Exhibit 99.1

Impact of Recent Internal Reorganization

As a result of an internal reorganization of the Company’s legal entity structure that occurred on December 24, 2018, Endo Finance became an entity which is disregarded as separate from a U.S. person, and as such the Company believes that each of the existing senior notes (the “Notes”) should thereafter be treated as debt of a U.S. person for U.S. federal income tax purposes. Consequently, the Company intends to treat interest paid on the Notes as U.S. source interest income for U.S. federal income tax purposes after December 24, 2018.

The U.S. federal income tax consequences of the internal reorganization to a holder of Notes depend in part on whether the above described internal reorganization of the Company’s legal structure resulted in a “deemed exchange” of the Notes. Generally, a modification of a debt instrument will be treated, for U.S. federal income tax purposes, as a “deemed exchange” of an old debt instrument for a new debt instrument if the modification is “significant” as determined for U.S. federal income tax purposes. The Company has taken the position that the above described internal reorganization did not result in a deemed exchange of “old” Notes for “new” Notes for U.S. federal income tax purposes. The Internal Revenue Service could, however, take the position that such internal reorganization resulted in a deemed exchange. If such a position were taken and sustained, the deemed exchange would be a taxable exchange for U.S. federal income tax purposes. Holders are urged to consult their tax advisors regarding the tax consequences to them if the internal reorganization were treated as a deemed exchange.

THIS SUMMARY IS OF A GENERAL NATURE ONLY AND IS NOT INTENDED TO BE, AND SHOULD NOT BE INTERPRETED AS, LEGAL OR TAX ADVICE TO ANY PARTICULAR HOLDER OF NOTES. EACH HOLDER OF NOTES IS URGED TO CONSULT WITH ITS TAX ADVISOR CONCERNING THE U.S. FEDERAL INCOME TAX CONSEQUENCES IN CONNECTION WITH THE INTERNAL REORGANIZATION AND HOLDING THE NOTES THEREAFTER IN LIGHT OF ITS PARTICULAR CIRCUMSTANCES AND ANY CONSEQUENCES ARISING UNDER OTHER FEDERAL TAX LAWS AND THE LAWS OF ANY STATE, LOCAL OR NON-U.S. TAXING JURISDICTION.

 

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Exhibit 99.2

 

Endo International plc Announces Debt Refinancing Transactions, Including Cash Tender Offers and Consent Solicitations for up to $1.0 billion Aggregate Purchase Price of its Outstanding Senior Notes

DUBLIN, March  14, 2019 – Endo International plc (NASDAQ: ENDP) today announced a series of debt refinancing transactions that are intended to help manage the debt maturity profile of it and certain of its subsidiaries (collectively, the “Company” or “Endo”). These refinancing transactions are expected to include:

 

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an extension of the maturity of Endo’s revolving credit facility from April 2022 to March 2024 along with modifications to certain covenants contained therein, including increased flexibility with respect to the secured net leverage ratio springing maintenance covenant;

 

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the incurrence of additional secured indebtedness in aggregate principal amount of at least $1.0 billion; and

 

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cash tender offers (the “Tender Offers”) by Endo Finance LLC (“Endo Finance”), a wholly-owned subsidiary of Endo International plc, to purchase a portion of Endo’s outstanding indebtedness. The Tender Offers will be in an amount such that the maximum aggregate consideration (excluding accrued interest) paid by Endo Finance does not exceed $1.0 billion (subject to increase by Endo Finance, the “Aggregate Purchase Price”), of the outstanding

 

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7.25% Senior Notes due 2022 issued by Endo Finance and Endo Finco Inc. (“Endo Finco”) (the “7.25% 2022 Notes”);

 

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5.75% Senior Notes due 2022 issued by Endo Finance (the “5.75% 2022 Notes” and, together with the 7.25% 2022 Notes, the “Consent Notes”);

 

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5.375% Senior Notes due 2023 issued by Endo Finance and Endo Finco (the “5.375% 2023 Notes”); and

 

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6.000% Senior Notes due 2023 issued by Endo Finance, Endo Finco and Endo Designated Activity Company (the “6.000% 2023 Notes,” together with the 5.375% 2023 Notes, the “2023 Notes” and, the 2023 Notes collectively with the Consent Notes, the “Notes”),

subject to the Acceptance Priority Levels, the Aggregate Purchase Price and the Acceptance Sublimit described below.

