Site icon pharmaceutical daily

Eagle Pharmaceuticals Reports Fourth Quarter and Full Year 2019 Results

— Q4 2019 net income was $0.07 per basic and diluted share and adjusted non-GAAP net income was $0.49 per basic and $0.48 per diluted share

— FY 2019 net income was $1.04 per basic and $1.01 per diluted share and adjusted non-GAAP net income was $2.68 per basic and $2.61 per diluted share —

— Significant pipeline advancements position Eagle for five potential commercial launches over next three years —

— Company anticipates strong 2020 growth for total revenue and gross profit based on strength of marketed products, and assuming an on-time approval for RYANODEX® for exertional heat stroke and affirmation of orphan drug decision by the Appellate Court for BENDEKA®

— Received final approval from the U.S. Food and Drug Administration (“FDA”) for PEMFEXY™ (pemetrexed for injection), for an initial entry of PEMFEXY on February 1, 2022, and a subsequent uncapped entry on April 1, 2022 —

— Resubmitted NDA for RYANODEX (dantrolene sodium for injectable suspension) for the treatment of exertional heat stroke with a PDUFA date of July 8, 2020 —

— Entered into collaborations with NorthShore University HealthSystem and the University of Pennsylvania to investigate the potential use of RYANODEX for the treatment of traumatic brain injury, including concussion, and Alzheimer’s disease, respectively —

WOODCLIFF LAKE, N.J.–(BUSINESS WIRE)–Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced financial results for the three and twelve months ended December 31, 2019.

Business and Recent Highlights:

Financial Highlights

Fourth Quarter 2019

Full Year 2019

“Based on the current strength of our marketed products, and assuming an on-time approval for RYANODEX for exertional heat stroke and an affirmation of our orphan drug decision by the Appellate Court for BENDEKA, we believe that 2020 could be the best year in Eagle’s history in terms of total revenue and gross profit. We believe we are at the start of what could be a period of accelerated growth for Eagle,” stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

“We have multiple product candidates underway that have the potential to expand treatment options and provide first-in-class therapies to bridge significant care gaps across CNS/critical care and oncology patient populations. With a number of exciting studies under way in our critical care and oncology pipeline, we look forward to multiple data readouts this year, all of which will help us progress these important initiatives. We remain focused on realizing the full potential of our pipeline assets and creating value for our stakeholders,” concluded Tarriff.

Fourth Quarter 2019 Financial Results

Total revenue for the three months ended December 31, 2019 was $48.3 million, as compared to $56.1 million for the three months ended December 31, 2018.

Q4 2019 BELRAPZO product sales were $7.6 million, compared to $6.8 million in Q4 2018.

Q4 2019 RYANODEX product sales were $3.5 million, compared to $5.1 million in Q4 2018.

Royalty revenue was $32.8 million in the fourth quarter of 2019, compared to $35.7 million in the fourth quarter of 2018. BENDEKA royalties were $32.4 million in the fourth quarter of 2019, compared to $31.9 million in the fourth quarter of 2018. A summary of total revenue is outlined below:

 

 

Three Months Ended December 31,

 

2019

 

2018

 

(unaudited)

 

(unaudited)

Revenue (in thousands):

 

 

 

Product sales

$15,421

 

$20,343

Royalty revenue

32,837

 

35,711

Total revenue

$48,258

 

$56,054

Gross Margin was 76% during the fourth quarter of 2019, as compared to 67% in the fourth quarter of 2018. The expansion in gross margin in the fourth quarter of 2019 was primarily driven by a decrease in BENDEKA product sales to our marketing partner, on which Eagle earns no profit, and the increase in BENDEKA royalty revenue.

R&D expense was $11.3 million for the fourth quarter of 2019, compared to $5.9 million in the fourth quarter of 2018. The increase is largely attributable to spending on fulvestrant and payroll expenses. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense during the fourth quarter of 2019 was $9.1 million.

SG&A expense in the fourth quarter of 2019 increased to $22.5 million compared to $15.5 million in the fourth quarter of 2018. External legal spend associated with litigation on pemetrexed and vasopressin, as well as payroll costs, account for the year-over-year increase. Excluding stock-based compensation and other non-cash and non-recurring items, fourth quarter 2019 SG&A expense was $17.8 million.

Net income for the fourth quarter of 2019 was $1.0 million, or $0.07 per basic and diluted share, compared to net income of $12.6 million, or $0.88 per basic and $0.86 per diluted share, in the fourth quarter of 2018, due to the factors discussed above.

Adjusted non-GAAP net income for the fourth quarter of 2019 was $6.7 million, or $0.49 per basic and $0.48 per diluted share, compared to adjusted non-GAAP net income of $17.7 million or $1.23 per basic and $1.20 per diluted share in the fourth 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.

