Eagle Pharmaceuticals Reports Third Quarter 2019 Results

-- Net loss of $0.17 per basic and diluted share and adjusted non-GAAP net income of $0.27 per basic and $0.26 per diluted share in Q3 2019 --

-- Plan to initiate a clinical trial in December for Eagle’s innovative fulvestrant program, which has the potential to result in greater inhibition of estrogen receptors and better outcomes for patients with estrogen receptor-positive breast cancer --

-- Company returned to 2019 Hajj and enrolled additional EHS patients in its controlled clinical study --

-- Eagle expects to file a supplement to the current NDA for the treatment of brain damage secondary to nerve agent exposure in the second half of 2020 --

Tuesday, November 12, 2019 6:51 am EST

Dateline:

WOODCLIFF LAKE, N.J

Public Company Information:

NASDAQ:
EGRX

WOODCLIFF LAKE, N.J--(BUSINESS WIRE)--Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced financial results for the three- and nine-month periods ended September 30, 2019. Third quarter and recent highlights include:

  • Invested $12 million in research and development and external legal costs to advance Eagle’s pipeline.
  • Eagle’s Japanese marketing partner, SymBio Pharmaceuticals Limited, submitted a New Drug Application (“NDA”) for TREAKISYM, bendamustine ready-to-dilute liquid formulation, in Japan in September. Approval is expected in Q4 2020, which would trigger a $5 million milestone payment to Eagle. Potential payments to Eagle could reach $10 to $25 million per year in royalties and milestones.
  • Advanced clinical development plans for Eagle’s innovative fulvestrant program, which has the potential to change the treatment of estrogen receptor-positive breast cancer. The program aims to determine if the unique properties of Eagle’s product will result in greater inhibition of estrogen receptors and better patient outcomes compared to currently available treatment options. The Company expects to dose the first subject in December.
  • Enrolled additional patients in its controlled clinical study of RYANODEX® (dantrolene sodium for injectable suspension) for the treatment of exertional heat stroke (“EHS”) patients during the 2019 Hajj pilgrimage held from August 9-14 in Saudi Arabia. The Company has recruited a total of 41 patients at the 2015, 2018 and 2019 Hajj pilgrimages. Eagle has submitted a plan to the U.S. Food and Drug Administration (“FDA”) that proposes reviewing the data collectively for all 41 patients. If FDA agrees with this plan, Eagle plans to resubmit the NDA for EHS in response to the Complete Response Letter received in 2017.
  • The Company, in dialogue with FDA, has received further clarity regarding RYANODEX for the treatment of brain damage secondary to nerve agent exposure. FDA has recommended that, under the animal rule, an additional study be conducted in a second species. Eagle expects to file a supplement to the current NDA in the second half of 2020.
  • Total revenue for Q3 2019 was $41.1 million, compared to $51.3 million in Q3 2018, primarily reflecting lower BENDEKA® royalty revenue and lower product sales of BELRAPZO® and RYANODEX, partially offset by higher product sales of BENDEKA.
  • Q3 2019 net loss was $2.4 million, or $0.17 per basic and diluted share, compared to net income of $14.0 million, or $0.94 per basic and $0.91 per diluted share in Q3 2018.
  • Q3 2019 adjusted non-GAAP net income was $3.7 million, or $0.27 per basic and $0.26 per diluted share, compared to adjusted non-GAAP net income of $18.3 million, or $1.22 per basic and $1.18 per diluted share, in Q3 2018.
  • Cash and cash equivalents were $117.2 million, net accounts receivable was $44.8 million, and debt was $40.0 million as of September 30, 2019.

“In the third quarter, we invested over $12 million to further advance our pipeline. This includes $9 million in non-GAAP R&D expense as well as $3 million in external legal expense related to the pemetrexed and vasopressin litigations. We are advancing our pipeline, as evidenced by the news today on EHS, nerve agent and the planned initiation of our next clinical trial for fulvestrant. We are also pleased that our bendamustine program is expanding to Japan, and we are expecting $10-$25 million in annual royalty and milestone payments beginning in 2021. This is an exciting time for Eagle as we move closer to realizing the full potential of many of our late-stage products,” stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

Third Quarter 2019 Financial Results

Total revenue for the three months ended September 30, 2019 was $41.1 million, as compared to $51.3 million for the three months ended September 30, 2018.

