Eagle Pharmaceuticals Reports Third Quarter 2020 Results

November 2, 2020 Off By BusinessWire

— Q3 2020 net income was $0.52 per basic and $0.51 per diluted share and adjusted non-GAAP net income was $1.19 per basic and $1.17 per diluted share

— Granted Priority Review by U.S. Food and Drug Administration (“FDA”) for vasopressin; trial date set for January 11, 2021 —

— Held positive Type C meeting with FDA on fulvestrant (EA-114); next step is to submit formal protocol for clinical study —

— Promoted Brian Cahill as Eagle’s new Chief Financial Officer —

— Added experienced pharmaceutical industry executives to clinical, formulations and commercial leadership teams —

— Japanese licensing partner, SymBio, received approval of TREAKISYM ready-to-dilute formulation, triggering $5.0 million milestone payment to Eagle —

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, 2020.

Business and Recent Highlights:

  • Received formal notification from FDA granting Priority Review for the Company’s abbreviated new drug application (“ANDA”) filed for vasopressin. (Read more…) A trial date of January 11, 2021 has been set;
  • Added four experienced pharmaceutical industry executives to clinical, formulations and commercial leadership teams as follows: Judith (“Judi”) Ng-Cashin, M.D., is EVP and Chief Medical Officer; John Kimmet, is EVP, Oncology and Acute Care Marketing; Valentin R. Curt, M.D., is SVP, Clinical Drug Development; and Gaozhong Zhu, Ph.D., is SVP, Pharmaceutical Development;
  • Promoted Brian Cahill as the Company’s new Chief Financial Officer. Mr. Cahill has served as Eagle’s VP, Finance for the last four years and brings more than 20 years of public company and public accounting experience to the Company;
  • Received Board approval for a $25.0 million accelerated share repurchase transaction with JPMorgan as part of the Company’s existing $160.0 million share repurchase program. To date, Eagle has purchased $205.0 million, or approximately 22% of the Company’s issued shares, at approximately $55.00 per share;
  • Announced the publication of preclinical research on dantrolene sodium in the peer-reviewed Journal of Alzheimer’s Disease. The academic-based study, conducted by Eagle’s collaboration partner, the University of Pennsylvania, demonstrated dantrolene sodium improved memory and cognition in a mouse model of Alzheimer’s disease;
  • Initiating dose ranging studies in another animal model using intravenous administration of RYANODEX® for the treatment of brain damage secondary to nerve agent exposure and will include an arm using an intramuscular formulation of EA-111. Eagle believes that the preliminary results will allow the Company to update its Special Protocol Assessment with the FDA; and
  • Despite the ongoing COVID-19 pandemic, the Company has not experienced significant disruptions to its supply chain to date, and believes it has sufficient supply chain inventory to continue manufacturing and to provide product without interruption consistent with its current business plans and projections; the Company has experienced variable financial impacts and has also experienced delays in the timing of certain of its pre-clinical programs and delays in its ongoing litigation matters due to the COVID-19 pandemic; the Company continues to monitor the ongoing pandemic and evaluate and evolve its business plans and response strategy thereto.

Oncology Highlights:

  • Held a positive Type C meeting with FDA on fulvestrant and is in the process of gaining agreement on the details of the formal protocol for the clinical study;
  • Japanese licensing partner, SymBio, received regulatory approval for TREAKISYM ready-to-dilute (“RTD”) (250 ml) liquid formulation from the Pharmaceuticals and Medical Devices Agency in Japan. The approval covers all currently approved TREAKISYM indications (low-grade non-Hodgkin’s lymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia) and triggered a $5.0 million milestone payment to Eagle. SymBio’s conversion of its current lyophilized formulation of TREAKISYM to Eagle’s RTD liquid formulation and commercial launch are expected in January 2021;
  • Centers for Medicare & Medicaid Services established unique Healthcare Common Procedure Coding System code, or J-code, for PEMFEXY™ (Pemetrexed for Injection, 10 mg), a branded alternative to ALIMTA® effective October 1, 2020;
  • Granted a supplement approval by FDA for 500mg multiple-dose vial of PEMFEXY. The Company has initial market entry (equivalent to approximately a three-week supply of current ALIMTA utilization) on February 1, 2022, and a subsequent uncapped entry on April 1, 2022; and
  • The Company’s strategic collaboration partner, Tyme Technologies, Inc. (“Tyme”), announced that FDA granted Orphan Drug Designation for its lead product candidate, SM-88, a treatment for patients with pancreatic cancer.

