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Eagle Pharmaceuticals Reports First Quarter 2020 Results

— Q1 2020 net loss was ($0.21) per basic and diluted share and adjusted non-GAAP net income was $0.86 per basic and $0.84 per diluted share

— Advanced novel fulvestrant product candidate, EA-114, which has the potential to enhance estrogen receptor (“ER”) inhibition in advanced hormone-receptor (“HR”)-positive breast cancer —

— Received favorable patent litigation decision for BENDEKA® (bendamustine hydrochloride injection); ANDA holders to be enjoined from launching prior to 2031 —

— Preparing for multiple potential product launches in the next three years; 13 ongoing initiatives underway including six additional potential new indications for RYANODEX —

WOODCLIFF LAKE, N.J–(BUSINESS WIRE)–Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced financial results for the three months ended March 31, 2020.

Business and Recent Highlights:

Financial Highlights

“The momentum from late last year has continued into the first quarter of 2020, including advancing fulvestrant, receiving extended patent protection and orphan drug exclusivity affirmation for BENDEKA, and proceeding with other initiatives for RYANODEX. We believe that we are well positioned to realize the full potential of our robust portfolio of oncology and CNS/metabolic critical care products and pipeline candidates, given our strong cash flow and several potential near-term catalysts,” stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

First Quarter 2020 Financial Results

Total revenue for Q1 2020 was $46.0 million, as compared to $49.8 million for Q1 2019.

Q1 2020 BELRAPZO product sales were $4.6 million, compared to $3.2 million in Q1 2019.

Q1 2020 RYANODEX product sales were $11.4 million, compared to $4.0 million in Q1 2019.

Royalty revenue was $28.3 million in the first quarter of 2020, compared to $26.3 million in the first quarter of 2019. BENDEKA royalties were $28.0 million in the first quarter of 2020, compared to $26.0 million in the first quarter of 2019. A summary of total revenue is outlined below:

 

Three Months Ended March 31,

 

2020

 

2019

 

(unaudited)

 

(unaudited)

Revenue (in thousands):

 

 

 

Product sales

$17,694

 

$14,472

Royalty revenue

28,326

 

26,313

License and other revenue

 

9,000

Total revenue

$46,020

 

$49,785

Gross margin was 83% during the first quarter of 2020, as compared to 74% in the first quarter of 2019. The expansion in gross margin in the first quarter of 2020 was driven by an increase in RYANODEX product sales, lower BENDEKA product sales in the period to the Company’s marketing partner, on which Eagle earns no profit, and the increase in BENDEKA royalty revenue.

R&D expense was $9.4 million for the first quarter of 2020, compared to $6.4 million in the first quarter of 2019. The year-over-year increase is largely attributable to spending related to its fulvestrant product candidate as well as payroll expenses. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense during the first quarter of 2020 was $7.8 million.

SG&A expense in the first quarter of 2020 increased to $24.8 million compared to $18.1 million in the first quarter of 2019. External legal spend, external sales and marketing spend, and stock-based compensation expense, as well as a $2.5 million expense related to the collaboration with Tyme, account for most of the year-over-year increase. Excluding stock-based compensation and other non-cash and non-recurring items, first quarter 2020 SG&A expense was $15.5 million.

Net loss for the first quarter of 2020 was $2.9 million, or ($0.21) per basic and diluted share, compared to net income of $9.0 million, or $0.64 per basic and $0.62 per diluted share, in the first quarter of 2019.

Adjusted non-GAAP net income for the first quarter of 2020 was $11.7 million, or $0.86 per basic and $0.84 per diluted share, compared to adjusted non-GAAP net income of $14.6 million or $1.05 per basic and $1.01 per diluted share in the first quarter of 2019. 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.

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 March 31, 2020, the Company had $202.0 million in cash and cash equivalents plus $54.5 million in net accounts receivable, $34.5 million of which was due from Teva. The Company had $148 million in outstanding debt, including $110.0 million drawn on its revolving credit facility. Therefore, at March 31, 2020, the Company had net cash plus receivables of $108.5 million. Since March 31, the Company has re-paid the full $110.0 million drawn under its revolving credit facility.

On March 17, 2020, the Company announced that Eagle’s Board of Directors approved a new share repurchase program, which replaced the Company’s existing share repurchase program providing for the repurchase of up to an aggregate of $160.0 million of the Company’s outstanding common stock. In the first quarter of 2020, the Company repurchased $1.0 million of Eagle’s common stock as part of the share repurchase program. From August 2016 through March 31, 2020, the Company repurchased $172.9 million of its common stock.

