UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 2.02 | Results of Operations and Financial Condition. |
On August 9, 2021, the Company issued a press release announcing its financial results for the fiscal second quarter ended June 30, 2021.
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 August 9, 2021, the Company issued a press release announcing a licensing agreement with AOP Orphan for U.S. commercial rights to Landiolol.
A copy of this press release is furnished as Exhibit 99.2 to this Current Report on Form 8-K. The information contained in this Item 7.01, including Exhibit 99.2, is being “furnished” and shall not be deemed filed for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that section or Sections 11 and 12 (a)(2) of the Securities Act. The information in this Item 7.01, including Exhibit 99.2, shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act or into any filing or other document pursuant to the Exchange Act, except as otherwise expressly stated in such filing.
| Item 9.01 | Financial Statements and Exhibits. |
| Exhibit No. | Description | |
| 99.1 | Press Release of the Company announcing financial results for the fiscal second quarter ended June 30, 2021, dated August 9, 2021. | |
| 99.2 | Press Release of the Company announcing a licensing agreement with AOP Orphan, dated August 9, 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: August 9, 2021 | EAGLE PHARMACEUTICALS, INC. | |
| By: | /s/ Scott Tarriff | |
| Scott Tarriff | ||
| Chief Executive Officer | ||
Exhibit 99.1
For Immediate Release
Eagle Pharmaceuticals Reports Second Quarter 2021 Results
Q2 2021 net income was $0.28 per basic and $0.27 per diluted share and adjusted non-GAAP net income was $0.95 per basic and $0.93 per diluted share
Announced licensing agreement for U.S. commercial rights to Landiolol, a beta-1 adrenergic blocker and a leading hospital emergency use product in Europe and Japan
Responded to CRL for vasopressin and anticipates commercial launch by year-end; vasopressin patent trial decision expected around mid-September
FDA maintained Priority Review for the Company’s Abbreviated New Drug Application (“ANDA”) for vasopressin and assigned a GDUFA date of December 15, 2021
Expects approximately $20-$25 million from combined royalty and milestone revenue next year for TREAKISYM (bendamustine), if TREAKISYM RI formulation is approved
WOODCLIFF LAKE, NJ—August 9, 2021—Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced financial results for the three and six months ended June 30, 2021.
Business and Recent Highlights:
| · | Entered into a licensing agreement for the U.S. commercial rights to Landiolol, a leading hospital emergency use product in Europe and Japan. Landiolol is currently approved in Europe for the treatment of non-compensatory sinus tachycardia and tachycardic supraventricular arrhythmias. Eagle will support the submission of a new drug application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) seeking approval for Landiolol for the short-term reduction of ventricular rate in patients with supraventricular tachycardia (“SVT”), including atrial fibrillation and atrial flutter. |
| · | Advanced vasopressin program and continue to expect a commercial launch prior to year-end: |
| o | Responded to the Complete Response Letter (“CRL”) for its Abbreviated New Drug Application (“ANDA”) for vasopressin received from FDA in February 2021; | |
| o | FDA maintained Priority Review for the Company’s ANDA for vasopressin and assigned a GDUFA date of December 15, 2021; | |
| o | Patent trial against Endo Par Innovation Company, LLC took place on July 7, 2021; Court ruling expected around mid-September. |
| · | Approval of TREAKISYM (bendamustine) ready-to-dilute (“RTD”) formulation, in combination with rituximab for treatment of relapsed or refractory diffuse large B-cell lymphoma (“r/r DLBCL”) received from the Pharmaceuticals and Medical Devices Agency (“PMDA”) in Japan. This represents a meaningful extension of Eagle’s bendamustine franchise and is expected to significantly increase the market opportunity for bendamustine; |
| · | Filing of TREAKISYM rapid infusion (“RI”) (50ml) liquid formulation with the PMDA in Japan. Eagle expects RTD, and RI, if approved, formulations to generate approximately $20-$25 million of combined royalty and milestone revenue; |
| · | Appointed former FDA Official and Public Health Expert Dr. Luciana Borio to its Board of Directors; and |
| · | Continue to pursue additional in-licensing and acquisition opportunities to broaden Eagle’s pipeline and revenue streams. |
Page 2: Eagle Pharmaceuticals Reports Second Quarter 2021 Results
Financial Highlights
Second Quarter 2021
Total revenue for Q2 2021 was $48.1 million, compared to $41.9 million in Q2 2020, primarily reflecting higher product sales of BELRAPZO® and RYANODEX®, partially offset by lower product sales of BENDEKA®.