Third Quarter 2020 Financial Highlights

  • Total revenue for Q3 2020 was $49.9 million, compared to $41.1 million in Q3 2019, primarily reflecting increased product sales of BELRAPZO® and RYANODEX, as well as the $5.0 million milestone from SymBio, partially offset by lower product sales of BENDEKA.
  • Net income for Q3 2020 was $7.1 million, or $0.52 per basic and $0.51 per diluted share, compared to net loss for Q3 2019 of $2.4 million, or ($0.17) per basic and diluted share.
  • Adjusted non-GAAP net income for Q3 2020 was $16.1 million, or $1.19 per basic and $1.17 per diluted share, compared to adjusted non-GAAP net income for Q3 2019 of $3.7 million, or $0.27 per basic and $0.26 per diluted share.
  • Cash and cash equivalents were $89.7 million, net accounts receivable was $52.2 million, and debt was $36.0 million as of September 30, 2020.

“Our strong third-quarter results demonstrate the efficiency of our business model as we continue to reinvest in our company. This momentum is further supported by multiple near-term product opportunities we are advancing, including vasopressin, fulvestrant, RYANODEX for several indications and PEMFEXY, along with our key partnerships with SymBio for bendamustine and Tyme for pancreatic cancer and other oncology indications. We are also excited to welcome a talented group of pharmaceutical executives to the Eagle team and look forward to their contributions in support of our promising lineup of products and anticipated upcoming launches. The next 12-18 months look to be an active period for Eagle, and I am optimistic about our prospects going forward,” stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

Third Quarter 2020 Financial Results

Total revenue for Q3 2020 was $49.9 million, as compared to $41.1 million for Q3 2019.

Q3 2020 BELRAPZO product sales were $8.7 million, compared to $3.4 million in Q3 2019.

Q3 2020 RYANODEX product sales were $4.2 million, compared to $2.6 million in Q3 2019.

Royalty revenue was $27.6 million in the third quarter of 2020, compared to $26.5 million in the third quarter of 2019. BENDEKA royalties were $27.6 million in the third quarter of 2020, compared to $26.2 million in the third quarter of 2019. A summary of total revenue is outlined below:

 

Three Months Ended September 30,

 

2020

 

2019

 

(unaudited)

 

(unaudited)

Revenue (in thousands):

 

 

 

Product sales

$17,317

 

$14,659

Royalty revenue

27,611

 

26,488

License and other revenue

5,000

 

Total revenue

$49,928

 

$41,147

Gross Margin was 76% during the third quarter of 2020, as compared to 64% in the third quarter of 2019. The expansion in gross margin in the third quarter of 2020 was driven by an increase in RYANODEX sales, lower BENDEKA product sales in the period to our marketing partner, on which Eagle earns no profit, the increase in BENDEKA royalty revenue, and the $5.0 million milestone payment from SymBio.

R&D expense was $4.8 million for the third quarter of 2020, compared to $10.2 million in the third quarter of 2019. The decrease primarily resulted from lower spending on vasopressin and RYANODEX for the treatment of exertional heat stroke, as well as lower stock-based compensation expense. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense during the third quarter of 2020 was $5.3 million.

SG&A expense in the third quarter of 2020 decreased to $17.7 million compared to $18.5 million in the third quarter of 2019, primarily due to decreases in travel and entertainment expenses, trade show costs, and external legal expenses. Excluding stock-based compensation and other non-cash and non-recurring items, third quarter 2020 SG&A expense was $11.9 million.

Net income for the third quarter of 2020 was $7.1 million, or $0.52 per basic and $0.51 per diluted share, compared to net loss of $2.4 million, or ($0.17) per basic and diluted share, in the third quarter of 2019.

Adjusted non-GAAP net income for the third quarter of 2020 was $16.1 million, or $1.19 per basic and $1.17 per diluted share, compared to adjusted non-GAAP net income of $3.7 million or $0.27 per basic and $0.26 per diluted share in the third 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

  • R&D expense in 2020, on a non-GAAP basis, is expected to be $40-$44 million, as compared to $31 million in 2019.
  • SG&A spend in 2020, on a non-GAAP basis, is expected to be $61-$64 million, as compared to $56 million in 2019.

