UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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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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| Item 2.02 | Results of Operations and Financial Condition. |
On March 2, 2021, Eagle Pharmaceuticals, Inc., or the Company, issued a press release announcing its financial results for the fiscal fourth quarter and fiscal year ended December 31, 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 7.01 | Regulation FD Disclosure. |
On March 2, 2021, the Company released an updated investor presentation of the Company’s business model, products, and product candidates. The investor presentation will be used from time to time in meetings with investors.
A copy of the above-referenced presentation is furnished as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference. The information furnished pursuant to Item 7.01 of this current report, including Exhibit 99.2, shall not be deemed “filed” for purposes 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 8.01 | Other Events. |
An excerpt of the presentation slides from the investor presentation are attached hereto as Exhibit 99.3 to this Current Report.
| Item 9.01 | Financial Statements and Exhibits. |
|
Exhibit No.
|
Description | |
| 99.1 | Press Release of the Company dated March 2, 2021 | |
| 99.2 | Presentation of the Company dated March 2021 | |
| 99.3 | Excerpt from Presentation of the Company dated March 2021 | |
| 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: March 2, 2021 | EAGLE PHARMACEUTICALS, INC. | |
| By: | /s/ Scott Tarriff | |
| Scott Tarriff | ||
| Chief Executive Officer | ||
Exhibit 99.1
For Immediate Release
Eagle Pharmaceuticals Reports Fourth Quarter and Full Year 2020 Results and Provides Pipeline Review
-- Q4 2020 net income was $0.62 per basic and $0.60 per diluted share and adjusted non-GAAP net income was $0.98 per basic and $0.96 per diluted share –
-- FY 2020 net income was $0.89 per basic and $0.87 per diluted share and adjusted non-GAAP net income was $3.62 per basic and $3.54 per diluted share --
-- Posted strong 36% adjusted non-GAAP earnings growth 2020 over 2019 --
WOODCLIFF LAKE, NJ—March 2, 2021—Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced financial results for the three and twelve months ended December 31, 2020, and reviewed key pipeline programs.
Business and Recent Highlights:
| · | Posted strong year-over-year adjusted non-GAAP earnings growth of 36%; |
| · | Received a complete response letter (“CRL”) from U.S. Food and Drug Administration (“FDA”) for its Abbreviated New Drug Application (“ANDA”) for vasopressin. Eagle had a post-CRL meeting with FDA late last week and believes it has clear agreement on how to proceed. As previously disclosed, FDA restated that it has prioritized Eagle’s ANDA, and it is also flagged as a COVID priority. Eagle plans to re-submit its ANDA by mid-year. The patent trial against Endo Par Innovation Company, LLC was postponed and is now scheduled to begin on July 7, 2021; the Company believes it will have 180 days of exclusivity. |
| · | 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, and |
| · | Continued productive engagement with FDA for EA-114, the Company’s fulvestrant product candidate. The Company now has agreement for the clinical design and study endpoints, and following additional formulation work, intends to begin a clinical trial in patients. |
Page 2: Eagle Pharmaceuticals Reports Fourth Quarter 2020 Results
Financial Highlights
Fourth Quarter 2020
| · | Total revenue for Q4 2020 was $49.9 million, compared to $48.3 million in Q4 2019, primarily reflecting increased product sales of Ryanodex and Belrapzo. |
| · | Q4 2020 net income was $8.1 million, or $0.62 per basic and $0.60 per diluted share, compared to net income of $1.0 million, or $0.07 per basic and diluted share in Q4 2019. |
| · | Q4 2020 adjusted non-GAAP net income was $12.8 million, or $0.98 per basic and $0.96 per diluted share, compared to adjusted non-GAAP net income of $6.7 million, or $0.49 per basic and $0.48 per diluted share, in Q4 2019. |
| · | Cash and cash equivalents were $103.2 million, net accounts receivable was $51.1 million, and debt was $34 million as of December 31, 2020. |
Full Year 2020
| · | Total revenue for the 12 months ended December 31, 2020 was $187.8 million, compared to $195.9 million in 2019. 2020 included a $5.0 million milestone from SymBio for regulatory approval of Treakisym ready-to-dilute (250 ml) liquid bendamustine formulation. |
| · | 2020 net income was $12.0 million, or $0.89 per basic and $0.87 per diluted share, compared to net income of $14.3 million, or $1.04 per basic and $1.01 per diluted share in 2019. |
| · | 2020 adjusted non-GAAP net income was $48.7 million, or $3.62 per basic and $3.54 per diluted share, compared to adjusted non-GAAP net income of $36.9 million, or $2.68 per basic and $2.61 per diluted share in 2019. |
| · | From August 2016 through December 31, 2020, Eagle has repurchased $206.9 million of its common stock. |
“2020 proved to be a strong earnings year for Eagle, with 36% year-over-year growth, despite the significant challenges brought about by the COVID-19 pandemic. Our balance sheet remains healthy and provides a solid basis to support our development programs and future growth prospects. Our key pipeline products – vasopressin, fulvestrant and Ryanodex for nerve agent exposure – represent significant opportunities, and we are pleased to have a path forward. We remain committed to completing the additional work to advance them through the regulatory process,” stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.