Royalty revenue was $26.5 million in the third quarter of 2019, compared to $35.2 million in the third quarter of 2018. BENDEKA royalties were $26.2 million in the third quarter of 2019, compared to $33.8 million in the third quarter of 2018. A summary of total revenue is outlined below:

 

Three Months Ended September 30,

 

2019

 

2018

 

(unaudited)

 

(unaudited)

Revenue (in thousands):

 

 

 

Product sales

14,659

 

16,163

Royalty revenue

26,488

 

35,174

Total revenue

41,147

 

51,337

Gross Margin was 64% during the third quarter of 2019, as compared to 75% in the third quarter of 2018. The compression in gross margin in the third quarter of 2019 was primarily driven by an increase in BENDEKA product sales to our marketing partner, on which Eagle earns no profit, and the decrease in BENDEKA royalty revenue.

R&D expense was $10.2 million for the third quarter of 2019, compared to $6.0 million in the third quarter of 2018. The increase is largely attributable to spending on fulvestrant and vasopressin. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense during the third quarter of 2019 was $9.0 million.

SG&A expense in the third quarter of 2019 increased to $18.5 million compared to $13.9 million in the third quarter of 2018. External legal spend associated with litigation on pemetrexed and vasopressin as well as higher stock compensation expense account for the year-over-year increase. Excluding stock-based compensation and other non-cash and non-recurring items, third quarter 2019 SG&A expense was $13.4 million.

Net loss for the third quarter of 2019 was $2.4 million, or $0.17 per basic and diluted share, compared to net income of $14.0 million, or $0.94 per basic and $0.91 per diluted share, in the third quarter of 2018, due to the factors discussed above.

Adjusted non-GAAP net income for the third quarter of 2019 was $3.7 million, or $0.27 per basic and $0.26 per diluted share, compared to adjusted non-GAAP net income of $18.3 million or $1.22 per basic and $1.18 per diluted share in the third quarter of 2018. For a full reconciliation of adjusted non-GAAP net income to the most comparable GAAP financial measures, please see the tables at the end of this press release.

2019 Expense Guidance

  • R&D spend in 2019, on a non-GAAP basis, is expected to be $32.0-$36.0 million, as compared to $38.0 million in 2018.
  • SG&A spend in 2019, on a non-GAAP basis, is expected to be $51.0-$54.0 million, as compared to $43.0 million in 2018.

The guidance provided in this section represents forward-looking information, and actual results may vary. Please see the risks and assumptions referred to in the Forward-Looking Statements section of this press release.

Liquidity

As of September 30, 2019, the Company had $117.2 million in cash and cash equivalents plus $44.8 million in net accounts receivable, $34.4 million of which was due from Teva Pharmaceutical Industries Ltd. The Company had $40.0 million in outstanding debt. Therefore, at September 30, 2019, the Company had net cash plus receivables of $122.0 million.

Conference Call

As previously announced, Eagle management will host its third quarter 2019 conference call as follows:

Date

 

Tuesday, November 12, 2019

Time

 

8:30 A.M. EST

Toll free (U.S.)

 

866-342-8591

International

 

203-518-9713

Webcast (live and replay)

 

www.eagleus.com, under the “Investor + News” section

A replay of the conference call will be available for one week after the call's completion by dialing 800-839-4577 (US) or 402-220-2682 (International) and entering conference call ID EGRXQ319. The webcast will be archived for 30 days at the aforementioned URL.

About Eagle Pharmaceuticals, Inc.

Eagle is a specialty pharmaceutical company focused on developing and commercializing injectable products that address the shortcomings, as identified by physicians, pharmacists and other stakeholders, of existing commercially successful injectable products. Eagle’s strategy is to utilize the FDA's 505(b)(2) regulatory pathway. Additional information is available on the Company’s website at www.eagleus.com.

Forward-Looking Statements

This press release contains forward-looking information within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and other securities laws. Forward-looking statements are statements that are not historical facts. Words and phrases such as “anticipated,” “forward,” “will,” “would,” “may,” “remain,” “potential,” “prepare,” “expected,” “believe,” “plan,” “near future,” “belief,” “guidance,” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding future events including, but not limited to: the Company’s clinical development plan for its fulvestrant formulation, as well as the development efforts for the other product candidates in its portfolio; the Company’s expense guidance for fiscal year 2019; the Company's ability to deliver value in 2019 and over the long term; and the Company’s plans and ability to advance the products in its pipeline. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond Eagle’s control, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. Such risks include, but are not limited to: whether the Company will incur unforeseen expenses or liabilities or other market factors; whether Eagle will successfully implement its development plan for its fulvestrant formulation or other product candidates; whether the FDA will ultimately approve the products in its pipeline for any indications; whether the Company can successfully market and commercialize its product candidates, including RYANODEX, BENDEKA and BELRAPZO, in the treatment of any indications; whether SymBio Pharmaceuticals Limited can successfully launch and commercialize TREAKISYM in Japan; fluctuations in the trading volume and market price of shares of the Company's common stock, general business and market conditions and management's determination of alternative needs and uses of the Company's cash resources, all of which may affect the Company's long-term performance; the success of our commercial relationships with Teva and SymBio and the parties’ ability to work effectively together; whether Eagle and its commercial partners will successfully perform their respective obligations under their respective agreements; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; the outcome of litigation involving any of our products or that may have an impact on any of our products; successful compliance with the FDA and other governmental regulations applicable to product approvals, manufacturing facilities, products and/or businesses; general economic conditions; the strength and enforceability of our intellectual property rights or the rights of third parties; competition from other pharmaceutical and biotechnology companies and the potential for competition from generic entrants into the market; the timing of product launches; the successful marketing of our products; the risks inherent in the early stages of drug development and in conducting clinical trials; that Eagle’s redirection of resources to other products in its pipeline may not be successful; and other factors that are discussed in Eagle’s filings with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and the Company does not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events.

