While we believe we take prudent measures to mitigate investment related risks, such risks cannot be fully eliminated, as circumstances may arise that are beyond our control.

 

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Item 4.    CONTROLS AND PROCEDURES

 

Based on their evaluation, as of March 31, 2015, our Chairman and Co-Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures (as defined in Rule 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended) are effective to provide reasonable assurance that information required to be disclosed by us in reports that we file or submit under the Securities Exchange Act of 1934, as amended, is recorded, summarized, processed and reported within the time periods specified in the SEC’s rules and forms and to provide reasonable assurance that such information is accumulated and communicated to our management, including our Chairman and Co-Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure. There have been 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, such internal control over financial reporting.

 

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Part II.  OTHER INFORMATION

 

Item 1.  LEGAL PROCEEDINGS

 

Please refer to Note 15 —Litigation , to our consolidated financial statements contained elsewhere in this Quarterly Report on Form 10-Q.

 

Item 1A.  RISK FACTORS

 

Forward-Looking Statements

 

This Quarterly Report on Form 10-Q contains forward-looking statements made pursuant to the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934 (the Exchange Act) and the Private Securities Litigation Reform Act of 1995, which statements are based on our beliefs and expectations as to future outcomes. These statements include, among others, statements relating to the following:

 

·                   Expectations of revenues, expenses, profitability, and cash flows, including our expectation that Orenitram ® (treprostinil) Extended Release Tablets (Orenitram) cost of product sales as a percentage of its net revenue will become comparable to our other treprostinil-based commercial products;

 

·                   The sufficiency of current and future working capital to support operations;

 

·                   Our ability to obtain financing;

 

·                   Our expectation that we will pay the full principal balance due on the converting Convertible Notes upon settlement and that we have sufficient resources available to pay all amounts due;

 

·                   The value of our common stock and our ability and plans to complete our current common stock repurchase program;

 

·                   The maintenance of domestic and international regulatory approvals;

 

·                   The expected volume and timing of sales of our existing commercial products — Remodulin ®  (treprostinil) Injection (Remodulin), Tyvaso ®  (treprostinil) Inhalation Solution (Tyvaso), Orenitram, Adcirca ®  (tadalafil) Tablets (Adcirca) and Unituxin TM  (dinutuximab) Injection (Unituxin) — and potential future commercial products such as esuberaprost and our antiviral drug candidates;

 

·                   The timing and outcome of clinical studies, other research and development efforts, and related regulatory filings, including: (1) our plans to complete our FREEDOM-EV study of Orenitram; (2) our aim to obtain United States Food and Drug Administration (FDA) approval for Orenitram as a combination therapy; (3) our plan to file for approval of Orenitram in Europe upon the successful completion of the FREEDOM-EV study; (4) our phase III clinical trial of esuberaprost in combination with Tyvaso; and (5) our collaboration with DEKA Research & Development Corp. to develop a pre-filled, semi-disposable pump system for subcutaneous Remodulin;

 

·                   The expected likelihood and timing of regulatory submissions and approvals for drug candidates under development and the timing of related sales, including: (1) pending regulatory filings by Medtronic, Inc. (Medtronic) and us with respect to the Remodulin Implantable System; and (2) our pending marketing authorization application for Unituxin with the European Medicines Agency (EMA);

 

·                   The outcome of potential future regulatory actions, including audits and inspections, by the FDA and international regulatory agencies;

 

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·                   The impact of competing therapies, including generic products (such as generic sildenafil) and newly-developed therapies, on sales of our commercial products;

 

·                   The expectation that we will be able to produce sufficient quantities and maintain adequate inventories of our commercial products, through both our in-house production capabilities and third-party production sites, and our ability to obtain and maintain related approvals by the FDA and other regulatory agencies;

 

·                   The adequacy of our intellectual property protections and the validity and expiration dates of the patents we own or license;

 

·                   Our expectations regarding our ability to defend our intellectual property relating to Remodulin against generic and other challenges, including but not limited to our ongoing litigation with Sandoz Inc. (Sandoz) and Teva Pharmaceuticals USA, Inc. (Teva);

 

·                   Our expectations regarding the subpoena by the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services relating to Remodulin, Tyvaso and Adcirca, including our marketing practices relating to these products, and the related investigation by the United States Department of Justice;

 

·                   Any statements that include the words “believe,” “seek,” “expect,” “anticipate,” “forecast,” “project,” “intend,” “estimate,” “should,” “could,” “may,” “will,” “plan,” or similar expressions; and

 

·                   Other statements contained or incorporated by reference in this Quarterly Report on Form 10-Q that are not historical facts.