The terms and conditions of the Tender Offers are described in Endo Finance’s Offer to Purchase and Consent Solicitation, dated March 14, 2019 (the “Offer to Purchase”), and the related Letter of Transmittal and Consent. The Tender Offers are conditioned, among other conditions set forth in the Offer to Purchase, upon the Company having received gross proceeds of an aggregate principal amount of at least $1.0 billion (the “financing condition”) from one or more issuances of secured indebtedness in the capital markets and/or from borrowings under the Company’s existing credit facilities. The Company’s ability to raise additional proceeds from one or more issuances of secured indebtedness will be dependent on then prevailing market conditions and other factors. Each of the Tender Offers is a separate offer (each, an “Offer”), and, subject to applicable law, each Offer may be individually amended, extended or terminated.

The following table summarizes certain material terms for the Tender Offers:

 

										Dollars per $1,000 Principal Amount of Notes
Title of Notes		CUSIP/ISIN Number		Aggregate Principal Amount Outstanding		Acceptance Priority Level		Acceptance Sublimit		Tender Offer Consideration (1)				Early Tender Premium				Total Consideration (1)(2)
7.25% Senior Notes due 2022		29271L AD6; U2918V AD7 / US29271LAD64; USU2918VAD74		$396,280,000 (3)		1		None		$	970			$	30			$	1,000
5.75% Senior Notes due 2022		29271L AA2; U2918V AA3 / US29271LAA26; USU2918VAA36		$700,000,000		2		None		$	930			$	30			$	960
5.375% Senior Notes due 2023		29271L AE4; U2918V AE5 / US29271L AE48; USU2918VAE57		$750,000,000		3		$500,000,000(4)		$	810			$	30			$	840
6.000% Senior Notes due 2023		29273E AC2; G3040E AB4; US29273EAC21; USG304OEAB41		$1,635,000,000		4				$	790			$	30			$	820

 

(1)	Excludes accrued and unpaid interest, which also will be paid.

(2)	Includes the Early Tender Premium.

(3)

Represents the outstanding aggregate principal amount of 7.25% 2022 Notes issued by Endo Finance LLC and Endo Finco Inc., which were issued in exchange for a like principal amount of 7.25% Senior Notes due 2022 (the “ EHSI Notes ”) issued by Endo Health Solutions Inc. (“ EHSI ”). For the avoidance of doubt, the Offers and Consent Solicitations do not apply to the outstanding $3.72 million principal amount of EHSI Notes which remain outstanding following such exchange.

(4)	The offers with respect to the 5.375% Senior Notes due 2023 and the 6.000% Senior Notes due 2023 are subject to an aggregate purchase price acceptance sublimit of $500,000,000.

In conjunction with the Tender Offers, Endo Finance is soliciting consents (the “Consent Solicitations”) from holders of the Consent Notes to certain proposed amendments (the “Proposed Amendments”) to the applicable indenture under which such series of Consent Notes were issued (each an “Indenture” and collectively, the “Indentures”), which would eliminate substantially all restrictive covenants, certain events of default and certain other provisions contained in each such Indenture. The adoption of the Proposed Amendments with respect to each series of Consent Notes requires the consent of the holders of at least a majority of the outstanding principal amount of each such series of Consent Notes (with respect to each series of Consent Notes, collectively, the “Requisite Consents”). Each tendering holder of the Consent Notes will be deemed to have consented to all of the Proposed Amendments as to the Consent Notes of the applicable series of Consent Notes tendered. If Endo Finance receives the Requisite Consents, it will execute a supplemental indenture to the applicable Indenture with respect to a series of Consent Notes under which Consent Notes of such series were issued (each a “Supplemental Indenture” and collectively the “Supplemental Indentures”). Each Supplemental Indenture will become effective upon execution thereof by Endo Finance, the co-issuer (as applicable), the guarantors thereto and Wells Fargo Bank, National Association, the trustee for each series of Consent Notes (the “Trustee”), but each Supplemental Indenture will provide that the Proposed Amendments with respect to a series of Consent Notes will not become operative until Endo Finance purchases in the Tender Offers at least a majority in principal amount of the outstanding applicable series of Consent Notes. Endo Finance may, in its sole discretion, complete Tender Offers for any series of Consent Notes even if valid consents sufficient to effect the Proposed Amendments to the corresponding Indenture are not received. If the Tender Offer for either series of Consent Notes is terminated, withdrawn or consummated without the Requisite Consents, the applicable Indentures will remain in effect in its present form. In the event of any proration of any series of Consent Notes, the Consents delivered with respect to such series of Consent Notes shall be null and void, but the validity of such Consent Notes tendered shall be unaffected.

Each of the Tender Offers and Consent Solicitations will expire at 11:59 P.M., New York City time, on April 10, 2019, unless extended (such date and time, as it may be extended, the “Expiration Date”) or earlier terminated by Endo Finance in accordance with the terms of the Offer to Purchase. No tenders submitted after the Expiration Date will be valid.