“Looking ahead, we have our exclusive Pemfexy launch in February 2022 and SymBio sales ramping in Japan. At the same time, we will continue pursuing both organic and inorganic opportunities that will deliver growth for many years to come,” concluded Tarriff.
Page 3: Eagle Pharmaceuticals Reports Fourth Quarter 2020 Results
Fourth Quarter 2020 Financial Results
Total revenue for the three months ended December 31, 2020 was $49.9 million, as compared to $48.3 million for the three months ended December 31, 2019.
Q4 2020 BELRAPZO product sales were $10.2 million, compared to $7.6 million in Q4 2019.
Q4 2020 RYANODEX product sales were $7.9 million, compared to $3.5 million in Q4 2019.
Royalty revenue was $27.0 million in the fourth quarter of 2020, compared to $32.8 million in the fourth quarter of 2019. BENDEKA royalties were $27.0 million in the fourth quarter of 2020, compared to $32.4 million in the fourth quarter of 2019. A summary of total revenue is outlined below:
| Three Months Ended December 31, | ||||||||
| 2020 | 2019 | |||||||
| (unaudited) | (unaudited) | |||||||
| Revenue (in thousands): | ||||||||
| Product sales, net | $ | 22,936 | $ | 15,421 | ||||
| Royalty revenue | 26,980 | 32,837 | ||||||
| Total revenue | $ | 49,916 | $ | 48,258 | ||||
Gross Margin was 75% during the fourth quarter of 2020, as compared to 76% in the fourth quarter of 2019. The compression in gross margin for the fourth quarter of 2020 was primarily driven by the launch of Treakisym product sales to our partner, on which Eagle earns no profit.
R&D expense was $9.4 million for the fourth quarter of 2020, compared to $11.3 million in the fourth quarter of 2019. The decrease is largely attributable to lower spend on fulvestrant and Ryanodex for EHS programs, partially offset by higher spend on vasopressin. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense during the fourth quarter of 2020 was $8.7 million.
SG&A expense in the fourth quarter of 2020 decreased to $18.2 million compared to $22.5 million in the fourth quarter of 2019. External legal spend associated with litigation on pemetrexed, a decrease of travel and entertainment and other expenses due to COVID-19, as well as differences in incentive pay, account for the year-over-year decrease. Excluding stock-based compensation and other non-cash and non-recurring items, fourth quarter 2020 SG&A expense was $11.2 million.
Net income for the fourth quarter of 2020 was $8.1 million, or $0.62 per basic and $0.60 per diluted share, compared to net income of $1.0 million, or $0.07 per basic and diluted share, in the fourth quarter of 2019, due to the factors discussed above.
