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Eagle Pharmaceuticals, Inc. (EGRX) SEC Filing 8-K Material Event for the period ending Monday, May 11, 2020

Eagle Pharmaceuticals, Inc.

CIK: 827871 Ticker: EGRX

Exhibit 99.1

 


 

For Immediate Release

 

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, NJ—May 11, 2020—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:

 

·Despite the ongoing COVID-19 pandemic, the Company has not experienced any impact 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 plan;

 

·Advanced pilot work on proprietary formulation of fulvestrant product candidate, EA-114, for HR-positive advanced breast cancer, met internal objectives, and requested additional meeting with U.S. Food and Drug Administration (“FDA”) to discuss regulatory path forward;

 

·Submitted Investigational New Drug (“IND”) application to FDA for a Phase 2 clinical trial in partnership with Hackensack University Medical Center to evaluate the efficacy of RYANODEX (dantrolene sodium) in patients infected with SARS-CoV-2, the virus causing the COVID-19 pandemic;

 

·Favorable patent litigation decision issued by the U.S. District Court for the District of Delaware for Eagle and Teva Pharmaceutical Industries Ltd. for BENDEKA upholding the asserted patent claims as valid and infringed by the defendants’ proposed ANDA products. Defendants will be enjoined from launching their ANDA products before 2031;

 

·Received United States Court of Appeals for the D.C. Circuit affirmation of district court decision requiring FDA to recognize seven years of orphan drug exclusivity for BENDEKA. Accordingly, the Company does not believe other bendamustine products to treat the same indication, unless clinically superior to BENDEKA, will enter the market before 2022;

 

·July 8, 2020 Prescription Drug User Fee Act (“PDUFA”) date for the Company’s resubmitted New Drug Application (“NDA”) for RYANODEX for the treatment of exertional heat stroke (“EHS”), in conjunction with body cooling;

 

 

 

 

Page 2: Eagle Pharmaceuticals Reports First Quarter 2020 Results

 

·Letter requesting summary judgment of non-infringement related to vasopressin filed with the United States District Court for the District of Delaware on April 17, after May trial date was postponed due to the COVID pandemic. Eagle is the first to file an ANDA referencing VASOSTRICT, 20 units/1mL;

 

·SymBio, the Company’s Japanese licensing partner, announced completion of patient enrollment in its clinical trial for TREAKISYM Rapid Infusion (“RI”), a liquid bendamustine injection with a ten-minute administration time, with expected regulatory approval in the second half of 2022. Eagle is entitled to a $5 million milestone payment upon approval of either TREAKISYM Ready-to-Dilute, filed on October 7, 2019, or RI, as well as royalties and milestones that could total $10 to $25 million per year if SymBio first launches TREAKISYM RTD and then its RI product;

 

·Received final approval from FDA for PEMFEXY™, a branded alternative to ALIMTA®
, following settlement of patent litigation with Eli Lilly and Company. This allows for 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;

 

·Announced collaboration and agreement on terms for an exclusive worldwide license with the University of Pennsylvania to develop dantrolene sodium for the potential treatment of people living with Alzheimer’s disease;

 

·Entered into strategic collaboration with Tyme Technologies Inc. (“Tyme”) to advance SM-88, a modified tyrosine derivative, for the treatment of cancer patients. Eagle made an initial investment of $20 million and will be responsible for 25% of the promotional sales efforts of SM-88 and will receive 15% royalty on net revenues of SM-88 in the United States. Tyme retains all commercial rights to SM-88 outside the U.S. and reserves the right to repurchase Eagle’s U.S. co-promotion right for $200 million; and

 

·Entered into a research agreement with NorthShore University HealthSystem to study RYANODEX for the treatment of traumatic brain injury, including concussion, for which there are currently no drug treatments.

 

Financial Highlights

 

·Total revenue for Q1 2020 was $46.0 million, compared to $49.8 million in Q1 2019, primarily reflecting lower product sales of BENDEKA, partially offset by higher product sales of RYANODEX and BELRAPZO®.

 

·Net loss for Q1 2020 was $2.9 million, or ($0.21) per basic and diluted share, compared to net income for Q1 2019 of $9.0 million, or $0.64 per basic and $0.62 per diluted share.

 

·Adjusted non-GAAP net income for Q1 2020 was $11.7 million, or $0.86 per basic and $0.84 per diluted share, compared to adjusted non-GAAP net income for Q1 2019 of $14.6 million, or $1.05 per basic and $1.01 per diluted share.

 

·Cash and cash equivalents were $202.0 million, net accounts receivable was $54.5 million, and debt was $148.0 million as of March 31, 2020.

 

·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.

 

“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.

 

 

 

 

Page 3: Eagle Pharmaceuticals Reports First Quarter 2020 Results

 

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.

 

 

 

Page 4: Eagle Pharmaceuticals Reports First Quarter 2020 Results

 

2020 Expense Guidance

 

·R&D spend in 2020, on a non-GAAP basis, is expected to be $46-$50 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 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.

 

 

 

 

Page 5: Eagle Pharmaceuticals Reports First Quarter 2020 Results

 

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.