With respect to the 2023 Notes, tendered Notes may be validly withdrawn from the Tender Offer at or prior to, but not after 5:00 p.m., New York City time, on March 27, 2019 (such date and time, as it may be extended, the “Early Tender Date”). With respect to the Consent Notes, tendered Notes may be validly withdrawn (and Consents validly

 

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revoked) from the applicable Tender Offer, at or prior to, but not after, the date the applicable Supplemental Indenture is executed. In the case of each of the 2023 Notes and the Consent Notes, such date and time, as it may be extended, is referred to as the “Withdrawal Deadline.” Holders who tender their Notes after the Withdrawal Deadline, but prior to the Expiration Date, may not withdraw their tendered Notes unless withdrawal rights are required to be extended pursuant to applicable law.

Subject to the terms and conditions of the Tender Offers and Consent Solicitations, holders who validly tender, and do not validly withdraw, their Notes at or prior to the Early Tender Date, and whose Notes are accepted for purchase, will receive the applicable total consideration set forth in the table above for each $1,000 principal amount of Notes purchased pursuant to the Tender Offers (the “Total Consideration”), which includes the early tender premium set forth in the table above per $1,000 principal amount of Notes (the “Early Tender Premium”). Subject to the terms and conditions of the Tender Offers and Consent Solicitations, holders who validly tender their Notes after the Early Tender Date and at or prior to the Expiration Date, and whose Notes are accepted for purchase, will receive only the applicable tender offer consideration amount set forth in the table above for each $1,000 principal amount of Notes purchased pursuant to the Tender Offers (the “Tender Offer Consideration”), which is equal to the applicable Total Consideration minus the Early Tender Premium. In addition to the applicable Total Consideration or the Tender Offer Consideration, as the case may be, all holders of Notes accepted for purchase pursuant to the Tender Offers will also receive on the Early Settlement Date (as defined below), if any, or the Final Settlement Date (as defined below), as applicable, accrued and unpaid interest on their Notes purchased from the applicable last interest payment date with respect to such Notes up to, but not including, the Early Settlement Date or the Final Settlement Date, as applicable.

The Notes accepted for purchase will be accepted in accordance with their Acceptance Priority Levels set forth in the table above (with 1 being the highest Acceptance Priority Level), provided that (a) Endo Finance will only accept for purchase Notes of any and all series up to an amount such that the aggregate amount of Total Consideration and/or Tender Offer Consideration, as the case may be, paid by Endo Finance pursuant to the Tender Offers will not exceed the Aggregate Purchase Price, (b) Endo Finance will not purchase an aggregate amount of 2023 Notes such that the aggregate purchase price for such 2023 Notes is in excess of the acceptance sublimit applicable to such series as set forth in footnote 4 to the table above (the “Acceptance Sublimit”), and (c) Notes tendered and not validly withdrawn at or prior to the Early Tender Date will be accepted for purchase in priority to Notes tendered after the Early Tender Date and at or prior to the Expiration Date. Endo Finance reserves the right, but is under no obligation, to increase the Aggregate Purchase Price and/or the Acceptance Sublimit or to otherwise alter the terms of any Tender Offer at any time, subject to compliance with applicable law, which could result in Endo Finance purchasing a greater aggregate principal amount of any or all series of Notes in the Tender Offers.

Subject to the terms and conditions of the Tender Offers and Consent Solicitations, Endo Finance will have the option, but not the obligation, to accept for purchase and purchase, subject to the Aggregate Purchase Price and the applicable Acceptance Sublimit (if any), any Notes validly tendered and not validly withdrawn at or prior to the Early Tender Date on the early settlement date (the “Early Settlement Date”), which may occur no earlier than March 29, 2019. To the extent that Endo Finance does not elect early settlement or to the extent early settlement is elected but the Tender Offers are not fully subscribed at the Early Tender Date, Endo Finance expects to purchase Notes that have been validly tendered in accordance with the terms and conditions of the Tender Offers and Consent Solicitations, promptly following the Expiration Date (the “Final Settlement Date”), which is currently expected to occur on April 12, 2019. Notes accepted on any Early Settlement Date or the Final Settlement Date will be accepted subject to the Aggregate Purchase Price, the Acceptance Priority Levels, the applicable Acceptance Sublimit (if any) and proration, each as described in the Offer to Purchase. If the aggregate purchase price of the 2023 Notes validly tendered and not validly withdrawn exceeds the Acceptance Sublimit, the 2023 Notes purchased will be subject to proration based on the Acceptance Priority Levels for the 2023 Notes and the aggregate purchase price of 2023 Notes tendered in the Offer, provided that subject to the Acceptance Priority Levels for the 2023 Notes, any 2023 Notes tendered at or prior to the Early Tender Date will be accepted for purchase in priority to 2023 Notes tendered after the Early Tender Date and at or prior to the Expiration Date and if the Acceptance Sublimit for the 2023 Notes is exceeded at the Early Tender Date, the 2023 Notes tendered at or prior to the Early Tender Date shall constitute a separate proration pool.