Adjusted non-GAAP net income for the fourth quarter of 2020 was $12.8 million, or $0.98 per basic and $0.96 per diluted share, compared to adjusted non-GAAP net income of $6.7 million or $0.49 per basic and $0.48 per diluted share in the fourth 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 Fourth Quarter 2020 Results
Full Year 2020 Financial Results
Total revenue for the year ended December 31, 2020 was $187.8 million, as compared to $195.9 million for the year ended December 31, 2019. A summary of total revenue is outlined below:
| Twelve Months Ended December 31, | ||||||||
| 2020 | 2019 | |||||||
| Revenue (in thousands): | ||||||||
| Product sales, net | $ | 72,323 | $ | 73,989 | ||||
| Royalty revenue | 110,479 | 112,903 | ||||||
| License and other income | 5,000 | 9,000 | ||||||
| Total revenue | $ | 187,802 | $ | 195,892 | ||||
Product sales decreased by $1.7 million in the year ended December 31, 2020, primarily driven by decreases in product sales of Bendeka of $15.7 million, coupled with decreases in Belrapzo’s product sales of $2.1 million, primarily due to volume decreases. In addition, the COVID-19 pandemic and associated lockdowns have resulted in a decrease in healthcare utilization broadly and specifically have led to a reduction in the utilization of physician-administered oncology products including Belrapzo and Bendeka. The decreased sales were partially offset by increases in product sales of Ryanodex of $15.2 million due to higher volume coupled with product sales of $0.9 million from the 2020 product launch of Treakisym.
Gross margin was 76% in 2020, as compared to 69% in 2019. The increase in gross margin in 2020 was primarily related to an increase in product sales of Ryanodex and a decrease in product sales of Bendeka.
R&D expense decreased to $30.8 million in 2020, compared to $36.8 million in 2019, primarily reflecting a decrease in project spending for Ryanodex for the EHS indication. This decrease was partially offset by increased spend related to the Company's fulvestrant formulation initiative. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense in 2020 was $27.8 million.
SG&A expenses increased by $2.2 million to $78.6 million in 2020, compared to $76.4 million in 2019. The increase primarily reflects costs related to the collaboration with Tyme and increases in stock compensation, partially offset by travel and entertainment expense which decreased due to COVID-19 restrictions on travel coupled with lower external legal fees. Excluding stock-based compensation and other non-cash and non-recurring items, SG&A expense in 2020 was $50.9 million.
Net income for the year ended December 31, 2020 was $12.0 million or $0.89 per basic and $0.87 per diluted share as compared to net income of $14.3 million or $1.04 per basic and $1.01 per diluted share for the year ended December 31, 2019, as a result of the factors discussed above.
Adjusted non-GAAP net income for 2020 was $48.7 million, or $3.62 per basic and $3.54 per diluted share, compared to adjusted non-GAAP net income of $36.9 million, or $2.68 per basic and $2.61 per diluted share in 2019.
Page 5: Eagle Pharmaceuticals Reports Fourth Quarter 2020 Results
2021 Expense Guidance
| · | R&D spend in 2021, on a non-GAAP basis, is expected to be $26-$30 million, as compared to $27.8 million in 2020. |
| · | SG&A spend in 2021, on a non-GAAP basis, is expected to be $56-$60 million, as compared to $50.9 million in 2020. |
The guidance provided in this section represents forward-looking information, and actual results may vary. Please see the risks and assumptions referred to in the Forward-Looking Statements section of this press release.
Liquidity
As of December 31, 2020, the Company had $103.2 million in cash and cash equivalents plus $51.1 million in net accounts receivable, $29.9 million of which was due from Teva Pharmaceutical Industries Ltd. The Company had $34 million in outstanding debt. Therefore, as of December 31, 2020, the Company had net cash plus receivables of $120.3 million.
In the fourth quarter of 2020, the Company purchased $4.0 million of Eagle’s common stock as part of its $160.0 million Share Repurchase Program. From August 2016 through December 31, 2020, the Company has repurchased $206.9 million of its common stock.