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, 2020, the Company had $89.7 million in cash and cash equivalents plus $52.2 million in net accounts receivable, $34.3 million of which was due from Teva. The Company had $36.0 million in outstanding debt. Therefore, as of September 30, 2020, the Company had net cash plus receivables of $105.9 million.

In the third quarter of 2020, the Company repurchased $28.0 million of its common stock as part of the Company’s $160.0 million share repurchase program. From August 2016 through September 30, 2020, the Company repurchased $205.0 million of its common stock.

Conference Call

As previously announced, Eagle management will host its Q3 2020 conference call as follows:

Date

 

 

 

 

 

 

 

 

 

 

 

 

Monday, November 2, 2020

Time

 

 

 

 

 

 

 

 

 

 

 

 

8:30 A.M. ET

Toll free (U.S.)

 

 

 

 

 

866-342-8591

International

 

 

 

 

 

203-518-9713

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 800-934-3336 (US) or 402-220-1148 (International) and entering conference call ID EGRXQ320. 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 current and anticipated 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, including for the treatment of brain damage secondary to Nerve Agent exposure and ability to update its Special Protocol Assessment with the FDA; the Company’s clinical development plan for its fulvestrant product candidate, EA-114, including potential approval of its submitted ANDA for vasopressin, as well as the development efforts for the other product candidates in its portfolio; the timing of the Company’s PEMFEXY and vasopressin launches, if ever; the period of market exclusivity for vasopressin; the success of the Company’s collaborations with its strategic partners; the Company’s expense guidance for fiscal year 2020; the Company’s expectations with respect to near-term product opportunities and commercial launches and the ability of the leadership team to support the Company’s growth; statements regarding the efficiency and strength of the Company’s business model; 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 ongoing 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 continued 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 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 the University of Pennsylvania, Teva, Tyme and SymBio 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 (the “SEC”) on March 2, 2020 as updated by its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2020 and June 30, 2020, filed with the SEC on May 11, 2020 and August 10, 2020, respectively, 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, 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 amortization expense, stock-based compensation expense, depreciation expense, expense related to collaboration with Tyme, severance, non-cash interest expense, fair value adjustments on equity investment, fair value adjustments on unsettled accelerated share repurchase agreement 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, 2020 December 31, 2019
ASSETS
Current assets:
Cash and cash equivalents

$

89,681

 

$

109,775

 

Accounts receivable, net

 

52,199

 

 

48,004

 

Inventories

 

6,586

 

 

6,566

 

Prepaid expenses and other current assets

 

15,330

 

 

15,104

 

Total current assets

 

163,796

 

 

179,449

 

Property and equipment, net

 

2,123

 

 

2,202

 

Intangible assets, net

 

13,584

 

 

15,583

 

Goodwill

 

39,743

 

 

39,743

 

Deferred tax asset, net

 

15,340

 

 

13,669

 

Other assets

 

13,575

 

 

3,908

 

Total assets

$

248,161

 

$

254,554

 

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable

$

13,068

 

$

5,462

 

Accrued expenses and other liabilities

 

24,445

 

 

28,361

 

Current portion of long-term debt

 

8,000

 

 

5,000

 

Total current liabilities

 

45,513

 

 

38,823

 

Other long-term liabilities

 

2,844

 

 

3,000

 

Long-term debt, less current portion

 

27,017

 

 

33,557

 

Total liabilities

 

75,374

 

 

75,380

 

Commitments and Contingencies
Stockholders’ equity:
Preferred stock, 1,500,000 shares authorized and no shares issued or outstanding as of September 30, 2020 and December 31, 2019

 

 

 

 

Common stock, $0.001 par value; 50,000,000 shares authorized; 16,624,681 and 16,537,846 shares issued as of September 30, 2020 and December 31, 2019, respectively

 

17

 

 

17

 

Additional paid in capital

 

296,198

 

 

278,518

 

Retained earnings

 

76,432

 

 

72,500

 

Treasury stock, at cost, 3,594,551 and 2,907,687 shares as of September 30, 2020 and December 31, 2019, respectively

 

(199,860

)

 

(171,861

)

Total stockholders’ equity

 

172,787

 

 

179,174

 

Total liabilities and stockholders’ equity

$

248,161

 

$

254,554

 

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

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Revenue:
Product sales

$

17,317

 

$

14,659

 

$

49,387

 

$

58,568

 

Royalty revenue

 

27,611

 

 

26,488

 

 

83,499

 

 

80,066

 

License and other revenue

 

