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Eagle Pharmaceuticals Reports Third Quarter 2021 Results

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Eagle Pharmaceuticals reported a Q3 2021 net loss of $5.6 million, or $0.43 per share, a decline from a net income of $7.1 million in Q3 2020. Total revenue decreased to $39.9 million, down from $49.9 million year-over-year, primarily due to lower sales of BELRAPZO and BENDEKA. Adjusted non-GAAP net income was $7.5 million, down from $16.1 million in the previous year. Eagle is preparing for key product launches, including vasopressin and PEMFEXY, and secured a worldwide licensing agreement for CAL02, an antitoxin agent ready for Phase 2b/3 development.

Positive
  • Entered into a worldwide licensing agreement for CAL02, ready for Phase 2b/3 development.
  • Received favorable court decision confirming no patent infringement for vasopressin product.
  • Expected product launches for vasopressin and PEMFEXY within the next 90 days could boost revenue.
  • Gross margin improved to 79% from 76% year-over-year despite revenue decline.
Negative
  • Total revenue for Q3 2021 decreased by 20% compared to Q3 2020.
  • Net loss of $5.6 million in Q3 2021 compared to net income of $7.1 million in Q3 2020.
  • Adjusted non-GAAP net income significantly decreased, down to $7.5 million from $16.1 million year-over-year.
  • R&D expenses surged to $23.3 million compared to $4.8 million in Q3 2020, affecting profitability.
  • Q3 2021 net loss was $0.43 per basic and diluted share and adjusted non-GAAP net income was $0.57 per basic and $0.56 per diluted share
  • Expect to receive approval for Abbreviated New Drug Application (“ANDA”) for vasopressin; December 15, 2021 GDUFA date
  • Received favorable district court decision that Eagle’s proposed vasopressin product does not infringe any of the patents Par asserted against Eagle
  • Entered into worldwide licensing agreement for CAL02, a novel first-in-class antitoxin agent ready for Phase 2b/3 development for the treatment of severe bacterial pneumonia
  • Licensed U.S. commercial rights to landiolol, a beta-1 adrenergic blocker, a leading hospital emergency use product in Europe and Japan

 

WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)-- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced financial results for the three and nine months ended September 30, 2021.

Business and Recent Highlights:

  • Entered into a worldwide licensing agreement for the commercial rights to CAL02, a novel first-in-class antitoxin agent ready for Phase 2b/3 development for the treatment of severe bacterial pneumonia in combination with traditional antibacterial drugs.
  • Vasopressin updates:
    • In August 2021, received favorable decision from the U.S. District Court for the District of Delaware that Eagle’s proposed vasopressin product does not infringe any of the patents Par Pharmaceutical, Inc. asserted against Eagle.
    • U.S. Food and Drug Administration (“FDA”) maintained Priority Review for the Company’s ANDA with December 15, 2021 GDUFA date.
    • Received a 30-day information request from the FDA; Eagle fully responded to the request on September 20, 2021, and there are no other review requests outstanding.
  • Granted U.S. Patent No. 11,103,483, “Formulations of Bendamustine,” which has been listed in the FDA Orange Book for BENDEKA® and BELRAPZO®.
  • Entered into a licensing agreement for the U.S. commercial rights to landiolol, a leading hospital emergency use product in Europe and Japan. Landiolol is currently approved in Europe for the treatment of non-compensatory sinus tachycardia and tachycardic supraventricular arrhythmias. Eagle will support the submission of a new drug application to the FDA seeking approval for landiolol for the short-term reduction of ventricular rate in patients with supraventricular tachycardia, including atrial fibrillation and atrial flutter.

Financial Highlights

Third Quarter 2021

  • Total revenue for Q3 2021 was $39.9 million, compared to $49.9 million in Q3 2020, primarily reflecting lower product sales of BELRAPZO and BENDEKA, partially offset by higher product sales of TREAKISYM.
  • Q3 2021 net loss was $5.6 million, or $0.43 per basic and diluted share, compared to net income of $7.1 million, or $0.52 per basic and $0.51 diluted share in Q3 2020.
  • Q3 2021 adjusted non-GAAP net income was $7.5 million, or $0.57 per basic and $0.56 per diluted share, compared to adjusted non-GAAP net income of $16.1 million, or $1.19 per basic and $1.17 per diluted share, in Q3 2020.
  • Cash and cash equivalents were $99.7 million, net accounts receivable was $45.3 million, and debt was $28.0 million as of September 30, 2021.

“We are preparing for two significant product launches, vasopressin and PEMFEXY™, expected within the next ninety days that we believe will meaningfully increase the revenue and profitability of Eagle. With the recent licensing of CAL02 and landiolol, our expectation going forward is that we will utilize our cash and possibly the balance sheet to further strengthen the pipeline and portfolio,” stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.

