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. ¨
EXPLANATORY NOTE
As previously disclosed, on March 28, 2022, Eagle Pharmaceuticals, Inc. (the “Company”) and Acacia Pharma Group plc, a public company organized under the laws of England and Wales (“Acacia Pharma”), issued an announcement disclosing the agreed terms of a proposed cash and share offer by the Company for the entire issued and to be issued share capital of Acacia Pharma to be effected by means of a court sanctioned scheme of arrangement under Part 26 of the UK Companies Act 2006 (the “Acquisition”). The Acquisition was subject to closing conditions and certain further terms, including, among others (i) the approval of the Scheme by a majority in number of Acacia Pharma’s shareholders present and voting (and entitled to vote) at the meeting(s) of Acacia Pharma’s shareholders to be convened by order of the High Court of Justice of England and Wales (the “Court”) pursuant to section 896 of the Companies Act (and any separate class meeting which may be required by the Court (or at any adjournment thereof)), either in person or by proxy, representing not less than 75 percent in value of the Acacia Pharma shares held by such shareholders (or the relevant class or classes thereof); (ii) the sanction of the Scheme by the Court; and (iii) the Scheme becoming effective no later than June 30, 2022.
As previously disclosed, in connection with the Acquisition, on April 27, 2022, Acacia Pharma published a Scheme Document (the “Scheme Document”) to Acacia Pharma shareholders relating to the Acquisition.
The Company is hereby reporting the closing of the Acquisition as of June 9, 2022, as contemplated by the Scheme Document.
| Item 1.01 | Entry into a Material Definitive Agreement. |
Upon closing of the Acquisition, the Company guaranteed a term loan facility, dated as of January 10, 2020, by and between Acacia Pharma Limited (“APL”), a direct subsidiary of Acacia Pharma, and Cosmo Technologies Ltd. (the “Credit Facility”). The Credit Facility provides for up to €25 million in loans, all of which was drawn as of closing of the Acquisition. The Credit Facility has a maturity date of July 27, 2025 and is interest-only for 36 months following the initial draw down on July 27, 2020, after which the loan will be repayable in 24 monthly installments. The Credit Facility bears interest at 9% per annum, pursuant to the terms of an amendment agreement to the Credit Facility entered into on June 9, 2022. The guarantee provides that the Company shall guarantee the punctual performance by APL of APL’s obligations pursuant to the terms of the Credit Facility (as amended) and that the Company will immediately on demand pay any amount owed by APL under the Credit Facility (as amended) as if the Company was the principal obligor in the event that such amount is not paid by APL.
In addition to the above, the Credit Facility contains, among other things, covenants, representations and warranties, payment defaults, representation and warrant defaults, covenant defaults, cross default to material indebtedness, bankruptcy and insolvency defaults, material judgment defaults, defaults for failing to comply with certain sub-license agreements with Cosmo Technologies Ltd., and a default related to APL ceasing to do business. The occurrence of an event of default could result in termination of the Credit Facility and the acceleration of the obligations under the Credit Facility. The covenants include limitations on other indebtedness, liens, sales of assets and mergers and acquisitions.
| Item 2.01 | Completion of Acquisition or Disposition of Assets. |
Pursuant to the terms of the Scheme Document, on June 9, 2022, in connection with the consummation of the Acquisition (the “Closing”) each Acacia Pharma shareholder became entitled to receive €0.68 in cash and 0.0049 shares of common stock of the Company (the “Share Consideration”) for each Acacia Pharma share held by such shareholder. In connection with settlement of the cash consideration and Share Consideration to the Acacia Pharma shareholders, the Company will: (i) pay approximately €71,615,407 in cash on hand and (ii) issue 516,024 shares of the Company’s common stock, par value $0.001 per share (the “Common Stock”), in each case upon the terms and subject to the conditions of the Scheme Document. Settlement of the cash consideration and the Share Consideration is expected to be completed by June 23, 2022.
| Item 2.03 | Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant. |
The information included in Item 1.01 above is hereby incorporated by reference in its entirety into this Item 2.03.
| Item 3.02 | Unregistered Sales of Equity Securities. |
The information under Item 2.01 of this Current Report on Form 8-K with respect to the Share Consideration to be issued pursuant to the Acquisition is incorporated herein by reference. The shares of the Company’s Common Stock to be issued as Share Consideration will be issued to Acacia shareholders in reliance on the exemption from registration provided by Section 3(a)(10) of the Securities Act of 1933, as amended (the “Securities Act”).
| Item 7.01 | Regulation FD Disclosure. |
On June 9, 2022, Acacia Pharma and the Company announced that the Court had sanctioned the Scheme and, accordingly, the Scheme had become effective upon the court’s order being delivered to the registrar of companies, which took place on June 9, 2022. A copy of the press release (the “Joint Release”) is attached as Exhibit 99.1 to this Current Report on Form 8-K. In addition, on June 9, 2022, the Company issued an additional press release (the “Company’s Press Release”) announcing that the Scheme became effective and the Acquisition was completed following the sanction of the Scheme by the High Court of Justice in England and Wales.
On June 9, 2022, the Company released an investor presentation relating to the Company’s business, prospects and updates, including the Acquisition as well as the Company’s products and product candidates. The Company will refer to the presentation during its previously announced presentation at the William Blair 42nd Annual Growth Stock Conference taking place on June 9, 2022, at 9:40am ET, which is accessible via webcast as set forth in the Company’s press release issued on May 26, 2022 and on the Company’s website at https://investor.eagleus.com/, and the investor presentation may be used from time to time in meetings with investors.
Copies of the full text of the Joint Press Release, the Company’s Press Release and investor presentation referenced above are filed as Exhibit 99.1, 99.2 and 99.3 to this Current Report on Form 8-K and are incorporated herein by reference. The information contained in this Item 7.01, including Exhibits 99.1, 99.2 and 99.3, 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 Exhibits 99.1, 99.2 and 99.3, 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. |
(a) Financial Statements of Business Acquired
The financial statements of the acquired business required by this item have not been filed on this Report but will be filed by amendment not later than 71 calendar days after the date that this Report was required to be filed.
(b) Pro Forma Financial Information
The pro forma financial information required by this item has not been filed on this Report but will be filed by amendment not later than 71 calendar days after the date that this Report was required to be filed.
(d) Exhibits
See Exhibit Index attached hereto.