Conference Call

As previously announced, Eagle management will host its first quarter 2020 conference call as follows:

 

Date

 

 

 

 

 

 

 

 

 

 

 

 

Monday, May 11, 2020

 

Time

 

 

 

 

 

 

 

 

 

 

 

 

8:30 A.M. ET

 

Toll free (U.S.)

 

 

 

 

 

877-876-9173

 

International

 

 

 

 

 

785-424-1667

 

Webcast (live and replay)

 

 

 

 

 

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

Participants should dial in 15 minutes prior to the start of the call to ensure timely access.

A replay of the conference call will be available for one week after the call’s completion by dialing 800-839-6803 (US) or 402-220-6056 (International) and entering conference call ID EGRXQ120. The webcast will be archived for 30 days at the aforementioned URL.

About Eagle Pharmaceuticals, Inc.

Eagle is a fully integrated pharmaceutical company with research and development, clinical, manufacturing and commercial expertise. Eagle is committed to developing innovative medicines that result in meaningful improvements in patients’ lives. Eagle’s commercialized products include RYANODEX®, BENDEKA®, BELRAPZO®, and its oncology and CNS/metabolic critical care pipeline includes product candidates with the potential to address underserved therapeutic areas across multiple disease states. Additional information is available on Eagle’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 expectations regarding the anticipated and potential impact of the ongoing COVID-19 pandemic on the Company’s business and operations, including sales, marketing, manufacturing and supply chain interruptions; the number and timing of potential product launches, development initiatives and new indications for RYANODEX; the Company’s clinical development plan for its fulvestrant product candidate, EA-114, as well as the development efforts for the other product candidates in its portfolio; the potential benefits and efficacy of RYANODEX, including the potential for RYANODEX to be a possible therapeutic option for patients with SARS-CoV-2 infection and expansion into other potential indications; preclinical data of RYANODEX for the treatment of patients with SARS-CoV-2 infection and the progress and development of RYANODEX in a Phase 2 clinical trial evaluating RYANODEX as a treatment for patients with SARS-CoV-2 infection; the potential for other products treating the same indication as BENDEKA entering the market before 2022; the potential of dantrolene sodium as a treatment for Alzheimer’s disease; the timing of the Company’s PEMFEXY launch, if ever; the success of the Company’s collaborations with its strategic partners; 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 the Company’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 and uncertainties include, but are not limited to: the impacts of the COVID-19 pandemic, including disruption or impact in the sales of the Company’s marketed products, interruptions or other adverse effects to clinical trials, delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems, disruption in the operations of the Company’s third party partners and disruption of the global economy, and the overall impact of the COVID-19 pandemic on the Company’s business, financial condition and results of operations; risks that the Company’s business, financial condition and results of operations will be impacted by the spread of COVID-19 in the geographies where the Company’s third-party partners operate; whether the Company will incur unforeseen expenses or liabilities or other market factors; risks that results from in vitro laboratory tests of RYANODEX are not necessarily predictive of future clinical trial and in vivo results; whether the Company will successfully implement its development plan for its fulvestrant product candidate, EA-114, or other product candidates; delay in or failure to obtain regulatory approval of the Company’s product candidates; whether the Company can successfully market and commercialize its product candidates, including RYANODEX, BENDEKA and BELRAPZO; the success of the Company’s relationships with its partners, including Hackensack University Medical Center, the University of Pennsylvania, Teva, Tyme and NorthShore University HealthSystem and the parties’ ability to work effectively together; 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, including the COVID-19 pandemic, on economic activity and the performance of the financial markets generally; the strength and enforceability of the Company’s 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 risks inherent in the early stages of drug development and in conducting clinical trials; and those risks and uncertainties identified in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 filed with the Securities and Exchange Commission on March 2, 2020 and its other subsequent filings with the Securities and Exchange Commission. 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, severance, non-cash interest expense, expense related to collaboration with Tyme, fair value adjustments on equity investment, 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.

— Financial tables follow –

 

EAGLE PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share amounts)
 
March 31, 2020 December 31, 2019
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents

$

202,016

 

$

109,775

 

Accounts receivable, net

 

54,491

 

 

48,004

 

Inventories

 

8,434

 

 

6,566

 

Prepaid expenses and other current assets

 

10,631

 

 

15,104

 

Total current assets

 

275,572

 

 

179,449

 

Property and equipment, net

 

2,423

 

 

2,202

 

Intangible assets, net

 

14,917

 

 

15,583

 

Goodwill

 

39,743

 

 

39,743

 

Deferred tax asset, net

 

13,759

 

 

13,669

 

Other assets

 

15,530

 

 

3,908

 

Total assets

$

361,944

 

$

254,554

 

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable

$

9,756

 

$

5,462

 

Accrued expenses and other liabilities

 