Third Quarter 2021 Financial Results

Total revenue for the three months ended September 30, 2021 was $39.9 million, as compared to $49.9 million for the three months ended September 30, 2020.

Q3 2021 BELRAPZO product sales were $4.9 million, compared to $8.7 million in Q3 2020.

Q3 2021 RYANODEX® product sales were $4.5 million, compared to $4.2 million in Q3 2020.

Royalty revenue was $27.7 million in the third quarter of 2021, compared to $27.6 million in the third quarter of 2020. BENDEKA royalties were $26.5 million in the third quarter of 2021, compared to $27.6 million in the third quarter of 2020. A summary of total revenue is outlined below:

Three Months Ended September 30,

 

2021

 

2020

(unaudited) (unaudited)
Revenue (in thousands):
Product sales, net

$

12,124

$

17,317

Royalty revenue

 

27,729

 

27,611

License and other revenue

 

 

5,000

Total revenue

$

39,853

$

49,928

 

Gross Margin was 79% during the third quarter of 2021, as compared to 76% in the third quarter of 2020. The increase in gross margin for the third quarter of 2021 was driven by revenue mix.

R&D expense was $23.3 million for the third quarter of 2021, compared to $4.8 million in the third quarter of 2020. The increase includes a $10.0 million upfront payment related to our license agreement with Combioxin for CAL02, a $5.0 million upfront expense related to our licensing agreement with AOP Orphan for landiolol, a $0.8 million increase in development and pre-launch inventory costs for vasopressin and a $1.1 million increase related to PEMFEXY. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense during the third quarter of 2021 was $7.6 million.

SG&A expenses in the third quarter of 2021 totaled $18.5 million compared to $17.7 million in the third quarter of 2020. This increase is primarily related to higher external legal costs partially offset by a decrease in stock-based compensation expense. Excluding stock-based compensation and other non-cash and non-recurring items, third quarter 2021 SG&A expense was $14.5 million.

Net loss for the third quarter of 2021 was $5.6 million, or $0.43 per basic and diluted share, compared to net income of $7.1 million, or $0.52 per basic and $0.51 per diluted share, in the third quarter of 2020, due to the factors discussed above.

Adjusted non-GAAP net income for the third quarter of 2021 was $7.5 million, or $0.57 per basic and $0.56 per diluted share, compared to adjusted non-GAAP net income of $16.1 million or $1.19 per basic and $1.17 per diluted share in the third quarter of 2020. 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.

2021 Expense Guidance

  • R&D spend in 2021, on a non-GAAP basis, is expected to be $34-$38 million, as compared to $27.8 million in 2020.
  • SG&A spend in 2021, on a non-GAAP basis, is expected to be $52-$56 million, as compared to $50.9 million in 2020.
  • 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, 2021, the Company had $99.7 million in cash and cash equivalents plus $45.3 million in net accounts receivable. The Company had $28.0 million in outstanding debt. Therefore, as of September 30, 2021, the Company had net cash plus receivables of $117.0 million.

In the third quarter of 2021, the Company purchased $8.3 million of its common stock as part of its $160.0 million Share Repurchase Program. From August 2016 through September 30, 2021, the Company has repurchased $219.4 million of its common stock.

Conference Call

As previously announced, Eagle management will host its third quarter 2021 conference call as follows:

Date

 

 

 

 

 

Tuesday, November 9, 2021

Time

 

 

 

 

 

8:30 A.M. EDT

Toll free (U.S.)

 

 

 

 

 

866-342-8591

International

 

 

 

 

 

203-518-9822

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 800-839-8292 (US) or 402-220-6069 (International) and entering conference call ID EGRXQ321. 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 number and timing of potential product launches, development initiatives or new indications for the Company’s product candidates; the period of market exclusivity for any of the Company’s product candidates; potential future revenue or earnings of the Company, including resulting from potential product launches of vasopressin and PEMFEXY; the Company's clinical development plan for the product candidates in its portfolio; the ability of the Company’s executive team to execute on the Company’s strategy and build stockholder value; the timing, scope or likelihood and timing of regulatory filings and approvals from the FDA for the Company’s product candidates and the Company’s ability to maintain regulatory approval of its products and product candidates; the potential timing of the Company’s commercial launch of PEMFEXY, vasopressin or landiolol, if ever; the Company’s plans for and ability to support the commercial launch of landiolol in the United States, if approved; the ability of the Company’s product candidates, including landiolol, vasopressin and PEMFEXY, to deliver value to stockholders; ; the success of the Company's collaborations with its strategic partners and the timing and results of these partners’ preclinical studies and clinical trials; the Company’s timing and ability to enroll patients in ongoing and upcoming clinical trials; the ability of the Company to obtain and maintain coverage and adequate reimbursement for its products; the implementation of certain healthcare reform measures; 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 ability to deliver value in 2021 and over the long term; the Company’s ability to utilize its cash and other assets to increase shareholder value; the Company’s ability to effectively manage and control expenses in line with its budget; 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; whether the Company will successfully implement its development plan for its 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; the success of the Company's relationships with its partners; 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” sections of the Company's Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission (the “SEC”) on March 5, 2021, as updated by the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, which the Company expects to file with the SEC on November 9, 2021, and its other subsequent 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, except as required by law.