| · | Q2 2021 net income was $3.6 million, or $0.28 per basic and $0.27 per diluted share, compared to net loss of $0.3 million, or ($0.02) per basic and diluted share in Q2 2020. |
| · | Q2 2021 adjusted non-GAAP net income was $12.4 million, or $0.95 per basic and $0.93 per diluted share, compared to adjusted non-GAAP net income of $8.0 million, or $0.59 per basic and $0.57 per diluted share, in Q2 2020. |
| · | Cash and cash equivalents were $108.7 million, net accounts receivable was $52.7 million, and debt was $30 million as of June 30, 2021. |
“We had a strong and productive quarter on multiple fronts and have laid the foundation for important growth drivers going forward. We made good progress with vasopressin during the quarter and continue to believe that we will be able to launch that important product before year-end. We are just months away from our February 2022 PEMFEXY™ launch, which allows us an initial period of exclusivity in a billion-dollar market. With the potential for an additional royalty and milestone revenue stream of $20-$25 million from the expanding TREAKISYM franchise in Japan, next year could be a record earnings year for Eagle,” stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.
“The licensing agreement for Landiolol represents Eagle’s first new chemical entity and is a true catalyst in reshaping our company as we evolve from a specialty pharmaceutical company into a mainstream pharmaceutical company, with a vibrant pipeline of products. Landiolol solidifies our hospital and critical care product portfolio, and we plan to leverage our current sales force with little additional infrastructure costs to promote the product. We are also pursuing other such opportunities to build value for the company and look forward to providing updates,” concluded Tarriff.
Page 3: Eagle Pharmaceuticals Reports Second Quarter 2021 Results
Second Quarter 2021 Financial Results
Total revenue for the three months ended June 30, 2021 was $48.1 million, compared to $41.9 million for the three months ended June 30, 2020.
Q2 2021 BELRAPZO® product sales were $7.6 million, compared to $4.1 million in Q2 2020.
Q2 2021 RYANODEX® product sales were $7.9 million, compared to $4.7 million in Q2 2020.
Royalty revenue was $28.5 million in the second quarter of 2021, compared to $27.6 million in the second quarter of 2020. BENDEKA® royalties were $27.8 million in the second quarter of 2021, compared to $27.5 million in the second quarter of 2020. A summary of total revenue is outlined below:
| Three Months Ended June 30, | ||||||||
| 2021 | 2020 | |||||||
| (unaudited) | (unaudited) | |||||||
| Revenue (in thousands): | ||||||||
| Product sales, net | $ | 19,621 | $ | 14,376 | ||||
| Royalty revenue | 28,503 | 27,562 | ||||||
| Total revenue | $ | 48,124 | $ | 41,938 | ||||
Gross Margin was 78% during the second quarter of 2021, as compared to 69% in the second quarter of 2020. The increase in gross margin for the second quarter of 2021 was driven by revenue mix.
R&D expense was $9.9 million for the second quarter of 2021, compared to $7.1 million in the second quarter of 2020. The increase is largely attributable to development cost for vasopressin of $1.5 million, RYANODEX related projects of $0.8 million and PEMFEXY of $0.6 million, partially offset by $0.5 million decrease in development activity related to fulvestrant. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense during the second quarter of 2021 was $9.2 million.
SG&A expenses in the second quarter of 2021 totaled $16.6 million compared to $18.0 million in the second quarter of 2020. The decrease is primarily related to lower stock compensation expense and marketing spend. Excluding stock-based compensation and other non-cash and non-recurring items, second quarter 2021 SG&A expense was $12.4 million.