Full Year 2019 Financial Results

Total revenue for the year ended December 31, 2019 was $195.9 million, as compared to $213.3 million for the year ended December 31, 2018. A summary of total revenue is outlined below:

 

 

Twelve Months Ended December 31,

 

2019

 

2018

 

 

 

 

Revenue (in thousands):

 

 

 

Product sales

$73,989

 

$70,835

Royalty revenue

112,903

 

142,927

License and other income

9,000

 

Total revenue

$195,892

 

$213,312

Product sales increased $3.6 million in the year ended December 31, 2019, primarily driven by increases in sales of BELRAPZO and BENDEKA. The increased sales were partially offset by decreases in product sales of RYANODEX due to lower volume on a low reorder cycle period and the discontinuation of Non-Alcohol Docetaxel Injection in September 2018. Royalty revenue totaled $112.9 million in 2019 compared to $142.9 million in 2018. BENDEKA royalties were $111.2 million in 2019, compared to $134.4 million in 2018. In 2019, Eagle received a milestone payment of $9 million for BENDEKA.

Gross margin was 69% in 2019, as compared to 71% in 2018. The compression in gross margin in 2019 was primarily driven by an increase in product sales of BELRAPZO, an increase in BENDEKA product sales to our marketing partner, on which Eagle earns no profit, the decrease in RYANODEX product sales, and the decrease in BENDEKA royalty revenue.

R&D expense decreased to $36.8 million in 2019, compared to $44.4 million in 2018, primarily reflecting a decrease in project spending for the Company’s fulvestrant formulation, partially offset by the cost of bringing vasopressin to market. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense in 2019 was $31.1 million.

SG&A expenses increased by $15.9 million to $76.4 million in 2019, compared to $60.5 million in 2018. External legal spend associated with litigation on pemetrexed and vasopressin, as well as payroll costs, account for the year-over-year increase. Excluding stock-based compensation and other non-cash and non-recurring items, SG&A expense in 2019 was $56.4 million.

Net income for the year ended December 31, 2019 was $14.3 million or $1.04 per basic and $1.01 per diluted share as compared to net income of $31.9 million or $2.16 per basic and $2.09 per diluted share for the year ended December 31, 2018, as a result of the factors discussed above.

Adjusted non-GAAP net income for 2019 was $36.9 million, or $2.68 per basic and $2.61 per diluted share, compared to adjusted non-GAAP net income of $59.2 million, or $4.01 per basic and $3.87 per diluted share in 2018.

2020 Expense Guidance

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 December 31, 2019, the Company had $109.8 million in cash and cash equivalents plus $48.0 million in net accounts receivable, $38.3 million of which was due from Teva Pharmaceutical Industries Ltd. The Company had $39.0 million in outstanding debt. Therefore, at December 31, 2019, the Company had net cash plus receivables of $118.8 million.

In the fourth quarter of 2019, we purchased $3.0 million of Eagle’s common stock as part of our $150.0 million Share Repurchase Program. From August 2016 through December 31, 2019, we have repurchased $171.9 million of our common stock.

Conference Call

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

 

Date

 

Monday, March 2, 2020

 

Time

 

8:30 A.M. EDT

 

Toll free (U.S.)

 

877-876-9173

 

International

 

785-424-1667

 

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 800-839-3020 (US) or 402-220-7234 (International) and entering conference call ID EGRXQ419. The webcast will be archived for 30 days at the aforementioned URL.

About Eagle Pharmaceuticals, Inc.

Eagle is a pharmaceutical company focused on developing and commercializing innovative and differentiated injectable products that address the shortcomings, as identified by physicians, pharmacists and other stakeholders, of existing commercially successful injectable products. 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 such as: 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 assumptions with respect to RYANODEX for EHS and the orphan drug appellate decision for BENDEKA; approval of SymBio’s product, TREAKISYM, and whether such approval will be on-time; the Company’s timing and ability to repurchase additional shares of the Company’s common stock, if any, under its share repurchase program; the Company’s expense guidance for fiscal year 2020; the Company’s ability to deliver value in 2020 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; fluctuations in the trading volume and market price of shares of the Company’s common stock 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 the Company’s relationships with its partners, including the United States Army Medical Research Institute of Chemical Defense, the University of Pennsylvania, Teva, Tyme and NorthShore University HealthSystem 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, including the potential adverse effects of public health issues, such as the coronavirus outbreak, on economic activity and the performance of the financial markets generally; 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 stock-based compensation expense, depreciation expense, amortization expense, change in fair value of contingent consideration, severance, debt issuance costs, non-cash interest expense, expense of acquired in-process research and development, asset impairment charge, restructuring charge and the tax effect 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.

 
EAGLE PHARMACEUTICALS, INC.