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, expense of acquired in-process research and development expense, amortization expense, severance, non-cash interest expense, expense related to collaboration with Tyme, fair value adjustments on equity investment, fair value adjustments related to derivative instrument, convertible promissory note related credit losses, accretion of discount on convertible promissory note 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 (UNAUDITED)
(In thousands, except share amounts)
 
 
September 30, 2021 December 31, 2020
ASSETS
Current assets:
Cash and cash equivalents

$

99,741

 

$

103,155

 

Accounts receivable, net

 

45,335

 

 

50,678

 

Inventories

 

9,315

 

 

8,075

 

Prepaid expenses and other current assets

 

17,303

 

 

4,157

 

Total current assets

 

171,694

 

 

166,065

 

Property and equipment, net

 

1,775

 

 

2,077

 

Intangible assets, net

 

10,799

 

 

12,917

 

Goodwill

 

39,743

 

 

39,743

 

Deferred tax asset, net

 

17,713

 

 

15,180

 

Other assets

 

14,537

 

 

17,208

 

Total assets

$

256,261

 

$

253,190

 

LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable

$

12,717

 

$

6,268

 

Accrued expenses and other liabilities

 

27,714

 

 

23,817

 

Current portion of long-term debt

 

8,000

 

 

8,000

 

Total current liabilities

 

48,431

 

 

38,085

 

Other long-term liabilities

 

3,048

 

 

3,959

 

Long-term debt, less current portion

 

19,489

 

 

25,135

 

Total liabilities

 

70,968

 

 

67,179

 

Commitments and Contingencies
Stockholders' equity:
Preferred stock, 1,500,000 shares authorized and no shares issued or outstanding as of September 30, 2021 and December 31, 2020

 

 

 

 

Common stock, $0.001 par value; 50,000,000 shares authorized; 16,886,123 and 16,739,203 shares issued as of September 30, 2021 and December 31, 2020, respectively

 

17

 

 

17

 

Additional paid in capital

 

320,566

 

 

305,403

 

Accumulated other comprehensive loss

 

(882

)

 

 

Retained earnings

 

82,058

 

 

84,489

 

Treasury stock, at cost, 3,941,541 and 3,682,176 shares as of September 30, 2021 and December 31, 2020, respectively

 

(216,466

)

 

(203,898

)

Total stockholders' equity

 

185,293

 

 

186,011

 

Total liabilities and stockholders' equity

$

256,261

 

$

253,190

 

 
EAGLE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(In thousands, except share and per share amounts)
 
 
Three Months Ended September 30, Nine Months Ended September 30,

 

2021

 

 

 

2020

 

 

 

2021

 

 

 

2020

 

Revenue:
Product sales, net

$

12,124

 

$

17,317

 

$

48,865

 

$

49,387

 

Royalty revenue

 

27,729

 

 

27,611

 

 

80,361

 

 

83,499

 

License and other revenue

 

 

 

5,000

 

 

 

 

5,000

 

Total revenue

 

39,853

 

 

49,928

 

 

129,226

 

 

137,886

 

Operating expenses:
Cost of product sales

 

5,486

 

 

8,726

 

 

21,835

 

 

23,804

 

Cost of royalty revenue

 

2,773

 

 

3,260

 

 

8,036

 

 

9,120

 

Research and development

 

23,289

 

 

4,828

 

 

47,488

 

 

21,390

 

Selling, general and administrative

 

18,482

 

 

17,697

 

 

54,997

 

 

60,411

 

Total operating expenses

 

50,030

 

 

34,511

 

 

132,356

 

 

114,725

 

(Loss) income from operations

 

(10,177

)

 

15,417

 

 

(3,130

)

 

23,161

 

Interest income

 

197

 

 

46

 

 

395

 

 

542

 

Interest expense

 

(396

)

 

(489

)

 

(1,240

)

 

(2,164

)