Non-GAAP Financial Performance Measures

In addition to financial information prepared in accordance with U.S. GAAP, this press release also contains adjusted non-GAAP net income and adjusted non-GAAP earnings per share attributable to Eagle. The Company believes these measures provide investors and management with supplemental information relating to operating performance and trends that facilitate comparisons between periods and with respect to projected information.

Adjusted non-GAAP net income excludes share-based compensation expense, depreciation, amortization of acquired intangible assets, changes in fair value of contingent consideration, severance, non-cash interest expense, expense of acquired in-process research and development, asset impairment charge, restructuring charge and the tax impact of these adjustments. The Company believes these non-GAAP financial measures help indicate underlying trends in the Company’s business and are important in comparing current results with prior period results and understanding projected operating performance. Non-GAAP financial measures provide the Company and its investors with an indication of the Company’s baseline performance before items that are considered by the Company not to be reflective of the Company’s ongoing results. See the attached Reconciliation of GAAP to Adjusted Non-GAAP Net Income and Adjusted Non-GAAP Earnings per Share and Reconciliation of GAAP to Adjusted Non-GAAP EBITDA for details of the amounts excluded and included to arrive at adjusted non-GAAP net income, adjusted non-GAAP earnings per share amounts, and adjusted non-GAAP EBITDA amounts, respectively.

These adjusted measures are non-GAAP and should be considered in addition to, but not as a substitute for, the information prepared in accordance with U.S. GAAP. The Company strongly encourages investors to review its consolidated financial statements and publicly-filed reports in their entirety and cautions investors that the non-GAAP measures used by the Company may differ from similar measures used by other companies, even when similar terms are used to identify such measures.

-- Financial tables follow –

EAGLE PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)

(In thousands, except share amounts)

 
 

September 30, 2019

December 31, 2018

 
ASSETS
Current assets:
Cash and cash equivalents

$

117,211

 

$

78,791

 

Accounts receivable, net

 

44,812

 

 

66,486

 

Inventories

 

7,247

 

 

8,304

 

Prepaid expenses and other current assets

 

10,516

 

 

10,263

 

Total current assets

 

179,786

 

 

163,844

 

Property and equipment, net

 

2,319

 

 

2,397

 

Intangible assets, net

 

16,213

 

 

18,103

 

Goodwill

 

39,743

 

 

39,743

 

Deferred tax asset, net

 

13,997

 

 

13,822

 

Other assets

 

4,980

 

 

694

 

Total assets

$

257,038

 

$

238,603

 

LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable

$

11,232

 

$

9,917

 

Accrued expenses and other liabilities

 

27,127

 

 

23,519

 

Current portion of long-term debt

 

4,000

 

 

6,250

 

Total current liabilities

 

42,359

 

 

39,686

 

Other long-term liabilities

 

3,227

 

Long-term debt, less current portion

 

35,687

 

 

38,155

 

Commitments and Contingencies
Stockholders' equity:
Preferred stock, 1,500,000 shares authorized and no shares issued or
outstanding as of September 30, 2019 and December 31, 2018
Common stock, $0.001 par value; 50,000,000 shares authorized;
16,524,848 and 16,504,283 shares issued as of September 30, 2019 and
December 31, 2018, respectively

 

17

 

 

17

 

Additional paid in capital

 

273,153

 

 

256,458

 

Retained earnings

 

71,495

 

 

58,187

 

Treasury stock, at cost, 2,855,316 and 2,590,258 shares as of September
30, 2019 and December 31, 2018, respectively

 

(168,900

)

 

(153,900

)

Total stockholders' equity

 

175,765

 

 

160,762

 