 

Forward-looking statements appear in the section entitled Part I, Item 2—Management’s Discussion and Analysis of Financial Condition and Results of Operations and elsewhere in this Quarterly Report on Form 10-Q. These statements are subject to risks and uncertainties, and our actual results may differ materially from anticipated results. Factors that may cause such differences include, but are not limited to, those discussed below. We undertake no obligation to publicly update forward-looking statements, whether as a result of new information, future events or otherwise.

 

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Risks Related to Our Business

 

We rely heavily on sales of Remodulin, Tyvaso and Adcirca to generate revenues and support our operations.

 

Sales of Remodulin, Tyvaso and Adcirca comprise substantially all of our revenues. A wide variety of events, many of which are described in other risk factors below, could cause sales of these products to decline. For instance, we would be unable to sell any of these products if their regulatory approvals were withdrawn. Any substantial change in the prescribing practices or dosing patterns of patients using Remodulin, Tyvaso or Adcirca due to combination or competing therapies, side effects, adverse events, deaths or any other reasons could decrease related revenues. We also face potential generic competition. For example, during the fourth quarter of 2012, generic sildenafil became commercially available, which could negatively affect future demand for Adcirca. We are also defending our intellectual property related to Remodulin against generic challenges by Sandoz and Teva. In addition, we rely on third parties to produce, market, distribute and sell Remodulin, Tyvaso and Adcirca. The inability of any one of these third parties to perform these functions satisfactorily could result in a reduction in sales. In addition, any failure to effectively manage our internal production processes could result in an inability to meet patient demand. Because we are highly dependent on sales of Remodulin, Tyvaso and Adcirca, a reduction in sales of any one of these products could have a negative and material adverse impact on our operations.

 

If our products fail in clinical trials, we will be unable to obtain or maintain FDA and international regulatory approvals and will be unable to sell those products.

 

To obtain regulatory approvals from the FDA and international regulatory agencies such as the EMA, we must conduct clinical trials demonstrating that our products are safe and effective. In the past, several of our product candidates failed or were discontinued at various stages in the development process. Moreover, we may need to amend ongoing trials or the FDA and/or international regulatory agencies may require us to perform additional trials beyond those we planned. Such occurrences could result in significant delays and additional costs, and related clinical trials may be unsuccessful. Approval of a new drug application or biologics license application could be subject to delays if the FDA determines that it cannot review or approve the application as submitted. In such a case, the FDA would issue a refuse-to-file letter or a complete response letter outlining deficiencies in the submission, and the FDA may require substantial additional studies, testing or information in order to complete its review of the application. We may fail to address any of these deficiencies adequately and consequently would be unable to obtain FDA approval to market the product candidate.

 

In addition, we are enrolling a phase IV clinical trial called FREEDOM-EV, which is a study of Orenitram in combination with other approved pulmonary arterial hypertension (PAH) therapies. One primary endpoint of the study is time to clinical worsening. The primary endpoint of our phase III study of esuberaprost in combination with Tyvaso is also time to clinical worsening. We have not previously conducted a study with a time to clinical worsening primary endpoint. Our inexperience with this type of trial design may impact our ability to conduct these trials appropriately and achieve positive results, or complete the trials within our anticipated timetable. In particular, failure to prove the efficacy of Orenitram in combination with other PAH therapies could materially limit the commercial potential of Orenitram and impede our growth.

 

The length of time that it takes for us to complete clinical trials and obtain regulatory approval for marketing varies by product, product use and country. Furthermore, we cannot predict with certainty the length of time it will take to complete necessary clinical trials or obtain regulatory approval of our future products.