Net income for the second quarter of 2021 was $3.6 million, or $0.28 per basic and $0.27 per diluted share, compared to net loss of $0.3 million, or ($0.02) per basic and diluted share, in the second quarter of 2020, due to the factors discussed above.
Adjusted non-GAAP net income for the second quarter of 2021 was $12.4 million, or $0.95 per basic and $0.93 per diluted share, compared to adjusted non-GAAP net income of $8.0 million or $0.59 per basic and $0.57 per diluted share in the second quarter of 2020. For a full reconciliation of adjusted non-GAAP net income to the most comparable GAAP financial measures, please see the tables at the end of this press release.
Page 4: Eagle Pharmaceuticals Reports Second Quarter 2021 Results
2021 Expense Guidance
| · | R&D spend in 2021, on a non-GAAP basis, is expected to be $34-$38 million, as compared to $27.8 million in 2020. |
| · | SG&A spend in 2021, on a non-GAAP basis, is expected to be $52-$56 million, as compared to $50.9 million in 2020. |
The guidance provided in this section represents forward-looking information, and actual results may vary. Please see the risks and assumptions referred to in the Forward-Looking Statements section of this press release.
Liquidity
As of June 30, 2021, the Company had $108.7 million in cash and cash equivalents plus $52.7 million in net accounts receivable. The Company had $30 million in outstanding debt. Therefore, as of June 30, 2021, the Company had net cash plus receivables of $131.4 million.
In the second quarter of 2021, the Company purchased $2.9 million of its common stock as part of its $160.0 million Share Repurchase Program. From August 2016 through June 30, 2021, the Company has repurchased $211.2 million of its common stock.
Conference Call
As previously announced, Eagle management will host its second quarter 2021 conference call as follows:
| Date | Monday, August 9, 2021 |
| 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 888-562-2815 (US) or 402-220-7352 (International) and entering conference call ID EGRXQ221. 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 Second Quarter 2021 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; potential future revenue or earnings of the Company; the Company's clinical development plan for the product candidates in its portfolio; the ability of the Company’s executive team to execute on the Company’s strategy and build stockholder value; the timing, scope or likelihood and timing of regulatory filings and approvals from the FDA for the Company’s product candidates, and the Company’s ability to maintain regulatory approval of its products and product candidates; the potential timing of the Company’s commercial launch of PEMFEXY, vasopressin or Landiolol, if ever; the Company’s plans for and ability to support the commercial launch of Landiolol in the United States, if approved; the ability of the Company’s product candidates, including Landiolol, vasopressin and PEMFEXY, to deliver value to stockholders; the success of the Company's collaborations with its strategic partners and the timing and results of these partners’ preclinical studies and clinical trials, including the Company’s collaboration with its Japanese licensing partner, SymBio, with respect to the commercialization of SymBio’s product TREAKISYM; the future commercial success of TREAKISYM RTD and, if approved, TREAKISYM RI, including anticipated royalty and milestone revenue and potential market opportunity; 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 timing of court decisions or other actions with respect to ongoing litigation; the Company's timing and ability to repurchase additional shares of the Company's common stock, if any, under its Share Repurchase Program; the Company's ability to deliver value in 2021 and over the long term; the Company’s ability to utilize its cash and other assets to increase shareholder value; the Company’s ability to effectively manage and control expenses in line with its budget; and the Company's plans and ability to advance the products in its pipeline. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the Company's control, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. Such risks and uncertainties include, but are not limited to: the impacts of the COVID-19 pandemic, including disruption or impact in the sales of the Company's marketed products, interruptions or other adverse effects to clinical trials, delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems, disruption in the operations of the Company's third party partners and disruption of the global economy, and the overall impact of the COVID-19 pandemic on the Company's business, financial condition and results of operations; risks that the Company's business, financial condition and results of operations will be impacted by the spread of COVID-19 in the geographies where the Company's third-party partners operate; whether the Company will incur unforeseen expenses or liabilities or other market factors; whether the Company will successfully implement its development plan for its product candidates; delay in or failure to obtain regulatory approval of the Company's product candidates; delays in or failure to obtain regulatory approval of any license agreements with third parties; whether the Company can successfully market and commercialize its product candidates; the success of the Company's relationships with its partners; the availability and pricing of third party sourced products and materials; the outcome of litigation involving any of our products or that may have an impact on any of the Company’s products; successful compliance with the FDA and other governmental regulations applicable to product approvals, manufacturing facilities, products and/or businesses; general economic conditions, including the potential adverse effects of public health issues, including the COVID-19 pandemic, on economic activity and the performance of the financial markets generally; the strength and enforceability of the Company's intellectual property rights or the rights of third parties; competition from other pharmaceutical and biotechnology companies and the potential for competition from generic entrants into the market; the risks inherent in the early stages of drug development and in conducting clinical trials; and those risks and uncertainties identified in the “Risk Factors” sections of the Company's Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission (the “SEC”) on March 5, 2021, as updated by the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, which the Company expects to file with the SEC on August 9, 2021, and its other subsequent filings with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and the Company does not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events.
