The Company’s chief operating decision maker is the Chief Executive Officer, who evaluates the performance of its segments based on total revenues and segment profitability. Segment profitability represents segment gross profit less direct research and development (“R&D&D”) and direct SG&A. Certain general and administrative and R&D expenses not allocated to the segments, including certain special items, net charges for litigation settlements and other contingencies, amortization of intangible assets, impairment charges and other expenses not directly attributable to the segments are reported separately or outside of segment profitability. Items below the earnings from operations line on the Company’s condensed consolidated statements of operations are not presented by segment, since they are excluded from the measure of segment profitability. The Company does not report
Presented in the table below is segment information for the periods identified and a reconciliation of segment information to total consolidated information.
On December 5, 2016, the Company announced a restructuring program representing a series of actions in certain locations that are anticipated to further streamline its operations globally. Since 2015, the Company has made a number of significant acquisitions, and as part of the holistic, global integration of these acquisitions, the Company is focused on how to best optimize and maximize all of its assets across the organization and across all geographies.
Charges for restructuring and ongoing cost reduction initiatives are recorded in the period the Company commits to a restructuring or cost reduction plan, or executes specific actions contemplated by the plan and all criteria for liability recognition have been met.
During the second quarter of 2018, the Company commenced comprehensive restructuring and remediation activities, which are aimed at reducing the complexity at the Morgantown, West Virginia plant and include the discontinuation and transfer to other manufacturing sites of a number of products, a reduction of the workforce and extensive process and facility remediation. The restructuring actions other than for this plant wereare substantially complete as of December 31, 2018. We have incurred total restructuring related costs of approximately $655.4 million through June 30, 2019. During 2019, we have incurred approximately $54.4 million in restructuring expenses for non-cash asset write-offs at the Morgantown plant.complete. At this time, the total expenses related to the additional restructuring and remediation activities at the Morgantown West Virginia plant cannot be reasonably estimated.
The following table summarizes the restructuring charges and the reserve activity from December 31, 20182019 to June 30, 2019:2020:
MYLAN N.V. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
16.Collaboration and Licensing Agreements
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18. | Collaboration and Licensing Agreements |
We periodically enter into collaboration and licensing agreements with other pharmaceutical companies for the development, manufacture, marketing and/or sale of pharmaceutical products. Our significant collaboration agreements are primarily focused on the development, manufacturing, supply and commercialization of multiple, high-value generic biologic compounds, insulin analog products and respiratory products, among other complex products. Under these agreements, we have future potential milestone payments and co-development expenses payable to third parties as part of our licensing, development and co-development programs. Payments under these agreements generally become due and are payable upon the satisfaction or achievement of certain developmental, regulatory or commercial milestones or as development expenses are incurred on defined projects. Milestone payment obligations are uncertain, including the prediction of timing and the occurrence of events triggering a future obligation and are not reflected as liabilities in the condensed consolidated balance sheets, except for milestone and royalty obligations reflected as acquisition related contingent consideration. Refer to Note 1211 Financial Instruments and Risk Management for additional information.further discussion of contingent consideration. Our potential maximum development milestones not accrued for at June 30, 20192020 totaled approximately $476.0$391 million which includes the new agreements entered into as described in Note 4 Acquisitions and Other Transactions.. We estimate that the amounts that may be paid through the end of 20192020 to be approximately $79.0$73 million. These agreements may also include potential sales-based milestones and call for us to pay a percentage of amounts earned from the sale of the product as a royalty or a profit share. The amounts disclosed do not include sales-based milestones or royalty or profit share obligations on future sales of product as the timing and amount of future sales levels and costs to produce products subject to these obligations is not reasonably estimable. These sales-based milestones or royalty or profit share obligations may be significant depending upon the level of commercial sales for each product.
On February 28, 2018, the Company and Revance Therapeutics, Inc. (“Revance”) entered into a collaboration agreement (the “Revance Collaboration Agreement”) pursuant to which the Company and Revance will collaborate exclusively, on a world-wide basis (excluding Japan), to develop, manufacture and commercialize a biosimilar to the branded biologic product (onabotulinumtoxinA) marketed as BOTOX®.
On August 22, 2019, the Company and Revance entered into an amendment (the “Amendment”) to the Revance Collaboration Agreement, pursuant to which Revance had agreed to extend the period of time for the Company to decide whether to continue the development and commercialization of a biosimilar to the branded biologic product (onabotulinumtoxinA) marketed as BOTOX® beyond the initial development plan to prepare for and conduct the Biosimilar Initial Advisory Meeting (BIAM) with the U.S. Food and Drug Administration (“FDA”). In accordance with the Amendment, the Company was required to notify Revance of its decision on or before the later of (i) April 30, 2020 or (ii) thirty calendar days from the date that Revance provides Mylan with certain deliverables. On June 1, 2020, the Company and Revance announced a decision to continue the development program for a biosimilar to the branded biologic product (onabotulinumtoxinA) marketed as BOTOX®. As a result, during the second quarter of 2020, the Company recorded $30 million of R&D expense for a milestone payment that was due upon the decision to continue the program.
There have been no other significant changes to our collaboration and licensing agreements as disclosed in our 20182019 Form 10-K.
17.Income Taxes
CARES Act
On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) was enacted and signed into law. The CARES Act includes several provisions, including increasing the amount of deductible interest, allowing companies to carryback certain Net Operating Losses (“NOLs”) and increasing the amount of NOLs that corporations can use to offset income. We anticipate that the applicable provisions of the CARES Act will reduce our 2020 income tax expense by approximately $26.0 million, of which $4.0 million has been recorded as of June 30, 2020. We will continue to monitor and assess the impact the CARES Act may have on our business and financial results.
Tax Examinations
The Company is subject to income taxes and tax audits in many jurisdictions. A certain degree of estimation is thus required in recording the assets and liabilities related to income taxes. Tax audits and examinations can involve complex issues, interpretations, and judgments and the resolution of matters that may span multiple years, particularly if subject to litigation or negotiation.
MYLAN N.V. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
Although the Company believes that adequate provisions have been made for these uncertain tax positions, the Company’s assessment of uncertain tax positions is based on estimates and assumptions that the Company believes are reasonable but the estimates for unrecognized tax benefits and potential tax benefits may not be representative of actual outcomes, and variations from such estimates could materially affect the Company’s financial condition, results of operations or cash flows in the period of resolution, settlement or when the statutes of limitations expire.
Mylan is subject to ongoing U.S. Internal Revenue Service (“IRS”) examinations and is a voluntary participant in the IRS Compliance Assurance Process (“CAP”), which allows Mylan to work collaboratively with the IRS to identify and review tax matters on an ongoing basis.examinations. The years 2015 2016 and 2017through 2018 are open years under examination. The years 2012, 2013 and 2014 have one matter open, and a Tax Court petition has been filed regarding the matter and a trial was held in December 2018 and is discussed further below. On February 27, 2015, Mylan N.V. acquired Mylan Inc. and Abbott Laboratories’ (“Abbott”) non-U.S. developed markets specialty and branded generics business (collectively, the “EPD Business Acquisition”). In connection with the EPD Business Acquisition, we entered into intercompany transactions with our affiliates that affect our U.S. tax liability. Mylan N.V. is not incorporated in the U.S. and expects to be treated as a non-U.S. corporation for U.S. federal income tax purposes. As part of our ongoing participation and cooperation in the CAP, we have received and responded to various IRS requests for information about, among other matters, the EPD Business Acquisition, including the interest rates used for intercompany loans and our status as a non-U.S. corporation for U.S. federal income tax purposes, and we have been meeting with the IRS to discuss our respective positions on these matters and potential resolution of them.
During the second quarter of 2019, we reached an agreement in principle with the IRS to resolve all issues relating to our positions on the EPD Business Acquisition.February 27, 2015 acquisition by Mylan N.V. of Mylan Inc. and Abbott Laboratories’ non-U.S. developed markets specialty and branded generics business. Under the agreement in principle, which was finalized as part of a closing agreement with the IRS on October 11, 2019, our status as a non-U.S. corporation for U.S. Federal income tax purposes would behas been confirmed, and we would adjusthave adjusted the interest rates used for intercompany loans. As a result, duringDuring the second quarter of 2019, the Company recorded a reserve of approximately $140.0 million as part of its liability for uncertain tax
MYLAN N.V. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
positions, with a net impact to the income tax provision of approximately $129.9 million. We are currently inmillion related to this matter. Once the process of memorializing a closing agreement with the IRS which we expect to enter intowas finalized in the third quarter.fourth quarter of 2019, the Company increased the reserve by $15.0 million with a corresponding increase to the income tax provision.
Several international audits are currently in progress. In some cases, the tax auditors have proposed adjustments to our tax positions including with respect to intercompany transactions, and we are in ongoing discussions with the auditors regarding the validity of their positions. The Company has recorded a reserve for uncertain tax positions of $99.6 million and $89.2 million, including interest and penalties, in connection with its international audits at June 30, 2020 and December 31, 2019, respectively. In certain cases, these audits can also result in non-tax consequences. For example, under French law, certain tax matters are automatically referred for criminal investigation.
The Company’s major state taxing jurisdictions remain open from fiscal year 20082013 through 2018, with several state audits currently in progress. The Company’s major international taxing jurisdictions remain open from 2012 through 2018, some of which are indemnified by Strides Arcolab Limited (“Strides Arcolab”) for tax assessments.
Tax Court Proceedings
The Company's U.S. federal income tax returns for 2007 through 2011 had been subject to proceedings in U.S. Tax Court involving a dispute with the IRS regarding whether the proceeds received by the Company in connection with the 2008 sale of its rights in nebivolol constituted a capital gain or ordinary income. The Company and the IRS filed a joint stipulation of settled issues with the Tax Court that resolved all issues in this dispute and the Tax Court issued the final order closing the case during the three months ended March 31, 2018.
The Company's U.S. federal income tax returns for 2012 through 2014 had been subject to proceedings in U.S. Tax Court involving a dispute with the IRS regarding whether certain costs related to Abbreviated New Drug Applicationsabbreviated new drug applications were eligible to be expensed and deducted immediately or required to be amortized over longer periods. A trial was held in U.S. Tax Court in December 2018. Both parties delivered their final post-trial briefs on June 27, 2019 and are awaiting the court’s final decision.
Accounting for Uncertainty in Income Taxes
The impact of an uncertain tax position that is more likely than not of being sustained upon audit by the relevant taxing authority must be recognized at the largest amount that is more likely than not to be sustained. No portion of an uncertain tax position will be recognized if the position has less than a 50% likelihood of being sustained.
During the six months ended June 30, 2019, primarily due to the settlement in principle reached with the IRS and the expiration of federal and foreign statutes of limitations expirations, the Company increased its net liability for unrecognized tax benefits by approximately $46.1 million. During the six months ended June 30, 2018, as a result
MYLAN N.V. AND SUBSIDIARIES
Notes to the income tax provision of approximately $53.0 million.Condensed Consolidated Financial Statements (Unaudited) - Continued
The Company is involved in various disputes, governmental and/or regulatory inquiries, investigations and proceedings, tax proceedings and litigation matters, both in the U.S. and abroad, that arise from time to time, some of which could result in losses, including damages, fines and/or civil penalties, and/or criminal charges against the Company. These matters are often complex and have outcomes that are difficult to predict. The Company is also party to certain proceedings and litigation matters for which it may be entitled to indemnification under the respective sale and purchase agreements relating to the acquisitions of the former Merck Generics business, Agila Specialties Private Limited, Abbott’sAbbott Laboratories’ non-U.S. developed markets specialty and branded generics business, and certain other acquisitions.
While the Company believes that it has meritorious defenses with respect to the claims asserted against it and intends to vigorously defend its position, the process of resolving these matters is inherently uncertain and may develop over a long period of time, and so it is not possible to predict the ultimate resolution of any such matter. It is possible that an unfavorable resolution of any of the ongoing matters or the inability or denial of Merck KGaA, Strides Arcolab, Abbott Laboratories, or another indemnitor or insurer to pay an indemnified claim, could have a material adverse effect on the Company’s business, financial condition, results of operations, cash flows and/or ordinary share price.
Some of these governmental inquiries, investigations, proceedings and litigation matters with which the Company is involved are described below, and unless otherwise disclosed, the Company is unable to predict the outcome of the matter or to provide an estimate of the range of reasonably possible material losses. The Company records accruals for loss contingencies to the extent we conclude it is probable that a liability has been incurred and the amount of the loss can be reasonably estimated. The Company is also involved in other pending proceedings for which, in the opinion of the Company based upon facts and circumstances known at the time, either the likelihood of loss is remote or any reasonably possible loss associated with the
MYLAN N.V. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
resolution of such proceedings is not expected to be material to the Company’s business, financial position, results of operations, cash flows and/or ordinary share price. If and when any reasonably possible losses associated with the resolution of such other pending proceedings, in the opinion of the Company, become material, the Company will disclose such matters.