Forward-Looking Statements
This Current Report 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: statements regarding the timing of the settlement of the Acquisition; satisfaction of terms and conditions of the loan agreement entered to which a subsidiary of Acacia Pharma is a party and the Company is a guarantor; the estimated addressable market size and estimated sales figures for BARHEMSYS, BYFAVO, Landiolol and other products or product candidates; potential future royalty and milestone revenue, including for Treakisym; the Company’s marketing, product development, partnering and growth strategy, including relating to the commercialization of BARHEMSYS and BYFAVO and the ability of Eagle to expand the application of BARHEMSYS and BYFAVO; the timing, scope or likelihood and timing of regulatory filings and approvals from the FDA for the Company’s product candidates, including Landiolol; the ability of BARHEMSYS, BYFAVO, Landiolol and other products and product candidates to address unmet clinical needs; the potential market opportunity for Eagle’s products or product candidates, including for BARHEMSYS, BYFAVO and Landiolol; expectations regarding expansion of the Company’s product portfolio, including potential acquisitions of oncology or other assets; the ability of the Company’s executive team to execute on the Company’s strategy and build stockholder value; expectations regarding the Company’s future growth; and the ability of the Company’s product candidates 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: the risk that the anticipated benefits of the Company’s recently completed transaction with Acacia Pharma Group are not realized; the impacts of the COVID-19 pandemic and geopolitical events such as the conflict in Ukraine, 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 or other events on the Company’s business, financial condition and results of operations; 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 or its partners’ product candidates; whether the Company can successfully market and commercialize its products or 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 its 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 and geopolitical events, 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 factors in addition to the foregoing that may impact the Company’s financial projects and guidance, including among other things, any potential business development transactions, acquisitions, restructurings or legal settlements, in addition to any unanticipated factors, that may cause the Company’s actual results and outcomes to materially differ from its projections and guidance; 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, 2021, filed with the SEC on March 8, 2022, as updated by Eagle’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, filed with the SEC on May 9, 2022, and its other subsequent filings with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements contained in this Current Report 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.
| Item 9.01 | Financial Statements and Exhibits. |
| Exhibit No. | Description | |
| 99.1 | Joint Press Release, dated June 9, 2022. | |
| 99.2 | Company’s Press Release, dated June 9, 2022. | |
| 99.3 | Investor Presentation, dated June 9, 2022. | |
| 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: June 9, 2022 | EAGLE PHARMACEUTICALS, INC. | |
| By: | /s/ Scott Tarriff | |
| Scott Tarriff | ||
| Chief Executive Officer | ||
Exhibit 99.1
Acacia Pharma Group PLC
THIS ANNOUNCEMENT CONTAINS REGULATED INFORMATION
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN, INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF THAT JURISDICTION
FOR IMMEDIATE RELEASE
9 June 2022, 1.00 p.m. (Brussels time)
RECOMMENDED ACQUISITION
of
ACACIA PHARMA GROUP PLC
by
EAGLE PHARMACEUTICALS, INC.
to be effected by means of a scheme of arrangement under Part 26 of the Companies Act 2006
Scheme becoming effective
Acacia Pharma Group PLC (the “Company” or “Acacia”) and Eagle Pharmaceuticals, Inc. (“Eagle”) are pleased to announce, in relation to the recommended acquisition of Acacia by Eagle by means of a Court-sanctioned scheme of arrangement under Part 26 of the Companies Act 2006 (the “Scheme”), that the Scheme has today become effective following the delivery of the Court Order to the Registrar of Companies at Companies House.
The delisting of Acacia Shares and the cancellation of admission to trading of Acacia Shares on Euronext Brussels takes effect today, 9 June 2022.
Holders of Scheme Shares who appeared on Acacia’s register of members at 6.00 p.m. (London, UK time) on 8 June 2022 will be entitled to receive €0.68 in cash and 0.0049 New Eagle Shares for each Scheme Share held. Settlement of the consideration in relation to the Scheme is expected to be effected on or before 23 June 2022. For further details, reference is made to the the scheme document issued by Acacia on 26 April 2022 and available on its website at www.acaciapharma.com/investors/shareholder-meetings (the “Scheme Document”).
Unless otherwise defined, all capitalised terms in this announcement (the “Announcement”) shall have the meaning given to them in the Scheme Document.
| Enquiries | |
| Eagle Pharmaceuticals, Inc. | Tel: +1 (201) 326-5300 |
| Scott Tarriff | |
| William Blair (Financial Adviser to Eagle) | Tel: +1 (312) 236 1600 |
| Christian Hodneland, Eugene Kim, Ty Weston | |
| In-Site Communications, Inc. (PR Adviser to Eagle) | Tel: +1 (212) 452-2793 |
| Lisa M. Wilson | |
| Acacia Pharma Group plc | Tel: +1 317 505 1280 |
| Mike Bolinder | |
| Greenhill (Joint Financial Adviser to Acacia) | Tel: +44 20 7198 7400 |
| Kevin Costantino, Rupert Hill, Dean Rodrigues, James Warr | |
| Jefferies (Joint Financial Advisor to Acacia) | Tel: +44 7827 953950 |
| Gil Bar-Nahum | |
| MEDiSTRAVA Consulting (PR Adviser to Acacia) | Tel: +44 20 3928 6900 |
| Frazer Hall, Mark Swallow, David Dible |
Cooley (UK) LLP is acting as legal adviser to Eagle in connection with the Scheme. NautaDutilh BV is acting as legal adviser to Eagle in connection with Belgian law. Sullivan & Cromwell LLP is acting as legal adviser to Acacia in connection with the Scheme. Eubelius CVBA is acting as legal adviser to Acacia in connection with Belgian law and its listing on Euronext Brussels.
Important notice
This Announcement is for information purposes only and is not intended to and does not constitute, or form part of, an offer, invitation or the solicitation of an offer to purchase, otherwise acquire, subscribe for, sell or otherwise dispose of any securities, or the solicitation of any vote or approval in any jurisdiction, pursuant to the Scheme or otherwise, nor the announcement of a forthcoming solicitation of any offer to acquire or dispose of securities or of any vote or approval, nor shall there be any sale, issuance or transfer of securities of Acacia or Eagle in any jurisdiction. The information contained in this Announcement should not be construed to constitute any form of advice or recommendation, including but not limited to investment, tax, legal or other advice, and should not be relied upon as the basis for any decision or action.
The Scheme will be implemented solely pursuant to the terms of the Scheme Document, which contains the full terms and conditions of the Scheme, including details of how to vote in respect of the Scheme. Any voting decision or response in relation to the Scheme should be made only on the basis of the information contained in the Scheme Document and the Forms of Proxy.
The Scheme Document has been prepared in accordance with and for the purpose of complying with applicable English law and information disclosed may not be the same as that which would have been disclosed if the Scheme Document had been prepared in accordance with the laws of jurisdictions outside England and Wales.
The Scheme is governed by English law and is not a public takeover bid within the meaning of the Belgian Act of 1 April 2007 on public takeover bids. To the extent relevant, the Scheme Document has been prepared in compliance with the Company’s obligations as a company listed on Euronext Brussels. Neither this Announcement nor the Scheme Document is a prospectus or a prospectus-equivalent document. This Announcement and the Scheme Document have not been submitted to nor approved by the Belgian Financial Services and Markets Authority.