The Tender Offers are subject to the satisfaction or waiver of certain conditions to the Tender Offers set forth in the Offer to Purchase, including the financing condition.

 

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Full details of the terms and conditions of the Tender Offers and the Consent Solicitations are described in the Offer to Purchase and related Letter of Transmittal, which are being sent by Endo Finance to record holders of the Notes. Holders of the Notes are encouraged to read these documents, as they contain important information regarding the Tender Offers and the Consent Solicitations.

Endo Finance has retained J.P. Morgan Securities LLC to act as the Dealer Manager for the Tender Offers and Solicitation Agent for the Consent Solicitations and D.F. King & Co., Inc. as the Tender Agent and Information Agent for the Tender Offers and the Consent Solicitations. Questions regarding the Tender Offers and the Consent Solicitations may be directed to J.P. Morgan Securities LLC at (212) 834-3260 (collect) or (866) 834-4666 (toll-free) or D.F. King & Co., Inc. at (212) 269-5550 (collect), (800) 370-1164 (U.S. toll-free) or email at endofin@dfking.com . Requests for additional copies of this Offer to Purchase or the Letter of Transmittal should be directed to the Information Agent at the phone number above.

None of Endo Finance, Endo International plc or its other affiliates or subsidiaries, their respective boards of directors, managers or other governing bodies, officers and employees, the Dealer Manager, the Solicitation Agent, the Tender Agent, the Information Agent or the Trustee is making any representation or recommendation to any holder as to whether or not to tender such holder’s Notes or deliver Consents. Holders should consult their own financial and tax advisors and must make their own decision as to whether to tender their Notes and, if applicable, deliver Consents pursuant to the Tenders Offers and Consent Solicitations and, if so, the amount of Notes to tender.

The Tender Offers and the Consent Solicitations are only being made pursuant to the Offer to Purchase and the related Letter of Transmittal. This press release is neither an offer to purchase nor a solicitation of an offer to sell any Notes in the Tender Offers, and is not a solicitation of consents to the Proposed Amendments. The Tender Offers and the Consent Solicitations are not being made to, nor will Notes be accepted for purchase from or on behalf of, holders of Notes in any jurisdiction in which the making or acceptance thereof would not be in compliance with the securities or other laws of such jurisdiction. In any jurisdiction in which the Tender Offers are required to be made by a licensed broker or dealer, the Tender Offers will be deemed to be made on behalf of Endo Finance by one or more registered brokers or dealers that are licensed under the laws of such jurisdiction.

Endo Finance reserves the right, subject to applicable law, with respect to any or all of the Tender Offers and/or the Consent Solicitations to (a) extend the Early Tender Date, Withdrawal Deadline or Expiration Date to a later date and time announced by Endo Finance; (b) increase the Aggregate Purchase Price and/or the Acceptance Sublimit; (c) waive in whole or in part any or all conditions to the Tender Offers and Consent Solicitations; (d) delay the acceptance for purchase of any Notes or delay the purchase of any Notes; or (e) otherwise modify or terminate any Tender Offer with respect to one or more series of Notes and/or the Consent Solicitations.

This press release shall not constitute an offer to sell, or the solicitation of any offer to buy, any securities, nor shall there be any sales of securities mentioned in this press release in any jurisdiction in which such offer, solicitation or sale would be unlawful.

About Endo International plc

Endo International plc (NASDAQ: ENDP) is a highly focused generics and specialty branded pharmaceutical company delivering quality medicines to patients in need through excellence in development, manufacturing and commercialization. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA. Learn more at www.endo.com

Forward-Looking Statements

Statements contained in this press release contain information that includes or is based on “forward-looking statements.” These statements, including Endo’s intention to consummate the debt refinancing transactions and the details thereof, contained in this press release are subject to risks and uncertainties. Endo has tried, whenever possible, to identify such statements by words such as “believes,” “expects,” “anticipates,” “intends,” “estimates,” “plan,” “projected,” “forecast,” “will,” “may” or similar expressions. Endo has based these forward-looking statements on its current expectations and projections about the growth of its business and financial performance, and the development of its industry. Because these statements reflect Endo’s current views concerning future events, these forward-looking statements involve risks and uncertainties. Readers should note that many risk

 

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factors previously disclosed in Endo’s filings with the Securities and Exchange Commission (the “SEC”) and those identified elsewhere in this press release could affect the Company’s future financial results and could cause the actual results to differ materially from those expressed in forward-looking statements contained in this press release.