Legal costs are recorded as incurred and are classified in SG&A in the Company’s condensed consolidated statements of operations.
Modafinil Antitrust Litigation
Beginning in April 2006, Mylan and four4 other drug manufacturers were named as defendants in civil lawsuits filed in or transferred to the U.S. District Court for the Eastern District of Pennsylvania (“EDPA”) by a variety of plaintiffs purportedly representing direct and indirect purchasers of the drug modafinil and in a lawsuit filed by Apotex, Inc., a manufacturer of generic drugs. These actions alleged violations of federal antitrust and state laws in connection with the generic defendants’ settlement of patent litigation with Cephalon relating to modafinil. Mylan has settled all of these lawsuits.
The Company recorded approximately $18.0 million of expense related to this matter in the lawsuits filed bysecond quarter of 2019, which was subsequently paid during the putative direct purchaser class and retailer opt-out plaintiffs and Apotex and has entered intoyear ended December 31, 2019. At December 31, 2019, the Company had a settlement agreement with the putative indirect purchasers fortotal accrual of approximately $14.4 million related to this matter, which is subject to court approval.included in other current liabilities in the condensed consolidated balance sheets. The amount accrued was paid during 2020.
On July 10, 2015, the Louisiana Attorney General filed a lawsuit in the 19th Judicial District Court in Louisiana against Mylan and three3 other drug manufacturers asserting state law claims based on the same underlying allegations as those made in the litigation then pending in the EDPA. On December 8, 2016, the District Court dismissed the lawsuit with prejudice, which the State of Louisiana appealed. The appeals court subsequently remanded the lawsuit to the District Court to include certain language in order to make the District Court’s dismissal decision final and appealable.
On July 28, 2016, United Healthcare filed a complaint against Mylan Inc. and four other drug manufacturers in the United States District Court for the District of Minnesota, asserting state law claims based on the same underlying allegations as those made in the litigation then pending in the EDPA. On January 6, 2017, the case was transferred to the EDPA and is still pending. MPI has since been included as an additional party. In July 2019, the parties reached a settlement in principle.
The Company believes that it has strong defenses to thesethe remaining cases.case. Although it is reasonably possible that the Company may incur additional losses from these matters,this matter, any amount cannot be reasonably estimated at this time.
The Company recorded approximately $18.0 million
MYLAN N.V. AND SUBSIDIARIES
Notes to this matter at June 30, 2019, which is included in other current liabilities in the condensed consolidated balance sheets.Condensed Consolidated Financial Statements (Unaudited) - Continued
Pioglitazone
Beginning in December 2013, Mylan, Takeda, and several other drug manufacturers have beenwere named as defendants in civil lawsuits consolidated in the U.S. District Court for the Southern District of New York (“SDNY”) by plaintiffs which purport to represent direct and indirect purchasers of branded or generic Actos® and Actoplus Met®. These actions allege violations of state and federal competition laws in connection with the defendants’ settlements of patent litigation in 2010 related to Actos® and Actoplus Met®. Mylan’s motion to dismiss the indirect purchasers’ complaint was granted and no appeal was filed as to Mylan. Following the appellate decision relating to other defendants, the direct purchasers filed an amended complaint against Mylan and the other manufacturers. Mylan’s motion to dismiss the amended complaint is pending.
SEC Investigation
On September 10, 2015, Mylan N.V. received a subpoena from the SEC’s Division of Enforcement seeking documentswas granted with regard to certain related party matters. Mylan subsequently received additional requests for information. The SEC’s Division of Enforcement informed the Company in February 2019 that it had completed its investigation with no recommended further action.prejudice on October 8, 2019.
Trade Agreements Act (“TAA”)
On April 9, 2018, a subsidiary of Mylan N.V. received a civil investigative demand from the Commercial Litigation Branch of the U.S. Department of Justice (“DOJ”) concerning its TAA compliance for certain products. The company fully
MYLAN N.V. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
cooperated with DOJ. On September 14, 2018, the United States District Court for the Southern District of Ohio unsealed a qui tam lawsuit filed against the Mylan N.V. subsidiary concerning its TAA compliance for the same products identified in DOJ’s civil investigative demand. DOJ has declined to intervene in the lawsuit and has closed its investigation. The lawsuit has been stayed and we believe that its claims are without merit and intend to defend against them vigorously.
EpiPen® Auto-Injector and Certain Congressional Matters
Department of Veterans Affairs Request for Information
On June 30, 2017, the Company responded to a request for information from the Department of Veterans Affairs (“VA”) (acting on behalf of itself and other government agencies) requesting certain historical pricing data related to the EpiPen® Auto-Injector. The Company and the VA arehave been engaged in a continuing dialogue regarding the classification of the EpiPen® Auto-Injector as a covered drug under Section 603 of the Veterans Health Care Act of 1992, Public Law 102-585. The Company historically classified EpiPen® Auto-Injector has been classified as a non coverednon-covered drug with the VA based upon long standing written guidance from the federal government. The Company has voluntarily reclassified the EpiPen® Auto-Injector as a covered drug, effective from April 1, 2017. The Company is fully cooperating with the VA.
SEC Request for Information/Subpoenas
On October 7, 2016, Mylan received a document request from the SEC’s Division of Enforcement seeking communications with the Centers for Medicare and Medicaid Services and documents concerning Mylan products sold and related to the Medicaid Drug Rebate Program (“MDRP”), and any related complaints. On November 15, 2016, Mylan received a follow-up letter, modifying the initial document request, seeking information on and public disclosures regarding the Company’s previously disclosed settlement with the DOJ (“the MDRP Settlement”) and the classification of the EpiPen® Auto-Injector under the MDRP. Mylan subsequently received subpoenas and additional requests for information. The Company has been cooperating fully with the SEC staff’s investigation. Following recent discussions, the Company reached an agreement-in-principle in July 2019 with the staff of the Division of Enforcement that would include allegations that the Company violated Sections 17(a)(2) and 17(a)(3) of the Securities Act of 1933 and the reporting, books and records, and internal controls provisions of the Securities Exchange Act of 1934, as amended, and the rules thereunder, and a civil penalty of $30.0 million. Under the settlement, Mylan would neither admit nor deny these allegations. The Company recorded an accrual for this amount for the period ended June 30, 2019. This agreement-in-principle between the staff of the Division of Enforcement and the Company is subject to approval by the SEC and, if approved, would fully resolve the Division of Enforcement’s investigation.
On April 25, 2017, Mylan received a comment letter from the staff of the SEC’s Division of Corporation Finance (“Corporation Finance”) with respect to Mylan’s Annual Report on Form 10-K for the year ended December 31, 2016, requesting information regarding Mylan’s accounting treatment of the MDRP Settlement, including with respect to the determinations that the settlement amount should be recorded as a charge against earnings in the third quarter of 2016 rather than against any earlier periods, and that the settlement amount should be classified as an expense rather than a reduction of revenue. The Company responded to the comment letter in May 2017 and we will continue to respond to any additional correspondence from Corporation Finance. As noted above, the Company has reached an agreement-in-principle with the staff of the Division of Enforcement concerning the subject matter of Corporation Finance’s comment letter.
FTC Request for Information
On November 18, 2016, Mylan received a request from the U.S. Federal Trade Commission (“FTC”) Bureau of Competition seeking documents and information relating to its preliminary investigation into potential anticompetitive practices relating to epinephrine auto-injectors. Mylan is fully cooperating with the FTC.
Federal Securities Litigation
Purported class action complaints were filed in October 2016 against Mylan N.V., Mylan Inc. and certain of their current and former directors and officers (collectively, for purposes of this paragraph, the “defendants”) in the United States District Court for the Southern District of New York (“SDNY”) on behalf of certain purchasers of securities of Mylan N.V. and/or Mylan Inc. on the NASDAQ. The complaints alleged that defendants made false or misleading statements and omissions of purportedly material fact, in violation of federal securities laws, in connection with disclosures relating to Mylan N.V. and Mylan Inc.’s classification of their EpiPen® Auto-Injector as a non-innovator drug for purposes of the MDRP. The complaints sought damages, as well as the plaintiffs’ fees and costs. On March 20, 2017, a consolidated amended complaint was filed,
MYLAN N.V. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
alleging substantially similar claims and seeking substantially similar relief, but adding allegations that defendants made false or misleading statements and omissions of purportedly material fact in connection with allegedly anticompetitive conduct with respect to EpiPen® Auto-Injector and certain generic drugs, and alleging violations of both federal securities laws (on behalf of a purported class of certain purchasers of securities of Mylan N.V. and/or Mylan Inc. on the NASDAQ) and Israeli securities laws (on behalf of a purported class of certain purchasers of securities of Mylan N.V. on the Tel Aviv Stock Exchange). On March 28, 2018, defendants’ motion to dismiss the consolidated amended complaint was granted in part (including the dismissal of claims arising under Israeli securities laws) and denied in part. On July 6, 2018, the plaintiffs filed a second amended complaint, including certain current and former directors and officers and additional allegations in connection with purportedly anticompetitive conduct with respect to EpiPen® Auto-Injector and certain generic drugs. On August 6, 2018, defendants filed a motion to dismiss the second amended complaint, which was granted in part and denied in part on March 29, 2019. On June 17, 2019, plaintiffs filed a third amended complaint, including certain current and former directors and employees/officers and additional allegations in connection with purportedly anticompetitive conduct with respect to certain generic drugs. On February 26, 2019, MYL Litigation Recovery I LLC (an assignee of entities that purportedly purchased stock of Mylan N.V.) filed an additional complaint against Mylan N.V., Mylan Inc., and certain of their current and former directors and officers in the SDNY asserting allegations pertaining to EpiPen® Auto-Injector under the federal securities laws that overlap in part with those asserted in the third amended complaint identified above. MYL Litigation Recovery I LLC’s complaint seeks damages as well as the plaintiff’s costs. On June 5, 2019, defendants filed a motion to dismiss certain of MYL Litigation Recovery I LLC’s claims, which remains pending. We believe that the claims in these lawsuits are without merit and intend to defend against them vigorously.
Israeli Securities Litigation
On October 13, 2016, a purported shareholder of Mylan N.V. filed a lawsuit, together with a motion to certify the lawsuit as a class action on behalf of certain Mylan N.V. shareholders on the Tel Aviv Stock Exchange, against Mylan N.V. and four of its directors and officers (collectively, for purposes of this paragraph, the “defendants”) in the Tel Aviv District Court (Economic Division) (the “Friedman Action”). The plaintiff alleges that the defendants made false or misleading statements and omissions of purportedly material fact in Mylan N.V.’s reports to the Tel Aviv Stock Exchange regarding Mylan N.V.’s classification of its EpiPen® Auto-Injector for purposes of the MDRP, in violation of both U.S. and Israeli securities laws, the Israeli Companies Law and the Israeli Torts Ordinance. The plaintiff seeks damages, among other remedies. On April 30, 2017, another purported shareholder of Mylan N.V. filed a separate lawsuit, together with a motion to certify the lawsuit as a class action on behalf of certain Mylan N.V. shareholders on the Tel Aviv Stock Exchange, in the Tel Aviv District Court (Economic Division), alleging substantially similar claims and seeking substantially similar relief against the defendants and other directors and officers of Mylan N.V., but alleging also that this group of defendants made false or misleading statements and omissions of purportedly material fact in connection with allegedly anticompetitive conduct with respect to EpiPen® Auto-Injector and certain generic drugs, and alleging violations of both U.S. federal securities laws and Israeli law (the “IEC Fund Action”). On April 10, 2018, the Tel Aviv District Court granted the motion filed by plaintiffs in both the Friedman Action and the IEC Fund Action, voluntarily dismissing the Friedman Action and staying the IEC Fund Action until a judgment is issued in the purported class action securities litigation pending in the U.S. We believe that the claims in these lawsuits are without merit and intend to defend against them vigorously.