Disclaimers
William Blair is acting as financial adviser exclusively for Eagle and no one else in connection with the Scheme; will not regard any other person as a client in relation to the Scheme and will not be responsible to anyone other than Eagle for providing the protections afforded to clients of William Blair or its affiliates, nor for providing advice in relation to the Scheme or any other matters referred to in this Announcement. Neither William Blair nor any of its affiliates, directors or employees owes or accepts any duty, liability or responsibility whatsoever (whether direct or indirect, consequential, whether in contract, in tort, in delict, under statute or otherwise) to any person who is not a client of William Blair in connection with this Announcement, any statement contained herein, the Scheme or otherwise.
Greenhill and Jefferies are acting as joint financial advisers exclusively for Acacia and no-one else in connection with the Scheme; will not regard any other person as a client in relation to the Scheme and will not be responsible to anyone other than Acacia for providing the protections afforded to clients of Greenhill, Jefferies or their respective affiliates, nor for providing advice in relation to the Scheme or any other matters referred to in this Announcement.
Overseas Jurisdictions
The release, publication or distribution of this Announcement or the Scheme Document, or any copy thereof, in or into jurisdictions other than the UK and Belgium may be restricted by law and therefore any persons who are resident in, or who are subject to the law of, any jurisdiction other than the UK and Belgium should inform themselves about, and observe, any applicable legal or regulatory requirements. In particular, the ability of persons who are not resident in the UK or Belgium to vote their Acacia Shares with respect to the Scheme at the Court Meeting, or to appoint another person as proxy to vote at the Court Meeting on their behalf, may be affected by the laws of the relevant jurisdictions in which they are located. Any failure to comply with the applicable restrictions may constitute a violation of the securities laws of any such jurisdiction. To the fullest extent permitted by applicable law, the companies and persons involved in the Scheme disclaim any responsibility or liability for the violation of such restrictions by any person.
Copies of this Announcement, the Scheme Document and any other formal documentation relating to the Scheme are not being and must not be, directly or indirectly, mailed or otherwise forwarded, distributed or sent in, into or from any Restricted Jurisdiction or any jurisdiction where to do so would violate the laws of that jurisdiction and persons receiving such documents (including custodians, nominees and trustees) must not mail or otherwise forward, distribute or send such documents in or into or from any Restricted Jurisdiction. Doing so may render invalid any related purported vote in respect of the Scheme.
Further details in relation to Overseas Shareholders are contained in the Scheme Document.
Notice to US investors
US Holders should note that the Scheme relates to shares of an English company and is proposed to be implemented by means of a scheme of arrangement provided for under English law and which will be subject to the procedural and disclosure requirements and practices applicable in the UK to schemes of arrangement, which are different from those that may be applicable in the United States. The financial information included in this Announcement and the Scheme Document, if any, has been prepared in accordance with International Financial Reporting Standards, and thus may not be comparable to financial information of US companies or companies whose financial statements are prepared in accordance with generally accepted accounting principles in the US.
Securities may not be offered or sold in the United States unless registered under the US Securities Act, and applicable state securities laws or exempt from such registration. In reliance on the exemption provided by section 3(a)(10) of the US Securities Act, the issuance of the New Eagle Shares to be issued pursuant to the Scheme has not been and will not be registered with the SEC under the US Securities Act.
Neither the SEC nor any US state securities commission has approved or disapproved of the New Eagle Shares to be issued in connection with the Scheme, or determined if this Announcement is accurate or complete or has passed upon the fairness or the merits of the proposal described herein. Any representation to the contrary is a criminal offence in the United States.
Each Acacia Shareholder is urged to consult his or her tax adviser regarding the tax consequences of the Scheme applicable to him or her.
It may be difficult for US investors to enforce their rights and any claim arising out of the US federal securities laws, as Acacia is incorporated under the laws of England and Wales, some of its officers and directors may be residents of, and some or all of its assets are or may be located in, a non-US jurisdiction. US investors may not be able to sue a non-US company or its officers or directors in a non-US court for violations of the US securities laws. Further, it may be difficult to compel a non-US company and its affiliates to subject themselves to a US court’s judgment.
Forward looking statements
This Announcement (including information incorporated by reference in this Announcement), oral statements made regarding the Scheme, and other information published by Acacia, the Acacia Group, Eagle and/or the Eagle Group contain statements, which are, or may be deemed to be, “forward-looking statements”. Forward-looking statements are prospective in nature and are not based on historical facts, but rather on current expectations and projections of the management of Acacia, the Acacia Group, Eagle and/or the Eagle Group (as applicable) about future events, and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements.
The forward-looking statements contained in this Announcement include statements relating to the expected effects of the Scheme on Acacia, the Acacia Group, Eagle or the Eagle Group (including their future prospects, developments and strategies), the expected timing and scope of the Scheme and other statements other than historical facts. Often, but not always, forward-looking statements can be identified by the use of forward-looking words such as “plans”, “expects” or “does not expect”, “is expected”, “is subject to”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “should”, “would”, “might” or “will” be taken, occur or be achieved. These statements include, but are not limited to, statements regarding future events such as: the strategic fit of Barhemsys® and Byfavo® with Eagle’s specialised hospital-based salesforce; statements regarding the addressable market size and commercial potential for Barhemsys® and Byfavo® and other products or product candidates; the expected structure, anticipated synergies, terms, timing and closing of the Scheme; Eagle’s marketing, product development, partnering and growth strategy, including relating to the commercialisation of Barhemsys® and Byfavo®, and the ability of Acacia’s technology and know-how to help Eagle achieve its strategy; the expectation that the addition of Barhemsys® and Byfavo® will be accretive to Eagle, and the timing thereof; the expected sources of financing for the Scheme and the cash resources of Eagle; the ability of Eagle to expand the application of the Acacia products; the timing, scope or likelihood and timing of regulatory filings and approvals from the FDA for Eagle’s product candidates, including landiolol; the ability of Barhemsys® and Byfavo® to address unmet clinical needs; the ability of Barhemsys® to offer significant economic savings to hospitals and ambulatory centres; the ability of Byfavo® to offer potential health and economic benefits and enable shorter procedure times and greater patient throughput; the ability of the Scheme to create value for Eagle’s shareholders; and the ability of Eagle’s executive team to execute on Eagle’s strategy and build stockholder value.