Conference Call
As previously announced, Eagle management will host its fourth quarter 2020 conference call as follows:
| Date | Tuesday, March 2, 2020 | |
| Time | 8:30 A.M. EDT | |
| Toll free (U.S.) | 877-876-9173 | |
| International | 785-424-1667 | |
| Webcast (live and replay) | www.eagleus.com, under the “Investor + News” section |
A replay of the conference call will be available for one week after the call's completion by dialing 800-934-7612 (US) or 402-220-6980 (International) and entering conference call ID EGRXQ420. 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 6: Eagle Pharmaceuticals Reports Fourth 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 number and timing of potential product launches, development initiatives or new indications for the Company’s product candidates; the period of market exclusivity for any of the Company’s product candidates; 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 as a treatment for nerve agent exposure and additional indications; the ability of the Company’s executive team to execute on the Company’s strategy and build shareholder value; the timing, scope or likelihood and timing of regulatory filings and approvals from the FDA for the Company’s product candidates; the timing of the Company's PEMFEXY launch, if ever; the success of the Company's collaborations with its strategic partners and the timing and results of these partners’ preclinical studies and clinical trials, including the Company’s collaboration with its Japanese licensing partner, SymBio, with respect to the commercialization of SymBio’s product TREAKISYM, and the timing of the potential product launch of TREAKISYM; the ability of the Company’s fulvestrant product candidate, EA-114, to improve clinical outcomes for post-menopausal metastatic breast cancer patients; the Company’s timing and ability to enroll patients in ongoing and upcoming clinical trials; the ability of the Company to obtain and maintain coverage and adequate reimbursement for its products; the implementation of certain healthcare reform measures; the Company's timing and ability to repurchase additional shares of the Company's common stock, if any, under its share repurchase program; the Company's ability to deliver value in 2021 and over the long term; the Company’s ability to utilize its cash and other assets to increase shareholder value; the Company’s ability to effectively manage and control expenses in line with its budget; and the Company's plans and ability to advance the products in its pipeline. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the Company's control, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. Such risks and uncertainties include, but are not limited to: the impacts of the COVID-19 pandemic, including disruption or impact in the sales of the Company's marketed products, interruptions or other adverse effects to clinical trials, delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems, disruption in the operations of the Company's third party partners and disruption of the global economy, and the overall impact of the COVID-19 pandemic on the Company's business, financial condition and results of operations; risks that the Company's business, financial condition and results of operations will be impacted by the spread of COVID-19 in the geographies where the Company's third-party partners operate; whether the Company will incur unforeseen expenses or liabilities or other market factors; 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; the success of the Company's relationships with its partners, including the University of Pennsylvania, Teva, Tyme, NorthShore University HealthSystem 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” sections of the Company's Annual Report on Form 10-K for the year ended December 31, 2020, which the Company expects to file on March 2, 2021, as updated by the Company’s 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 7: Eagle Pharmaceuticals Reports Fourth 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, debt issuance costs, non-cash interest expense, expense of acquired in-process research and development, expense related to collaboration with Tyme, fair value adjustments on equity investment, fair value adjustment on settled 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
-- Financial tables follow –
Page 8: Eagle Pharmaceuticals Reports Fourth Quarter 2020 Results
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Exhibit 99.2
1 1 INVESTOR Update March 2, 2021
2 Forward - Looking Statements This presentation contains forward - looking information within the meaning of the Private Securities Litigation Reform Act of 199 5, as amended, and other securities laws. Forward - looking statements are statements that are not historical facts. Words and phrases such as “anticipated,” “forward,” “will,” “wo uld,” “may,” “remain,” “potential,” “prepare,” “expected,” “believe,” “plan,” “near future,” “belief,” “guidance,” and similar expressions are intended to identify forward - loo king statements. These statements include, but are not limited to, statements regarding future events such as: the number and timing of potential product launches, development init iat ives or new indications for the Company’s product candidates; the period of market exclusivity for any of the Company’s product candidates; the Company's clinical development pla n 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 RYA NODEX, including the potential for RYANODEX as a treatment for nerve agent exposure and additional indications; the timing, scope or likelihood of regulatory filings and appr ova ls from the FDA for the Company’s product candidates; the timing of the Company's PEMFEXY launch, if ever; the success of the Company's collaborations with its strate gic partners and the timing and results of these partners’ preclinical studies and clinical trials, including the Company’s collaboration with its Japanese licensing partner, Sy mBio, with respect to the commercialization of SymBio’s product TREAKISYM, and the timing of the potential product launch of TREAKISYM; the ability of the Company’s fulvest ran t product candidate, EA - 114, to improve clinical outcomes for post - menopausal metastatic breast cancer patients; the Company’s timing and ability to enroll patients in ongoing and upcoming clinical trials; the ability of the Company to obtain and maintain coverage and adequate reimbursement for its products; the implementation of certain health car e reform measures; the Company's timing and ability to repurchase additional shares of the Company's common stock, if any, under its share repurchase program; the Compan y's ability to deliver value in 2021 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 ce rtain 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 th ose 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 pa ndemic, 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, m anu facturing and supply chain interruptions, adverse effects on healthcare systems, disruption in the operations of the Company's third party partners and disruption of the globa l e conomy, 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, financi al 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 cli nical 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; del ay in or failure to obtain regulatory approval of the Company's product candidates; whether the Company can successfully market and commercialize its product candidates; the succe ss of the Company's relationships with its partners, including the University of Pennsylvania, Teva, Tyme, NorthShore University HealthSystem 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 produc ts 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 faciliti es, products and/or businesses; general economic conditions, including the potential adverse effects of public health issues, including the COVID - 19 pandemic, on economic activi ty 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; comp eti tion 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 dru g development and in conducting clinical trials; and those risks and uncertainties identified in the “Risk Factors” sections of the Company's Annual Report on Form 10 - K for the year ended December 31, 2020, which the Company expects to file on March 2, 2021, as updated by the company’s subsequent filings with the Securities and Exchange Commission. Re aders 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 oblig ation 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 ev ents.