EpiPen® Auto-Injector Civil Litigation
Mylan Specialty and other Mylan-affiliated entities have been named as defendants in putative indirect purchaser class actions relating to the pricing and/or marketing of the EpiPen® Auto-Injector. The plaintiffs in these cases assert violations of various federal and state antitrust and consumer protection laws, the Racketeer Influenced and Corrupt Organizations Act (“RICO”), as well as common law claims. Plaintiffs’ claims include purported challenges to the prices charged for the EpiPen® Auto-Injector and/or the marketing of the product in packages containing two auto-injectors, as well as allegedly anti-competitive conduct. A Mylan officer and other non-Mylan affiliated companies were also named as defendants in some of the class actions. These lawsuits were filed in the various federal and state courts and have either been dismissed or transferred into a multidistrict litigation (“MDL”) in the U.S. District Court for the District of Kansas and have been consolidated. Mylan filed a motion to dismiss the consolidated amended complaint, which was granted in part and denied in part. On December 7, 2018, the Plaintiffsplaintiffs filed a motion for class certification. ThisOn February 27, 2020, the District Court issued an order denying in part and granting in part plaintiffs’ motion remainsfor class certification. The District Court declined to certify consumer protection and unjust enrichment damages classes, as well as an injunctive relief class. The District Court certified an antitrust class that applies to 17 states and a RICO class. We filed a petition for permission to appeal the class certification decision on March 12, 2020, which was denied. On July 15, 2020, Defendants filed a motion for summary judgment as to the remaining claims asserted by plaintiffs. The motion is pending. A trial date has been scheduled for November 2020.April 2021. We believe that the remaining claims in these lawsuits are without merit and intend to defend against them vigorously.
On February 14, 2020, Mylan Specialty and other Mylan-affiliated entities, together with other non-Mylan affiliated companies, were named as defendants in a putative direct purchaser class action filed in the U.S. District Court for the District of Kansas relating to the pricing and/or marketing of the EpiPen® Auto-Injector. The plaintiff in this case asserts federal antitrust claims which are based on allegations that are similar to those in the putative indirect purchaser class actions discussed above. On June 18, 2020, the District Court granted Mylan’s motion to compel pre-suit mediation; the litigation is stayed
MYLAN N.V. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
pending completion of pre-suit mediation. We believe that the claims in this lawsuit are without merit and intend to defend against them vigorously.
Beginning in March 2020, Mylan Inc. and Mylan Specialty, together with other non-Mylan affiliated companies, were named as defendants in putative direct purchaser class actions filed in the U.S. District Court for the District of Minnesota relating to contracts with certain pharmacy benefit managers concerning EpiPen® Auto-Injector. The plaintiffs claim that the alleged conduct resulted in the exclusion or restriction of competing products and the elimination of pricing constraints in violation of RICO and federal antitrust law. Plaintiffs have requested the consolidation of these lawsuits. We believe that the claims in these lawsuits are without merit and intend to defend against them vigorously.
On April 24, 2017, Sanofi-Aventis U.S., LLC (“Sanofi”) filed a lawsuit against Mylan Inc. and Mylan Specialty in the U.S. District Court for the District of New Jersey. This lawsuit has been transferred into the aforementioned MDL. In this
MYLAN N.V. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
lawsuit, Sanofi alleges exclusive dealings and anti-competitive marketing practices in violation of the antitrust laws in connection with the sale and marketing of the EpiPen® Auto-Injector. On November 1, 2018, Sanofi filed a Motion for a Suggestion of Remand of the case to the U.S. District Court for the District of New Jersey. On January 23, 2019, the Court denied Sanofi’s motion without prejudice. On June 28, 2019, Mylan filed a motion for summary judgment as to the claims asserted by Sanofi and Sanofi filed both a motion for partial summary judgment with respect to its claims against Mylan and for summary judgment with respect to Mylan’s counterclaims. These motions remain pending. We believe that Sanofi’s claims in this lawsuit are without merit and intend to defend against them vigorously.
EpiPen® Auto-Injector State AG Investigations
The Company and certain of its affiliated entities received subpoenas and informal requests from various state attorneys general seeking information and documents relating to the pricing and/or marketing of the EpiPen® Auto-Injector. The Company has cooperated and is fully cooperating with the various state attorneys general.
U.S. Congress/State Requests for Information and Documents
Mylan received several requests for information and documents from various Committees of the U.S. Congress and federal and state lawmakers concerning the marketing, distribution and sales of Mylan products. Mylan cooperated with federal and state lawmakers as appropriate in response to their requests.
The Company has a total accrual of approximately $40.0$10.0 million related to this matter at June 30, 2019,2020, which is included in other current liabilities in the condensed consolidated balance sheets. The Company believes that it has strong defenses to current and future potential civil litigation, as well as governmental investigations, and enforcement proceedings, discussed in this “EpiPen® Auto-Injector and Certain Congressional Matters”Auto-Injector” section of this Note 2018 Litigation. Although it is reasonably possible that the Company may incur additional losses from these matters, any amount cannot be reasonably estimated at this time. In addition, the Company expects to incur additional legal and other professional service expenses associated with such matters in future periods and will recognize these expenses as services are received. The Company believes that the ultimate amount paid for these services and claims could have a material effect on the Company's business, financial condition, results of operations, cash flows and/or ordinary share price in future periods.
Opioids
On July 27, 2017, Mylan N.V. received a subpoena from the DOJ seeking information relating to opioids manufactured, marketed or sold by Mylan during the period from January 1, 2013 to December 31, 2016. On August 29, 2017, Mylan N.V. received a civil investigative demand from the Attorney General of the State of Missouri seeking information relating to opioids manufactured, marketed or sold by Mylan during the period from January 1, 2010 to the present and related subject matter. Mylan is fully cooperating with these subpoena requests.
Mylan along with other manufacturers, distributors, pharmacies, pharmacy benefit managers, and individual healthcare providers is a defendant in more than 700 cases in the United States and Canada filed by various plaintiffs, including counties, cities and other local governmental entities, asserting civil claims related to sales, marketing and/or distribution practices with respect to prescription opioid products. The lawsuits generally seek equitable relief and monetary damages (including punitive and/or exemplary damages) based on a variety of legal theories, including various statutory and/or common law claims, such as negligence, public nuisance and unjust enrichment. The vast majority of these lawsuits have been consolidated in an MDL in the U.S. District Court for the Northern District Court of Ohio. Mylan believes that the claims in these lawsuits are without merit and intends to defend against them vigorously.
Drug Pricing Matters
Department of Justice
On December 3, 2015, a subsidiary of Mylan N.V. received a subpoena from the Antitrust Division of the DOJ seeking information relating to the marketing, pricing, and sale of our generic Doxycycline products and any communications with competitors about such products.
MYLAN N.V. AND SUBSIDIARIES
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On September 8, 2016, a subsidiary of Mylan N.V., as well as certain employees and a member of senior management, received subpoenas from the DOJ seeking additional information relating to the marketing, pricing and sale of our generic Cidofovir, Glipizide-metformin, Propranolol and Verapamil products and any communications with competitors about such products. Related search warrants also were executed.
On May 10, 2018, a subsidiary of Mylan N.V. received a civil investigative demand from the Civil Division of the DOJ seeking information relating to the pricing and sale of its generic drug products.
The Company is fully cooperating with the DOJ.
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Civil Litigation
Beginning in 2016, the Company, along with other manufacturers, has been named as a defendant in lawsuits generally alleging anticompetitive conduct with respect to generic drugs. The lawsuits have been filed by plaintiffs, including putative classes of direct purchasers, indirect purchasers, and indirect resellers, as well as individual direct and indirect purchasers.purchasers and certain counties. They allege harm under federal and state laws, including federal and state antitrust laws, state consumer protection laws and unjust enrichment claims. Some of the lawsuits also name as defendants Mylan’s President, as a defendant and includeincluding allegations against him with respect to doxycycline hyclate delayed release.release, and one of Mylan’s sales employees, including allegations against him with respect to certain generic drugs. The lawsuits have been consolidated in an MDL proceeding in the EDPA. Defendants filed motions to dismiss certain complaints that each allege anticompetitive conduct with respect to single drug products. On October 16, 2018, the Court denied the motions with respect to the federal law claims. On February 15, 2019, the Court granted in part and denied in part the motions with respect to the state law claims. On February 21, 2019, Defendants filed a motion to dismiss certain complaints that allege anticompetitive conduct with respect to multiple drug products, which remains pending. was denied on August 15, 2019. On July 14, 2020, the Court ordered that certain plaintiffs’ complaints regarding three individual drug products proceed as bellwethers. Mylan is named in those plaintiffs’ complaints that regard one of the three individual drug products. A scheduling order has not yet been issued for these matters.
The Company believes that the claims in these lawsuits are without merit and intends to defend against them vigorously.
Attorneys General Litigation
On December 21, 2015, the Company received a subpoena and interrogatories from the Connecticut Office of the Attorney General seeking information relating to the marketing, pricing and sale of certain of the Company’s generic products (including generic doxycycline) and communications with competitors about such products. On December 14, 2016, attorneys general of twentycertain states originally filed a complaint in the United States District Court for the District of Connecticut against several generic pharmaceutical drug manufacturers, including Mylan, alleging anticompetitive conduct with respect to, among other things, doxycycline hyclate delayed release. The complaint washas subsequently been amended, including on June 18, 2018, to add certain attorneys general alleging violations of federal and state antitrust laws, as well as violations of various states’ consumer protection laws. This lawsuit has been transferred to the aforementioned MDL proceeding in the EDPA. On June 18, 2018,The operative complaint includes attorneys general of forty-sevenNaN states, the District of Columbia and the Commonwealth of Puerto Rico filed a consolidated amended complaint against various drug manufacturers, including Mylan.Rico. Mylan is alleged to have engaged in anticompetitive conduct with respect to doxycycline hyclate delayed release, doxycycline monohydrate, glipizide-metformin, and verapamil. The amended complaint also includes claims asserted by attorneys general of thirty-sevenNaN states and the Commonwealth of Puerto Rico against certain individuals, including Mylan’s President, with respect to doxycycline hyclate delayed release. The allegations in the amended complaint are similar to those in the previously filed complaints. On February 21, 2019, Defendants filed motions to dismiss the amended complaint’s allegations of anticompetitive conduct with respect to multiple drug products, which was denied on August 15, 2019, and the ability of the state attorneys general to seek certain forms of relief under federal antitrust law, which remainremains pending. On May 31, 2019, Defendants filed a motion to dismiss certain state law claims, which remains pending.
On May 10, 2019, certain attorneys general of forty-three states and the Commonwealth of Puerto Rico filed a new complaint against various drug manufacturers and individuals, including Mylan and one of its sales employees, alleging anticompetitive conduct with respect to additional generic drugs. On November 1, 2019, the May 10, 2019 complaint was amended, adding additional states as plaintiffs. The Complaintoperative complaint is brought by attorneys general of NaN states, certain territories and the District of Columbia. The amended complaint also includes claims asserted by attorneys general of thirty-nineNaN states and the Commonwealth of Puerto Ricocertain territories against several individuals, including a Mylan sales employee. On July 14, 2020, the Court ordered that this complaint proceed as a bellwether. A scheduling order has not yet been issued for this matter.
On June 10, 2020, attorneys general of NaN states, certain territories and the District of Columbia filed a new complaint against drug manufacturers, including Mylan, and individual defendants (none from Mylan), alleging anticompetitive conduct with respect to additional generic drugs.
We believe that the claims in these lawsuits are without merit and intend to defend against them vigorously.
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Securities Litigation
U.S. Securities Litigation
Purported class action complaints were filed in October 2016 against Mylan N.V., Mylan Inc. and certain of their current and former directors and officers (collectively, for purposes of this paragraph, the “defendants”) in the SDNY on behalf of certain purchasers of securities of Mylan N.V. and/or Mylan Inc. on the NASDAQ. The complaints alleged that defendants made false or misleading statements and omissions of purportedly material fact, in violation of federal securities laws, in connection with disclosures relating to Mylan N.V. and Mylan Inc.’s classification of their EpiPen® Auto-Injector as a non-innovator drug for purposes of the MDRP. The complaints sought damages, as well as the plaintiffs’ fees and costs. On March 20, 2017, a consolidated amended complaint was filed, alleging substantially similar claims and seeking substantially similar relief, but adding allegations that defendants made false or misleading statements and omissions of purportedly material fact in connection with allegedly anticompetitive conduct with respect to EpiPen® Auto-Injector and certain generic drugs, and alleging violations of both federal securities laws (on behalf of a purported class of certain purchasers of securities of Mylan N.V. and/or Mylan Inc. on the NASDAQ) and Israeli securities laws (on behalf of a purported class of certain purchasers of securities of Mylan N.V. on the Tel Aviv Stock Exchange). On March 28, 2018, defendants’ motion to dismiss the consolidated amended complaint was granted in part (including the dismissal of claims arising under Israeli securities laws) and denied in part. On July 6, 2018, the plaintiffs filed a second amended complaint, including certain current and former directors and officers and additional allegations in connection with purportedly anticompetitive conduct with respect to EpiPen® Auto-Injector and certain generic drugs. On August 6, 2018, defendants filed a motion to dismiss the second amended complaint, which was granted in part and denied in part on March 29, 2019. On June 17, 2019, plaintiffs filed a third amended complaint, including certain current and former directors and employees/officers and additional allegations in connection with purportedly anticompetitive conduct with respect to certain generic drugs. On July 31, 2019, defendants filed a motion to dismiss certain of the claims in the third amended complaint, which was granted in part and denied in part on April 6, 2020. On August 30, 2019, plaintiffs filed a motion for class certification, which was granted on April 6, 2020. The certified class covers all persons or entities that purchased Mylan common stock between February 21, 2012 and May 24, 2019 excluding defendants, current and former officers and directors of Mylan, members of their immediate families and their legal representatives, heirs, successors or assigns, and any entity in which defendants have or had a controlling interest.