5,000

 

 

 

 

5,000

 

 

9,000

 

Total revenue

 

49,928

 

 

41,147

 

 

137,886

 

 

147,634

 

Operating expenses:
Cost of product sales

 

8,726

 

 

12,137

 

 

23,804

 

 

39,866

 

Cost of royalty revenue

 

3,260

 

 

2,785

 

 

9,120

 

 

9,440

 

Research and development

 

4,828

 

 

10,172

 

 

21,390

 

 

25,504

 

Selling, general and administrative

 

17,697

 

 

18,537

 

 

60,411

 

 

53,906

 

Total operating expenses

 

34,511

 

 

43,631

 

 

114,725

 

 

128,716

 

Income (loss) from operations

 

15,417

 

 

(2,484

)

 

23,161

 

 

18,918

 

Interest income

 

46

 

 

570

 

 

542

 

 

1,701

 

Interest expense

 

(489

)

 

(628

)

 

(2,164

)

 

(1,979

)

Other expense

 

(6,049

)

 

 

 

(10,249

)

 

Total other expense, net

 

(6,492

)

 

(58

)

 

(11,871

)

 

(278

)

Income (loss) before income tax (provision) benefit

 

8,925

 

 

(2,542

)

 

11,290

 

 

18,640

 

Income tax (provision) benefit

 

(1,866

)

 

152

 

 

(7,358

)

 

(5,332

)

Net Income (Loss)

$

7,059

 

$

(2,390

)

$

3,932

 

$

13,308

 

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

$

0.52

 

$

(0.17

)

$

0.29

 

$

0.96

 

Diluted

$

0.51

 

$

(0.17

)

$

0.28

 

$

0.94

 

Weighted average number of common shares outstanding:
Basic

 

13,531,372

 

 

13,668,091

 

 

13,620,981

 

 

13,791,071

 

Diluted

 

13,786,803

 

 

13,668,091

 

 

13,917,800

 

 

14,147,658

 

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

 

2020

 

 

2019

 

Cash flows from operating activities:
Net income

$

3,932

 

$

13,308

 

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

 

(1,671

)

 

(175

)

Depreciation expense

 

656

 

 

725

 

Amortization expense of right-of-use assets

 

980

 

 

754

 

Amortization expense of intangible assets

 

1,999

 

 

1,890

 

Fair value adjustments on equity investment

 

7,700

 

 

 

Stock-based compensation expense

 

18,435

 

 

16,815

 

Amortization of debt issuance costs

 

301

 

 

282

 

Fair value adjustments on unsettled accelerated share repurchase agreement

 

2,549

 

 

 

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

 

(4,195

)

 

21,674

 

Inventories

 

(20

)

 

1,057

 

Prepaid expenses and other current assets

 

(2,774

)

 

(253

)

Accounts payable

 

7,606

 

 

1,315

 

Accrued expenses and other liabilities

 

(3,916

)

 

3,608

 

Other assets and other long-term liabilities, net

 

(1,845

)

 

(1,813

)

Net cash provided by operating activities

 

29,737

 

 

59,187

 

Cash flows from investing activities:
Purchase of equity investment security

 

(17,500

)

 

 

Purchase of property and equipment

 

(577

)

 

(647

)

Net cash used in investing activities

 

(18,077

)

 

(647

)

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

 

555

 

 

78

 

Employee withholding taxes related to stock-based awards

 

(1,310

)

 

(198

)

Proceeds from existing revolving credit facility

 

110,000

 

 

 

Repayment of existing revolving credit facility

 

(110,000

)

 

 

Payment of debt

 

(3,000

)

 

(5,000

)

Repurchases of common stock

 

(27,999

)

 

(15,000

)

Net cash used in financing activities

 

(31,754

)

 

(20,120

)

Net (decrease) increase in cash and cash equivalents

 

(20,094

)

 

38,420

 

Cash and cash equivalents at beginning of period

 

109,775

 

 

78,791

 

Cash and cash equivalents at end of period

$

89,681

 

$

117,211

 

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

$

3,036

 

$

6,587

Interest

 

1,878

 

 

1,787

 

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

 

842

 

 

1,700

 

 

Contacts

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

In-Site Communications, Inc.