Although Acacia and Eagle believe that the expectations reflected in such forward-looking statements are reasonable (other than where expressly disclaimed), none of Acacia, the Acacia Group, Eagle and/or the Eagle Group can give any assurance that such expectations will prove to be correct. By their nature, forward-looking statements involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by such forward-looking statements. These factors include, but are not limited to: changes in the global political, economic, business and competitive environments (including, but not limited to, the impacts of the COVID-19 pandemic and geopolitical events such as the ongoing conflict between Ukraine and Russia and related sanctions against Russia); delay in, or inability to obtain, or meet conditions imposed for, required governmental and regulatory approvals; interruptions or other adverse effects to clinical trials; legal or regulatory developments and changes, including, but not limited to, changes in environmental and health and safety regulations; government actions; foreign exchange rate and interest rate fluctuations; changes in tax rates; weak, volatile or illiquid capital and/or credit markets; market position of the companies comprising the Acacia Group; earnings; financial position; cash flows; return on capital and operating margins; anticipated investments; the ability of Eagle and/or the Acacia Group to obtain capital/additional finance; an unexpected decline in revenue or profitability; retention of senior management; the maintenance of labour relations; fluctuations in commodity prices and other input costs; operating and financial restrictions as a result of financing arrangements; changes in consumer habits and preferences, including a reduction in demand by customers; competitive product and pricing pressures; future business combinations or disposals; success of business and operating initiatives; changes in the level of capital investment; manufacturing and supply chain interruptions, adverse effects on healthcare systems, disruption in the operations of third party partners and disruption of the global economy, and the overall impact of the COVID-19 pandemic or other events on Eagle or Acacia’s business, financial condition and results of operations; unforeseen expenses or liabilities or other market factors; whether Eagle will successfully implement its development plan for, and successfully market and commercialise, its product candidates; the success of relationships with partners; the availability and pricing of third party sourced products and materials; the outcome of litigation involving any products or that may have an impact on any of Eagle or Acacia’s products; successful compliance with the FDA and other governmental regulations applicable to product approvals, manufacturing facilities, products and/or businesses; the strength and enforceability of Eagle or Acacia’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; satisfaction of the Scheme’s closing conditions; factors in addition to the foregoing that may impact Eagle or Acacia’s expectations, including, among other things, any potential business development transactions, acquisitions, restructurings or legal settlements, in addition to any unanticipated factors, that may cause actual results and outcomes to materially differ; and other risks and uncertainties, including those identified in the “Risk Factors” section of Eagle's Annual Report on Form 10-K for the year ended December 31, 2021, filed with the Securities and Exchange Commission (the “SEC”) on March 8, 2022, as updated by Eagle’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, filed with the SEC on May 9, 2022, and its other subsequent filings with the SEC.
Other unknown or unpredictable factors could cause actual results to differ materially from those expected, estimated or projected in the forward-looking statements. If any one or more of these risks or uncertainties materialises or if any one or more of the assumptions prove incorrect, actual results may differ materially from those expected, estimated or projected. Such forward-looking statements should therefore be construed in the light of such factors.
None of Acacia, the Acacia Group, Eagle nor the Eagle Group, nor any of their respective associates or directors, officers, employees or advisers, provides any representation, assurance or guarantee that the occurrence of the events expressed or implied in any forward-looking statements in this Announcement will actually occur. Given these risks and uncertainties, you are cautioned not to place any reliance on these forward-looking statements.
Specifically, statements of estimated cost savings and synergies relate to future actions and circumstances which, by their nature, involve risks, uncertainties and contingencies. As a result, the cost savings and synergies referred to may not be achieved, may be achieved later or sooner than estimated, or those achieved could be materially different from those estimated and there may be additional changes to the operations of the Acacia Group. As a result, and given the fact that the changes relate to the future, the resulting cost synergies may be materially greater or less than those estimated.
Other than in accordance with their legal or regulatory obligations, none of Acacia, the Acacia Group, Eagle or the Eagle Group is under any obligation, and each of the foregoing expressly disclaim any intention or obligation to update or to revise any forward-looking statements other than as required by law or by the rules of any competent regulatory authority, whether as a result of new information, future events or otherwise.
No profit forecasts or estimates
No statement in this Announcement, or incorporated by reference in this Announcement, is intended as a profit forecast, profit estimate or quantified benefits statement for any period and no statement in this Announcement should be interpreted to mean that earnings or earnings per Acacia Share or per share of common stock of Eagle, as appropriate, for the current or future financial years would necessarily match or exceed the historical published earnings or earnings per Acacia Share or per share of common stock of Eagle, as appropriate.
Hard copies
Acacia Shareholders may request a hard copy of this Announcement and any information incorporated into it by reference to another source in hard copy form by writing to Acacia Pharma Group PLC, The Officers’ Mess Royston Road, Duxford, Cambridge, England, CB22 4QH or by calling Anne-Marie Elsley, the Company Secretary, on +44 1223 919760, during normal business hours. A hard copy of this Announcement will not be sent unless so requested. Acacia Shareholders may also request that all future documents, announcements and information sent in relation to the Scheme should be sent in hard copy form, again by writing to the address set out above or by calling the telephone number above.
Exhibit 99.2
For Immediate Release
Eagle Pharmaceuticals Completes Acquisition of Acacia Pharma Group plc, Expanding Acute Care Footprint
| · | Adds two U.S. Food and Drug Administration (“FDA”) approved new chemical entities with strong patent protection |
| · | BARHEMSYS® (amisulpride for injection) and BYFAVO® (remimazolam for injection) join Eagle portfolio, with an estimated combined $3.1 billion per year1 addressable market and projected annual peak sales of $2752 million in the U.S. |
| · | Expected to be earnings accretive by 2024 |
WOODCLIFF LAKE, NJ—June 9, 2022—Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced it has completed the acquisition of the entire issued share capital of Acacia Pharma Group plc (“Acacia Pharma”) (EURONEXT: ACPH) by way of a scheme of arrangement under Part 26 of the United Kingdom’s Companies Act 2006 (the “Transaction”).
“The closing of this transaction is a great achievement for Eagle both strategically and financially. The addition of the two products expands our presence in the acute care space, and we believe that our highly capable hospital-based salesforce will have great success commercializing these assets. We believe BARHEMSYS and BYFAVO represent two compelling opportunities, as both address significant unmet clinical needs,” stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.
“With the recent launches of vasopressin and PEMFEXYTM and the completion of this transaction, Eagle has gone from three commercial products to eight within a year, with a ninth on the horizon if the new drug application submitted for landiolol last month is approved. The acquisition of Acacia Pharma should not only help improve the care of patients undergoing medical treatments but also solidify our leadership position in the hospital and oncology space and bring long-term value to our shareholders,” concluded Tarriff.
1 Assumes a number of doses per patient at a WAC price of $85 per 10mg dose for the prophylaxis and rescue addressable market. These estimates are the result of market research performed by or for Eagle Pharmaceuticals.
