UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
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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).
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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 2.02 | Results of Operations and Financial Condition. |
On November 2, 2020, Eagle Pharmaceuticals, Inc., or the Company, issued a press release announcing its financial results for the three and nine months ended September 30, 2020.
A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. The information contained in Item 2.02 of this Current Report on Form 8-K, including 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 Securities Act, 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 5.02 | Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. |
(b) Departure of Chief Financial Officer
On October 29, 2020, Pete Meyers ceased to serve as the Company’s Chief Financial Officer. In connection with his departure, Mr. Meyers is entitled to receive the severance compensation provided for under the Company’s previously disclosed Amended and Restated Severance Benefit Plan and Mr. Meyers’ participation agreement thereunder, for a non-change in control covered termination. Mr. Meyer’s receipt of severance compensation was contingent upon his execution of a release of claims against the Company, and such release has been received by the Company.
(c) Appointment of Chief Financial Officer
On October 29, 2020, the Executive Committee of the Board of Directors, or the Board, of the Company, upon authority delegated to the Executive Committee by the Board, appointed Brian Cahill as the Company’s Chief Financial Officer, principal financial officer and principal accounting officer of the Company effective immediately.
Mr. Cahill, age 52, has served as the Vice President of Finance of the Company since January 2018 and previously served as the Company’s Corporate Controller from October 2016 to December 2017. Prior to joining the Company, Mr. Cahill held Corporate Controller positions from November 2015 to October 2016 at Aralez Pharmaceuticals, Inc., a specialty pharmaceutical company, and from October 2006 to October 2015 at Par Pharmaceutical Companies, Inc., a generic and branded pharmaceutical company, where he had broad responsibility for the technical accounting, management and Securities and Exchange Commission reporting, income tax, revenue controls, financial business integration, payroll, and accounts payable functions. Mr. Cahill also held positions of increasing responsibility from November 1999 to October 2006 at PricewaterhouseCoopers LLP. Mr. Cahill holds a Bachelor of Science in Accounting from Manhattan College and is a Certified Public Accountant.
There are no family relationships between Mr. Cahill and any director or executive officer of the Company. There are no related party transactions involving Mr. Cahill and the Company requiring disclosure under Item 404(a) of Regulation S-K.
Information regarding any material compensatory arrangement between the Company and Mr. Cahill in connection with his appointment as Chief Financial Officer, or any grant or award to Mr. Cahill under any such arrangement, has not been finalized and, therefore, is unavailable at this time. The Company will disclose such information, when it becomes available, in a Current Report on Form 8-K which will be filed with the SEC.
| Item 7.01 | Regulation FD Disclosure |
On November 2, 2020, the Company issued a press release announcing the appointment of Mr. Cahill as its Chief Financial Officer as well as the employment of four additions to the Company’s clinical, formulations and commercialization leadership teams. A copy of the press release is furnished as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.
The information contained in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.2 attached hereto, shall not be deemed “filed” for purposes of Section 18 of 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 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 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Earnings Release dated November 2, 2020. | |
| 99.2 | Press Release dated November 2, 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: November 2, 2020 | EAGLE PHARMACEUTICALS, INC. | ||
| By: | /s/ Scott Tarriff | ||
| Scott Tarriff | |||
| Chief Executive Officer | |||
Exhibit 99.1
For Immediate Release
Eagle Pharmaceuticals Reports Third Quarter 2020 Results
-- 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, NJ—November 2, 2020—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. 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; |
Page 2: Eagle Pharmaceuticals Reports Third Quarter 2020 Results
| · | 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. |
Page 3: Eagle Pharmaceuticals Reports Third Quarter 2020 Results
“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.
Page 4: Eagle Pharmaceuticals Reports Third Quarter 2020 Results
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.
Page 5: Eagle Pharmaceuticals Reports Third Quarter 2020 Results
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.
Page 6: Eagle Pharmaceuticals Reports Third 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 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.