Endo does not undertake any obligation to update its forward-looking statements after the date of this press release for any reason, even if new information becomes available or other events occur in the future, except as required under applicable securities law. Readers are advised to consult any further disclosures made on related subjects in the Company’s reports filed with the SEC. Also note that, as described under the caption “Risk Factors” contained in Item 1A of the Endo’s Annual Report on Form 10-K for the fiscal year ended December 31, 2018, the Company provides a cautionary discussion of the risks, uncertainties and possibly inaccurate assumptions relevant to its business. These are factors that, individually or in the aggregate, the Company thinks could cause its actual results to differ materially from expected and historical results. Readers should understand that it is not possible to predict or identify all such factors. Consequently, readers should not consider this to be a complete discussion of all potential risks or uncertainties.

Investors should also be aware that while Endo does, at various times, communicate with securities analysts, it is against the Company’s policy to disclose to them selectively any material non-public information or other confidential information. Accordingly, investors should not assume that Endo agrees with any statement or report issued by an analyst, irrespective of the content of the statement or report. To the extent that reports issued by securities analysts contain any projections, forecasts or opinions, such reports are not Endo’s responsibility.

Source: Endo International plc

Investors: Pravesh Khandelwal, (845) 364-4833; Media: Heather Zoumas Lubeski, (484) 216-6829

 

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Exhibit 99.3

 

Endo International plc Announces Proposed Private Offering Of Senior Secured Notes

DUBLIN, March 14, 2019 – Endo International plc (NASDAQ: ENDP) (“Endo”) today announced that Par Pharmaceutical, Inc. (the “Issuer”), its wholly-owned subsidiary, intends to offer senior secured notes, subject to market and customary conditions. The notes will be senior secured obligations of the Issuer and will be guaranteed by Endo and certain of Endo’s subsidiaries and will be secured by first priority liens on the same collateral that secures Endo’s obligations under its existing senior secured credit facilities and existing senior secured notes.

Endo intends to use the net proceeds from the proposed offering, together with cash on hand, to fund cash tender offers (the “Tender Offers”) by Endo Finance LLC, a wholly-owned subsidiary of Endo, to purchase a portion of Endo’s outstanding senior unsecured notes and to pay certain related premiums, fees and expenses. Endo intends to use the remaining net proceeds, if any, from this offering to reduce Endo’s outstanding indebtedness, including by means of one or more redemptions, repurchases or other repayments of any of Endo’s outstanding indebtedness.

The notes and the related guarantees have not been, and will not be, registered under the Securities Act of 1933, as amended (the “Securities Act”), or any applicable state or foreign securities laws, and will be offered only to qualified institutional buyers in reliance on Rule 144A, and to persons outside the United States in compliance with Regulation S under the Securities Act. Unless so registered, the notes and the related guarantees may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Securities Act and applicable state securities laws. This press release will not constitute an offer to sell or a solicitation of an offer to buy any notes or any other securities.

About Endo International plc

Endo International plc (NASDAQ: ENDP) is a highly focused generics and specialty branded pharmaceutical company delivering quality medicines to patients in need through excellence in development, manufacturing and commercialization. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA. Learn more at www.endo.com.

Forward-Looking Statements

This press release contains forward-looking statements including, but not limited to, Endo’s financing plans, including Endo’s intention to offer notes, the Tender Offers and the details thereof and the use of proceeds of the proposed offering. Endo has tried, whenever possible, to identify such statements by words such as “believes,” “expects,” “anticipates,” “intends,” “estimates,” “plan,” “projected,” “forecast,” “will,” “may” or similar expressions. Endo has based these forward-looking statements on its current expectations and projections about the growth of its business and financial performance, and the development of its industry. Because these statements reflect Endo’s current views concerning future events, these forward-looking statements involve risks and uncertainties. Readers should note that many risk factors previously disclosed in Endo’s filings with the Securities and Exchange Commission (the “SEC”) and those identified elsewhere in this press release could affect Endo’s future financial results and could cause the actual results to differ materially from those expressed in forward-looking statements contained in this press release.

Endo does not undertake any obligation to update its forward-looking statements after the date of this press release for any reason, even if new information becomes available or other events occur in the future, except as required under applicable securities law. Readers are advised to consult any further disclosures made on related subjects in Endo’s reports filed with the SEC. Also note that, as described under the caption “Risk Factors” contained in Item 1A of the Endo’s Annual Report on Form 10-K for the fiscal year ended December 31, 2018, Endo provides a cautionary discussion of the risks, uncertainties and possibly inaccurate assumptions relevant to its business. These are factors that, individually or in the aggregate, Endo thinks could cause its actual results to differ materially from expected and historical results. Readers should understand that it is not possible to predict or identify all such factors. Consequently, readers should not consider this to be a complete discussion of all potential risks or uncertainties.