T: 212-452-2793

E: [email protected]

Public Relations for Eagle Pharmaceuticals, Inc.:
Faith Pomeroy-Ward

T: 817-807-8044

E: [email protected]

Read full story here

Eagle Pharmaceuticals Reports Third Quarter 2020 Results

November 2, 2020 Off By BusinessWire

— Q3 2020 net income was $0.52 per basic and $0.51 per diluted share and adjusted non-GAAP net income was $1.19 per basic and $1.17 per diluted share

— Granted Priority Review by U.S. Food and Drug Administration (“FDA”) for vasopressin; trial date set for January 11, 2021 —

— Held positive Type C meeting with FDA on fulvestrant (EA-114); next step is to submit formal protocol for clinical study —

— Promoted Brian Cahill as Eagle’s new Chief Financial Officer —

— Added experienced pharmaceutical industry executives to clinical, formulations and commercial leadership teams —

— Japanese licensing partner, SymBio, received approval of TREAKISYM ready-to-dilute formulation, triggering $5.0 million milestone payment to Eagle —

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, 2020.

Business and Recent Highlights:

  • Received formal notification from FDA granting Priority Review for the Company’s abbreviated new drug application (“ANDA”) filed for vasopressin. (Read more…) A trial date of January 11, 2021 has been set;
  • Added four experienced pharmaceutical industry executives to clinical, formulations and commercial leadership teams as follows: Judith (“Judi”) Ng-Cashin, M.D., is EVP and Chief Medical Officer; John Kimmet, is EVP, Oncology and Acute Care Marketing; Valentin R. Curt, M.D., is SVP, Clinical Drug Development; and Gaozhong Zhu, Ph.D., is SVP, Pharmaceutical Development;
  • Promoted Brian Cahill as the Company’s new Chief Financial Officer. Mr. Cahill has served as Eagle’s VP, Finance for the last four years and brings more than 20 years of public company and public accounting experience to the Company;
  • Received Board approval for a $25.0 million accelerated share repurchase transaction with JPMorgan as part of the Company’s existing $160.0 million share repurchase program. To date, Eagle has purchased $205.0 million, or approximately 22% of the Company’s issued shares, at approximately $55.00 per share;
  • Announced the publication of preclinical research on dantrolene sodium in the peer-reviewed Journal of Alzheimer’s Disease. The academic-based study, conducted by Eagle’s collaboration partner, the University of Pennsylvania, demonstrated dantrolene sodium improved memory and cognition in a mouse model of Alzheimer’s disease;
  • Initiating dose ranging studies in another animal model using intravenous administration of RYANODEX® for the treatment of brain damage secondary to nerve agent exposure and will include an arm using an intramuscular formulation of EA-111. Eagle believes that the preliminary results will allow the Company to update its Special Protocol Assessment with the FDA; and
  • Despite the ongoing COVID-19 pandemic, the Company has not experienced significant disruptions to its supply chain to date, and believes it has sufficient supply chain inventory to continue manufacturing and to provide product without interruption consistent with its current business plans and projections; the Company has experienced variable financial impacts and has also experienced delays in the timing of certain of its pre-clinical programs and delays in its ongoing litigation matters due to the COVID-19 pandemic; the Company continues to monitor the ongoing pandemic and evaluate and evolve its business plans and response strategy thereto.

Oncology Highlights:

  • Held a positive Type C meeting with FDA on fulvestrant and is in the process of gaining agreement on the details of the formal protocol for the clinical study;
  • Japanese licensing partner, SymBio, received regulatory approval for TREAKISYM ready-to-dilute (“RTD”) (250 ml) liquid formulation from the Pharmaceuticals and Medical Devices Agency in Japan. The approval covers all currently approved TREAKISYM indications (low-grade non-Hodgkin’s lymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia) and triggered a $5.0 million milestone payment to Eagle. SymBio’s conversion of its current lyophilized formulation of TREAKISYM to Eagle’s RTD liquid formulation and commercial launch are expected in January 2021;
  • Centers for Medicare & Medicaid Services established unique Healthcare Common Procedure Coding System code, or J-code, for PEMFEXY™ (Pemetrexed for Injection, 10 mg), a branded alternative to ALIMTA® effective October 1, 2020;
  • Granted a supplement approval by FDA for 500mg multiple-dose vial of PEMFEXY. The Company has initial market entry (equivalent to approximately a three-week supply of current ALIMTA utilization) on February 1, 2022, and a subsequent uncapped entry on April 1, 2022; and
  • The Company’s strategic collaboration partner, Tyme Technologies, Inc. (“Tyme”), announced that FDA granted Orphan Drug Designation for its lead product candidate, SM-88, a treatment for patients with pancreatic cancer.