Other expense

 

(2,284

)

 

(6,049

)

 

(1,797

)

 

(10,249

)

Total other expense, net

 

(2,483

)

 

(6,492

)

 

(2,642

)

 

(11,871

)

(Loss) income before income tax benefit (provision)

 

(12,660

)

 

8,925

 

 

(5,772

)

 

11,290

 

Income tax benefit (provision)

 

7,038

 

 

(1,866

)

 

3,341

 

 

(7,358

)

Net (loss) income

$

(5,622

)

$

7,059

 

$

(2,431

)

$

3,932

 

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

$

(0.43

)

$

0.52

 

$

(0.19

)

$

0.29

 

Diluted

$

(0.43

)

$

0.51

 

$

(0.19

)

$

0.28

 

Weighted average number of common shares outstanding:
Basic

 

13,077,298

 

 

13,531,372

 

 

13,103,203

 

 

13,620,981

 

Diluted

 

13,077,298

 

 

13,786,803

 

 

13,103,203

 

 

13,917,800

 

 
EAGLE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
(In thousands)
 
 
Nine Months Ended September 30,

 

2021

 

 

2020

 

Cash flows from operating activities:
Net (loss) income

$

(2,431

)

$

3,932

 

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

 

(2,533

)

 

(1,671

)

Depreciation expense

 

575

 

 

656

 

Noncash operating lease expense related to right-of-use assets

 

768

 

 

980

 

Amortization expense of intangible assets

 

2,118

 

 

1,999

 

Fair value adjustments on equity investment

 

1,900

 

 

7,700

 

Stock-based compensation expense

 

14,873

 

 

18,435

 

Convertible promissory note related credit losses

 

150

 

 

 

Amortization of debt issuance costs

 

354

 

 

301

 

Fair value adjustments related to derivative instrument

 

(254

)

 

2,549

 

Accretion of discount on convertible promissory note

 

(102

)

 

 

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

 

5,343

 

 

(4,195

)

Inventories

 

(1,240

)

 

(20

)

Prepaid expenses and other current assets

 

(8,821

)

 

(2,774

)

Accounts payable

 

6,449

 

 

7,606

 

Accrued expenses and other liabilities

 

3,897

 

 

(3,916

)

Other assets and other long-term liabilities, net

 

(908

)

 

(1,845

)

Net cash provided by operating activities

 

20,138

 

 

29,737

 

Cash flows from investing activities:
Purchase of equity investment security

 

 

 

(17,500

)

Purchase of property and equipment

 

(274

)

 

(577

)

Purchase of convertible promissory note

 

(5,000

)

 

 

Net cash used in investing activities

 

(5,274

)

 

(18,077

)

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

 

1,841

 

 

555

 

Employee withholding taxes related to stock-based awards

 

(1,551

)

 

(1,310

)

Proceeds from existing revolving credit facility

 

 

 

110,000

 

Repayment of existing revolving credit facility

 

 

 

(110,000

)

Payment of debt

 

(6,000

)

 

(3,000

)

Repurchases of common stock

 

(12,568

)

 

(27,999

)

Net cash used in financing activities

 

(18,278

)

 

(31,754

)

Net decrease in cash and cash equivalents

 

(3,414

)

 

(20,094

)

Cash and cash equivalents at beginning of period

 

103,155

 

 

109,775

 

Cash and cash equivalents at end of period

$

99,741

 

$

89,681

 

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

$

6,303

 

$

3,036

 

Interest

 

917

 

 

1,878

 

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

 

 

 

842

 

 
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,

 

2021

 

 

 

2020

 

 

 

2021

 

 

 

2020

 

Net (loss) income - GAAP

$

(5,622

)

$

7,059

 

$

(2,431

)

$

3,932

 

 
Adjustments:
Cost of product revenues:
Amortization expense

 

301

 

 

261

 

 

903

 

 

784

 

Research and development:
Stock-based compensation expense

 

641

 

 

(514

)

 

2,177

 

 

2,070

 

Depreciation expense

 

57

 

 

72

 

 

164

 

 

206

 

Expense of acquired in-process research & development

 

15,000

 

 

-

 

 

15,000

 

 

-

 

Severance

 

-

 

 

-

 

 

274

 

 

-

 

Selling, general and administrative:
Stock-based compensation expense

 

3,443

 

 

5,236

 

 

12,696

 

 

16,365

 

Expense related to collaboration with Tyme

 

-

 

 

-

 

 

-

 

 

2,500

 

Amortization expense

 

405

 

 

405

 

 

1,215

 

 

1,215

 

Depreciation expense

 

140

 

 

124

 

 

411

 

 

450

 

Severance

 