2 Estimate is based on market research performed by or for Eagle Pharmaceuticals.
Key Highlights
| · | Strong synergistic fit with Eagle’s infrastructure and current and planned portfolio of hospital products; |
| · | Two commercially compelling FDA-approved products: |
| · | BARHEMSYS® is the first and only antiemetic approved by the FDA for rescue treatment of postoperative nausea and vomiting (“PONV”) despite prophylaxis3. Eagle currently calls on healthcare providers and institutions representing over 70% of the expected BARHEMSYS addressable market opportunity; |
| · | BARHEMSYS is also approved for the treatment of PONV in patients who have not received prophylaxis and for the prevention of PONV. The total estimated annual U.S. addressable market for prophylaxis and rescue is $2.7 billion4; |
| · | BYFAVO® is indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less, with an estimated total addressable market in procedural sedation of more than $0.4 billion per year in the U.S.5 |
| · | Opportunity to realize the full potential of BARHEMSYS and BYFAVO by leveraging Eagle’s longstanding relationships and highly experienced, hospital-based salesforce; |
| · | The addition of diversified but complementary revenue streams, accelerating Eagle’s growth and strengthening its advantage in acute care; and |
| · | Expected to be earnings accretive in 2024. |
Product Descriptions BARHEMSYS® (amisulpride for injection)6 is the first and only FDA-approved product for PONV rescue after failed prophylaxis. It is a selective dopamine D2 /D3 antagonist with a broad, differentiated label. PONV is a common complication of surgery, occurring in approximately 30% of all surgical patients and 80% of high-risk patients. PONV is associated with the use of anesthetic gases and opioid painkillers and is particularly common following gynecological, abdominal, breast, eye, and ear operations, especially those lasting an hour or more. PONV can delay hospital discharge; result in re-admission after in-patient procedures; and lead to day-case patients being admitted to the hospital, all of which can result in significantly increased healthcare costs. By reducing these risks, BARHEMSYS® offers the potential for significant economic savings to hospitals and ambulatory centers. There are approximately 70 million invasive surgical procedures where patients receive antiemetic prophylaxis annually in the U.S. Approximately 10 million of these patients per year require PONV rescue treatment. BARHEMSYS is the only drug with an FDA-approved indication to treat patients who have failed PONV prophylaxis. It has an established safety profile and efficacy demonstrated in multiple well-controlled clinical studies. BARHEMSYS® is nonsedating, a common complaint of standard antiemetic agents. Patients experiencing PONV who were treated in a pivotal clinical trial and failed prophylaxis were treated with BARHEMSYS. These patients were observed to have shorter post-anesthesia care (PACU) and hospital stays then patients who were not. Please see Important Safety Information for BARHEMSYS, below.
3 FDA labels for other recommended treatments do not include treatment after failed prophylaxis.
4 Based on the number of doses per patient at a WAC price of $85 per 10mg dose.
5 These estimates are the result of market research performed by or for Eagle Pharmaceuticals.
6 https://bynder.acaciapharma.com/m/5d7c2cd0d58865f7/original/Barhemsys-Prescribing-Information.pdf
BYFAVO® (remimazolam for injection) 7 is a rapid onset/offset procedural sedative with an established safety and efficacy profile. Additional benefits include predictability and a readily available reversal agent. Please see Important Safety Information, including boxed warning, below. BYFAVO has a compelling commercial opportunity, addressing a clear unmet need. There has been no innovation in the sedation space for over 20 years. Customers seek a fast onset, titratability, and rapid recovery for quick discharge, and shorter procedure times allow for increased procedural volumes. BYFAVO has a broad label and potential health economic benefits and may enable shorter procedure times and greater patient throughput. It is indicated for procedural sedation in adults in procedures lasting 30 minutes or less and has a substantial clinical data package demonstrating efficacy and safety in colonoscopies and bronchoscopies, including the most challenging patients.
Advisors
Cooley (UK) LLP acted as legal advisor and William Blair & Company, L.L.C. acted as exclusive financial advisor to Eagle Pharmaceuticals in connection with the transaction. Locust Walk served as a transaction advisor to Eagle Pharmaceuticals. NautaDutilh BV acted as legal advisor to Eagle Pharmaceuticals in connection with Belgian law.
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 vasopressin injection, PEMFEXY™, RYANODEX®, BENDEKA®, BELRAPZO®, TREAKISYM (Japan), 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.
7 https://bynder.acaciapharma.com/m/403e8c343b2922de/original/Byfavo-PI.pdf
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,” “could,” “should,” “may,” “remain,” “potential,” “prepare,” “expected,” “believe,” “plan,” “near future,” “belief,” “guidance,” “estimate,” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding future events such as: statements regarding expectations with respect to whether and when the Acacia acquisition may be earnings accretive; expectations with respect to synergies; expectations that the acquisition of Acacia Pharma will help improve the care of patients undergoing medical treatments, solidify the Company's leadership position in the hospital and oncology space and bring long-term value to the Company's shareholders; the estimated addressable market size and estimated sales figures for BARHEMSYS, BYFAVO and other products or product candidates; the Company’s marketing, product development, partnering and growth strategy, including relating to the commercialization of BARHEMSYS and BYFAVO and the Company’s ability to expand the application of BARHEMSYS and BYFAVO; the timing, scope or likelihood and timing of regulatory filings and approvals from the FDA for the Company’s product candidates, including landiolol; the ability of BARHEMSYS, BYFAVO, landiolol and other products and product candidates to address unmet clinical needs; the potential market opportunity for the Company’s products or product candidates, including for BARHEMSYS, BYFAVO and landiolol; expectations regarding expansion of the Company’s product portfolio, including potential acquisitions; the ability of the Company’s executive team to execute on the Company’s strategy and build stockholder value; the ability of Eagle’s hospital-based sales force to commercialize BARHEMSYS and BYFAVO; expectations regarding the Company’s future growth; and the ability of the Company’s product candidates 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: the risk that the anticipated benefits of the Company’s recently completed transaction with Acacia Pharma are not realized; the impacts of the COVID-19 pandemic and geopolitical events such as the conflict in Ukraine, 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 or other events on the Company’s business, financial condition and results of operations; 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 or its partners’ product candidates; whether the Company can successfully market and commercialize its products or 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 its 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 and geopolitical events, 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 factors in addition to the foregoing that may impact the Company’s financial projects and guidance, including among other things, any potential business development transactions, acquisitions, restructurings or legal settlements, in addition to any unanticipated factors, that may cause the Company’s actual results and outcomes to materially differ from its projections and guidance; 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, 2021, filed with the Securities and Exchange Commission (the “SEC”) on March 8, 2022 and its other subsequent filings with the SEC, including the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, which the Company filed with the SEC on May 9, 2022. Readers are cautioned not to place undue reliance on these forward-looking statements. 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
Important Safety Information for BARHEMSYS® (amisulpride) Injection
Contraindication
BARHEMSYS is contraindicated in patients with known hypersensitivity to amisulpride.