Third Quarter 2020 Financial Highlights

  • Total revenue for Q3 2020 was $49.9 million, compared to $41.1 million in Q3 2019, primarily reflecting increased product sales of BELRAPZO® and RYANODEX, as well as the $5.0 million milestone from SymBio, partially offset by lower product sales of BENDEKA.
  • Net income for Q3 2020 was $7.1 million, or $0.52 per basic and $0.51 per diluted share, compared to net loss for Q3 2019 of $2.4 million, or ($0.17) per basic and diluted share.
  • Adjusted non-GAAP net income for Q3 2020 was $16.1 million, or $1.19 per basic and $1.17 per diluted share, compared to adjusted non-GAAP net income for Q3 2019 of $3.7 million, or $0.27 per basic and $0.26 per diluted share.
  • Cash and cash equivalents were $89.7 million, net accounts receivable was $52.2 million, and debt was $36.0 million as of September 30, 2020.

“Our strong third-quarter results demonstrate the efficiency of our business model as we continue to reinvest in our company. This momentum is further supported by multiple near-term product opportunities we are advancing, including vasopressin, fulvestrant, RYANODEX for several indications and PEMFEXY, along with our key partnerships with SymBio for bendamustine and Tyme for pancreatic cancer and other oncology indications. We are also excited to welcome a talented group of pharmaceutical executives to the Eagle team and look forward to their contributions in support of our promising lineup of products and anticipated upcoming launches. The next 12-18 months look to be an active period for Eagle, and I am optimistic about our prospects going forward,” stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

Third Quarter 2020 Financial Results

Total revenue for Q3 2020 was $49.9 million, as compared to $41.1 million for Q3 2019.

Q3 2020 BELRAPZO product sales were $8.7 million, compared to $3.4 million in Q3 2019.

Q3 2020 RYANODEX product sales were $4.2 million, compared to $2.6 million in Q3 2019.

Royalty revenue was $27.6 million in the third quarter of 2020, compared to $26.5 million in the third quarter of 2019. BENDEKA royalties were $27.6 million in the third quarter of 2020, compared to $26.2 million in the third quarter of 2019. A summary of total revenue is outlined below:

 

Three Months Ended September 30,

 

2020

 

2019

 

(unaudited)

 

(unaudited)

Revenue (in thousands):

 

 

 

Product sales

$17,317

 

$14,659

Royalty revenue

27,611

 

26,488

License and other revenue

5,000

 

Total revenue

$49,928

 

$41,147

Gross Margin was 76% during the third quarter of 2020, as compared to 64% in the third quarter of 2019. The expansion in gross margin in the third quarter of 2020 was driven by an increase in RYANODEX sales, lower BENDEKA product sales in the period to our marketing partner, on which Eagle earns no profit, the increase in BENDEKA royalty revenue, and the $5.0 million milestone payment from SymBio.

R&D expense was $4.8 million for the third quarter of 2020, compared to $10.2 million in the third quarter of 2019. The decrease primarily resulted from lower spending on vasopressin and RYANODEX for the treatment of exertional heat stroke, as well as lower stock-based compensation expense. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense during the third quarter of 2020 was $5.3 million.

SG&A expense in the third quarter of 2020 decreased to $17.7 million compared to $18.5 million in the third quarter of 2019, primarily due to decreases in travel and entertainment expenses, trade show costs, and external legal expenses. Excluding stock-based compensation and other non-cash and non-recurring items, third quarter 2020 SG&A expense was $11.9 million.

Net income for the third quarter of 2020 was $7.1 million, or $0.52 per basic and $0.51 per diluted share, compared to net loss of $2.4 million, or ($0.17) per basic and diluted share, in the third quarter of 2019.

Adjusted non-GAAP net income for the third quarter of 2020 was $16.1 million, or $1.19 per basic and $1.17 per diluted share, compared to adjusted non-GAAP net income of $3.7 million or $0.27 per basic and $0.26 per diluted share in the third 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

  • R&D expense in 2020, on a non-GAAP basis, is expected to be $40-$44 million, as compared to $31 million in 2019.
  • SG&A spend in 2020, on a non-GAAP basis, is expected to be $61-$64 million, as compared to $56 million in 2019.