-

 

 

-

 

 

334

 

 

245

 

 
Other:
Non-cash interest expense

 

118

 

 

118

 

 

354

 

 

354

 

Fair value adjustments on equity investment

 

2,300

 

 

3,500

 

 

1,900

 

 

7,700

 

Convertible promissory note related credit losses

 

50

 

 

-

 

 

150

 

 

-

 

Fair value adjustments related to derivative instrument

 

(66

)

 

2,549

 

 

(254

)

 

2,549

 

Accretion of discount on convertible promissory note

 

(46

)

 

-

 

 

(102

)

 

-

 

Tax effect of the non-GAAP adjustments

 

(9,205

)

 

(2,663

)

 

(9,608

)

 

(2,466

)

 
Adjusted non-GAAP net income

$

7,516

 

$

16,147

 

$

23,183

 

$

35,904

 

 
Adjusted non-GAAP earnings per share:
Basic

$

0.57

 

$

1.19

 

$

1.77

 

$

2.64

 

Diluted

$

0.56

 

$

1.17

 

$

1.74

 

$

2.58

 

Weighted average number of common shares outstanding:
Basic

 

13,077,298

 

 

13,531,372

 

 

13,103,203

 

 

13,620,981

 

Diluted

 

13,307,559

 

 

13,786,803

 

 

13,290,677

 

 

13,917,800

 

 
EAGLE PHARMACEUTICALS, INC.
RECONCILIATION OF GAAP TO ADJUSTED NON-GAAP EBITDA (UNAUDITED)
(In thousands)
 
 
Three Months Ended
September 30,
Nine Months Ended
September 30,
Twelve Months Ended
September 30,
Twelve Months Ended
December 31,

 

2021

 

 

 

2020

 

 

2021

 

 

 

2020

 

2021

 

2020

 
Net (loss) income - GAAP

$

(5,622

)

$

7,059

$

(2,431

)

$

3,932

$

5,626

 

$

11,989

 
Add back:
Interest expense, net of interest income

 

199

 

 

443

 

845

 

 

1,622

 

1,238

 

 

2,015

Income tax (benefit) provision

 

(7,038

)

 

1,866

 

(3,341

)

 

7,358

 

(11

)

 

10,688

Depreciation and amortization expense

 

903

 

 

862

 

2,693

 

 

2,655

 

3,576

 

 

3,538

 
Add back:
Stock-based compensation expense

 

4,084

 

 

4,722

 

14,873

 

 

18,435

 

21,194

 

 

24,756

Fair value adjustments on equity investment

 

2,300

 

 

3,500

 

1,900

 

 

7,700

 

(500

)

 

5,300

Expense of acquired in-process research & development

 

15,000

 

 

-

 

15,000

 

 

-

 

15,000

 

 

-

Convertible promissory note related credit losses

 

50

 

 

-

 

150

 

 

-

 

150

 

 

-

Fair value adjustments related to derivative instrument

 

(66

)

 

2,549

 

(254

)

 

2,549

 

159

 

 

2,962

Expense related to collaboration with Tyme

 

-

 

 

-

 

-

 

 

2,500

 

-

 

 

2,500

Severance

 

-

 

 

-

 

608

 

 

245

 

1,287

 

 

924

Adjusted Non-GAAP EBITDA

$

9,810

 

$

21,001

$

30,043

 

$

46,996

$

47,719

 

$

64,672

 

Investor Relations for Eagle Pharmaceuticals, Inc.:

Lisa M. Wilson

In-Site Communications, Inc.

T: 212-452-2793

E: lwilson@insitecony.com

Source: Eagle Pharmaceuticals, Inc.

FAQ

What were Eagle Pharmaceuticals' Q3 2021 financial results?

Eagle Pharmaceuticals reported a Q3 2021 net loss of $5.6 million, total revenue of $39.9 million, and adjusted non-GAAP net income of $7.5 million.

What is the expected GDUFA date for Eagle Pharmaceuticals' vasopressin product?

The expected GDUFA date for Eagle's vasopressin product is December 15, 2021.

What are the upcoming product launches for Eagle Pharmaceuticals?

Eagle Pharmaceuticals is preparing for the launches of vasopressin and PEMFEXY within the next 90 days.

How did Eagle Pharmaceuticals' revenue change in Q3 2021 compared to Q3 2020?

Total revenue decreased by 20%, from $49.9 million in Q3 2020 to $39.9 million in Q3 2021.

What licensing agreements did Eagle Pharmaceuticals enter into recently?

Eagle entered into a worldwide licensing agreement for CAL02 and secured U.S. commercial rights for landiolol.

EAGLE PHARMS INC

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