3 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 n et income and adjusted non - GAAP earnings per share attributable to Eagle. The Company believes these measures provide investors and management with supplemental informati on 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 rela ted to collaboration with Tyme Technologies, Inc, 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 underlyi ng 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. These adjusted measures are non - GAAP and should be considered in addition to, but not as a substitute for, the information prepa red in accordance with U.S. GAAP. The Company strongly encourages investors to review its consolidated financial statements and publicly - filed reports in their entire ty 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 id ent ify such measures.
4 Agenda: Q4 Earnings & Pipeline Update Eagle Vision & Strategy Quarterly Results Pipeline Review Question & Answer 1 2 3 4 Scott Tarriff Brian Cahill David Pernock and Judi Ng - Cashin All SPEAKER TOPIC
5 Todays Speakers Scott Tarriff Founder, Chief Executive Officer and Director Brian Cahill Chief Financial Officer Judi Ng - Cashin Chief Medical Officer David Pernock Chief Operating Officer
6 6 Eagle Vision & Strategy Scott Tarriff
7 Strong Foundation for Potential Long - Term Growth Invested $231mm (21%+ of revenue) in R&D (2013 – 2020) $257mm in cash flow from operations (2015 – 2020) $207mm repurchased since August 2016; approx. 13 mm basic shares outstanding as of December 2020 Highly Efficient Business Model Successful Capital Reinvestment Sustainable Profitability Robust Balance Sheet No net debt and flexibility to actively deploy capital for opportunities
8 8 Q4 2020 Results Brian Cahill
9 9 Pipeline Review David Pernock and Judi Ng - Cashin
10 10 External Partnerships David Pernock
11 External Partnerships SM - 88 • In 2020 Eagle and TYME entered into a share purchase agreement and a co - promotion agreement for SM - 88 • SM - 88 is a novel investigational agent in two Phase II/III studies for pancreatic cancer • For SM - 88 Eagle shall earn 15% of U.S. net sales and will be responsible for 25% of the promotional effort • Tyme may buy out Eagle’s rights at any time under the co - promotion agreement for $200mm • SymBio received approval of TREAKISYM Ready - To - Dilute (“RTD”) bendamustine formulation and launched in January 2021 • SymBio is currently conducting a clinical trial for a rapid infusion bendamustine product and pursuing additional indications • Eagle earns tiered royalties on net sales of licensed products and a sales milestone for potential peak revenue of $10mm to $25mm
12 12 PEMFEXY Ρ
13 Lung Cancer *cancer.net Lung cancer is the 2nd most common cancer*, second to skin cancer in the U.S. Non - small cell lung cancer is the most common type, accounting for 84% of all lung cancer diagnoses* Mesothelioma, another type of lung cancer, has an annual U.S. incidence of approximately 3,300 cases* This year, an estimated 228,820 adults in the U.S. will be diagnosed with lung cancer* Lung Cancer
14 PEMFEXY ΠIs FDA - Approved For: Nonsquamous Non - Small Cell Lung Cancer Nonsquamous Non - Small Cell Lung Cancer in combination with cisplatin for initial treatment or locally in combination for advanced or metastatic disease Nonsquamous Non - Small Cell Lung Cancer maintenance, when disease has not progressed after four cycles of platinum - based first - line chemotherapy Nonsquamous Non - Small Cell Lung Cancer after prior chemotherapy as a single agent for locally advanced or metastatic disease Mesothelioma Mesothelioma in combination with cisplatin for malignant pleural mesothelioma when disease is unresectable.