Page 6: Eagle Pharmaceuticals Reports Second Quarter 2021 Results
Non-GAAP Financial Performance Measures
In addition to financial information prepared in accordance with U.S. GAAP, this press release also contains adjusted non-GAAP net income and adjusted non-GAAP earnings per share attributable to Eagle. The Company believes these measures provide investors and management with supplemental information relating to operating performance and trends that facilitate comparisons between periods and with respect to projected information.
Adjusted non-GAAP net income excludes stock-based compensation expense, depreciation expense, amortization expense, severance, non-cash interest expense, expense related to collaboration with Tyme, fair value adjustments on equity investment, fair value adjustments related to derivative instrument, convertible promissory note related credit losses, accretion of discount on convertible promissory note and the tax effect of these adjustments. The Company believes these non-GAAP financial measures help indicate underlying trends in the Company’s business and are important in comparing current results with prior period results and understanding projected operating performance. Non-GAAP financial measures provide the Company and its investors with an indication of the Company’s baseline performance before items that are considered by the Company not to be reflective of the Company’s ongoing results. See the attached Reconciliation of GAAP to Adjusted Non-GAAP Net Income and Adjusted Non-GAAP Earnings per Share and Reconciliation of GAAP to Adjusted Non-GAAP EBITDA for details of the amounts excluded and included to arrive at adjusted non-GAAP net income, adjusted non-GAAP earnings per share amounts, and adjusted non-GAAP EBITDA amounts, respectively.
These adjusted measures are non-GAAP and should be considered in addition to, but not as a substitute for, the information prepared in accordance with U.S. GAAP. The Company strongly encourages investors to review its consolidated financial statements and publicly-filed reports in their entirety and cautions investors that the non-GAAP measures used by the Company may differ from similar measures used by other companies, even when similar terms are used to identify such measures.
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 7: Eagle Pharmaceuticals Reports Second Quarter 2021 Results
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Exhibit 99.2
For Immediate Release
Eagle Pharmaceuticals Announces Licensing Agreement with AOP Orphan for U.S. Commercial Rights to Landiolol, a Beta-1 Adrenergic Blocker
-- Eagle poised to facilitate regulatory pathway for approval in the U.S. based on existing data from Japanese and European studies, with no additional clinical work expected –
-- Anticipates filing new drug application (“NDA”) in Q1 2022, with expected ten-month review, based on well-defined feedback from U.S. Food and Drug Administration provided during AOP Orphan’s Type C meeting --
-- Landiolol, a leading hospital emergency use product, is approved in Europe for the treatment of non-compensatory sinus tachycardia and tachycardic supraventricular arrhythmias --
-- Eagle to support seeking the approval of Landiolol for the short-term reduction of ventricular rate in patients with supraventricular tachycardia, including atrial fibrillation and atrial flutter in the U.S. --
-- Studies of additional indications, including sepsis and other cardioprotective indications, have begun in Europe, with the potential to be pursued in the U.S. --
-- Enrollment of study of pediatric patients with supraventricular tachycardia is underway in Europe and will serve as the basis for initial pediatric study plans for a future FDA submission –
-- Company expects five years of new chemical entity exclusivity --
WOODCLIFF LAKE, NJ—August 9, 2021—Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced that it has entered into a licensing agreement with AOP Orphan Pharmaceuticals GmbH (“AOP Orphan”), a privately owned Austrian company devoted to the treatment of rare and special diseases, for the commercial rights to its product, Landiolol in the United States. Landiolol, a leading hospital emergency use product, is currently approved in Europe for the treatment of non-compensatory sinus tachycardia and tachycardic supraventricular arrhythmias. The Company will support the submission of a new drug application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) seeking approval for Landiolol for the short-term reduction of ventricular rate in patients with supraventricular tachycardia (“SVT”), including atrial fibrillation and atrial flutter.