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.:
Faith Pomeroy-Ward
T: 817-807-8044
E: faith@fpwservices.com
-- Financial tables follow –
Page 7: Eagle Pharmaceuticals Reports Third Quarter 2020 Results
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 | ||||
Page 8: Eagle Pharmaceuticals Reports Third Quarter 2020 Results
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, | |||||||||||||||
| 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 | ||||||||||||
Page 9: Eagle Pharmaceuticals Reports Third Quarter 2020 Results
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 | ||||||
Page 10: Eagle Pharmaceuticals Reports Third Quarter 2020 Results
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, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Net income (loss) - GAAP | $ | 7,059 | $ | (2,390 | ) | $ | 3,932 | $ | 13,308 | |||||||
| Adjustments: | ||||||||||||||||
| Cost of product revenues: | ||||||||||||||||
| Amortization expense | 261 | 225 | 784 | 675 | ||||||||||||
| Research and development: | ||||||||||||||||
| Stock-based compensation expense | (514 | ) | 1,081 | 2,070 | 3,320 | |||||||||||
| Depreciation expense | 72 | 71 | 206 | 210 | ||||||||||||
| Selling, general and administrative: | ||||||||||||||||
| Stock-based compensation expense | 5,236 | 4,570 | 16,365 | 13,495 | ||||||||||||
| Expense related to collaboration with Tyme | - | - | 2,500 | - | ||||||||||||
| Amortization expense | 405 | 405 | 1,215 | 1,215 | ||||||||||||
| Depreciation expense | 124 | 171 | 450 | 515 | ||||||||||||
| Severance | - | - | 245 | - | ||||||||||||
| Other: | ||||||||||||||||
| Non-cash interest expense | 118 | 94 | 354 | 282 | ||||||||||||
| Fair value adjustments on equity investment | 3,500 | - | 7,700 | - | ||||||||||||
| Fair value adjustments on unsettled accelerated share repurchase agreement | 2,549 | - | 2,549 | - | ||||||||||||
| Tax effect of the non-GAAP adjustments | (2,663 | ) | (556 | ) | (2,466 | ) | (2,875 | ) | ||||||||
| Adjusted non-GAAP net income | $ | 16,147 | $ | 3,671 | $ | 35,904 | $ | 30,145 | ||||||||
| Adjusted non-GAAP earnings per share: | ||||||||||||||||
| Basic | $ | 1.19 | $ | 0.27 | $ | 2.64 | $ | 2.19 | ||||||||
| Diluted | $ | 1.17 | $ | 0.26 | $ | 2.58 | $ | 2.13 | ||||||||
| Weighted number of common shares outstanding: | ||||||||||||||||
| Basic | 13,531,372 | 13,668,091 | 13,620,981 | 13,791,071 | ||||||||||||
| Diluted | 13,786,803 | 14,120,025 | 13,917,800 | 14,147,658 | ||||||||||||
Page 11: Eagle Pharmaceuticals Reports Third Quarter 2020 Results
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, | |||||||||||||||||||||
| 2020 | 2019 | 2020 | 2019 | 2020 | 2019 | |||||||||||||||||||
| Net income (loss)- GAAP | $ | 7,059 | $ | (2,390 | ) | $ | 3,932 | $ | 13,308 | $ | 4,937 | $ | 14,313 | |||||||||||
| Add back: | ||||||||||||||||||||||||
| Interest expense, net of interest income | 443 | 58 | 1,622 | 278 | 1,861 | 517 | ||||||||||||||||||
| Income tax provision (benefit) | 1,866 | (152 | ) | 7,358 | 5,332 | $ | 9,711 | 7,685 | ||||||||||||||||
| Depreciation and amortization expense | 862 | 872 | 2,655 | 2,615 | 3,532 | 3,492 | ||||||||||||||||||
| Add back: | ||||||||||||||||||||||||
| Stock-based compensation expense | 4,722 | 5,651 | 18,435 | 16,815 | $ | 23,618 | 21,998 | |||||||||||||||||
| Debt issuance cost | - | - | - | - | 88 | 88 | ||||||||||||||||||
| Fair value adjustments on equity investment | 3,500 | - | 7,700 | - | $ | 7,700 | - | |||||||||||||||||
| Fair value adjustments on unsettled accelerated share repurchase agreement | 2,549 | 2,549 | 2,549 | - | ||||||||||||||||||||
| 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 | $ | 21,001 | $ | 4,039 | $ | 46,996 | $ | 38,348 | $ | 57,696 | $ | 49,048 | ||||||||||||
Exhibit 99.2
For Immediate Release
Eagle Pharmaceuticals Strengthens Management Team to Prepare for Future Growth
-- Key additions deepen scientific, analytics and commercial expertise; positions Eagle to advance product pipeline and prepare for future commercial launches in oncology and critical care businesses --
-- Promoted Brian Cahill as Eagle’s new Chief Financial Officer --
WOODCLIFF LAKE, NJ—November 2, 2020—Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced four additions to its clinical, formulations and commercialization leadership teams: 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. Dr. Ng-Cashin, Mr. Kimmet, Dr. Curt, and Dr. Zhu will report to David Pernock, Eagle’s President and Chief Operating Officer. In addition, on October 29, 2020, Brian Cahill, Eagle’s VP, Finance, was promoted to the role of Chief Financial Officer, and Pete Meyers, Eagle’s former Chief Financial Officer, left the Company to pursue other opportunities.