 

Our clinical trials may be discontinued, delayed or disqualified for various reasons. These reasons include:

 

·                   The drug is ineffective, or physicians and/or patients believe that the drug is ineffective;

 

·                   We fail to reach agreement with the FDA or non-U.S. regulatory agencies regarding the scope or design of our clinical trials;

 

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·                   Patients do not enroll in our studies at the rate we expect;

 

·                   We are unable to obtain approval from institutional review boards to conduct clinical trials at their respective sites;

 

·                   Ongoing or new clinical trials conducted by drug companies in addition to our own clinical trials reduce the availability of patients for our trials;

 

·                   Other investigational or approved therapies are viewed as more effective or convenient by physicians or patients;

 

·                   Our clinical trial sites, contracted clinical trial administrators or clinical studies conducted entirely by third parties do not adhere to trial protocols and required quality controls under FDA good clinical practice (GCP) regulations and similar regulations outside the United States;

 

·                   Patients experience severe side effects during treatment or die during our trials because of adverse events related to the trial drug, advanced disease, or other medical complications; and

 

·                   The results of our clinical trials conducted in countries outside of the United States are not acceptable to the United States or other countries, and the results of our clinical trials conducted in the United States are not acceptable to regulators in other countries.

 

In addition, the FDA and its international counterparts have substantial discretion over the approval process for pharmaceutical products. As such, these regulatory agencies may not agree that we have demonstrated the requisite level of product safety and efficacy to grant approval.

 

We may not compete successfully with established and newly developed drugs or products, or the companies that develop and market them.

 

We compete with well-established drug companies for, among other things, funding, licenses, expertise, personnel, clinical trial patients and investigators, consultants and third-party collaborators. We also compete with these companies for market share. Most of these competitors have substantially greater financial, marketing, manufacturing, sales, distribution and technical resources, and a larger number of approved products, than we do. These competitors also possess greater experience in areas critical to success such as research and development, clinical trials, sales and marketing and regulatory matters. There are several treatments that compete with our commercial therapies, as well as several other therapies under development, such as Actelion’s Uptravi (selexipag) drug candidate, which is an oral prostacyclin IP receptor agonist. For the treatment of PAH, we compete with a number of approved products in the United States and worldwide, including the following: Flolan ® , Ventavis ® , Ilomedin ® , Tracleer ® , Revatio ® , Letairis ® , Volibris ®  Veletri ® , Adempas ® , Opsumit ® , generic epoprostenol and generic sildenafil citrate. Patients and doctors may perceive these competing products, or products developed in the future, as safer, more effective, more convenient and/or less expensive than our therapies. Alternatively, doctors may reduce the prescribed doses of our products if they prescribe them in combination with our competitors’ products. In addition, many competing PAH therapies are less invasive than Remodulin and the use of these products may delay or prevent initiation of Remodulin therapy. Any of these circumstances could negatively impact our operating results.

 

Development of new products or technologies by others may make our products obsolete or seemingly inferior.

 

Other companies may introduce new products that may render all or some of our technologies and products obsolete or noncompetitive. For example, both Adempas and Opsumit were recently approved by the FDA for the treatment of PAH. Our commercial therapies may also have to compete with investigational products currently in development, including Uptravi, which was submitted by Actelion in December 2014 to the FDA and EMA for approval to treat PAH. In addition, alternative approaches to treating chronic diseases, such as gene therapy or cell therapy, may make our products obsolete or

 

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noncompetitive. If introduced into the market, investigational therapies for PAH could be used in combination with, or as a substitute for, our therapies. If this occurs, doctors may reduce or discontinue the use of our products for their patients.

 

Sales of our products are subject to reimbursement from government agencies and other third parties. Pharmaceutical pricing and reimbursement pressures may negatively impact our sales.

 

The commercial success of our products depends, in part, on the availability of reimbursements by governmental payers such as Medicare and Medicaid, and private insurance companies. An estimated 35-50% of Remodulin, Tyvaso and Adcirca sales in the United States are reimbursed under the Medicare and Medicaid programs. In the United States, the European Union and other potentially significant markets for our products such as China and Japan, government payers and/or third-party payers are increasingly attempting to limit or regulate the price of medicinal products and frequently challenge the pricing of new and expensive drugs. Our prostacyclin analogue products (Remodulin, Tyvaso and Orenitram) are expensive therapies. Consequently, it may be difficult for our distributors to obtain adequate reimbursement for our products from third-party payers to motivate such distributors to support our products. Alternatively, third-party payers may reduce the amount of reimbursement for our products based on changes in pricing of other therapies for PAH. If third-party payers do not approve our products for reimbursement, or limit reimbursements, patients and physicians could choose competing products that are approved for reimbursement or provide lower out-of-pocket costs.