Investors should also be aware that while Endo does, at various times, communicate with securities analysts, it is against Endo’s policy to disclose to them selectively any material non-public information or other confidential information. Accordingly, investors should not assume that Endo agrees with any statement or report issued by an analyst, irrespective of the content of the statement or report. To the extent that reports issued by securities analysts contain any projections, forecasts or opinions, such reports are not Endo’s responsibility.

Source: Endo International plc

Investors: Pravesh Khandelwal, (845) 364-4833; Media: Heather Zoumas Lubeski, (484) 216-6829

Exhibit 99.4

There have been no material changes to our risk factors included in Item 1A. “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2018 (the “2018 Form 10-K”) other than as described below.

We have been, continue to be and may be the subject of lawsuits, product liability claims, other significant legal proceedings, government investigations or product recalls for which we may be unable to obtain or maintain insurance adequate to cover potential liabilities.

Our business exposes us to significant potential risks from lawsuits, product liability claims, other significant legal proceedings, government investigations or product recalls, including, but not limited to, such matters associated with the testing, manufacturing, marketing and sale of our products. Some plaintiffs have received substantial damage awards in some jurisdictions against healthcare companies based upon various legal theories, including without limitation claims for injuries allegedly caused by the use of their products. We have been, continue to be and may be subject to various product liability cases, as well as other significant legal proceedings and government investigations.

For example, we and our subsidiaries, along with other manufacturers of prescription opioid medications, are the subject of lawsuits and have received subpoenas and other requests for information from various state and local government agencies regarding the sale, marketing and/or distribution of prescription opioid medications. Numerous claims against opioid manufacturers have been and may continue to be filed by or on behalf of states, counties, cities, Native American tribes, other government-related persons or entities, hospitals, health systems, unions, health and welfare funds, other third-party payers and/or individuals. See Note 15. Commitments and Contingencies in the Consolidated Financial Statements included in Part IV, Item 15 of the 2018 Form 10-K for more information. In these cases, plaintiffs seek various remedies, including without limitation, declaratory and/or injunctive relief; compensatory, punitive and/or treble damages; restitution, disgorgement, civil penalties, abatement, attorneys’ fees, costs and/or other relief. In addition to direct expenditures for damages, settlement and defense costs in connection with these claims, proceedings and investigations, there is a possibility of loss of revenues, injunctions and disruption of business. Furthermore, we and other manufacturers of prescription opioid medications have been, and will likely continue to be, subject to negative publicity and press, which could harm our brand and the demand for our products. There are also regulatory and legislative proposals being made that could impact us and other manufacturers of prescription opioid medications. See the risk factor “Our business and financial condition may be adversely affected by legislation” in the 2018 Form 10-K for more information.

Our current and former products may cause, or may appear to cause, serious adverse side effects or potentially dangerous drug interactions if misused or improperly prescribed or as a result of faulty surgical technique. For example, we and/or certain of our subsidiaries and certain other manufacturers have been named as defendants in multiple lawsuits in various federal and state courts alleging personal injury resulting from use of transvaginal surgical mesh products designed to treat pelvic organ prolapse and stress urinary incontinence. The U.S. Food and Drug Administration (“FDA”) held a public advisory committee meeting in February 2019 during which the members of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee discussed and made recommendations regarding the safety and effectiveness of surgical mesh to treat pelvic organ prolapse. Although we have not sold transvaginal surgical mesh products since March 2016, it is possible that the outcome of the advisory committee meeting and the FDA’s actions, if any, based on the outcome of the advisory committee meeting could result in additional litigation against the Company. See Note 15. Commitments and Contingencies in the Consolidated Financial Statements included in Part IV, Item 15 of the 2018 Form 10-K for more information.

Any failure to effectively identify, analyze, report and protect adverse event data and/or to fully comply with relevant laws, rules and regulations around adverse event reporting could expose the Company to penalties, fines and reputational damage.

In addition, in the age of social media, plaintiffs’ attorneys have a wide variety of tools to advertise their services and solicit new clients for litigation, including using judgments obtained in litigation against other pharmaceutical companies as an advertising tool. For these or other reasons, any significant product liability or mass tort litigation in which we are a defendant could have a larger number of plaintiffs than such actions have seen historically and we could also see an increase in number of cases filed against us because of the increasing use of widespread and media-varied advertising. Furthermore, a ruling against other pharmaceutical companies in product liability or mass tort litigation in which we are not a defendant could have a negative impact on pending litigation where we are a defendant.

In addition, in the case of products that do not meet approved specifications or for which subsequent data demonstrate such products may be unsafe, ineffective or misused, it may be necessary for us to initiate voluntary or mandatory recalls or withdraw such products from the market. Any such recall or withdrawal could result in adverse publicity, costs connected to the recall and loss of revenue. Adverse publicity could also result in an increased number of additional product liability claims, whether or not these claims have a basis in scientific fact. See the risk factor “Public concern around the abuse of opioids, including law enforcement concerns over diversion and marketing of opioids, and regulatory efforts to combat abuse, could result in costs to our business” in the 2018 Form 10-K for more information.