15 Currently marketed by Lilly as ALIMTA® (pemetrexed) 100mg and 500mg powder single dose vials ALIMTA ® (Eli Lilly) - PEMFEXY Œ (Eagle) – U.S. Sales of $1.265B* 1.2B Eagle first to market 505(b)(2) PEMFEXY Ρ (pemetrexed) 500mg liquid multi - dose vial – Granted unique J - code by CMS – Launch planned February 2022 – Generic entrants blocked until May 24, 2022 *Eli Lilly Q4 2020 Earnings
16 Eagle’s Differentiated PEMFEXY Œ (pemetrexed): Other pemetrexed formulations are single - dose powder, which require reconstitution Eagle’s formulation is available in a 500mg liquid ready - to - dilute multi - dose vial Some patients may need 2 - 3 vials; time - consuming for pharmacist/nurse and wastage occurs frequently because they are not multi - dose vials PEMFEXY Ρ eliminates the reconstitution process wastage and helps prevent medication errors. The vial can be reused under refrigeration for 28 days.
17 Key Opinion Leader Survey Findings During a recent KOL survey* performed by an outside firm 90% of the respondents would prefer a liquid multi - dose product over a powder, and 44% indicated moderate wastage. *December 2019 Quantitative Market Research N=150
18 18 Vasopressin
19 Vasopressin Overview Currently Endo/Par markets VASOSTRICT® (vasopressin) 2020 U.S. annual sales of $785mm* Eagle is first - to - file an ANDA referencing VASOSTRICT® for the 20 units per ml presentation 180 - day market exclusivity expected Trial date for patent trial with Par entities rescheduled for July 7, 2021 Vasopressin injection is FDA - approved to increase blood pressure in adults with vasodilatory shock (e.g., post - cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines *Endo Q4 2020 Earnings
20 20 EA - 114 (Fulvestrant)
21 Current Treatment Landscape in HR+ / HER2 – Breast Cancer Blocking ovarian function permanently with surgery or temporary with drugs called gonadotropin - releasing hormone (GnRH) agonists Blocking estrogen production using drugs called aromatase inhibitors (AI), such as letrozole, anastrozole and exemestane. These agents block the activity of an enzyme called aromatase which the body uses to make estrogen. Selective Estrogen Receptor Modulators (SERM) – Selective Estrogen Receptor Modulators (SERMS) such as tamoxifen and toremifene bind to estrogen receptors, preventing estrogen from binding. Selective Estrogen Receptor Down - Regulators (SERDs) – Selective Estrogen Receptor Down - Regulators (SERDs) work in a somewhat different way to block estrogen’s effects. SERDs are antiestrogens that have the main characteristic of being pure receptor antagonists. Fulvestrant is the only FDA approved SERD that downregulates estrogen receptors. Treatment Strategies for Hormone - Sensitive Breast Cancer
22 EA - 114 (Fulvestrant) Insights and Path Forward ▪ Eagle conducted two clinical trials comparing Eagle’s formulation to Faslodex® ▪ These studies followed 750 subjects for 140 - 280 days ▪ Analyzed thousands of collected data points and discerned the need for a distinctive delivery system ▪ Sought KOL feedback on proposed delivery approach ▪ Based on Eagle’s work and clinical insight, we believe that a significant population of patients may clinically benefit from this new approach to fulvestrant delivery ▪ Have agreement with the FDA on trial design and study endpoints ▪ Following additional formulation work we intend to begin a new clinical trial in patients, which will harness the lessons learned from our in - depth work and clinical insights Our goal is to introduce a new approach to fulvestrant delivery that provides an efficient path to approval
23 23 Nerve Agent Medical Countermeasure
24 RYANODEX Potential for Nerve Agent (NA) Exposure Nerve agents are the most toxic of the known chemical warfare agents • Rapid treatment with available agents decreases risk of mortality but does not ameliorate risk of brain damage. NA survivors may experience permanent neurologic damage and death • Agreement with the United States Army Medical Research Institute of Chemical Defense (USAMRICD) to evaluate the neuroprotective effects of RYANODEX in an accepted NA model • Results of study conducted with USAMRICD demonstrated a statistically significant reduction in brain damage secondary to NA exposure in RYANODEX - treated animals, compared with controls (p value ≤0.04) • Initiating dose ranging studies in another animal model using IV administration of RYANODEX®; will include an arm using an IM formulation of EA - 111. Preliminary results expected to allow the Company to update its SPA (Special Protocol Assessment) with FDA First - of - its - kind neuroprotective medical countermeasure for the amelioration of brain damage due to nerve agent exposure and, if approved, may receive orphan drug exclusivity (ODE) for organophosphate exposure