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, 2020, the Company had $89.7 million in cash and cash equivalents plus $52.2 million in net accounts receivable, $34.3 million of which was due from Teva. The Company had $36.0 million in outstanding debt. Therefore, as of September 30, 2020, the Company had net cash plus receivables of $105.9 million.

In the third quarter of 2020, the Company repurchased $28.0 million of its common stock as part of the Company’s $160.0 million share repurchase program. From August 2016 through September 30, 2020, the Company repurchased $205.0 million of its common stock.

Conference Call

As previously announced, Eagle management will host its Q3 2020 conference call as follows:

Date

 

 

 

 

 

 

 

 

 

 

 

 

Monday, November 2, 2020

Time

 

 

 

 

 

 

 

 

 

 

 

 

8:30 A.M. ET

Toll free (U.S.)

 

 

 

 

 

866-342-8591

International

 

 

 

 

 

203-518-9713

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 800-934-3336 (US) or 402-220-1148 (International) and entering conference call ID EGRXQ320. 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 current and anticipated 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, including for the treatment of brain damage secondary to Nerve Agent exposure and ability to update its Special Protocol Assessment with the FDA; the Company’s clinical development plan for its fulvestrant product candidate, EA-114, including potential approval of its submitted ANDA for vasopressin, as well as the development efforts for the other product candidates in its portfolio; the timing of the Company’s PEMFEXY and vasopressin launches, if ever; the period of market exclusivity for vasopressin; the success of the Company’s collaborations with its strategic partners; the Company’s expense guidance for fiscal year 2020; the Company’s expectations with respect to near-term product opportunities and commercial launches and the ability of the leadership team to support the Company’s growth; statements regarding the efficiency and strength of the Company’s business model; 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 ongoing 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 continued 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 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 the University of Pennsylvania, Teva, Tyme and SymBio 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 (the “SEC”) on March 2, 2020 as updated by its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2020 and June 30, 2020, filed with the SEC on May 11, 2020 and August 10, 2020, respectively, 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, 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 amortization expense, stock-based compensation expense, depreciation expense, expense related to collaboration with Tyme, severance, non-cash interest expense, fair value adjustments on equity investment, fair value adjustments on unsettled accelerated share repurchase agreement 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, 2020 December 31, 2019
ASSETS
Current assets:
Cash and cash equivalents

$

89,681

 

$

109,775

 

Accounts receivable, net

 

52,199

 

 

48,004

 

Inventories

 

6,586

 

 

6,566

 

Prepaid expenses and other current assets

 

15,330

 

 

15,104

 

Total current assets

 

163,796

 

 

179,449

 

Property and equipment, net

 

2,123

 

 

2,202

 

Intangible assets, net

 

13,584

 

 

15,583

 

Goodwill

 

39,743

 

 

39,743

 

Deferred tax asset, net

 

15,340

 

 

13,669

 

Other assets

 

13,575

 

 

3,908

 

Total assets

$

248,161

 

$

254,554

 

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable

$

13,068

 

$

5,462

 

Accrued expenses and other liabilities

 

24,445

 

 

28,361

 

Current portion of long-term debt

 

8,000

 

 

5,000

 

Total current liabilities

 

45,513

 

 

38,823

 

Other long-term liabilities

 

2,844

 

 

3,000

 

Long-term debt, less current portion

 

27,017

 

 

33,557

 

Total liabilities

 

75,374

 

 

75,380

 

Commitments and Contingencies
Stockholders’ equity:
Preferred stock, 1,500,000 shares authorized and no shares issued or outstanding as of September 30, 2020 and December 31, 2019

 

 

 

 

Common stock, $0.001 par value; 50,000,000 shares authorized; 16,624,681 and 16,537,846 shares issued as of September 30, 2020 and December 31, 2019, respectively

 

17

 

 

17

 

Additional paid in capital

 

296,198

 

 

278,518

 

Retained earnings

 

76,432

 

 

72,500

 

Treasury stock, at cost, 3,594,551 and 2,907,687 shares as of September 30, 2020 and December 31, 2019, respectively

 

(199,860

)

 

(171,861

)

Total stockholders’ equity

 

172,787

 

 

179,174

 

Total liabilities and stockholders’ equity

$

248,161

 

$

254,554

 

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

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Revenue:
Product sales

$

17,317

 

$

14,659

 

$

49,387

 

$

58,568

 

Royalty revenue

 

27,611

 

 

26,488

 

 

83,499

 

 

80,066

 