On February 26, 2019, MYL Litigation Recovery I LLC (an assignee of entities that purportedly purchased stock of Mylan N.V.) filed an additional complaint against Mylan N.V., Mylan Inc., and certain of their current and former directors and officers in the SDNY asserting allegations pertaining to EpiPen® Auto-Injector under the federal securities laws that overlap in part with those asserted in the third amended complaint identified above. MYL Litigation Recovery I LLC’s complaint seeks damages as well as the plaintiff’s costs. On June 5, 2019, defendants filed a motion to dismiss certain of MYL Litigation Recovery I LLC’s claims, which was granted in part and denied in part on March 30, 2020. On May 6, 2020, plaintiff filed an amended complaint against Mylan N.V., Mylan Inc., and certain of their current and former officers and directors, including allegations in connection with purportedly anticompetitive conduct with respect to EpiPen® Auto-Injector.
On February 14, 2020, the Abu Dhabi Investment Authority filed a complaint against Mylan N.V. and Mylan Inc. in the SDNY asserting allegations pertaining to EpiPen® Auto-Injector and certain generic drugs under the federal securities laws that overlap with those asserted in the third amended complaint identified above. The Abu Dhabi Investment Authority’s complaint seeks damages as well as the plaintiff’s fees and costs. On June 26, 2020, defendants filed a motion to dismiss certain of plaintiff’s claims. The motion is pending.
Beginning in April 2020, Mylan N.V., its directors and certain of its officers were named as defendants in lawsuits filed in federal court, including a putative class action, alleging certain federal securities law violations for purportedly failing to disclose or misrepresenting material information in the definitive proxy statement filed by Mylan N.V. with the SEC in connection with the Combination. The lawsuits generally seek various relief including (i) enjoining the defendants from proceeding with consummating, or closing the Combination and any vote on the Combination unless and until Mylan discloses and disseminates the purportedly material information; (ii) in the event the Combination is consummated, rescinding it and setting it aside or awarding rescissory damages; and (iii) reasonable attorneys and expert fees. Plaintiffs in each of these cases have dismissed their cases against defendants.
On June 26, 2020, a putative class action complaint was filed by the Public Employees Retirement System of Mississippi against Mylan N.V. and certain of its directors and officers (collectively for the purposes of this paragraph, the “defendants”) in the U.S. District Court for the Western District of Pennsylvania on behalf of certain purchasers of securities of
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Mylan N.V. The complaint alleges that defendants made false or misleading statements and omissions of purportedly material fact, in violation of federal securities laws, in connection with disclosures relating to Mylan’s Morgantown manufacturing plant and inspections at the plant by the FDA. The complaint alleges that Mylan N.V.’s stock traded at artificially inflated prices as a result of the allegedly misleading statements and omissions. Plaintiff seeks certification of a class of purchasers of Mylan N.V. securities between February 16, 2016 and May 7, 2019. The complaint seeks damages, as well as the plaintiff’s fees and costs.
We believe that the claims in these lawsuits are without merit and intend to defend against them vigorously.
Israeli Securities Litigation
On October 13, 2016, a purported shareholder of Mylan N.V. filed a lawsuit, together with a motion to certify the lawsuit as a class action on behalf of certain Mylan N.V. shareholders on the Tel Aviv Stock Exchange, against Mylan N.V. and 4 of its directors and officers (collectively, for purposes of this paragraph, the “defendants”) in the Tel Aviv District Court (Economic Division) (the “Friedman Action”). The plaintiff alleges that the defendants made false or misleading statements and omissions of purportedly material fact in Mylan N.V.’s reports to the Tel Aviv Stock Exchange regarding Mylan N.V.’s classification of its EpiPen® Auto-Injector for purposes of the MDRP, in violation of both U.S. and Israeli securities laws, the Israeli Companies Law and the Israeli Torts Ordinance. The plaintiff seeks damages, among other remedies. On April 30, 2017, another purported shareholder of Mylan N.V. filed a separate lawsuit, together with a motion to certify the lawsuit as a class action on behalf of certain Mylan N.V. shareholders on the Tel Aviv Stock Exchange, in the Tel Aviv District Court (Economic Division), alleging substantially similar claims and seeking substantially similar relief against the defendants and other directors and officers of Mylan N.V., but alleging also that this group of defendants made false or misleading statements and omissions of purportedly material fact in connection with allegedly anticompetitive conduct with respect to EpiPen® Auto-Injector and certain generic drugs, and alleging violations of both U.S. federal securities laws and Israeli law (the “IEC Fund Action”). On April 10, 2018, the Tel Aviv District Court granted the motion filed by plaintiffs in both the Friedman Action and the IEC Fund Action, voluntarily dismissing the Friedman Action and staying the IEC Fund Action until a judgment is issued in the purported class action securities litigation pending in the U.S. We believe that the claims in the IEC Fund Action are without merit and intend to defend against them vigorously.
Opioids
On July 27, 2017, Mylan N.V. received a subpoena from the DOJ seeking information relating to opioids manufactured, marketed or sold by Mylan during the period from January 1, 2013 to December 31, 2016. On August 29, 2017, Mylan N.V. received a civil investigative demand from the Attorney General of the State of Missouri seeking information relating to opioids manufactured, marketed or sold by Mylan during the period from January 1, 2010 to the present and related subject matter. In November 2019, a subsidiary of Mylan N.V. received a subpoena from the New York Department of Financial Services as part of an industry-wide inquiry into the effect of opioid prescriptions on New York health insurance premiums. Mylan is fully cooperating with these subpoena requests.
Mylan along with other manufacturers, distributors, pharmacies, pharmacy benefit managers, and individual healthcare providers is a defendant in more than 1,000 cases in the United States and Canada filed by various plaintiffs, including counties, cities and other local governmental entities, asserting civil claims related to sales, marketing and/or distribution practices with respect to prescription opioid products. In addition, lawsuits have been filed as putative class actions including on behalf of children with Neonatal Abstinence Syndrome due to alleged exposure to opioids. The lawsuits generally seek equitable relief and monetary damages (including punitive and/or exemplary damages) based on a variety of legal theories, including various statutory and/or common law claims, such as negligence, public nuisance and unjust enrichment. The vast majority of these lawsuits have been consolidated in an MDL in the U.S. District Court for the Northern District Court of Ohio. A liability-only trial has been scheduled for March 2021 in a coordinated proceeding in West Virginia state court involving Mylan and numerous other manufacturers, distributors, and pharmacies. Mylan believes that the claims in these lawsuits are without merit and intends to defend against them vigorously.
Valsartan
Mylan N.V., and certain of its subsidiaries, along with numerous other manufacturers, retailers and others, have been named (or plaintiffs are seeking to name certain Mylan entities) as defendants in lawsuits in the United States, Canada and other countries stemming from recalls of valsartan-containing medications. The United States litigation,vast majority of these lawsuits have been consolidated in an MDL in the District of New Jersey, which is taking place in an
includes class action and individual allegations seeking the refund
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MDL in the District of New Jersey, includes class action and individual allegations seeking the refund of the purchase price and other economic damages allegedly sustained by consumers who purchased valsartan-containing products as well as claims for personal injuries allegedly caused by ingestion of the medication. Moreover, Mylan has received requests to indemnify purchasers of Mylan’s active pharmaceutical ingredient and/or finished dose forms of the product. We believe that the claims in these lawsuits are without merit and intend to defend against them vigorously.
European Commission Proceedings
Perindopril
On July 9, 2014, the European Commission (the “Commission”) issued a decision finding that Mylan Laboratories Limited and Mylan, as well as several other companies, had violated European Union (“EU”) competition rules relating to the product Perindopril and fined Mylan Laboratories Limited approximately €17.2 million, including approximately €8.0 million jointly and severally with Mylan Inc. The Company paid approximately $21.7 million related to this matter during the fourth quarter of 2014. In September 2014, the Company filed an appeal of the Commission’s decision to the General Court of the EU. A hearing on the appeal before the General Court of the EU was held in June 2017 and the Commission’s decision was affirmed. Mylan has appealed the decision to the European Court of Justice (“CJEU”). Mylan has received a notice from an organization representing health insurers in the Netherlands stating an intention to commence follow-on litigation and asserting damages.
Citalopram
On June 19, 2013, the Commission issued a decision finding that Generics [U.K.] Limited, (“GUK”) as well as several other companies, had violated EU competition rules relating to the product Citalopram and fined GUK approximately €7.8 million, jointly and severally with Merck KGaA. GUK appealed the Commission’s decision to the General Court of the EU. The case is currently on appeal to the CJEU. The U.K. applied and was granted permission to intervene in this proceeding. GUK has received notices from European national health services and health insurers stating an intention to commence follow-on litigation and asserting damages. The national health servicesservice in England and Wales havehas instituted litigation against all parties to the Commission’s decision, including GUK. This litigation has been stayed pending the CJEU’s decision.
GUK has also sought indemnification from Merck KGaA with respect to the €7.8 million portion of the fine for which Merck KGaA and GUK were held jointly and severally liable. Merck KGaA has counterclaimed against GUK seeking the same indemnification. In June 2018, the Frankfurt Regional Court issued a judgment dismissing GUK claims against Merck KGaA and ordered GUK to indemnify Merck KGaA with respect to the amount for which the parties were held jointly and severally liable. GUK has appealed this decision. The proceedings have been stayed pending the CJEU appeal decision.
The Company has accrued approximately €7.4 million as of each of December 31, 2019 and June 30, 2019 and December 31, 20182020 related to this matter. It is reasonably possible that we will incur additional losses above the amount accrued but we cannot estimate a range of such reasonably possible losses at this time. There are no assurances, however, that settlements reached and/or adverse judgments received, if any, will not exceed amounts accrued.
U.K. Competition and Markets Authority
Paroxetine
On August 12, 2011, GUK received notice that the Office of Fair Trading (subsequently changed to the Competition and Markets Authority (the “CMA”)) opened an investigation to explore the possible infringement of the Competition Act 1998 and Articles 101 and 102 of the Treaty on the Functioning of the EU, with respect to alleged agreements related to Paroxetine. The CMA issued a decision on February 12, 2016, finding that, GUK, Merck KGaA and other companies were liable for infringing EU and U.K. competition rules. With respect to Merck KGaA and GUK, the CMA issued a penalty of approximately £5.8 million, for which Merck KGaA is liable for the entire amount; and of that amount GUK is jointly and severally liable for approximately £2.7 million, which has been accrued for as of December 31, 2019 and June 30, 2019.2020. The matter is currently on appeal to the Competition Appeals Tribunal (“CAT”), which on March 8, 2018, referred certain questions of law to the CJEU. The CJEU sought written observations from GUK, which were filed in September 2018. A hearing on the questions and the parties’ observations was held before the CJEU has been scheduled foron September 19, 2019.
On January 30, 2020, the CJEU ruled on the questions of law referred to it and the proceedings before the CAT had resumed.
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Italy Investigation
On April 18, 2018, certain employees of Mylan S.p.A. were served with search warrants issued by the The Public Prosecutor’s Office in Milan, Italy seeking informationis conducting an investigation of Mylan S.p.A. and other pharmaceutical companies concerning interactions with an Italian hospital and sales of certain reimbursable drugs. Mylan S.p.A. drugs.has reached an agreement-in-principle to resolve the investigation with no admission of liability or wrongdoing. The Companyagreement-in-principle is assisting itssubject to judicial approval. The matter as to certain employees in their cooperation with the investigation. of Mylan S.p.A. is ongoing.