Landiolol is a short-acting, ultra-high selective beta-1 adrenoceptor blocker developed by AOP Orphan that has a selective effect on heart rate over cardiac contractility. Landiolol is available in two forms (20 mg/2ml concentrate, 300 mg powder) and is designed for use in emergency, cardiac critical care, operating room, and intensive care settings. It is registered in several European countries for the treatment of non-compensatory sinus tachycardia and tachycardic supraventricular arrhythmias. The drug uses a proprietary dosing algorithm to facilitate the administration.
Under the terms of the agreement, Eagle will facilitate the U.S. regulatory pathway for the approval of Landiolol. In addition, Eagle will be responsible for the U.S. commercialization of the product upon approval. Landiolol, which has not previously been marketed in the U.S., is covered by several patents, and the Company anticipates five years of new chemical entity (“NCE”) exclusivity.
Landiolol is already commercially available in Japan (Onoact®) and several European markets as RAPIBLOC®. A review of multiple clinical studies suggests that Landiolol is a useful option for the rapid short-term control of tachyarrhythmias (Syed YY. Landiolol: A Review in Tachyarrhythmias. Drugs. 2018 Mar;78(3):377-388. doi: 10.1007/s40265-018-0883-9. PMID: 29470800.). A Type C meeting was held with FDA in July 2020, at which time AOP Orphan proposed a submission strategy in which it would provide summaries of pre-existing safety and efficacy data and a meta-analysis of published randomized controlled trials. FDA tentatively agreed with this methodological approach and deemed data sets adequate to support a proposed NDA.
“This is an exciting near-term opportunity for Eagle, with the potential to file an NDA in the first quarter of next year. The clinical advantages of Landiolol are well recognized within the medical community, and we look forward to advancing this asset for FDA approval in the United States. Our deep understanding of the U.S. regulatory landscape, along with our established research and development infrastructure, will be valuable in accelerating the program. Once approved, we plan to leverage our current sales force and relationships in the critical care setting to promote the product. There is broad potential to expand the portfolio of future indications for Landiolol’s use,” stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.
“With this license agreement, we are solidifying our hospital and critical care product portfolio, as we look to capitalize on multiple near- and longer-term opportunities. As we have stated, executing on our growth strategy for Eagle beyond 2021 has been a priority. With the anticipated launch of vasopressin, the February 2022 launch of PEMFEXY, the recent launch of bendamustine in Japan, our current pipeline, and now the future potential Landiolol launch, we believe we have a firm foundation for sustained future growth,” concluded Tarriff.
“The step into the American market forms the basis for further expansion of AOP Orphan. I am convinced that with an experienced partner like Eagle, we will succeed in making Landiolol available to patients in the U.S. as well,” stated Georg Fischer, Chief Executive Officer of AOP Orphan.