 

In the United States, the federal government and others are increasingly focused on analyzing the impact of various regulatory programs on the federal deficit, which could result in increased pressure on federal programs to reduce costs. In addition, financial pressures may cause the federal government or other third-party payers to seek cost containment more aggressively through mandatory discounts or rebates on our products, policies requiring the automatic substitution of generic products, more rigorous requirements for initial reimbursement approvals for new products or other similar measures. For example, there have been proposals to reduce reimbursement rates and/or adopt mandatory rebates under Medicare Part B, which covers Remodulin and Tyvaso. A reduction in the availability or extent of reimbursement from government health care programs could have a material adverse effect on our business and results of our operations.

 

In Europe, the success of our commercial products and future products depends largely on obtaining and maintaining government reimbursement at acceptable levels. In many European countries, patients are unlikely to use prescription drugs that are not reimbursed by their governments. Countries in Europe are under increasing pressure to reduce the cost of health care. Changes to current reimbursement policies may adversely affect our ability to sell our products or sell our products on a profitable basis. In many markets outside the United States, governments control the prices of prescription pharmaceuticals through the implementation of reference pricing, price cuts, rebates, revenue-related taxes and profit control. Furthermore, international governments expect prices of prescription pharmaceuticals to decline over the life of the product or as prescription volumes increase. In addition, in December 2011, we received marketing approval for the intravenous use of Remodulin in most of the countries that are members of the European Economic Area (EEA); however, we are in the process of obtaining approval of our risk management plan on a country-by-country basis, and must obtain pricing approval in each of these member countries before we can market Remodulin. Delays in obtaining these approvals, or failure to obtain satisfactory pricing approvals, could impact our future sales growth. Additionally, in granting pricing approval for the intravenous use of Remodulin, a member country may approve a lower reimbursement price for intravenous Remodulin than for subcutaneous Remodulin, or reduce the reimbursement price for both methods of administering Remodulin. Any regulatory action reducing the reimbursement rates for intravenous and subcutaneous Remodulin could have a material adverse effect on our revenues, results of operations and our business.

 

Our production strategy exposes us to significant risks.

 

We must be able to produce sufficient quantities of our commercial products to satisfy the growing demand for our products. We produce Remodulin, Tyvaso and Orenitram, including the active ingredient in each of these products, at our own facilities and rely on third parties for additional production capacity.  We rely on Minnetronix, Inc. as the sole manufacturer of the Tyvaso Inhalation System, and on Eli Lilly and Company (Lilly) as the sole manufacturer of Adcirca.

 

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We substantially rely on third parties to adhere to and maintain production processes in accordance with all applicable regulatory requirements. If any of these critical third-party production and supply arrangements are interrupted for compliance issues or other reasons, we may not have sufficient inventory to meet future demand. In addition, any change in suppliers and/or service providers could interrupt the production of our commercial products and impede the progress of our commercial launch plans and clinical trials.

 

In addition, our internal production process also subjects us to risks as we engage in increasingly complex production processes. For example, Remodulin, Tyvaso and Unituxin must be formulated in a sterile environment, which is challenging to maintain on a commercial scale. In addition, Unituxin is a monoclonal antibody. As with all biologic products, monoclonal antibodies are inherently more difficult to produce than our treprostinil-based products and involve increased risk of viral and other contaminants.  Finally, we have limited experience producing Orenitram on a commercial scale, and currently all Orenitram production is performed internally.  It could take substantial time to establish an FDA-approved contract manufacturer as a back-up supplier of Orenitram, or this process may not be successful at all.

 

Additional risks we face with our production strategy include the following:

 

·                   We and our third-party producers are subject to the FDA’s current Good Manufacturing Practices and similar international regulatory standards. We are limited in our ability to exercise control over regulatory compliance by our third-party producers;

 

·                   As we expand our production operations to include new elements of the production process or new products, we may experience difficulty designing and implementing processes and procedures to ensure compliance with applicable regulations;

 

·                   Even if we and our third-party producers are in compliance with applicable domestic and international drug production regulations, the sterility and quality of the products being produced could be substandard and, therefore, such products would be unavailable for sale or use or subject to recalls;

 

·                   If we had to replace our own production operations or a third-party producer, the FDA and its international counterparts would require new testing and compliance inspections. Furthermore, a new producer would have to be familiarized with the processes necessary to produce and commercially validate our products, as producing our treprostinil-based and biologic products is complex;

 

·                   We may be unable to contract with needed producers on satisfactory terms or at all; and

 

·                   The supply of materials and components necessary to produce and package our products may become scarce or unavailable. Disruptions to the supply of these materials could delay the production and subsequent sale of such products. Any products produced with substituted materials or components would be subject to approval from the FDA and international regulatory agencies before they could be sold. The timing of any such regulatory approval is difficult to predict.