Product Liability
The Company is involved in a number of product liability lawsuits and claims related to alleged personal injuries arising out of certain products manufactured and/or distributed by the Company. The Company believes that it has meritorious defenses to these lawsuits and claims and intends to defend against them vigorously. From time to time, the Company has agreed to settle or otherwise resolve certain lawsuits and claims on terms and conditions that are in the best interests of the Company. The Company has accrued approximately $15.7$14.5 million and $10.9$12.6 million at December 31, 2019 and June 30, 2019 and December 31, 2018,2020, respectively. It is reasonably possible that we will incur additional losses and fees above the amount accrued but we cannot estimate a range of such reasonably possible losses or legal fees related to these claims at this time. There are no assurances, however, that settlements reached and/or adverse judgments received, if any, will not exceed amounts accrued.
Intellectual Property
On October 19, 2017, Teva Pharmaceutical Industries Ltd. (“Teva”) commenced an action with the Irish High Court against Mylan Teoranta alleging that Mylan’s glatiramer acetate 40mg/mL product, which is manufactured in Ireland, approved by the FDA and is currently being sold in the U.S., infringes two European patents, EP (IE) 2 949 335 and EP (IE) 3 050 556. Teva subsequently dropped its infringement allegation related to the EP (IE) 3 050 556 patent. The matter has now been resolved and Mylan will continue its production activities with respect to the U.S. 40mg/mL product in Ireland.
On September 22, 2017, Amgen Inc. and Amgen Manufacturing Limited (“Amgen”) sued Mylan Inc., Mylan N.V., Mylan GMBH, and MPI in the Western District of Pennsylvania asserting that Mylan’s Fulphila® infringes U.S. patent numbers 8,273,707 and 9,643,997. On June 4, 2018, the FDA approved Mylan’s Fulphila® (pegfilgrastim-jmdb), a biosimilar to Neulasta® (pegfilgrastim), co-developed with Biocon. In July 2018, Mylan began selling Fulphila®. Amgen is seeking monetary damages, injunctive relief, attorneys’ fees, costs and other relief.
On July 31, 2015, BTG International Ltd., Janssen Biotech, Inc., Janssen Oncology, Inc., and Janssen Research & Development, LLC (“Janssen”) sued Mylan Inc. and MPI, along with numerous other abbreviated new drug application (“ANDA”) applicants, in the District of New Jersey and asserted that Mylan’s and the other ANDA applicants’ abiraterone acetate ANDA products infringe U.S. Patent number 8,822,438 (“’438”).
Mylan and others filed Inter Partes Review (“IPR”) petitions challenging the validity of the ’438 patents’ claims. On January 17, 2018, the U.S. Patent and Trademark Appeal Board (“PTAB”) issued Final Written Decisions in the IPR proceedings finding all claims of the ’438 patent unpatentable as obvious. On October 26, 2018, the district court issued an opinion similarly finding the ’438 patents’ claims invalid as obvious. On October 31, 2018, the FDA approved Mylan’s abiraterone acetate ANDA. Mylan, along with certain other ANDA applicants, began selling their abiraterone acetate ANDA products in November 2018.
Janssen appealed both the district court and IPR decisions to the Federal Circuit. On May 14, 2019, the Federal Circuit affirmed the PTAB’s decision that all claims of the ‘438 patent were unpatentable as obvious. As a result of this finding, the Federal Circuit did not need to consider Janssen’s appeal of the district court decision. Janssen did not seek a further appeal of the decision with the Federal Circuit, but the deadline to request review by the Supreme Court has not passed.
The Company has useduses its business judgment in connection with the decision to launch the 40mg/mL glatiramer acetate, Fulphila® and abiraterone acetate products and has also used its business judgment in certain other situations to decide to market and sell certain products, in each case based on its belief that the applicable patents are invalid and/or that its products do not infringe, notwithstanding the fact that allegations of patent infringement(s) or other potential third party rights have not been finally resolved by the courts. The risk involved in doing so can be substantial because the remedies available to the owner of a patent for infringement may include, a reasonable royalty on sales or damages measured by the profits lost by the patent owner. If there is a finding of willful infringement, damages may be increased up to three3 times. Moreover, because of the discount pricing typically involved with bioequivalent products, patented branded products generally realize a substantially higher profit
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margin than generic and biosimilar products. Mylan intends to defend against any such patent infringement claims vigorously. However, an adverse decision could have an adverse effect that is material to our business, financial condition, results of operations, cash flows and/or ordinary share price.
Celgene
Mylan filed suit in 2014 against Celgene Corporation (“Celgene”) alleging monopolization and restraint of trade in the markets for thalidomide and lenalidomide. Following discovery and summary judgment, the District Court scheduled a trial on Mylan’s claims that had survived pre-trial motion practice for October 2019. In July 2019, the parties resolved the litigation, whereby Mylan will receive $62 million and the case will be dismissed.
Other Litigation
The Company is involved in various other legal proceedings that are considered normal to its business. The Company has approximately $7.1$8.4 million accrued related to these various other legal proceedings at June 30, 2019.2020.
On July 29, 2019, the Company, Pfizer, Inc. ("Pfizer”), Upjohn Inc., a wholly-owned subsidiaryTable of Pfizer ("Upjohn"), and certain other affiliated entities entered into a Business Combination Agreement (the "Business Combination Agreement") pursuant to which the Company will combine with Upjohn in a Reverse Morris Trust transaction (the "Combination"). Upjohn is a global, primarily off-patent branded and generic established medicines business, which includes 20 primarily off-patent solid oral dose legacy brands, such as Lyrica, Lipitor, Celebrex and Viagra, as well as certain generic medicines.Contents
Prior to the Combination and pursuant to a Separation Agreement (the "Separation Agreement"), dated as of July 29, 2019, between Pfizer and Upjohn, Pfizer will, among other things, transfer to Upjohn substantially all of the assets and liabilities comprising Upjohn’s business (the “Separation”) and, thereafter, Pfizer will distribute to Pfizer shareholders all of the issued and outstanding shares of Upjohn (the "Distribution" and, together with the Separation and the Combination, the “Transaction”). The Combination is expected to occur immediately after the Distribution. Following the Combination, it is anticipated that Pfizer’s shareholders will own approximately 57 percent and the Company's ordinary shareholders will own approximately 43 percent of Upjohn's common stock.
Prior to, and as a condition of, the Distribution, Upjohn will make a cash payment to Pfizer equal to $12.0 billion. Upjohn has obtained commitments for the initial financing of the transaction in the form of a bridge loan from certain financial institutions. If Upjohn obtains additional funding by issuing securities or obtaining other loans, the amount of the bridge facility will be correspondingly reduced. The bridge loan is subject to customary terms and conditions including a financial covenant.
The consummation of the Combination is subject to various customary closing conditions, including (i) approval by the Company's ordinary shareholders, (ii) anti-trust approvals in various countries, (iii) completion of the Separation (including the payment of $12 billion of cash by Upjohn to Pfizer) and the Distribution, (iv) confirmation by applicable tax authorities of the intended tax treatment of the transaction, (v) obtaining other regulatory approvals necessary to complete the Combination, and (vi) the absence of any law or order from any court or governmental authority restraining, enjoining or prohibiting the transaction.
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis addresses material changes in the financial condition and results of operations of Mylan N.V. and subsidiaries for the periods presented. Unless context requires otherwise, the “Company”, “Mylan”, “our”, or “we” refer to Mylan N.V. and its subsidiaries. This discussion and analysis should be read in conjunction with the Consolidated Financial Statements, the related Notes to Consolidated Financial Statements and Management’s Discussion and Analysis of Financial Condition and Results of Operations included in Mylan N.V.’s Annual Report on Form 10-K for the year ended December 31, 2018,2019, as amended (the “2018“2019 Form 10-K”), the unaudited interim financial statements and related Notes included in Part I — ITEM 1 of this Quarterly Report on Form 10-Q (“Form 10-Q”) and our other Securities and Exchange Commission (the “SEC”) filings and public disclosures. The interim results of operations and comprehensive earnings for the three and six months ended June 30, 2019,2020, and cash flows for the six months ended June 30, 20192020 are not necessarily indicative of the results to be expected for the full fiscal year or any other future period.
This Form 10-Q contains “forward-looking statements.” These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may include, without limitation, statements about the proposed Combination (as defined above)below), the expected timetable for completing the Combination, the benefits and synergies of the Combination, future opportunities for the combined company and products and any other statements regarding Mylan’s, and Upjohn’sthe Upjohn Business’s (as defined below) or the combined company’s future operations, financial or operating results, capital allocation, dividend policy, debt ratio, anticipated business levels, future earnings, planned activities, anticipated growth, market opportunities, strategies, competition,competitions, and other expectations and targets for future periods. These may often be identified by the use of words such as “will,” “may,” “could,” “should,” “would,” “project,” “believe,” “anticipate,” “expect,” “plan,” “estimate,” “forecast,” “potential,” “pipeline,” “intend,” “continue,” “target,” “seek” and variations of these words or comparable words. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to:
•with respect to the Combination, the parties’ ability to meet expectations regarding the timing, completion and accounting and tax treatments of the Combination, changes in relevant tax and other laws, the parties’ ability to consummate the Combination, the conditions to the completion of the Combination including receipt of approval of Mylan’s shareholders, not being satisfied or waived on the anticipated timeframe or at all, the regulatory approvals required for the Combination not being obtained on the terms expected or on the anticipated schedule or at all, the integration of Mylan and the Upjohn Business being more difficult, time consuming or costly than expected, Mylan’s and Upjohn’sthe Upjohn Business’s failure to achieve expected or targeted future financial and operating performance and results, the possibility that the combined company may be unable to achieve expected benefits, synergies and operating efficiencies in connection with the Combination within the expected time framestimeframes or at all or to successfully integrate Mylan and the Upjohn Business, customer loss and business disruption being greater than expected following the Combination, the retention of key employees being more difficult following the Combination, changes in third-party relationships and changes in the economic and financial conditions of the business of Mylan or Upjohn; the Upjohn Business;
•the potential impact of public health outbreaks, epidemics and pandemics, such as the COVID-19 pandemic;
•actions and decisions of healthcare and pharmaceutical regulators;
•failure to achieve expected or targeted future financial and operating performance and results;
•uncertainties regarding future demand, pricing and reimbursement for our or Upjohn’sthe Upjohn Business’s products;
•any regulatory, legal, or other impediments to Mylan’s or Upjohn’sthe Upjohn Business’s ability to bring new products to market, including, but not limited to, where Mylan or the Upjohn Business uses its business judgment and decides to manufacture, market, and/or sell products, directly or through third parties, notwithstanding the fact that allegations of patent infringement(s) have not been finally resolved by the courts (i.e., an “at-risk launch”);
•success of clinical trials and Mylan’s or Upjohn’sthe Upjohn Business’s ability to execute on new product opportunities;
•any changes in or difficulties with our or Upjohn’sthe Upjohn Business’s manufacturing facilities, including with respect to remediation and restructuring activities, supply chain or inventory or the ability to meet anticipated demand;
•the scope, timing, and outcome of any ongoing legal proceedings, including government investigations, and the impact of any such proceedings on our or Upjohn’sthe Upjohn Business’s financial condition, results of operations, and/or cash flows;
•the ability to meet expectations regarding the accounting and tax treatments of acquisitions, including Mylan’s acquisition of Mylan Inc. and Abbott Laboratories’ non-U.S. developed markets specialty and branded generics business (the “EPD Business”); acquisitions;
•changes in relevant tax and other laws, including but not limited to changes in the U.S. tax code and healthcare and pharmaceutical laws and regulations in the U.S. and abroad;
•any significant breach of data security or data privacy or disruptions to our or Upjohn’sthe Upjohn Business’s information technology systems;
•the ability to protect intellectual property and preserve intellectual property rights;
•the effect of any changes in customer and supplier relationships and customer purchasing patterns;
•the ability to attract and retain key personnel;
•the impact of competition;
•identifying, acquiring, and integrating complementary or strategic acquisitions of other companies, products, or assets being more difficult, time-consuming or costly than anticipated;
•the possibility that Mylan may be unable to achieve expected synergies and operating efficiencies in connection with business transformation initiatives, strategic acquisitions, strategic initiatives or restructuring programs within the expected time-framestimeframes or at all;
•uncertainties and matters beyond the control of management, including but not limited to general political and economic conditions and global exchange rates; and
•inherent uncertainties involved in the estimates and judgments used in the preparation of financial statements, and the providing of estimates of financial measures, in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and related standards or on an aadjusted basis.
djusted basis. For more detailed information on the risks and uncertainties associated with Mylan’s business activities, see the risks described in the 20182019 Form 10-K, this Form 10-Q and our other filings with the SEC. These risks, as well as other risks associated with Mylan, the Upjohn Business, the combined company and the Combination are also more fully discussed in the Registration Statement on Form S-4, as amended, which includes a proxy statement/prospectus, which was filed by Upjohn (as defined below) with the SEC on October 25, 2019 and declared effective by the SEC on February 13, 2020, the Registration Statement on Form 10, which includes an information statement, which was filed by Upjohn with the SEC on June 12, 2020 and declared effective by the SEC on June 30, 2020, a definitive proxy statement, which was filed by Mylan with the SEC on February 13, 2020, and a prospectus, which was filed by Upjohn with the SEC on February 13, 2020. You can access Mylan’s filings with the SEC through the SEC website at www.sec.gov or through our website, and Mylan strongly encourages you to do so. Mylan routinely posts information that may be important to investors on our website at investor.mylan.com, and we use this website address as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC’s Regulation Fair Disclosure (Reg FD). The contents of our website are not incorporated by reference in this Form 10-Q and shall not be deemed “filed” under the Securities Exchange Act of 1934, as amended. Mylan undertakes no obligation to update any statements herein for revisions or changes after the filing date of this Form 10-Q other than as required by law.