CONSOLIDATED BALANCE SHEETS

(In thousands, except share amounts)

 
 

December 31, 2019

December 31, 2018

ASSETS
Current assets:
Cash and cash equivalents

$

109,775

 

$

78,791

 

Accounts receivable, net

 

48,004

 

 

66,486

 

Inventories

 

6,566

 

 

8,304

 

Prepaid expenses and other current assets

 

15,104

 

 

10,263

 

Total current assets

 

179,449

 

 

163,844

 

Property and equipment, net

 

2,202

 

 

2,397

 

Intangible assets, net

 

15,583

 

 

18,103

 

Goodwill

 

39,743

 

 

39,743

 

Deferred tax asset, net

 

13,669

 

 

13,822

 

Other assets

 

3,908

 

 

694

 

Total assets

$

254,554

 

$

238,603

 

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable

$

5,462

 

$

9,917

 

Accrued expenses and other liabilities

 

28,361

 

 

23,519

 

Current portion of long-term debt

 

5,000

 

 

6,250

 

Total current liabilities

 

38,823

 

 

39,686

 

 
Other long-term liabilities

 

3,000

 

Long-term debt, less current portion

 

33,557

 

 

38,155

 

Total liabilities

 

75,380

 

 

77,841

 

 
Stockholders’ equity:
Preferred stock, 1,500,000 shares authorized and no shares issued or
outstanding as of December 31, 2019 and 2018
Common stock, $0.001 par value; 50,000,000 shares authorized;
16,537,846 and 16,504,283 shares issued as of December 31, 2019 and
2018, respectively

 

17

 

 

17

 

Additional paid in capital

 

278,518

 

 

256,458

 

Retained earnings

 

72,500

 

 

58,187

 

Treasury stock, at cost, 2,907,687 and 2,590,258 shares as of December
31, 2019 and 2018, respectively

 

(171,861

)

 

(153,900

)

Total stockholders’ equity

 

179,174

 

 

160,762

 

Total liabilities and stockholders’ equity

$

254,554

 

$

238,603

 

 

 

EAGLE PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF INCOME

(In thousands, except share and per share amounts)

 
 

Three Months Ended December 31,

Year Ended December 31,

2019

2018

2019

2018

(unaudited)

(unaudited)

Revenue:
Product sales

$

15,421

 

$

20,343

 

$

73,989

 

$

70,385

 

Royalty revenue

 

32,837

 

 

35,711

 

 

112,903

 

 

142,927

 

License and other revenue

 

9,000

 

Total revenue

 

48,258

 

 

56,054

 

 

195,892

 

 

213,312

 

Operating expenses:
Cost of product sales

 

8,025

 

 

12,455

 

 

47,891

 

 

42,374

 

Cost of royalty revenue

 

3,566

 

 

6,102

 

 

13,006

 

 

19,542

 

Research and development

 

11,306

 

 

5,859

 

 

36,810

 

 

44,419

 

Selling, general and administrative

 

22,464

 

 

15,476

 

 

76,370

 

 

60,509

 

Restructuring charge

 

432

 

 

7,911

 

Asset impairment charge

 

2,704

 

Change in fair value of contingent consideration

 

(763

)

Total operating expenses

 

45,361

 

 

40,324

 

 

174,077

 

 

176,696

 

Income from operations

 

2,897

 

 

15,730

 

 

21,815

 

 

36,616

 

Interest income

 

468

 

 

122

 

 

2,169

 

 

158

 

Interest expense

 

(707

)

 

(618

)

 

(2,686

)

 

(2,736

)

Other income

 

700

 

 

700

 

Total other income (expense), net

 

461

 

 

(496

)

 

183

 

 

(2,578

)

Income before income tax

 

3,358

 

 

15,234

 

 

21,998

 

 

34,038

 

Income tax provision

 

2,353

 

 

2,644

 

 

7,685

 

 

2,135

 

Net Income

$

1,005

 

$

12,590

 

$

14,313

 

$

31,903

 

Earnings per share:
Basic

$

0.07

 

$

0.88

 

$

1.04

 

$

2.16

 

Diluted

$

0.07

 

$

0.86

 

$

1.01

 

$

2.09

 

Weighted average number of common shares outstanding:
Basic

 

13,646,043

 

 

14,367,077

 

 

13,754,516

 

 

14,768,625

 

Diluted

 

14,121,179

 

 

14,685,525

 

 

14,138,733

 

 

15,278,651

 

Contacts

Investor Relations for Eagle Pharmaceuticals, Inc.:
Lisa M. Wilson

In-Site Communications, Inc.

T: 212-452-2793

E: lwilson@insitecony.com

Public Relations for Eagle Pharmaceuticals, Inc.:
Rose Ramseth

WE Communications

T: 212-551-4841

M: 206-898-7551

E: rramseth@we-worldwide.com

Read full story here

Exit mobile version