The management of rapid heart rate (tachycardia) in critically ill patients can be quite complicated regardless of the underlying cause, which may include shock, arrhythmias, heart failure, and the postoperative setting. Beta blockers, also known as beta-adrenergic blocking agents, are a class of drugs that works by blocking the neurotransmitters norepinephrine and epinephrine from binding to receptors. These neurotransmitters contribute to the development of tachycardia. The b-1 receptor beta blockers are used frequently in critical care settings to manage tachycardia; however, the available b-1 beta blockers in the U.S. also can have the unwanted effects of decreasing the contractility, or muscle strength, of the heart, and of lowering blood pressure.
Landiolol has the potential to become a cornerstone therapy in the management of these patients. It is ultra short acting, with a rapid on and off effect that allows clinicians to balance heart rate control and blood pressure more precisely. In addition, it predominantly affects heart rate without much effect on cardiac contractility and blood pressure. The Company believes that clinicians will welcome Landiolol as a key therapeutic tool for the more precise management of tachycardia in the critical care setting.
There are additional clinical settings for which Landiolol has the potential to improve patient management. Enrollment is under way in Europe for a trial of Landiolol in patients with tachycardia and septic shock, and importantly, the product is also being studied in a pediatric population, for whom no beta-blocker drug products are approved in the U.S. for ventricular rate control. The U.S. FDA has tentatively agreed that this study could form the basis for initial pediatric study plan (“iPSP”) for a future submission to FDA.
“We believe that we can expedite and prepare a compelling submission for approval of this important cardioprotective therapeutic,” stated Judith Ng-Cashin, MD, Chief Medical Officer of Eagle Pharmaceuticals
Terms of the Agreement
The agreement is subject to regulatory clearance. Under the terms of the agreement, Eagle will make an upfront payment of $5 million, followed by additional payments upon regulatory approval(s) and based upon commercial sales. The agreement is subject to regulatory clearance.
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.
AOP Orphan Pharmaceuticals GmbH is an international pharmaceutical company with its registered office in Vienna and a focus on rare and special diseases. Over the past 25 years, the company has become an established provider of integrated therapy solutions from its headquarters in Vienna. This development has been made possible by a continually high level of investment in research and development on the one hand and a highly consistent and pragmatic orientation towards the needs of all our stakeholders on the other - especially the patients and their families but also the doctors and care professionals treating them. In the third quarter of 2020, AOP Orphan took over Amomed and SciPharm, two European health care companies, continuing its consistent path of growth into a pan-European health care group specializing in rare and special diseases.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and other securities law. 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 concerning potential regulatory approval of the licensing agreement between the Company and AOP Orphan; the timing of and AOP’s ability to obtain any regulatory approval of Landiolol; the Company’s ability to maintain regulatory approval of its products and product candidates, including Landiolol and vasopressin; the anticipated benefits of Landiolol and its potential acceptance by clinicians; the timing, progress and results of additional trials of Landiolol and the ability of such trial results to support regulatory filings and approvals; anticipated actions by FDA; the Company’s ability to support the commercial launch of Landiolol in the United States, if approved; the expected duration of new chemical entity exclusivity; the potential timing of commercial launch of vasopressin and PEMFEXY; anticipated future payments from the Company to AOP Orphan; and the ability of the Company’s product candidates, including Landiolol, vasopressin and PEMFEXY, to deliver value to stockholders. 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: delays in or failure to obtain regulatory approval of the license agreement with AOP Orphan; the impacts of the ongoing COVID-19 pandemic, including interruptions or other adverse effects on clinical trials and delays in regulatory review or further disruption or delay of any pending or future litigation; delay in or failure to obtain regulatory approval of the Company's product candidates and successful compliance with FDA and other governmental regulations applicable to product approvals; whether the Company will successfully implement its development plan for its product candidates; whether the Company can successfully market and commercialize its product candidates; the outcome of litigation involving any of its products or that may have an impact on any of its products; the strength and enforceability of the Company’s intellectual property rights or the rights of third parties; the risks inherent in 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, 2020 filed with the Securities and Exchange Commission (the “SEC”) on March 5, 2021, as updated by the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, filed with the SEC on May 10, 2021, and its other subsequent filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Investor Relations for Eagle Pharmaceuticals, Inc.:
Lisa M. Wilson
In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com