Company Overview
Mylan is a global pharmaceutical company committed to setting new standards in healthcare and providing 7 billion people access to high quality medicine. We offer a growing portfolio of more than 7,500 products, including prescription generic, branded generic, brand-name drugs and over-the-counter (“OTC”) remedies. We market our products in more than 165 countries and territories. Every member of ourOur approximately 35,000-strong global workforce is dedicated to delivering better health for a better world.
Over the last several years, Mylan has transformed itself through a clear, consistent and differentiated strategy into a company that is built to last. Fueling that durability is a business model anchored in providing access, Mylan’s core purpose.
Providing access requires that we satisfy the needs of an incredibly diverse global marketplace whose economic and political systems, approaches to delivering and paying for healthcare, languages and traditions, and customer and patient requirements vary by location and over time.
With these considerations in mind, we built and scaled our commercial, operational and scientific platforms to meet customers’ evolving needs in ways that are globally consistent and locally sensitive. As a result, not only are we succeeding in expanding people’s access to medicine, we are continually diversifying our business.
ThisThat diversification is what drives our durability. Durability allows us to withstand and overcome competitive pressures while continuing to innovate. It also allows us to generate consistent financial results, including reliable cash flows capable of supporting ongoing investments in long-term growth.
Financial Summary
The tables below are a summary of the Company’s financial results for the three and six months ended June 30, 2019 compared to the prior year periods:
|
| | | | | | | | | | | | | | |
| Three Months Ended |
| June 30, |
(In millions, except per share amounts) | 2019 | | 2018 | | Change | | % Change |
Total revenues | $ | 2,851.5 |
| | $ | 2,808.3 |
| | $ | 43.2 |
| | 2 | % |
Gross profit | 932.6 |
| | 962.5 |
| | (29.9 | ) | | (3 | )% |
Earnings from operations | 95.5 |
| | 178.9 |
| | (83.4 | ) | | (47 | )% |
Net (loss) earnings | (168.5 | ) | | 37.5 |
| | (206.0 | ) | | (549 | )% |
Net (loss) earnings per diluted ordinary share | $ | (0.33 | ) | | $ | 0.07 |
| | $ | (0.40 | ) | | (571 | )% |
| | | | | | | |
| Six Months Ended |
| June 30, |
(In millions, except per share amounts) | 2019 | | 2018 | | Change | | % Change |
Total revenues | $ | 5,347.0 |
| | $ | 5,492.8 |
| | $ | (145.8 | ) | | (3 | )% |
Gross profit | 1,737.8 |
| | 1,946.8 |
| | (209.0 | ) | | (11 | )% |
Earnings from operations | 119.5 |
| | 334.6 |
| | (215.1 | ) | | (64 | )% |
Net (loss) earnings | (193.5 | ) | | 124.6 |
| | (318.1 | ) | | (255 | )% |
Net (loss) earnings per diluted ordinary share | $ | (0.38 | ) | | $ | 0.24 |
| | $ | (0.62 | ) | | (258 | )% |
Certain Market and Industry Factors
As more fully explained in the 20182019 Form 10-K, the global pharmaceutical industry is a highly competitive and highly regulated industry. As a result, we face a number of industry-specific factors and challenges, which can significantly impact our results. The following discussion highlights some of these key factors and market conditions.
Generic products, particularly in the U.S., generally contribute most significantly to revenues and gross margins at the time of their launch, and even more so in periods of market exclusivity, or in periods of limited generic competition. As such, the timing of new product introductions can have a significant impact on the Company’s financial results. The entrance into the market of additional competition generally has a negative impact on the volume and pricing of the affected products. Additionally, pricing is often affected by factors outside of the Company’s control.
For branded products, the majority of the product’s commercial value is usually realized during the period in which the product has market exclusivity. In the U.S. and some other countries, when market exclusivity expires and generic versions of a product are approved and marketed, there can often be very substantial and rapid declines in the branded product’s sales. OTC products also participate in a competitive environment that includes both branded and private label products. In the OTC space, value is realized through innovation, access and consumer activation.
Certain markets in which we do business outside of the U.S. have undergone government-imposed price reductions, and further government-imposed price reductions are expected in the future. Such measures, along with the tender systems discussed below, are likely to have a negative impact on sales and gross profit in these markets. However, government initiatives in certain markets that appear to favor generic products could help to mitigate this unfavorable effect by increasing rates of generic substitution and penetration.
Additionally, a number of markets in which we operate outside of the U.S. have implemented, or may implement, tender systems for generic pharmaceuticals in an effort to lower prices. Generally speaking, tender systems can have an unfavorable impact on sales and profitability. Under such tender systems, manufacturers submit bids that establish prices for generic pharmaceutical products. Upon winning the tender, the winning company will receive priority placement for a period of time. The tender system often results in companies underbidding one another by proposing low pricing in order to win the tender. The loss of a tender by a third party to whom we supply active pharmaceutical ingredientingredients can also have a negative
impact on our sales and profitability. Sales continue to be negatively affected by the impact of tender systems in certain countries.
Recent Developments
Upjohn AgreementIMPACT OF THE CORONAVIRUS PANDEMIC ON OUR BUSINESS AND RESULTS OF OPERATIONS
As a leading global pharmaceutical company, Mylan is committed to continue doing its part in support of public health needs amid the evolving COVID-19 pandemic. The Company’s priorities remain protecting the health and safety of our workforce, continuing to produce critically needed medicines, deploying resources and expertise in the fight against COVID-19 through potential prevention and treatment efforts, supporting the communities in which we operate and maintaining the health of our overall business.
The following section discusses the important measures the Company is taking in light of the COVID-19 pandemic.
Employee Health and Safety
•Mylan continues to align with government and health authority guidelines in an effort to safeguard our workforce and continues to make assessments on an ongoing basis.
•While Mylan’s business operations are currently considered essential based on government guidelines throughout the world due to the important role pharmaceutical manufacturers play within the global healthcare system, many Mylan administrative offices continue operating under work from home protocols.
•Because protecting the health and safety of our workforce remains paramount, Mylan has taken extra precautions at manufacturing facilities to aid in the protection of site personnel and operations, including the implementation of social distancing guidelines, daily health assessments and split shifts where feasible.
•Customer facing field personnel have moved to a remote engagement model to ensure continued support for healthcare professionals, patient care and access to needed products.
•Global restrictions have been placed on travel and in-person meetings.
•Mylan has taken steps to protect the safety of study participants, our employees and staff at clinical trial sites and ensure regulatory compliance and scientific integrity of trial data.
Continuing to Produce Critically Needed Medicines
Manufacturing and Supply
•Mylan has activated worldwide business continuity plans to seek to ensure that our global supply chain platform continues to operate without significant disruption.
•All of our manufacturing facilities, and those of our key global partners, are currently operational and, at this time, we are not experiencing any significant disruptions to our supply chain, including the availability of active pharmaceutical ingredients. Also, we are currently not experiencing any negative impact on our customer service levels.
•Mylan continues to engage with regulatory authorities around the world who are committed to maintaining ongoing regulatory processes while also continuing to make available our global research and development ("R&D"), regulatory and manufacturing expertise and capacity to partners who may be in need of additional resources.
Commercial Operations
•Although the majority of our products globally have not seen a significant decline in customer utilization, as has been publicly reported for several markets and product categories, we are currently experiencing certain fluctuations in COVID-19 related demand trends. We will continue to monitor trends closely as we work to ensure patients have access to needed medicine.
•Inventory levels, both ours and those in our distribution channel, remain in-line with normal levels and are currently assessed to be sufficient for anticipated demand.
Deploying Resources and Expertise in the Fight Against COVID-19
Product Development
•Mylan is also donating certain products to the World Health Organization (WHO) to support its investigation of the potential effectiveness of several medicines in treating COVID-19 as part of the WHO’s global SOLIDARITY trial.
•On May 12, 2020, Mylan announced a global collaboration with Gilead Sciences, Inc. to expand access to the investigational antiviral remdesivir for the potential treatment of COVID-19. Under the terms of the license agreement Mylan has rights to manufacture and distribute remdesivir in 127 low-and middle-income countries, including India.
•On July 29, 2019,6, 2020, Mylan announced that the Company, Pfizer, Inc. ("Pfizer”), Upjohn Inc., a wholly-owned subsidiaryDrug Controller General of Pfizer ("Upjohn"India (the “DCGI”), approved its remdesivir 100 mg/vial for restricted emergency use in India as part of the DCGI’s accelerated approval process to address urgent, unmet needs amid the evolving COVID-19 pandemic.
Maintaining the Health of Our Overall Business
Access to Capital Markets and certainLiquidity
While currently we are not experiencing any negative liquidity trends related to the COVID-19 pandemic, we continue to closely monitor developments and the potential negative impact on our operating performance and our ability to access the capital markets.
Due to the Company’s ability to generate significant cash flows from operations, as well as its revolving credit agreement, other affiliated entities entered into a Business Combination Agreement (the "Business Combination Agreement") pursuantshort-term borrowing facilities and access to capital markets, we believe that we currently have, and will maintain, the ability to meet foreseeable liquidity needs.
Impact on Results of Operations
The global spread of COVID-19 has created significant volatility, uncertainty and economic disruption affecting the markets we serve in North America, Europe and Rest of World, which has had and continues to have an impact on our current year results of operations. The extent to which the COVID-19 pandemic will impact our business, operations and financial results in future periods will depend on numerous evolving factors that are beyond our control and that we may not be able to accurately predict. For additional information, see “Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations - Results of Operations.”
Restructuring Programs
On February 27, 2020, the Company will combine with Upjohnannounced that it has formalized the next steps in its efforts to sustain long-term value creation through the proactive transformation of its business. This transformation initiative includes a Reverse Morris Trust transactionnew global restructuring program (the "Combination"“2020 restructuring program”). UpjohnThe program is a global, primarily off-patent brandedintended to support the Company’s effort to improve operating performance and generic established medicines business, which includes 20 primarily off-patent solid oral dose legacy brands, such as Lyrica, Lipitor, Celebrexmeet anticipated market demands by ensuring that the Company is appropriately structured and Viagra, as well as certain generic medicines.
Priorresourced to deliver sustainable value to customers, patients, other stakeholders and shareholders. Key activities under the Combination and pursuantprogram include supply chain network optimization intended to a Separation Agreement (the "Separation Agreement"), dated as of July 29, 2019, between Pfizer and Upjohn, Pfizer will, among other things, transfer to Upjohn substantially allmaximize the efficiency of the assetsCompany’s global manufacturing and liabilities comprising Upjohn’sdistribution network capacity and further optimizing functional capabilities that support business (the “Separation”) and, thereafter, Pfizer will distribute to Pfizer shareholders allgrowth.
The Company is currently developing the details of the issuedinitiatives, including workforce actions and outstanding sharesother restructuring activities. Further details will be disclosed as plans are finalized, including the estimated amount or range of Upjohn (the "Distribution"amounts to be incurred by major cost type and togetherfuture cash expenditures associated with those initiatives.As a result of the SeparationCOVID-19 pandemic and the Combination, the “Transaction”). The Combination is expected to occur immediately after the Distribution. Following the Combination, it is anticipated that Pfizer’s shareholders will own approximately 57 percentrelated uncertainty and the Company's ordinary shareholders will own approximately 43 percent of Upjohn's common stock.