Eagle’s executive team is now comprised of Scott Tarriff, Founder and Chief Executive Officer; David Pernock, President and Chief Operating Officer; Brian Cahill, Chief Financial Officer; Daniel O’Connor, Chief Strategy Officer, Head of Corporate Development; Michael Moran, Executive Vice President, Sales, Business Development and Government Affairs; Michael Cordera, Executive Vice President, General Counsel, Chief Compliance Officer; Judith (“Judi”) Ng-Cashin, M.D., EVP and Chief Medical Officer; and John Kimmet, EVP, Oncology and Acute Care Marketing.
“We are delighted to welcome Judi, John, Valentin, and Gaozhong to the Eagle team. As we strive to advance our programs through the clinical phase and ultimately to the market, we believe we have significantly strengthened our team with the necessary expertise to offer us the best opportunity for near- and long-term success. These new additions, along with our current strong team, provides us with highly focused and experienced individuals to enable us to take full advantage of the opportunities ahead. David Pernock, our President and Chief Operating Officer, continues to be instrumental in providing direction, expertise and leadership; he will coordinate and be responsible for many of the activities of the expanded executive team. Lastly, I would like to congratulate Brian Cahill on his new role and thank Pete Meyers for his many contributions to the Company. With this leadership team in place, we are confident that we are now in the best possible position to execute our strategy and drive future growth,” stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.
Judi Ng-Cashin, M.D., EVP, Chief Medical Officer of Eagle Pharmaceuticals, is an accomplished pharmaceuticals executive and brings more than 17 years of industry experience, with expertise in clinical strategy and drug development across large pharmaceutical companies, contract research organizations (“CROs”), and small biotech entities. Prior to joining Eagle, Dr. Ng-Cashin served as Chief Medical Officer of AoBiome Therapeutics (“ApBiome”). In that role, she was responsible for AoBiome’s clinical development function, overseeing the research and development strategy and pipeline, manufacturing strategy, and quality across consumer and pharmaceutical products. Prior to AoBiome, Dr. Ng-Cashin spent several years in leadership roles at CROs, including Syneos Health, where she was responsible for building and leading the Safety and Pharmacovigilance business line, Medical and Scientific Strategy (leveraging scientific expertise and expanding brand), and Biotechnology Strategy functions. Prior to that, Dr. Ng-Cashin held positions of increasing responsibility at GlaxoSmithKline, including clinical development strategy, regulatory and safety oversight, and R&D prioritization. Dr. Ng-Cashin earned a BS in Psychology and a BA in Mathematics from Duke University, and a Doctor of Medicine degree from Rush Medical College. Her areas of medical expertise include infectious diseases, hematology/oncology, and dermatology.
John Kimmet, EVP, Marketing Oncology and Acute Care of Eagle Pharmaceuticals, brings more than 20 years of experience in the fields of sales, operations, marketing, and data analytics. Prior to joining Eagle, Mr. Kimmet served as Head of Strategic Planning & Decision Analysis at Bristol Myers Squibb (“BMS”). In this role, he led the Strategic Planning & Decision Analysis organization for the U.S. Hematology and Oncology franchise, including responsibility for franchise strategy, digital programs, data and analytics, finance, sales and marketing operations, and market research. Mr. Kimmet led the integration for the commercial franchise as part of the merger between Celgene and BMS. Prior to his Celgene and BMS roles, Mr. Kimmet spent 17 years in the telecom industry with key leadership roles at Verizon and Vodafone, including Executive Director, Marketing for Verizon Enterprise Solutions and Head of Customer Solutions and Service Operations for the Americas at Vodafone. Mr. Kimmet holds a Master’s Degree in Business Analytics from New York University and a Master of Business Administration from the Fuqua School of Business at Duke University. Mr. Kimmet also serves on the Forbes (CMO) Marketing Executive Council.