20,123

 

 

28,361

 

Current portion of long-term debt

 

116,000

 

 

5,000

 

Total current liabilities

 

145,879

 

 

38,823

 

Other long-term liabilities

 

3,454

 

 

3,000

 

Long-term debt, less current portion

 

30,781

 

 

33,557

 

Total liabilities

 

180,114

 

 

75,380

 

Commitments and Contingencies
Stockholders’ equity:
Preferred stock, 1,500,000 shares authorized and no shares issued or outstanding as of March 31, 2020 and December 31, 2019
Common stock, $0.001 par value; 50,000,000 shares authorized; 16,597,814 and 16,537,846 shares issued as of March 31, 2020 and December 31, 2019, respectively

 

17

 

 

17

 

Additional paid in capital

 

285,044

 

 

278,518

 

Retained earnings

 

69,629

 

 

72,500

 

Treasury stock, at cost, 2,933,320 and 2,907,687 shares as of March 31, 2020 and December 31, 2019, respectively

 

(172,860

)

 

(171,861

)

Total stockholders’ equity

 

181,830

 

 

179,174

 

Total liabilities and stockholders’ equity

$

361,944

 

$

254,554

 

 
EAGLE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share amounts)
(unaudited)
 
Three Months Ended March 31,

 

2020

 

 

2019

 

 
Revenue:
Product sales

$

17,694

 

$

14,472

 

Royalty revenue

 

28,326

 

 

26,313

 

License and other revenue

 

9,000

 

Total revenue

 

46,020

 

 

49,785

 

Operating expenses:
Cost of product sales

 

4,765

 

 

9,554

 

Cost of royalty revenue

 

3,038

 

 

3,546

 

Research and development

 

9,427

 

 

6,375

 

Selling, general and administrative

 

24,755

 

 

18,141

 

Total operating expenses

 

41,985

 

 

37,616

 

Income from operations

 

4,035

 

 

12,169

 

Interest income

 

346

 

 

494

 

Interest expense

 

(889

)

 

(686

)

Other expense

 

(6,500

)

Total other expense, net

 

(7,043

)

 

(192

)

(Loss) Income before income tax benefit (provision)

 

(3,008

)

 

11,977

 

Income tax benefit (provision)

 

137

 

 

(3,004

)

Net (Loss) Income

$

(2,871

)

$

8,973

 

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

$

(0.21

)

$

0.64

 

Diluted

$

(0.21

)

$

0.62

 

Weighted average number of common shares outstanding:
Basic

 

13,667,606

 

 

13,925,227

 

Diluted

 

13,667,606

 

 

14,418,211

 

 
EAGLE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(unaudited)
 
Three Months Ended March 31,

 

2020

 

 

2019

 

Cash flows from operating activities:
Net (loss) income

$

 

(2,871

)

$

 

8,973

 

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

 

(90

)

 

(287

)

Depreciation expense

 

472

 

 

503

 

Amortization expense

 

666

 

 

630

 

Fair value adjustments on equity investment

 

6,500

 

Stock-based compensation expense

 

7,472

 

 

5,782

 

Amortization of debt issuance costs

 

65

 

 

94

 

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

 

(6,487

)

 

2,556

 

Inventories

 

(1,868

)

 

(1,961

)

Prepaid expenses and other current assets

 

4,473

 

 

4,368

 

Accounts payable

 

4,294

 

 

6,869

 

Accrued expenses and other liabilities

 

(8,238

)

 

(1,083

)

Other assets and other long-term liabilities, net

 

(1,230

)

 

(263

)

Net cash provided by operating activities

 

3,158

 

 

26,181

 

Cash flows from investing activities:
Purchase of equity investment security

 

(17,500

)

Purchase of property and equipment

 

(472

)

 

(177

)

Net cash used in investing activities

 

(17,972

)

 

(177

)

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

 

330

 

 

42

 

Employee withholding taxes related to stock-based awards

 

(1,276

)

 

(198

)

Proceeds from existing revolving credit facility

 

110,000

 

Payment of debt

 

(1,000

)

 

(2,500

)

Repurchases of common stock

 

(999

)

Net cash provided by (used in) financing activities

 

107,055

 

 

(2,656

)

Net increase in cash and cash equivalents

 

92,241

 

 

23,348

 

Cash and cash equivalents at beginning of period

 

109,775

 

 

78,791

 

Cash and cash equivalents at end of period

$

 

202,016

 

$

 

102,139

 

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

$

 

24

 

$

 

(6,490

)

Interest

 

576

 

 

625

 

Right-of-use asset obtained in exchange for lease obligation – lease amendment

 

842

 

 

2,871

 

 

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

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