QT Prolongation
BARHEMSYS causes dose- and concentration-dependent prolongation of the QT interval. The recommended dosage is 5 mg or 10 mg as a single intravenous (IV) dose infused over 1 to 2 minutes.
Avoid BARHEMSYS in patients with congenital long QT syndrome and in patients taking droperidol.
Electrocardiogram (ECG) monitoring is recommended in patients with pre-existing arrhythmias/cardiac conduction disorders, electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, and in patients taking other medicinal products (e.g., ondansetron) or with other medical conditions known to prolong the QT interval.
Adverse Reactions
Common adverse reactions reported in ≥ 2% of adult patients who received BARHEMSYS 5 mg (n=748) and at a higher rate than placebo (n=741) in clinical trials for the prevention of PONV were: chills (4% vs. 3%), hypokalemia (4% vs. 2%), procedural hypotension (3% vs. 2%), and abdominal distention (2% vs. 1%).
Serum prolactin concentrations were measured in one prophylaxis study where 5% (9/176) of BARHEMSYS-treated patients had increased blood prolactin reported as an adverse reaction compared with 1% (1/166) of placebo-treated patients.
The most common adverse reaction, reported in ≥ 2% of adult patients who received BARHEMSYS 10 mg (n=418) and at a higher rate than placebo (n=416), in clinical trials for the treatment of PONV was infusion site pain (6% vs. 4%).
Use in Specific Populations
Lactation
Amisulpride is present in human milk. There are no reports of adverse effects on the breastfed child and no information on the effects of amisulpride on milk production.
BARHEMSYS may result in an increase in serum prolactin levels, which may lead to a reversible increase in maternal milk production. In a clinical trial, serum prolactin concentrations in females (n=112) increased from a mean of 10 ng/mL at baseline to 32 ng/mL after BARHEMSYS treatment and from 10 ng/mL to 19 ng/mL in males (n=61). No clinical consequences due to elevated prolactin levels were reported.
To minimize exposure to a breastfed infant, lactating women may consider interrupting breastfeeding and pumping and discarding breast milk for 48 hours after receiving a dose of BARHEMSYS.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Renal Impairment
Avoid BARHEMSYS in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2). The pharmacokinetics of amisulpride in patients with severe renal impairment have not been adequately studied in clinical trials. Amisulpride is known to be substantially excreted by the kidneys, and patients with severe renal impairment may have increased systemic exposure and an increased risk of adverse reactions.
No dosage adjustment is necessary in patients with mild to moderate renal impairment
(eGFR ≥ 30 mL/min/1.73 m2).
Drug Interactions
| · | BARHEMSYS causes dose- and concentration-dependent QT prolongation. To avoid potential additive effects, avoid use of BARHEMSYS in patients taking droperidol. |
| · | ECG monitoring is recommended in patients taking other drugs known to prolong the QT interval (e.g., ondansetron). |
| · | Reciprocal antagonism of effects occurs between dopamine agonists (e.g., levodopa) and BARHEMSYS. Avoid using levodopa with BARHEMSYS. |
Important Safety Information for BYFAVO™ (remimazolam) Injection
Indications
BYFAVO is a benzodiazepine indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less.
Important Safety Information
WARNING: PERSONNEL AND EQUIPMENT FOR MONITORING AND RESUSCITATION AND RISKS FROM CONCOMITANT USE WITH OPIOID ANALGESICS
Personnel and Equipment for Monitoring and Resuscitation
| · | Only personnel trained in the administration of procedural sedation, and not involved in the conduct of the diagnostic or therapeutic procedure, should administer BYFAVO. |
| · | Administering personnel must be trained in the detection and management of airway obstruction, hypoventilation, and apnea, including the maintenance of a patent airway, supportive ventilation, and cardiovascular resuscitation. |
| · | BYFAVO has been associated with hypoxia, bradycardia, and hypotension. Continuously monitor vital signs during sedation and during the recovery period. |
| · | Resuscitative drugs, and age- and size-appropriate equipment for bag-valve-mask–assisted ventilation must be immediately available during administration of BYFAVO. |
Risks From Concomitant Use With Opioid Analgesics and Other Sedative-Hypnotics
Concomitant use of benzodiazepines, including BYFAVO, and opioid analgesics may result in profound sedation, respiratory depression, coma, and death. The sedative effect of intravenous BYFAVO can be accentuated by concomitantly administered CNS depressant medications, including other benzodiazepines and propofol. Continuously monitor patients for respiratory depression and depth of sedation.
Contraindication
BYFAVO is contraindicated in patients with a history of severe hypersensitivity reaction to dextran 40 or products containing dextran 40.
Personnel and Equipment for Monitoring and Resuscitation
Clinically notable hypoxia, bradycardia, and hypotension were observed in Phase 3 studies of BYFAVO. Continuously monitor vital signs during sedation and through the recovery period. Only personnel trained in the administration of procedural sedation, and not involved in the conduct of the diagnostic or therapeutic procedure, should administer BYFAVO. Administering personnel must be trained in the detection and management of airway obstruction, hypoventilation, and apnea, including the maintenance of a patent airway, supportive ventilation, and cardiovascular resuscitation. Resuscitative drugs, and age- and size-appropriate equipment for bag-valve-mask–assisted ventilation must be immediately available during administration of BYFAVO. Consider the potential for worsened cardiorespiratory depression prior to using BYFAVO concomitantly with other drugs that have the same potential (e.g., opioid analgesics or other sedative-hypnotics). Administer supplemental oxygen to sedated patients through the recovery period. A benzodiazepine reversal agent (flumazenil) should be immediately available during administration of BYFAVO.
Risks From Concomitant Use With Opioid Analgesics and Other Sedative-Hypnotics
Concomitant use of BYFAVO and opioid analgesics may result in profound sedation, respiratory depression, coma, and death. The sedative effect of IV BYFAVO can be accentuated when administered with other CNS depressant medications (eg, other benzodiazepines and propofol). Titrate the dose of BYFAVO when administered with opioid analgesics and sedative-hypnotics to the desired clinical response. Continuously monitor sedated patients for hypotension, airway obstruction, hypoventilation, apnea, and oxygen desaturation. These cardiorespiratory effects may be more likely to occur in patients with obstructive sleep apnea, the elderly, and ASA-PS class III or IV patients.
Hypersensitivity Reactions
BYFAVO contains dextran 40, which can cause hypersensitivity reactions, including rash, urticaria, pruritus, and anaphylaxis. BYFAVO is contraindicated in patients with a history of severe hypersensitivity reaction to dextran 40 or products containing dextran 40.