Valentin R. Curt, M.D., SVP, Clinical Drug Development of Eagle Pharmaceuticals, has over 25 years of experience providing clinical leadership and medical monitoring support for U.S. and global clinical development programs, across multiple therapeutic areas and in all phases of development. His expertise includes managing interactions with global health authorities and contributions to the filing of seven NDAs/BLAs. Dr. Curt joins Eagle from Imbrium Therapeutics, a subsidiary of Purdue Pharma, where he was Executive Medical Director, Clinical R&D and served as Clinical Lead for its oncology portfolio and additional compounds in the CNS space. In prior roles at Daiichi Sankyo and Novartis, Dr. Curt provided clinical leadership for the global registration programs of the novel oral anticoagulant edoxaban (Savaysa®) and of the antihypertensives Diovan®, Co-Diovan® and Exforge® for the Asian markets, respectively, and led the development of additional programs in the thrombosis, acute coronary syndrome, heart failure, and lipid management areas. Previously, Dr. Curt worked with Boehringer Ingelheim as an external Clinical Advisor on neurology/cardiology (Micardis®, Aggrenox®, Mirapex®) and virology (Aptivus®) programs, and has held director-level positions with several biotechnology companies, leading clinical development programs in the areas of oncology and immunology. Dr. Curt holds an M.D. degree from the University of Medicine and Pharmacy of Craiova, in Romania, where he practiced medicine for four years before moving to the United States and joining the pharmaceutical industry.
Gaozhong Zhu, Ph.D., SVP, Pharmaceutical Development of Eagle Pharmaceuticals, has more than 20 years of industrial experience in developing and implementing chemistry, manufacturing and control strategies for various types of pharmaceuticals, with a proven track record of bringing new products from conception to commercialization. Dr. Zhu joins Eagle from Corvidia Therapeutics, where he was Vice President and Head of Pharmaceutical Development and Manufacturing, bringing expertise in developing various injectables, as well as in new product and technology development. Prior to that, Dr. Zhu held positions of increasing responsibility at Shire and Biogen, where he contributed to the successful development and launch of several major products in various therapeutic areas. Dr. Zhu is an inventor of multiple patents in drug delivery and formulations. He holds a Ph.D. in Pharmaceutics from The Ohio State University and a BS/MS in Chemistry from Peking University.
Brian Cahill, Chief Financial Officer of Eagle Pharmaceuticals, is a finance and accounting professional with more than 20 years of public company and public accounting experience. His expertise spans financial reporting, GAAP, Securities and Exchange Commission (“SEC”) filings, mergers and acquisitions and corporate income tax. Over the past four years, in his roles of Corporate Controller and then VP, Finance, he led Eagle’s financial reporting, accounting and treasury functions and played a pivotal role in designing and overseeing the Company’s business analytics process that is used for financial controls, management review, and financial reporting. Prior to joining Eagle, Mr. Cahill held Corporate Controller positions at Aralez Pharmaceuticals and Par Pharmaceuticals, where he had broad responsibility for the technical accounting, management and SEC reporting, income tax, revenue controls, payroll, and accounts payable functions. Mr. Cahill also held positions of increasing responsibility at PricewaterhouseCoopers LLP, where he focused on complex accounting, financial statements and reporting and disclosure issues. Mr. Cahill is a Certified Public Accountant and earned a BS in Accounting from Manhattan College.
“Each of these talented pharmaceutical industry professionals brings a depth and breadth of experience that strengthens our team at this exciting juncture for Eagle. We believe that their collective experience will position us to advance and commercialize our key pipeline products, including EA-114, our fulvestrant product candidate, and multiple potential new RYANODEX indications. Eagle has a number of significant near-term prospects ahead, and we welcome their contributions to capitalize on these opportunities across our oncology and critical care portfolios,” stated David Pernock, President and Chief Operating Officer of Eagle Pharmaceuticals.
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 timing and success of potential product launches and development initiatives for its fulvestrant product candidate, EA-114, and Ryanodex, including new indications for Ryanodex; the Company’s expectations with respect to near- and long-term product opportunities and commercial launches; the ability of the leadership team to execute the Company’s strategy and support its future growth; statements regarding the strength of the Company’s business model; statements regarding the accomplishments, experience and capabilities of individual members of the Company’s leadership team and the ability of such qualities to drive the Company’s success; 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 its products or that may have an impact on any of its 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 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 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.
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.:
Faith Pomeroy-Ward
T: 817-807-8044
E: faith@fpwservices.com
Source: Eagle Pharmaceuticals