25 EA - 111 (New Chemical Entity) Developing the next generation of ryanodine receptor antagonists • Significant benefits of an intramuscular (IM) formulation • EA - 111 would allow for easier and more rapid administration in emergency situations (military and civilian) • Enables point - of - care administration to patients in need • Eliminates need for IV - infusion
26 Eagle’s Nerve Agent Medical Countermeasure Program Eagle has put forth a significant amount of effort in developing Ryanodex for the treatment of brain damage secondary to nerve agent toxicity. Proof of Concept study using rat soman model conducted at MRIGlobal ( EGL - DTL - NC - 1704 ) Pivotal Good Laboratory Practices (GLP) study using rat soman model conducted at Research Laboratories of USAMRICD ( USAMRICD - SR - 1 - 19 - U - 1091 ) Results of these studies have demonstrated that Ryanodex - treated animals exhibited lower neuronal necrosis in brain cortical areas compared to animals treated with standard therapy alone.
27 Proof - of - Concept Study: MRIGlobal - EGL - DTL - NC - 1704 The positive outcome of this study provided the basis for the design of an adequately powered GLP study in a well - established rat model of soman exposure. Fronto - Parietal Cortex: Photomicrographs Fronto - Parietal Cortex: Mean Necrosis Scores 1.4 1.4 1 0.7 2.6 10 mg/kg 50 min 30 mg/kg 50 min 10 mg/kg 20 min 30 mg/kg 20 min water 50 min
28 Pivotal GLP Study in Rat Soman Model: USAMRICD - SR - 1 - 19 - U - 1091 Photomicrographs: Fronto - Parietal Cortex Most neurons were necrotic (denoted by black arrows) and only a few neurons (denoted by white arrows) were unaffected
29 Nerve Agent Medical Countermeasure Program Next Steps 29 We are planning further studies in Non - Human Primate soman models The FDA agrees with our model selection and has requested that Eagle submit a SPA for review prior to conducting the pivotal GLP studies Eagle will conduct preliminary PK/PD studies in soman model animals to fully understand the efficacy and dose range of Ryanodex to enable maximum benefit in such indications The pivotal GLP study potentially will be a PK/PD evaluation of Ryanodex in the characterized NHP Soman model to demonstrate efficacy and to help predict human dosing Eagle is also evaluating EA - 111 for an IM route of administration in parallel to the IV dosing approach of Ryanodex
30 30 Question & Answer
31 31 Thank You!
Exhibit 99.3
1 1 INVESTOR Update March 2, 2021
2 Forward - Looking Statements This presentation contains forward - looking information within the meaning of the Private Securities Litigation Reform Act of 199 5, as amended, and other securities laws. Forward - looking statements are statements that are not historical facts. Words and phrases such as “anticipated,” “forward,” “will,” “wo uld,” “may,” “remain,” “potential,” “prepare,” “expected,” “believe,” “plan,” “near future,” “belief,” “guidance,” and similar expressions are intended to identify forward - loo king statements. These statements include, but are not limited to, statements regarding future events such as: the number and timing of potential product launches, development init iat ives or new indications for the Company’s product candidates; the period of market exclusivity for any of the Company’s product candidates; the Company's clinical development pla n 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 RYA NODEX, including the potential for RYANODEX as a treatment for nerve agent exposure and additional indications; the timing, scope or likelihood of regulatory filings and appr ova ls from the FDA for the Company’s product candidates; the timing of the Company's PEMFEXY launch, if ever; the success of the Company's collaborations with its strate gic partners and the timing and results of these partners’ preclinical studies and clinical trials, including the Company’s collaboration with its Japanese licensing partner, Sy mBio, with respect to the commercialization of SymBio’s product TREAKISYM, and the timing of the potential product launch of TREAKISYM; the ability of the Company’s fulvest ran t product candidate, EA - 114, to improve clinical outcomes for post - menopausal metastatic breast cancer patients; the Company’s timing and ability to enroll patients in ongoing and upcoming clinical trials; the ability of the Company to obtain and maintain coverage and adequate reimbursement for its products; the implementation of certain health car e reform measures; the Company's timing and ability to repurchase additional shares of the Company's common stock, if any, under its share repurchase program; the Compan y's ability to deliver value in 2021 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 