 

Any of these factors could disrupt sales of our commercial products, delay clinical trials or commercialization of new products, result in product liability claims and product recalls, and entail higher costs. Interruptions in our production process could be significant given the length of time and complexity involved in obtaining necessary regulatory approvals for alternative arrangements, through either third parties or internal manufacturing processes.

 

We rely in part on third parties to perform activities that are critical to our business. Our ability to generate commercial sales or conduct clinical trials could suffer if our third-party suppliers and service providers fail to perform.

 

Third parties assist us in: (1) producing our commercial products; (2) conducting clinical trials, preclinical studies and other research and development activities; (3) obtaining regulatory approvals; (4) conducting pharmacovigilance-related and

 

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product complaint activities, including drug safety, reporting adverse events and product complaints; and (5) marketing and distributing our products. The involvement of third parties is necessary because we do not possess the internal capacity, and in certain cases the expertise, to perform all of these functions. Accordingly, the success of these third parties in performing their contractual obligations is critical to our operations.

 

For risks relating to the involvement of third parties in our production process, see the risk factor above, entitled Our production strategy exposes us to significant risks.

 

We rely on Accredo Health Group, Inc. (Accredo) and CVS Health Corporation (CVS) to distribute and sell Remodulin, Tyvaso and Orenitram in the United States. These distributors are also partially responsible for negotiating reimbursements from third-party payers for the cost of our therapies. From time-to-time, we increase the price of products sold to our U.S.-based and international distributors. Our price increases may not be fully reimbursed by third-party payers. If our distributors do not achieve acceptable profit margins on our products, they may reduce or discontinue the sale of our products. Furthermore, if our distributors devote fewer resources to sell our products or are unsuccessful in their sales efforts, our revenues may decline materially. Outside the U.S. we are substantially reliant on our international distributors to maintain regulatory approvals for our products and to market and sell our products in compliance with applicable laws and regulations.

 

We rely on Lilly to manufacture and supply Adcirca for us, and we use Lilly’s pharmaceutical wholesaler network to distribute Adcirca in the United States and Puerto Rico. If Lilly is unable to manufacture or supply Adcirca or its distribution network is disrupted, it could delay, disrupt or prevent us from selling Adcirca, which would slow the growth of our business. In addition, Lilly has the right to determine the price of Adcirca, which generally moves in parity with the price Lilly sets for Cialis® (both of these products contain the same active ingredient). Changes in Lilly’s prices could adversely impact demand or reimbursement for Adcirca, particularly in light of the commercial availability of generic sildenafil, the active ingredient in Revatio, which could be prescribed in lieu of Adcirca.

 

In addition, any change in service providers could interrupt the distribution of our commercial products and our other products and services, and impede the progress of our clinical trials, commercial launch plans and related revenues.

 

We rely heavily on third-party contract research organizations, contract laboratories, clinical investigative sites and other third-parties to conduct our clinical trials, preclinical studies and other research and development activities. In addition, the success of certain products we are developing will depend on clinical trials sponsored by third parties. Failure by any third party to conduct or assist us in conducting clinical trials in accordance with study protocols, quality controls and GCP, or other applicable U.S. or international requirements or to submit associated regulatory filings, could limit or prevent our ability to rely on results of those trials in seeking regulatory approvals.

 

We rely heavily on Medtronic for the success of our program to develop an implantable pump to deliver intravenous Remodulin (the Remodulin Implantable System). Medtronic has completed a clinical study in this regard, and submitted a premarket approval application (PMA) seeking FDA approval for the Remodulin Implantable System. We rely on Medtronic to respond to FDA requests for additional information with respect to its PMA, and following approval we will rely on Medtronic to manufacture the Remodulin Implantable System and to maintain appropriate quality controls relating to the system. As such, we can provide no assurances as to the timing or likelihood of the Remodulin implantable pump program’s success.

 

We are reliant on third parties to supply pumps and other supplies necessary to deliver Remodulin. There are a limited number of pumps available in the market, and the discontinuation of any particular pump could have a material, adverse impact on our Remodulin revenues.