Total liabilities and stockholders' equity

$

257,038

 

$

238,603

 

EAGLE PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF (LOSS) INCOME (UNAUDITED)

(In thousands, except share and per share amounts)

 
 

Three Months Ended September 30,

Nine Months Ended September 30,

2019

2018

2019

2018

 
Revenue:
Product sales

$

14,659

 

$

16,163

 

$

58,568

 

$

50,042

 

Royalty revenue

 

26,488

 

 

35,174

 

 

80,066

 

 

107,216

 

License and other revenue

 

9,000

 

Total revenue

 

41,147

 

 

51,337

 

 

147,634

 

 

157,258

 

Operating expenses:
Cost of product sales

 

12,137

 

 

8,621

 

 

39,866

 

 

29,919

 

Cost of royalty revenue

 

2,785

 

 

4,370

 

 

9,440

 

 

13,440

 

Research and development

 

10,172

 

 

5,975

 

 

25,504

 

 

38,560

 

Selling, general and administrative

 

18,537

 

 

13,878

 

 

53,906

 

 

45,033

 

Restructuring charge

 

91

 

 

7,479

 

Asset impairment charge

 

2,704

 

Change in fair value of contingent consideration

 

(763

)

Total operating expenses

 

43,631

 

 

32,935

 

 

128,716

 

 

136,372

 

(Loss) Income from operations

 

(2,484

)

 

18,402

 

 

18,918

 

 

20,886

 

Interest income

 

570

 

 

9

 

 

1,701

 

 

36

 

Interest expense

 

(628

)

 

(743

)

 

(1,979

)

 

(2,118

)

Total other expense, net

 

(58

)

 

(734

)

 

(278

)

 

(2,082

)

(Loss) Income before income tax benefit (provision)

 

(2,542

)

 

17,668

 

 

18,640

 

 

18,804

 

Income tax benefit (provision)

 

152

 

 

(3,628

)

 

(5,332

)

 

509

 

Net (Loss) Income

$

(2,390

)

$

14,040

 

$

13,308

 

$

19,313

 

(Loss) Earnings per share attributable to common stockholders:
Basic

$

(0.17

)

$

0.94

 

$

0.96

 

$

1.30

 

Diluted

$

(0.17

)

$

0.91

 

$

0.94

 

$

1.25

 

Weighted average number of common shares outstanding:
Basic

 

13,668,091

 

 

15,011,159

 

 

13,791,071

 

 

14,903,945

 

Diluted

 

13,668,091

 

 

15,483,037

 

 

14,147,658

 

 

15,482,768

 

EAGLE PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)

(In thousands)

 
 

Nine Months Ended September 30,

2019

2018

 
Cash flows from operating activities:
Net income

$

13,308

 

$

19,313

 

Adjustments to reconcile net income to net cash provided by operating activities:
Deferred income taxes

 

(175

)

 

2,040

 

Depreciation expense

 

1,479

 

 

918

 

Amortization expense

 

1,890

 

 

1,916

 

Stock-based compensation expense

 

16,815

 

 

14,512

 

Change in fair value of contingent consideration

 

(763

)

Amortization of debt issuance costs

 

282

 

 

282

 

Asset impairment charge

 

2,704

 

Non-cash restructuring charge

 

5,771

 

Changes in operating assets and liabilities which provided (used) cash:
Accounts receivable

 

21,674

 

 

(24,640

)

Inventories

 

1,057

 

 

(4,525

)

Prepaid expenses and other current assets

 

(253

)

 

(5,709

)

Accounts payable

 

1,315

 

 

(4,437

)

Accrued expenses and other liabilities

 

3,608

 

 

7,476

 

Other assets and other long-term liabilities, net

 

(1,813

)

 

(582

)

Net cash provided by operating activities

 

59,187

 

 

14,276

 

Cash flows from investing activities:
Purchase of property and equipment

 

(647

)

 

(52

)

Net cash used in investing activities

 

(647

)

 

(52

)

Cash flows from financing activities:
Proceeds from common stock option exercises

 

78

 

 

8,601

 

Payments related to employee net option exercises

 

(4,877

)

Employee withholding taxes related to stock-based awards

 

(198

)

Payment of contingent consideration

 

(15,001

)

Payment of debt

 

(5,000

)

 

(3,750

)

Repurchases of common stock

 

(15,000

)

 

(22,628

)

Net cash used in financing activities

 

(20,120

)

 

(37,655

)

Net increase (decrease) in cash and cash equivalents

 

38,420

 

 

(23,431

)

Cash and cash equivalents at beginning of period

 

78,791

 

 

114,657

 

Cash and cash equivalents at end of period

$

117,211

 

$

91,226

 

Supplemental disclosures of cash flow information:
Cash paid during the period for:
Income taxes, net

$

6,587

 

$

1,887

 

Interest

 

1,787

 

 

1,540

 

EAGLE PHARMACEUTICALS, INC.