Neonatal Sedation
Use of benzodiazepines during the later stages of pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) in the neonate. Observe newborns for signs of sedation and manage accordingly.
Pediatric Neurotoxicity
Published animal studies demonstrate that anesthetic and sedation drugs that block NMDA receptors and/or potentiate GABA activity increase neuronal apoptosis in the developing brain and result in long-term cognitive deficits when used for longer than 3 hours. The clinical significance of this is not clear. However, the window of vulnerability to these changes is believed to correlate with exposures in the third trimester of gestation through the first several months of life but may extend out to approximately 3 years of age in humans.
Anesthetic and sedation drugs are a necessary part of the care of children needing surgery, other procedures, or tests that cannot be delayed, and no specific medications have been shown to be safer than any other. Decisions regarding the timing of any elective procedures requiring anesthesia should take into consideration the benefits of the procedure weighed against the potential risks.
Adverse Reactions
The most common adverse reactions reported in >10% of patients (N=630) receiving BYFAVO 5-30 mg (total dose) and undergoing colonoscopy (two studies) or bronchoscopy (one study) were: hypotension, hypertension, diastolic hypertension, systolic hypertension, hypoxia, and diastolic hypotension.
Use in Specific Populations
Pregnancy
There are no data on the specific effects of BYFAVO on pregnancy. Benzodiazepines cross the placenta and may produce respiratory depression and sedation in neonates. Monitor neonates exposed to benzodiazepines during pregnancy and labor for signs of sedation and respiratory depression.
Lactation
Monitor infants exposed to BYFAVO through breast milk for sedation, respiratory depression, and feeding problems. A lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk during treatment and for 5 hours after BYFAVO administration.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. BYFAVO should not be used in patients less than 18 years of age.
Geriatric Use
No overall differences in safety or effectiveness were observed between these subjects and younger subjects. However, there is a potential for greater sensitivity (eg, faster onset, oversedation, confusion) in some older individuals. Administer supplemental doses of BYFAVO slowly to achieve the level of sedation required and monitor all patients closely for cardiorespiratory complications.
Hepatic Impairment
In patients with severe hepatic impairment, the dose of BYFAVO should be carefully titrated to effect. Depending on the overall status of the patient, lower frequency of supplemental doses may be needed to achieve the level of sedation required for the procedure. All patients should be monitored for sedation-related cardiorespiratory complications.
Abuse and Dependence
BYFAVO is a federally controlled substance (CIV) because it contains remimazolam which has the potential for abuse and physical dependence.
Exhibit 99.3
© 2022 Eagle Pharmaceuticals, Inc. All rights reserved. 1 1 Company Overview June 9, 2022 The information set forth herein is as of the date of the presentation and is based and conditioned on activities and review which remain ongoing, including FDA review and patent litigation, and is therefore subject to change.
2 © 2022 Eagle Pharmaceuticals, Inc. All rights reserved. Forward - Looking Statements This presentation contains “forward - looking statements” within the meaning of the Private Securities Litigation Reform Act of 19 95, as amended, and other securities laws. Forward - looking statements are statements that are not historical facts. Words and phrases such as “anticipated,” “forward,” “wi ll,” “would,” “could,” “should,” “may,” “remain,” “maintain,” “continue,” “potential,” “prepare,” “expect,” “estimate,” “believe,” “plan,” “near future,” “belief,” “guidance,” an d similar expressions are intended to identify forward - looking statements. These statements include, but are not limited to, statements regarding future events such as: statements reg arding the estimated addressable market size and estimated sales figures for BARHEMSYS, BYFAVO, Landiolol and other products or product candidates; potential future royalty and milestone revenue, including for Treakisym ; Eagle’s marketing, product development, partnering and growth strategy, including relating to the commercialization of BARHEM SYS and BYFAVO and the ability of Eagle to expand the application of BARHEMSYS and BYFAVO ; the timing, scope or likelihood and timing of regulatory filings and approva ls from the FDA for the Company’s product candidates, including Landiolol ; the ability of BARHEMSYS, BYFAVO, Landiolol and other products and product candidates to address unmet clinical needs; the potential market opportunity for Eagle’s products or product candidates, including for BARHEMSYS, BYFAVO and Landiolol ; expectations regarding expansion of the Company’s product portfolio, including potential acquisitions of oncology or other assets; the ability of the Company’s executive team to execute on the C omp any’s strategy and build stockholder value; expectations regarding the Company’s future growth; and the ability of the Company’s product candidates to deliver value to s toc kholders. 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 coul d c ause 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 risk that the anticipated benefits of the Company’s recently completed transaction with Acacia Pharma Group are not realized; the impacts of the COVID - 19 pandemic and geopolitical events such as the conflict in Ukraine, including disruption or impact in the sales of the Company's marketed products, interruptions or other a dve rse 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 or other events on the Company's business, financial conditi on and results of operations; whether the Company will incur unforeseen expenses or liabilities or other market factors; whether the Company will successfully implemen t i ts development plan for its product candidates; delay in or failure to obtain regulatory approval of the Company's or its partners’ product candidates; whether the Company c an successfully market and commercialize its products or product candidates; the success of the Company's relationships with its partners; the availability and pricing of th ird party sourced products and materials; the outcome of litigation involving any of its products or that may have an impact on any of the Company’s products; successful complianc e w ith the FDA and other governmental regulations applicable to product approvals, manufacturing facilities, products and/or businesses; general economic conditions, including th e potential adverse effects of public health issues, including the COVID - 19 pandemic and geopolitical events, on economic activity and the performance of the financial markets gener ally; the strength and enforceability of the Company's intellectual property rights or the rights of third parties; competition from other pharmaceutical and biotechnolog y c ompanies 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 trial s; and factors in addition to the foregoing that may impact the Company’s financial projects and guidance, including among other things, any potential business development transactions, ac quisitions, restructurings or legal settlements, in addition to any unanticipated factors, that may cause the Company’s actual results and outcomes to materially differ from its pr ojections and guidance; 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 3 1, 2021, filed with the Securities and Exchange Commission (the “SEC”) on March 8, 2022, the Company’s Quarterly Report on Form 10 - Q for the quarter ended March 31, 2022, filed with the SEC on May 9, 2022, and its other subsequent filings with the SEC. Readers are cautioned not to place undue reliance on the forward - looking statements contained i n this presentation, which speak only as of the date hereof. Except to the extent required by law, the Company undertakes no obligation to update such statements to reflect eve nts that occur or circumstances that exist after the date hereof.