 

 

 

 

Page 6: Eagle Pharmaceuticals Reports First Quarter 2020 Results

 

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.

 

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

-- Financial tables follow –

 

 

 

Page 7: Eagle Pharmaceuticals Reports First Quarter 2020 Results

 

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 

 

 

 

 

Page 8: Eagle Pharmaceuticals Reports First Quarter 2020 Results

 

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 

 

 

 

Page 9: Eagle Pharmaceuticals Reports First Quarter 2020 Results

  

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 

 

 

 

 

Page 10: Eagle Pharmaceuticals Reports First Quarter 2020 Results

 

EAGLE PHARMACEUTICALS, INC.

RECONCILIATION OF GAAP TO ADJUSTED NON-GAAP NET INCOME AND

ADJUSTED NON-GAAP EARNINGS PER SHARE

(In thousands, except share and per share amounts)

(unaudited)

 

   Three Months Ended March 31,    
   2020   2019 
Net (loss) income - GAAP  $(2,871)  $8,973 
           
Adjustments:          
Cost of product revenues:          
Amortization expense   261    225 
Research and development:          
Stock-based compensation expense   1,550    1,143 
Depreciation expense   177    69 
Selling, general and administrative:          
Stock-based compensation expense   5,922    4,639 
Expense related to collaboration with Tyme   2,500    - 
Amortization expense   405    405 
Depreciation expense   74    172 
Severance   245    - 
           
Other:          
Non-cash interest expense   118    94 
Fair value adjustments on equity investment   6,500    - 
Tax effect of the non-GAAP adjustments   (3,179)   (1,091)
           
Adjusted non-GAAP net income  $11,702   $14,629 
           
Adjusted non-GAAP earnings per share:          
Basic  $0.86   $1.05 
Diluted  $0.84   $1.01 
Weighted number of common shares outstanding:          
Basic   13,667,606    13,925,227 
Diluted   14,000,932    14,418,211 

 

 

 

 

Page 11: Eagle Pharmaceuticals Reports First Quarter 2020 Results

 

 

EAGLE PHARMACEUTICALS, INC.

RECONCILIATION OF GAAP TO ADJUSTED NON-GAAP EBITDA

(In thousands)

(unaudited)

 

   Three Months Ended March 31,   Twelve Months
Ended March 31,
   Twelve Months
Ended December 31,
 
   2020   2019   2020   2019 
Net (loss) income - GAAP  $(2,871)  $8,973   $2,469   $14,313 
                     
Add back:                    
Interest expense, net of interest income   543    192    868    517 
Income tax (benefit) provision   (137)   3,004    4,544    7,685 
Depreciation and amortization expense   917    871    3,538    3,492 
                     
Add back:                    
Stock-based compensation expense   7,472    5,782    23,688    21,998 
Debt issuance cost   -    -    88    88 
Fair value adjustments on equity investment   6,500    -    6,500    - 
Expense of acquired in-process research & development   -    -    500    500 
Expense related to collaboration with Tyme   2,500    -    2,500    - 
Severance   245    -    700    455 
Adjusted Non-GAAP EBITDA  $15,169   $18,822   $45,395   $49,048 

 

 

 

 

 

 

 

 

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): May 11, 2020

 

Eagle Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware 001-36306 20-8179278
(State or other jurisdiction (Commission File Number)   (IRS Employer Identification No.)  
of incorporation)    

 

50 Tice Boulevard, Suite 315
Woodcliff Lake, NJ
  07677
(Address of principal executive offices)     (Zip Code)  

 

Registrant’s telephone number, including area code: (201) 326-5300

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol   Name of each exchange on which registered
Common Stock (par value $0.001 per share)   EGRX   The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

Emerging growth company ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 

 

 

 

Item 2.02Results of Operations and Financial Condition.

 

On May 11, 2020, Eagle Pharmaceuticals, Inc., or the Company, issued a press release announcing its financial results for the fiscal first quarter ended March 31, 2020. A copy of the Company’s press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

 

The information in this Current Report on Form 8-K, including the information contained in the press release furnished as Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, or otherwise subject to the liabilities of that section, and shall not be deemed incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such filing.

 

Item 9.01Financial Statements and Exhibits.

 

(d)           Exhibits

 

Exhibit No.   Description  
99.1     Press Release dated May 11, 2020.
     
104   Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Dated: May 11, 2020                                                    EAGLE PHARMACEUTICALS, INC.
     
  By: /s/ Scott Tarriff
    Scott Tarriff
    Chief Executive Officer

 

 

  

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Eagle Pharmaceuticals, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2020 10-K Annual Report includes:

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Eagle Pharmaceuticals, Inc. provided additional information to their SEC Filing as exhibits

Ticker: EGRX
CIK: 827871
Form Type: 8-K Corporate News
Accession Number: 0001104659-20-059088
Submitted to the SEC: Mon May 11 2020 7:00:43 AM EST
Accepted by the SEC: Mon May 11 2020
Period: Monday, May 11, 2020
Industry: Pharmaceutical Preparations
Events:
  1. Earnings Release
  2. Financial Exhibit

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