Prior to, and as a conditioncomplexity of the Distribution, Upjohn will make a cash payment to Pfizer equal to $12.0 billion. Upjohncurrent environment, the Company has obtained commitments fordelayed the initial financingimplementation of the transaction2020 restructuring program which is leading to higher than expected costs in the form of a bridge loan from certain financial institutions. If Upjohn obtains additional funding by issuing securities or obtaining other loans, the amount of the bridge facility will be correspondingly reduced. The bridge loan is subject to customary terms and conditions including a financial covenant.2020.
The consummation of the Combination is subject to various customary closing conditions, including (i) approval by the Company's ordinary shareholders, (ii) anti-trust approvals in various countries, (iii) completion of the Separation (including the payment of $12 billion of cash by Upjohn to Pfizer) and the Distribution, (iv) confirmation by applicable tax authorities of the intended tax treatment of the transaction, (v) obtaining other regulatory approvals necessary to complete the Combination, and (vi) the absence of any law or order from any court or governmental authority restraining, enjoining or prohibiting the transaction.
Restructuring Activities
The Company previously announced a restructuring program representing a series of actions in certain locations that are anticipated to further streamline ourits operations globally. The restructuring program,actions, other than the additional restructuring and remediation activities at the Morgantown, West Virginia plant described below, wasare substantially complete as of December 31, 2018. We have incurred total restructuring related costs of approximately $655.4 million through June 30, 2019. During 2019, we have incurred approximately $54.4 million in restructuring expenses for non-cash asset write-offs at the Morgantown plant. As a result of the overall actions taken under the restructuring program through June 30, 2019, management believes the potential annual savings will be between approximately $400.0 million and $475.0 million once fully realized, with the majority of these savings improving operating cash flow.complete.
In April 2018, the U.S. Food and Drug Administration (the “FDA”) completed an inspection at Mylan’s plant in Morgantown, West Virginia and made observations through a Form 483. The Company submitted a comprehensive response to the FDA and committed to a robust improvement plan. In addition, based upon the Company’s recognition of the continued evolution of industry dynamics and regulatory expectations, during the second quarter of 2018, the Company commenced comprehensive restructuring and remediation activities, which are aimed at reducing the complexity at the Morgantown plant and include the discontinuation and transfer to other manufacturing sites of a number of products, a reduction of the workforce and extensive process and plantfacility remediation. The Company continues to incur incremental manufacturing variances related to these and other activities. In the fourth quarter of 2018, the Company received a warning letter related to the previously
disclosed observations at the plant. The issues raised in the warning letter are being addressed within the context of the Company’s comprehensive restructuring and remediation activities.
The Morgantown plant continues to supply products for On May 11, 2020 we received the U.S. market while we execute on and assess the restructuring and remediation activities. However, these activities have led to a temporary disruption in supply of certain products. Importantly, the profitabilityclose-out of the transferred and discontinued products is not proportionate to the reduced volumes of those products as the Company expects that manufacturing costs related to transferred products will be reduced and many of the discontinued products have lower than average gross margins. In addition, as it relates to North America, no significant newwarning letter.
product revenue is forecasted from the Morgantown plant in 2019, and we are forecasting that only five of our top 50 and only one out of the top 10 gross margin generating products will be manufactured in Morgantown in 2019.
For the three and six months ended June 30, 2019,2020, the Company incurred expenses amounting to approximately $93.7$127.1 million and $163.4 million, respectively for incremental manufacturing variances, site remediation and restructuring charges related to the Morgantown plant.plant, as well as continued product rationalization. At this time, the total expenses related to the additional restructuring and remediationongoing activities at the Morgantown plant cannot be reasonably estimated.
Mylan remains committed to maintaining the highest quality manufacturing standards at its facilities around the world and to continuous assessment and improvement in a time of evolving industry dynamics and regulatory expectations.
Upjohn Business Combination Agreement
On January 30,July 29, 2019, the Company, received FDAPfizer Inc. (“Pfizer”), Upjohn Inc., a wholly-owned subsidiary of Pfizer (“Upjohn” or “Newco”), and certain other affiliated entities entered into a Business Combination Agreement (as amended, the “Business Combination Agreement”) pursuant to which the Company will combine with Pfizer’s Upjohn Business (the “Upjohn Business”) in a Reverse Morris Trust transaction (the “Combination”). Newco, which will be the parent entity of the combined Upjohn Business and Mylan business, will be renamed “Viatris” effective as of the closing of the Combination. The Upjohn Business is a global, primarily off-patent branded and generic established medicines business, which includes 20 primarily off-patent solid oral dose legacy brands, such as Lyrica, Lipitor, Celebrex and Viagra.
Prior to the Combination and pursuant to a Separation and Distribution Agreement (as amended, the “Separation Agreement”), dated as of July 29, 2019, between Pfizer and Newco, Pfizer will, among other things, transfer to Newco substantially all of the assets and liabilities comprising the Upjohn Business (the “Separation”) and, thereafter, Pfizer will distribute to Pfizer stockholders all of the issued and outstanding shares of Newco (the “Distribution”). When the Distribution and Combination are completed, Pfizer stockholders as of the record date of the Distribution will own 57% of the outstanding shares of Newco common stock, and Mylan shareholders as of immediately before the Combination will own 43% of the outstanding shares of Newco common stock, in each case on a fully diluted basis. Newco will make a cash payment to Pfizer equal to $12 billion, to be funded with the proceeds of debt incurred by Newco, as partial consideration for the contribution of the Upjohn Business from Pfizer to Newco.
The consummation of the Combination is subject to the satisfaction (or, if applicable, valid waiver) of various conditions, including (a) the expiration or termination of any applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and the rules and regulations promulgated thereunder and the receipt of regulatory approvals in certain other jurisdictions, (b) the consummation of the Separation and the Distribution in accordance with the terms of the Separation Agreement, (c) the approval of WixelaTM InhubTM (fluticasone propionatethe Combination by Mylan shareholders, (d) the absence of any legal restraint (including legal actions or proceedings pursued by U.S. state authorities in the relevant states) preventing the consummation of the transactions, (e) in the case of Pfizer’s and salmeterol inhalation powder, USP)Newco’s obligations to consummate the transactions, (i) the distribution of $12 billion in cash from Upjohn to Pfizer in accordance with the terms of the Separation Agreement and (ii) the receipt by Pfizer of a U.S. Internal Revenue Service (“IRS”) ruling and tax opinion of its tax counsel with respect to the Combination, and (f) other customary closing conditions.
On March 17, 2020, Pfizer received the IRS ruling with respect to the Combination, which is generally binding, unless the relevant facts or circumstances change prior to closing. On June 30, 2020, Mylan’s shareholders voted to approve the Combination at the extraordinary general meeting of shareholders.
On May 29, 2020, Mylan, Pfizer, Newco and certain of their affiliates entered into Amendment No. 1 to the Business Combination Agreement (the “BCA Amendment”), and Pfizer and Newco entered into Amendment No. 2 to the first genericSeparation and Distribution Agreement (the “SDA Amendment” and, together with the BCA Amendment, the “Amendments”). In light of GlaxoSmithKline’s Advair Diskusthe ongoing regulatory review process, including delays related to the COVID-19 pandemic, the Amendments provide, among other things, that the closing of the Combination shall not occur prior to October 1, 2020 (unless otherwise agreed to by Mylan and Pfizer) and that the Outside Date (as defined in the Business Combination Agreement) shall be December 31, 2020. Mylan and Pfizer expect the closing of the Combination to occur in the fourth quarter of 2020.
On June 16, 2020, Upjohn entered into a revolving credit agreement (the “Upjohn Revolving Credit Agreement”), by and among Upjohn, certain lenders and issuing banks from time to time party thereto and Bank of America, N.A., as administrative agent (in such capacity, the “Upjohn Revolving Administrative Agent”). The commercial launchUpjohn Revolving Credit Agreement contains a revolving credit facility (the “Upjohn Revolving Credit Facility”) under which Upjohn may obtain extensions of credit in an aggregate principal amount not to exceed $4.0 billion, in U.S. dollars or alternative currencies including Euro, Sterling, Yen and any other currency that is approved by the Upjohn Revolving Administrative Agent and each lender under the Upjohn Revolving Credit Facility. The Upjohn Revolving Credit Facility will be available to Upjohn upon (a) its delivery of a certificate certifying that (i) the conditions to the consummation of the WixelaCombination have been satisfied or waived or are expected to be satisfied or waived on the date of funding of such facility or within one business day thereafter and (ii) the distribution by Pfizer to its stockholders of its shares of Upjohn’s common stock, by way of either, at Pfizer’s option, a spin-off or a split-off, pursuant to the Separation Agreement is expected to be, the Combination is expected to be, and the contribution of the Upjohn Business to Upjohn has been or is expected to be consummated on the Upjohn Revolver Closing Date (as defined below) or within one business day thereafter (an “RMT Condition Certificate”) and (b) the satisfaction of certain customary conditions (the date such conditions are satisfied or waived being referred to as the “Upjohn Revolver Closing Date”). Subject to satisfaction of the foregoing conditions, up to $1.5 billion under the Upjohn Revolving Credit Facility will be available to Upjohn in a single draw on the Upjohn Revolver Closing Date for the sole purpose of funding a portion of the cash payment of $12.0 billion by Upjohn to Pfizer as partial consideration for Pfizer’s contribution of the Upjohn Business to Upjohn, as required by the Separation Agreement.
On June 16, 2020, Upjohn entered into a delayed draw term loan credit agreement (the “Upjohn Term Loan Credit Agreement”), by and among Upjohn, Mizuho Bank, Ltd. and MUFG Bank, Ltd., as administrative agent. The Upjohn Term Loan Credit Agreement provides for an 18-month $600.0 million principal amount delayed draw senior unsecured term loan facility (the “Upjohn Term Loan Credit Facility”).
The Upjohn Term Loan Credit Facility will be available to Upjohn upon its delivery of an RMT Condition Certificate and upon satisfaction of certain customary conditions. Upjohn intends to borrow the full $600.0 million aggregate principal amount available under the Upjohn Term Loan Credit Facility in order to fund a portion of the cash payment to Pfizer and related transaction fees and expenses, as required by the Separation Agreement.
On June 22, 2020, Upjohn completed a private offering of $7.45 billion aggregate principal amount of Upjohn’s senior, U.S. dollar-denominated notes (the “Upjohn U.S. Dollar Notes”) and on June 23, 2020, Upjohn Finance B.V. (“Finco”), a wholly-owned financing subsidiary of Upjohn, completed a private offering of €3.60 billion aggregate principal amount of Finco’s senior, euro-denominated notes (the “Upjohn Euro Notes” and, together with the Upjohn U.S. Dollar Notes, the “Upjohn Notes”), which are guaranteed on a senior unsecured basis by Upjohn. Upjohn intends to use the net proceeds from the offerings of the Upjohn Notes, together with the net proceeds from the Upjohn Term Loan Credit Facility, to fund in full the $12.0 billion cash payment to Pfizer and related transaction fees and expenses. The Upjohn Notes are initially guaranteed on a senior unsecured basis by Pfizer, which guarantees will be automatically and unconditionally terminated and released without consent of holders upon the consummation of the Distribution. Upon the consummation of the Combination, the Mylan entities (which will be subsidiaries of Upjohn following the Combination) that are issuers or guarantors of the outstanding senior unsecured notes issued by Mylan N.V. or Mylan Inc. ( the “Mylan Notes”) will become guarantors of the Upjohn Notes, substantially concurrently with Upjohn becoming a guarantor of the Mylan Notes.
Upjohn had previously obtained commitments for the initial financing of the transaction in the form of a bridge loan from certain financial institutions. The bridge loan was subject to customary terms and conditions including a financial covenant. The commitments under the bridge loan commitment letter dated as of July 29, 2019 were reduced concurrently with the effectiveness of the Upjohn Revolving Credit Agreement and Upjohn Term Loan Credit Agreement, and were fully terminated upon the completion of each offering of Upjohn Notes.
Under the terms of the Business Combination Agreement and Separation Agreement, Mylan will be obligated to reimburse Pfizer for 43% of certain financing related costs if the Combination does not close and Viatris will be obligated to reimburse Pfizer for all such financing related costs if the Combination closes. As a result of the completion of the financing transactions described above, Mylan recorded an $85.0 million charge during the three months ended June 30, 2020, which is included as a component of selling, general and administrative expenses (“SG&A”) in the condensed consolidated statements of operations to reflect Mylan’s obligation to reimburse Pfizer for 43% of those financing related costs.