License and other revenue

 

5,000

 

 

 

 

5,000

 

 

9,000

 

Total revenue

 

49,928

 

 

41,147

 

 

137,886

 

 

147,634

 

Operating expenses:
Cost of product sales

 

8,726

 

 

12,137

 

 

23,804

 

 

39,866

 

Cost of royalty revenue

 

3,260

 

 

2,785

 

 

9,120

 

 

9,440

 

Research and development

 

4,828

 

 

10,172

 

 

21,390

 

 

25,504

 

Selling, general and administrative

 

17,697

 

 

18,537

 

 

60,411

 

 

53,906

 

Total operating expenses

 

34,511

 

 

43,631

 

 

114,725

 

 

128,716

 

Income (loss) from operations

 

15,417

 

 

(2,484

)

 

23,161

 

 

18,918

 

Interest income

 

46

 

 

570

 

 

542

 

 

1,701

 

Interest expense

 

(489

)

 

(628

)

 

(2,164

)

 

(1,979

)

Other expense

 

(6,049

)

 

 

 

(10,249

)

 

Total other expense, net

 

(6,492

)

 

(58

)

 

(11,871

)

 

(278

)

Income (loss) before income tax (provision) benefit

 

8,925

 

 

(2,542

)

 

11,290

 

 

18,640

 

Income tax (provision) benefit

 

(1,866

)

 

152

 

 

(7,358

)

 

(5,332

)

Net Income (Loss)

$

7,059

 

$

(2,390

)

$

3,932

 

$

13,308

 

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

$

0.52

 

$

(0.17

)

$

0.29

 

$

0.96

 

Diluted

$

0.51

 

$

(0.17

)

$

0.28

 

$

0.94

 

Weighted average number of common shares outstanding:
Basic

 

13,531,372

 

 

13,668,091

 

 

13,620,981

 

 

13,791,071

 

Diluted

 

13,786,803

 

 

13,668,091

 

 

13,917,800

 

 

14,147,658

 

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

 

2020

 

 

2019

 

Cash flows from operating activities:
Net income

$

3,932

 

$

13,308

 

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

 

(1,671

)

 

(175

)

Depreciation expense

 

656

 

 

725

 

Amortization expense of right-of-use assets

 

980

 

 

754

 

Amortization expense of intangible assets

 

1,999

 

 

1,890

 

Fair value adjustments on equity investment

 

7,700

 

 

 

Stock-based compensation expense

 

18,435

 

 

16,815

 

Amortization of debt issuance costs

 

301

 

 

282

 

Fair value adjustments on unsettled accelerated share repurchase agreement

 

2,549

 

 

 

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

 

(4,195

)

 

21,674

 

Inventories

 

(20

)

 

1,057

 

Prepaid expenses and other current assets

 

(2,774

)

 

(253

)

Accounts payable

 

7,606

 

 

1,315

 

Accrued expenses and other liabilities

 

(3,916

)

 

3,608

 

Other assets and other long-term liabilities, net

 

(1,845

)

 

(1,813

)

Net cash provided by operating activities

 

29,737

 

 

59,187

 

Cash flows from investing activities:
Purchase of equity investment security

 

(17,500

)

 

 

Purchase of property and equipment

 

(577

)

 

(647

)

Net cash used in investing activities

 

(18,077

)

 

(647

)

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

 

555

 

 

78

 

Employee withholding taxes related to stock-based awards

 

(1,310

)

 

(198

)

Proceeds from existing revolving credit facility

 

110,000

 

 

 

Repayment of existing revolving credit facility

 

(110,000

)

 

 

Payment of debt

 

(3,000

)

 

(5,000

)

Repurchases of common stock

 

(27,999

)

 

(15,000

)

Net cash used in financing activities

 

(31,754

)

 

(20,120

)

Net (decrease) increase in cash and cash equivalents

 

(20,094

)

 

38,420

 

Cash and cash equivalents at beginning of period

 

109,775

 

 

78,791

 

Cash and cash equivalents at end of period

$

89,681

 

$

117,211

 

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

$

3,036

 

$

6,587

Interest

 

1,878

 

 

1,787

 

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

 

842

 

 

1,700

 

 

Contacts

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

In-Site Communications, Inc.

T: 212-452-2793

E: [email protected]

Public Relations for Eagle Pharmaceuticals, Inc.:
Faith Pomeroy-Ward

T: 817-807-8044

E: [email protected]

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