© 2022 Eagle Pharmaceuticals, Inc. All rights reserved. 3 Eagle Pharmaceuticals Financial Position, Portfolio & Pipeline *As of 3/31/22; Does not take into account cash consideration paid at recent close of Acacia transaction Share Buybacks $236M* Net Working Capital of $138.5M* Cash + Receivables = $200M* BENDEKA ® BELRAPZO ® Current Portfolio BARHEMSYS ® BYFAVO ® Acquired Products Landiolol CAL02 Fulvestrant **Strategic collaboration with Tyme Technologies Product Pipeline TREAKISYM SymBio Japan Strong Financial Position Vasopressin PEMFEXY Œ RYANODEX ® SM - 88** 12.9M Diluted Shares Outstanding*
© 2022 Eagle Pharmaceuticals, Inc. All rights reserved. 4 Eagle Portfolio Overview RYANODEX ® BARHEMSYS ® Vasopressin BYFAVO ® BENDEKA ® PEMFEXY Œ BELRAPZO ® TREAKISYM SymBio Japan ACUTE CARE HOSPITAL ONCOLOGY Landiolol CAL02 Fulvestrant Commercially Available Products Newly Acquired Pipeline Products SM - 88* *In collaboration with TYME Technologies ;l
© 2022 Eagle Pharmaceuticals, Inc. All rights reserved. 5 BARHEMSYS And BYFAVO Are Now Part of the Eagle Portfolio Through the Completed Acacia Pharmaceuticals Transaction 1 Based on the number of doses per patient at a WAC price of $85 per 10mg dose. 2 Based on market research performed by or for Eagle. 3 Eagle internal estimates » First and only FDA - approved antiemetic for rescue treatment of postoperative nausea and vomiting (PONV) despite prophylaxis » Prophylaxis and rescue are an estimated $2.7 billion addressable market 1 BARHEMSYS and BYFAVO combined peak U.S. sales estimated to be $275M 3 FDA approved for PONV BARHEMSYS ® » Indicated for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less » Total potential addressable market in procedural sedation >$0.4B/year 2 Launched January 2021 FDA approved for procedural sedation BYFAVO ® L aunched August 2020
© 2022 Eagle Pharmaceuticals, Inc. All rights reserved. 6 ▪ BARHEMSYS and BYFAVO combined U.S. peak sales are estimated to be $275M* ▪ Landiolol U.S. peak sales are estimated to be $100M, if approved* ▪ Anticipate combined U.S. peak sales potential of $375M from BARHEMSYS, BYFAVO and landiolol , if approved* Eagle Hospital Business Overview RYANODEX ® Estimated Peak Sales* Vasopressin BARHEMSYS ® BYFAVO ® Landiolol CAL02 Hospital business currently being commercialized by 50 field resources Vasopressin Launched on January 17, 2022, with 180 days of marketing exclusivity. FDA - approved to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. Landiolol NDA submitted on May 31, 2022 seeking approval of landiolol, a novel therapeutic, for the short - term reduction of ventricular rate in patients with supraventricular tachycardia, including atrial fibrillation and atrial flutter. CAL02 Eagle is preparing to begin clinical trials for CAL02, a novel approach to the treatment of severe bacterial pneumonia, later this year. Acute Care Hospital Commercially Available Pipeline *Eagle internal estimates
© 2022 Eagle Pharmaceuticals, Inc. All rights reserved. 7 Eagle Oncology Business Overview BENDEKA ® BELRAPZO ® PEMFEXY Œ TREAKISYM Japan PEMFEXY Œ Launched on February 1, 2022, a ready - to - use liquid in a multi - dose vial with a unique J - code. Approved to treat nonsquamous non - small cell lung cancer and mesothelioma. Fully integrated into EAGLE CAN TM patient and provider support. TREAKISYM Eagle’s bendamustine franchise continues to grow, with the Japan launch of TREAKISYM ready - to - dilute (RTD) formulation. Symbio currently pursuing approval of the rapid infusion (RI) (50ml) liquid formulation. Fulvestrant Pilot studies underway of fulvestrant product candidate for the treatment of HR+/HER - advanced breast cancer. ONCOLOGY Commercially Available Pipeline Financial flexibility to potentially acquire an accretive oncology asset Fulvestrant SM - 88* *In collaboration with TYME Technologies
© 2022 Eagle Pharmaceuticals, Inc. All rights reserved. 8 Eagle Currently Has Eight Commercialized Assets Across Our Hospital and Oncology Business ACUTE CARE HOSPITAL Commercially Available RYANODEX ® For treatment of malignant hyperthermia, only formulation that allows for rapid response with 1 vial, 1 provider, less than 1 mi nute Vasopressin Vasopressin injection is FDA - approved to increase blood pressure in adults with vasodilatory shock (e.g., post - cardiotomy or se psis) who remain hypotensive despite fluids and catecholamines BARHEMSYS ® First and only FDA - approved antiemetic for rescue treatment of postoperative nausea and vomiting (PONV) despite prophylaxis BYFAVO ® Indicated for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less Pipeline Landiolol Beta - 1 adrenergic blocker; designed for use in emergency, critical care, and operating room settings. CAL02 Novel, first - in - class antitoxin agent in preparation for anticipated Phase 2b/3 clinical trial for treating severe community acq uired pneumonia ONCOLOGY Commercially Available BENDEKA ® Treatment of patients with chronic lymphocytic leukemia (CLL) and non - Hodgkin lymphoma (NHL) BELRAPZO ® Treatment of patients with chronic lymphocytic leukemia (CLL) and non - Hodgkin lymphoma (NHL) PEMFEXY Œ Approved for nonsquamous non - small cell lung cancer and mesothelioma TREAKISYM Bendamustine licensed to Symbio for sale of product in Japan Pipeline Fulvestrant Product candidate for the treatment of HR+/HER2 - advanced breast cancer SM - 88* Evaluating SM - 88 in high - risk sarcomas and metastatic breast cancer (HR+/HER2 - ) *In collaboration with TYME Technologies
© 2022 Eagle Pharmaceuticals, Inc. All rights reserved. 9 Eagle Pharmaceuticals Summary 8 Marketed Products 4 Significant Pipeline Assets Minimal Debt Profitable BENDEKA ® PEMFEXY Œ BELRAPZO ® ONCOLOGY TREAKISYM 1 2 3 4 Pipeline: Fulvestrant SM - 88* HOSPITAL RYANODEX ® BARHEMSYS ® Vasopressin BYFAVO ® 1 2 3 4 Pipeline: Landiolol CAL02 Eagle is a diversified pharmaceutical company with 8 marketed products, 4 pipeline assets, and a strong financial position *In collaboration with TYME Technologies Financial flexibility to potentially acquire an accretive oncology asset
© 2022 Eagle Pharmaceuticals, Inc. All rights reserved. 10 © 2022 Eagle Pharmaceuticals, Inc. All rights reserved. Thank You!