RECONCILIATION OF GAAP TO ADJUSTED NON-GAAP NET INCOME AND

ADJUSTED NON-GAAP EARNINGS PER SHARE (UNAUDITED)

(In thousands, except share and per share amounts)

 
 
 

Three Months Ended September 30,

Nine Months Ended September 30,

2019

2018

2019

2018

 
Net (loss) income - GAAP

$

(2,390

)

$

14,040

 

$

13,308

 

$

19,313

 

 
Adjustments:
Cost of product revenues:
Amortization expense

 

225

 

 

194

 

 

675

 

 

701

 

Research and development:
Stock-based compensation expense

 

1,081

 

 

831

 

 

3,320

 

 

3,094

 

Depreciation expense

 

71

 

 

66

 

 

210

 

 

405

 

Expense of acquired in-process research & development

 

-

 

 

-

 

 

-

 

 

1,200

 

Severance

 

-

 

 

68

 

 

-

 

 

466

 

Selling, general and administrative:
Stock-based compensation expense

 

4,570

 

 

3,641

 

 

13,495

 

 

11,418

 

Amortization expense

 

405

 

 

405

 

 

1,215

 

 

1,215

 

Depreciation expense

 

171

 

 

169

 

 

515

 

 

513

 

Other:
Non-cash interest expense

 

94

 

 

94

 

 

282

 

 

282

 

Change in fair value of contingent consideration

 

-

 

 

-

 

 

-

 

 

(763

)

Asset impairment charge

 

-

 

 

-

 

 

-

 

 

2,704

 

Restructuring charge

 

-

 

 

91

 

 

-

 

 

7,479

 

Tax effect of the non-GAAP adjustments

 

(556

)

 

(1,334

)

 

(2,875

)

 

(6,868

)

 
Adjusted non-GAAP net income

$

3,671

 

$

18,265

 

$

30,145

 

$

41,159

 

 
Adjusted non-GAAP earnings per share:
Basic

$

0.27

 

$

1.22

 

$

2.19

 

$

2.76

 

Diluted

$

0.26

 

$

1.18

 

$

2.13

 

$

2.66

 

Weighted number of common shares outstanding:
Basic

 

13,668,091

 

 

15,011,159

 

 

13,791,071

 

 

14,903,945

 

Diluted

 

14,120,025

 

 

15,483,037

 

 

14,147,658

 

 

15,482,768

 

EAGLE PHARMACEUTICALS, INC.

RECONCILIATION OF GAAP TO ADJUSTED NON-GAAP EBITDA (UNAUDITED)

(In thousands)

 
 

Twelve Months
Ended
September 30,

Twelve Months
Ended
December 31,

Three Months Ended September 30,

Nine Months Ended September 30,

2019

2018

2019

2018

2019

2018

 
Net (loss) income - GAAP

$

(2,390

)

$

14,040

$

13,308

$

19,313

 

$

25,898

$

31,903

 

 
Add back:
Interest expense, net of interest income

 

58

 

 

734

 

278

 

2,083

 

 

774

 

2,579

 

Income tax (benefit) provision

 

(152

)

 

3,628

 

5,332

 

(509

)

 

7,976

 

2,135

 

Depreciation and amortization expense

 

872

 

 

834

 

2,615

 

2,834

 

 

3,451

 

3,670

 

 
Add back:
Stock-based compensation expense

 

5,651

 

 

4,472

 

16,815

 

14,512

 

 

21,385

 

19,082

 

Change in fair value of contingent consideration

 

-

 

 

-

 

-

 

(763

)

 

-

 

(763

)

Asset impairment charge

 

-

 

 

-

 

-

 

2,704

 

 

-

 

2,704

 

Expense of acquired in-process research & development

 

-

 

 

-

 

-

 

1,200

 

 

500

 

1,700

 

Severance

 

-

 

 

68

 

-

 

466

 

 

-

 

466

 

Restructuring charge

 

-

 

 

91

 

-

 

7,479

 

 

432

 

7,911

 

Adjusted Non-GAAP EBITDA

$

4,039

 

$

23,867

$

38,348

$

49,319

 

$

60,416

$

71,387

 

 

Multimedia Files:

Preview image

Contact:

Investor Relations for Eagle Pharmaceuticals, Inc.:
Lisa M. Wilson
In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com

Business Wire InvestorHQsm