If we are found liable in any lawsuits, such as a product liability claim or series of claims, including those described above and below, or in connection with other legal proceedings, including those related to sales, marketing or pricing practices, government investigations, product recalls or the sale, marketing and/or distribution of prescription opioid medications, it could result in the imposition of damages, including punitive damages, substantial fines, significant reputational harm, civil lawsuits and criminal penalties, interruptions of business, modification of business practices, equitable remedies and other sanctions against us or our personnel as well as significant legal and other costs. We may also voluntarily settle cases even if we believe that we have meritorious defenses because of the significant legal and other costs that may be required to defend such actions. As a result, we may experience significant negative impacts on our operations. To satisfy judgments or settlements, we also may need to seek financing, which may not be available on terms acceptable to us, or at all, when required. Judgments also could cause defaults under our debt agreements and/or restrictions on our product use and we could incur losses as a result. Any of the risks above could materially and adversely impact our business, financial condition, results of operations, liquidity and cash flows.

Any such result may cause us to pursue one or more remedial measures, including internal reorganizations and/or other restructuring activities, strategic corporate alignment and cost-saving initiatives or other significant corporate transactions. See the risk factor “Our ability to fund our operations, maintain liquidity and meet our financing obligations is reliant on our operations, which are subject to significant risks and uncertainties” in the 2018 Form 10-K for more information. Likewise, any internal reorganizations and/or other restructuring activities, strategic corporate alignment and cost-saving initiatives or other significant corporate transactions may be complex, could entail significant cost and charges or could otherwise negatively impact shareholder value and there can be no assurance that we will be able to accomplish any of these alternatives on terms acceptable to us, or at all.

Additionally, the Company expects to record an increase of $50 million to its legal reserves for the first quarter of 2019 relating to a March 2019 settlement in principle of certain securities litigation pending in the Court of Common Pleas of Chester County, Pennsylvania against the Company, several current and former officers and directors, as well as other parties, entitled Public Employees’ Retirement System of Mississippi v. Endo International plc . The Company currently believes that the funding of the foregoing settlement in principle by the Company’s insurers is probable, and thus expects to record a corresponding insurance receivable during the first quarter of 2019, however, there can be no assurance that such insurance coverage will be adequate to cover the full amount of the settlement in principle or that we will receive such insurance coverage on the timeline currently anticipated.

We may not have and may be unable to obtain or maintain in the future product liability insurance on acceptable terms or with adequate coverage against potential liabilities or other losses, such as the cost of a recall, if any claim is brought against us, regardless of the success or failure of the claim. For example, we generally no longer have product liability insurance to cover the claims in connection with the mesh-related litigation described above. Additionally, we may be limited by the surviving insurance policies of our acquired subsidiaries, which may not be adequate to cover against potential liabilities or other losses. Even where claims are submitted to insurance carriers for defense and indemnity, there can be no assurance that the claims will be fully covered by insurance or that the indemnitors or insurers will remain financially viable. The failure to generate sufficient cash flow or to obtain other financing could affect our ability to pay the amounts due under those liabilities not covered by insurance.

See Note 15. Commitments and Contingencies in the Consolidated Financial Statements included in Part IV, Item 15 of the 2018 Form 10-K for further discussion of the forgoing and other material legal proceedings.

If other pharmaceutical companies use litigation and regulatory means to obtain approval for generic, over-the-counter or other competing versions of our drugs, our sales may suffer.

Under the Hatch-Waxman Act, the FDA can approve an Abbreviated New Drug Application (“ANDA”) for a generic bioequivalent version of a previously approved drug without requiring the ANDA applicant to undertake the full clinical testing necessary to obtain approval to market a new branded drug. In place of such clinical studies, an ANDA applicant usually needs only to submit data demonstrating that its generic product is the same as the referenced listed drug with respect to the active ingredient and is bioequivalent to the branded product. Over-the-counter (“OTC”) drugs may be developed under either the New Drug Applications (“NDA”) or OTC monograph process. The OTC monograph process allows for OTC products to be marketed without pre-market approval and generally does not require clinical studies.

Various manufacturers have filed ANDAs seeking FDA approval for generic versions of certain of our key pharmaceutical products including, but not limited to, LIDODERM ^® , VASOSTRICT ^® and AVEED ^® . In connection with such filings, these manufacturers have challenged the validity and/or enforceability of one or more of the underlying patents protecting our products. In the case of LIDODERM ^® , we no longer have patent protection in the markets where we sell these products. Our revenues from LIDODERM ^® have been negatively affected by multiple competing generic versions of LIDODERM ^® , the first of which launched in September 2013. We anticipate that these revenues could decrease further should one or more additional generic versions of LIDODERM ^® launch.