ce rtain 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 th ose 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 pa ndemic, 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, m anu facturing and supply chain interruptions, adverse effects on healthcare systems, disruption in the operations of the Company's third party partners and disruption of the globa l e conomy, 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, financi al 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 cli nical 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; del ay in or failure to obtain regulatory approval of the Company's product candidates; whether the Company can successfully market and commercialize its product candidates; the succe ss of the Company's relationships with its partners, including the University of Pennsylvania, Teva, Tyme, NorthShore University HealthSystem 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 produc ts 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 faciliti es, products and/or businesses; general economic conditions, including the potential adverse effects of public health issues, including the COVID - 19 pandemic, on economic activi ty 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; comp eti tion 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 dru g development and in conducting clinical trials; and those risks and uncertainties identified in the “Risk Factors” sections of the Company's Annual Report on Form 10 - K for the year ended December 31, 2020, which the Company expects to file on March 2, 2021, as updated by the company’s subsequent filings with the Securities and Exchange Commission. Re aders 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 oblig ation 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 ev ents.
3 3 EA - 114 (Fulvestrant)
4 EA - 114 (Fulvestrant) Insights and Path Forward ▪ Eagle conducted two clinical trials comparing Eagle’s formulation to Faslodex® ▪ These studies followed 750 subjects for 140 - 280 days ▪ Analyzed thousands of collected data points and discerned the need for a distinctive delivery system ▪ Sought KOL feedback on proposed delivery approach ▪ Based on Eagle’s work and clinical insight, we believe that a significant population of patients may clinically benefit from this new approach to fulvestrant delivery ▪ Have agreement with the FDA on trial design and study endpoints ▪ Following additional formulation work we intend to begin a new clinical trial in patients, which will harness the lessons learned from our in - depth work and clinical insights Our goal is to introduce a new approach to fulvestrant delivery that provides an efficient path to approval
5 5 Nerve Agent Medical Countermeasure
6 Eagle’s Nerve Agent Medical Countermeasure Program Eagle has put forth a significant amount of effort in developing Ryanodex for the treatment of brain damage secondary to nerve agent toxicity. Proof of Concept study using rat soman model conducted at MRIGlobal ( EGL - DTL - NC - 1704 ) Pivotal Good Laboratory Practices (GLP) study using rat soman model conducted at Research Laboratories of USAMRICD ( USAMRICD - SR - 1 - 19 - U - 1091 ) Results of these studies have demonstrated that Ryanodex - treated animals exhibited lower neuronal necrosis in brain cortical areas compared to animals treated with standard therapy alone.
7 Proof - of - Concept Study: MRIGlobal - EGL - DTL - NC - 1704 The positive outcome of this study provided the basis for the design of an adequately powered GLP study in a well - established rat model of soman exposure. Fronto - Parietal Cortex: Photomicrographs Fronto - Parietal Cortex: Mean Necrosis Scores 1.4 1.4 1 0.7 2.6 10 mg/kg 50 min 30 mg/kg 50 min 10 mg/kg 20 min 30 mg/kg 20 min water 50 min
8 Pivotal GLP Study in Rat Soman Model: USAMRICD - SR - 1 - 19 - U - 1091 Photomicrographs: Fronto - Parietal Cortex Most neurons were necrotic (denoted by black arrows) and only a few neurons (denoted by white arrows) were unaffected
9 Nerve Agent Medical Countermeasure Program Next Steps 9 We are planning further studies in Non - Human Primate soman models The FDA agrees with our model selection and has requested that Eagle submit a SPA for review prior to conducting the pivotal GLP studies Eagle will conduct preliminary PK/PD studies in soman model animals to fully understand the efficacy and dose range of Ryanodex to enable maximum benefit in such indications The pivotal GLP study potentially will be a PK/PD evaluation of Ryanodex in the characterized NHP Soman model to demonstrate efficacy and to help predict human dosing Eagle is also evaluating EA - 111 for an IM route of administration in parallel to the IV dosing approach of Ryanodex