Additionally, we recently received notice from a competing pharmaceutical company that manufactures one of our products that it intends to seek approval to launch a competing OTC version of such product. We are currently assessing the potential likelihood, timing and impact of any such launch, which could result in, among other things, a reduction of our net sales of such product and/or certain asset impairment charges that could be material. We cannot assure you that this, or any other manufacturer, will not take similar actions with respect to other products.

With respect to AVEED ^® , VASOSTRICT ^® and other branded pharmaceutical products, it has been and continues to be our practice to vigorously defend and pursue all available legal and regulatory avenues in defense of the intellectual property rights protecting our products. Despite our efforts to defend our products, litigation is inherently uncertain, and we cannot predict the timing or outcome of our efforts. If we are not successful in defending our intellectual property rights or opt to settle, or if a product’s marketing exclusivity rights expire or become otherwise unenforceable, our competitors could ultimately launch generic, OTC or other competing versions of our products, which would likely cause sales and revenues of the affected products to decline rapidly and materially, could require us to write off a portion or all of the intangible assets associated with the affected product and could have a material adverse effect on our business, results of operations, financial condition and cash flows.

In the case of VASOSTRICT ^® , Par Sterile Products, LLC (“PSP”) and Par Pharmaceutical, Inc. (“PPI”) received a notice letter from Eagle Pharmaceuticals, Inc. (“Eagle”) in April 2018 advising of the filing by such company of an ANDA for a generic version of VASOSTRICT ^® (vasopressin IV solution (infusion)). The Paragraph IV notice refers to patents the Company has listed in the Orange Book covering either vasopressin-containing pharmaceutical compositions or methods of using a vasopressin-containing dosage form to increase blood pressure in humans. In May 2018, PPI, PSP and Endo Par Innovation Company, LLC (“EPIC”) filed a lawsuit against Eagle in the United States District Court for the District of Delaware within the 45-day deadline to invoke a 30-month stay of FDA approval pursuant to the Hatch-Waxman legislative scheme. We intend to vigorously defend VASOSTRICT ^® ’s intellectual property rights and to pursue all available legal, business and regulatory avenues in defense of VASOSTRICT ^® , including enforcement of the product’s intellectual property rights. However, there can be no assurance that our defense will be successful. If a generic version of VASOSTRICT ^® were introduced to the market before 2020, our revenues from VASOSTRICT ^® would decrease significantly and, depending on the timing of such introduction and its effect on VASOSTRICT ^® pricing, could have a material adverse effect on our business, results of operations, financial condition and cash flows.

There are currently ongoing legal proceedings brought by us and/or our subsidiaries, and in certain cases our third party partners, against manufacturers seeking FDA approval for generic versions of our products. For a description of the material related legal proceedings, see Note 15. Commitments and Contingencies in the Consolidated Financial Statements included in Part IV, Item 15 of our 2018 Form 10-K.

We also believe it is likely that manufacturers may seek FDA approvals for generic, OTC or other competing versions of other of our key pharmaceutical products, either through the filing of ANDAs, through the OTC monograph process or the use of other means.

We are currently dependent on outside manufacturers for the manufacture of a significant amount of our products; therefore, we have and will continue to have limited control of the manufacturing process and related costs. Certain of our manufacturers currently constitute the sole source of one or more of our products.

Third party manufacturers currently manufacture a significant amount of our products pursuant to contractual arrangements. Certain of our manufacturers currently constitute the sole source of our products. For example, Teikoku Seiyaku Co., Ltd. is our sole source of LIDODERM ^® and GlaxoSmithKline plc is our sole source of VOLTAREN ^® Gel. Because of contractual restraints and the lead-time necessary to obtain FDA approval and/or Drug Enforcement Agency registration of a new manufacturer, there are no readily accessible alternatives to these manufacturers and replacement of any of these manufacturers may be expensive and time consuming and may cause interruptions in our supply of products to customers. Our business and financial viability are dependent on these third party manufacturers for continued manufacture of our products, the continued regulatory compliance of these manufacturers and the strength, validity and terms of our various contracts with these manufacturers. Any interruption or failure by these manufacturers to meet their obligations pursuant to various agreements with us on schedule or in accordance with our expectations, or any termination by these manufacturers of our supply arrangements, which, in each case, could be the result of one or many factors outside of our control, could delay or prevent our ability to achieve sales expectations, cause interruptions in our supply of products to customers, cause us to incur failure-to-supply penalties, disrupt our operations or cause reputational harm to our company, any or all of which could have a material adverse effect on our business, financial condition, results of operations and cash flows.