TMIn connection with the Separation Agreement and the Business Combination Agreement, Pfizer, Upjohn and Mylan previously agreed to review and negotiate a potential transfer of Pfizer’s Meridian Medical Technologies business (the “Meridian Business”) to Upjohn. The Meridian Business is Mylan’s supplier of EpiPen® Auto-Injectors pursuant to an agreement that had an expiration date of December 31, 2020 (the “EpiPen Supply Agreement”). InhubTM occurredInstead of proceeding with the transfer of the Meridian Business, Pfizer and Mylan agreed subsequent to June 30, 2020 to extend the EpiPen Supply Agreement for an additional four-year period through December 31, 2024, with an option for Mylan (or Upjohn) to further extend the term for an additional one-year period thereafter. Mylan and Pfizer have also reached a preliminary agreement on the general terms under which Pfizer would transfer certain Pfizer assets that currently form part of a pre-existing strategic collaboration between Pfizer and Mylan for generic drugs in February 2019.Japan to Mylan or, following the Combination, to Viatris. Any such proposed transaction would be subject to the finalization and execution of a definitive agreement that would contain customary closing conditions including, but not limited to, receipt of any necessary regulatory approvals.
Financial Summary
The tables below are a summary of the Company’s financial results for the three and six months ended June 30, 2020 compared to the prior year periods:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended | | | | | | |
| June 30, | | | | | | |
(In millions, except per share amounts) | 2020 | | 2019 | | Change | | % Change |
Total revenues | $ | 2,731.2 | | | $ | 2,851.5 | | | $ | (120.3) | | | (4) | % |
Gross profit | 1,025.7 | | | 932.6 | | | 93.1 | | | 10 | % |
Earnings from operations | 134.2 | | | 95.5 | | | 38.7 | | | 41 | % |
Net earnings (loss) | 39.4 | | | (168.5) | | | 207.9 | | | 123 | % |
Net earnings (loss) per diluted ordinary share | $ | 0.08 | | | $ | (0.33) | | | $ | 0.41 | | | 124 | % |
| | | | | | | |
| Six Months Ended | | | | | | |
| June 30, | | | | | | |
(In millions, except per share amounts) | 2020 | | 2019 | | Change | | % Change |
Total revenues | $ | 5,350.4 | | | $ | 5,347.0 | | | $ | 3.4 | | | — | % |
Gross profit | 1,931.8 | | | 1,737.8 | | | 194.0 | | | 11 | % |
Earnings from operations | 318.9 | | | 119.5 | | | 199.4 | | | 167 | % |
Net earnings (loss) | 60.2 | | | (193.5) | | | 253.7 | | | 131 | % |
Net earnings (loss) per diluted ordinary share | $ | 0.12 | | | $ | (0.38) | | | $ | 0.50 | | | 132 | % |
A detailed discussion of the Company’s financial results can be found below in the section titled “Results of Operations.” As part of this discussion, we also report sales performance using the non-GAAP financial measures of “constant currency” net sales and total revenues. These measures provide information on the change in net sales and total revenues assuming that foreign currency exchange rates had not changed between the prior and current period. The comparisons presented at constant currency rates reflect comparative local currency sales at the prior year’s foreign exchange rates. We routinely evaluate our net sales and total revenues performance at constant currency so that sales results can be viewed without the impact of foreign currency exchange rates, thereby facilitating a period-to-period comparison of our operational activities, and believe that this presentation also provides useful information to investors for the same reason.
More information about non-GAAP measures used by the Company as part of this discussion, including adjusted cost of sales, adjusted gross margins, adjusted net earnings and adjusted EPSEBITDA (all of which are defined below) can be found in “Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations - Results of Operations - Use of Non-GAAP Financial Measures.”
Results of Operations
Three Months Ended June 30, 20192020 Compared to Three Months Ended June 30, 20182019
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended | | | | | | | | | | |
| June 30, | | | | | | | | | | |
(In millions) | 2020 | | 2019 | | % Change | | 2020 Currency Impact (1) | | 2020 Constant Currency Revenues | | Constant Currency % Change (2) |
Net sales | | | | | | | | | | | |
North America | $ | 1,039.0 | | | $ | 1,023.4 | | | 2 | % | | $ | 2.2 | | | $ | 1,041.2 | | | 2 | % |
Europe | 935.0 | | | 989.6 | | | (6) | % | | 21.3 | | | 956.3 | | | (3) | % |
Rest of World | 721.9 | | | 805.2 | | | (10) | % | | 44.1 | | | 766.0 | | | (5) | % |
Total net sales | 2,695.9 | | | 2,818.2 | | | (4) | % | | $ | 67.6 | | | $ | 2,763.5 | | | (2) | % |
| | | | | | | | | | | |
Other revenues (3) | 35.3 | | | 33.3 | | | 6 | % | | (0.1) | | | 35.2 | | | 6 | % |
Consolidated total revenues (4) | $ | 2,731.2 | | | $ | 2,851.5 | | | (4) | % | | $ | 67.5 | | | $ | 2,798.7 | | | (2) | % |
|
| | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended |
| June 30, |
(In millions) | 2019 | | 2018 | | % Change | | 2019 Currency Impact (1) | | 2019 Constant Currency Revenues | | Constant Currency % Change (2) |
Net sales | | | | | | | | | | | |
North America | $ | 1,023.4 |
| | $ | 1,000.8 |
| | 2 | % | | $ | 2.2 |
| | $ | 1,025.6 |
| | 2 | % |
Europe | 989.6 |
| | 990.6 |
| | — | % | | 59.5 |
| | 1,049.1 |
| | 6 | % |
Rest of World | 805.2 |
| | 764.1 |
| | 5 | % | | 31.9 |
| | 837.1 |
| | 10 | % |
Total net sales | 2,818.2 |
| | 2,755.5 |
| | 2 | % | | $ | 93.6 |
| | $ | 2,911.8 |
| | 6 | % |
| | | | | | | | | | | |
Other revenues (3) | 33.3 |
| | 52.8 |
| | (37 | )% | | 0.7 |
| | 34.0 |
| | (36 | )% |
Consolidated total revenues (4) | $ | 2,851.5 |
| | $ | 2,808.3 |
| | 2 | % | | $ | 94.3 |
| | $ | 2,945.8 |
| | 5 | % |
____________(1)____________Currency impact is shown as unfavorable (favorable).
| |
(1)(2)The constant currency percentage change is derived by translating net sales or revenues for the current period at prior year comparative period exchange rates, and in doing so shows the percentage change from 2020 constant currency net sales or revenues to the corresponding amount in the prior year. (3)For the three months ended June 30, 2020, other revenues in North America, Europe, and Rest of World were approximately $14.9 million, $3.5 million, and $16.9 million, respectively. For the three months ended June 30, 2019, other revenues in North America, Europe, and Rest of World were approximately $19.1 million, $3.8 million, and $10.4 million, respectively. (4)Amounts exclude intersegment revenue that eliminates on a consolidated basis. | Currency impact is shown as unfavorable (favorable). |
| |
(2)
| The constant currency percentage change is derived by translating net sales or revenues for the current period at prior year comparative period exchange rates, and in doing so shows the percentage change from 2019 constant currency net sales or revenues to the corresponding amount in the prior year. |
| |
(3)
| For the three months ended June 30, 2019, other revenues in North America, Europe, and Rest of World were approximately $19.1 million, $3.8 million, and $10.4 million, respectively. |
| |
(4)
| Amounts exclude intersegment revenue that eliminates on a consolidated basis. |
Total Revenues
For the current quarter, Mylan reported total revenues of $2.85$2.73 billion,, compared to $2.81$2.85 billion for the comparable prior year period, representing an increasea decrease of $43.2$120.3 million, or 2%4%. Total revenues include both net sales and other revenues from third parties. Net sales for the current quarter were $2.82$2.70 billion,, compared to $2.76$2.82 billion for the comparable prior year period, representing an increasea decrease of $62.7$122.3 million, or 2%4%. Other revenues for the current quarter were $33.3$35.3 million,, compared to $52.8$33.3 million for the comparable prior year period, aperiod.
The decrease of $19.5 million.
The increase in net sales includedwas primarily the result of a decrease in net sales in the Rest of World segment of 10% and a decrease in net sales in the Europe segment of 6%, which were partially offset by an increase in the North America segment of 2% and in the Rest of World segment of 5%. Net sales in the Europe segment were essentially flat when compared to the prior year period. Mylan’s net sales were unfavorably impacted by the effect of foreign currency translation, primarily reflecting changes in the U.S. Dollar as compared to the currencies of Mylan’s subsidiaries in India, the European Union and Australia. The unfavorable impact of foreign currency translation on current period net sales was approximately $93.6$67.6 million, or 3%2%. On a constant currency basis, net sales increaseddecreased by approximately $156.3$54.7 million, or 6%2%. This increasedecrease was primarily driven by new productlower pricing and volumes from net sales of existing products, partially offset by a decrease innew product sales. In the second quarter of 2020, the COVID-19 pandemic negatively impacted our net sales, from existing products asprimarily in our Europe and Rest of World segments, by approximately 5%, primarily driven by lower retail pharmacy demand, lower non-COVID-19 related patient hospital visits and a resultlower number of lower volumesin person meetings with prescribers and to a lesser extent, pricing.payors.This negative impact included the reversal of the forward purchasing, which increased net sales by approximately 2% in the first quarter of 2020.
From time to time, a limited number of our products may represent a significant portion of our net sales, gross profit and net earnings. Generally, this is due to the timing of new product introductions and the amount, if any, of additional competition in the market. Our top ten products in terms of net sales, in the aggregate, represented approximately 24%26% and 22%24% for the three months ended June 30, 20192020 and 2018,2019, respectively. This percentage may fluctuate based upon the timing of new product launches, seasonality and the timing of the discontinuation of products.
Net sales are derived from our three geographic reporting segments: North America, Europe and Rest of World. The graph below shows net sales by segment for the three months ended June 30, 20192020 and 20182019 and the net change period over period:
North America Segment
Net sales from North America increased by $22.6$15.6 million or 2% during the three months ended June 30, 20192020 when compared to the prior year period. This increase was primarily driven by higher volumes from net sales of existing products and new product sales and partially offset by lower volumespricing on sales of existing products. Higher volumes from net sales of existing products and, to a lesser extent, pricing. New product sales were primarily driven by sales of Fulphila™ (biosimilar to Neulasta®) and the WixelaTM InhubTM. The volume decline fromand Yupelri®, partially offset by lower EpiPen volumes. Lower pricing on sales of existing products was due todriven by changes in the competitive environment.environment, including for Levothyroxine Sodium. The impact of foreign currency translation on current period net sales was insignificant within North America.
Europe Segment
Net sales from Europe decreased by $1.0$54.6 million or 6% during the three months ended June 30, 20192020 when compared to the prior year period. ThisThe decrease was primarily the resultdue to lower volumes from net sales of existing products due to COVID-19, the unfavorable impact of foreign currency translation of approximately $59.5$21.3 million or 6%2%, and to a lesser extent, lower pricing on sales of existing products. The unfavorable impact of foreign currency translationthese items was partially offset by new product sales, including Hulio™ and the TOBI Podhaler®, and higher volumes of existing products.sales. Constant currency net sales increaseddecreased by approximately $58.5$33.3 million, or 6%3%, when compared to the prior year period.
Rest of World Segment
Net sales from Rest of World increaseddecreased by $41.1$83.3 million or 5%10% during the three months ended June 30, 20192020 when compared to the prior year period. This increasedecrease was primarily the result of higher volumes of existing products primarily driven by products sold in China and new product sales in Australia and emerging markets. These increases were partially offset primarily by the unfavorable impact of foreign currency translation, lower volumes from net sales of existing products, driven by the negative impact of COVID-19 in many emerging markets including China, and to a lesser extent, by lower pricing onfrom net sales of existing products.products, primarily driven by government price cuts in Japan. These decreases were partially offset by new product sales, primarily in Australia. Overall, net sales from Rest of World were unfavorably impacted by the effect of foreign currency translation by approximately $31.9$44.1 million, or 4%5%. Constant currency net sales increaseddecreased by approximately $73.0$39.2 million, or 10%5% when compared to the prior year period.
Cost of Sales and Gross Profit
Cost of sales increaseddecreased from $1.85 billion for the three months ended June 30, 2018 to $1.92 billion for the three months ended June 30, 2019.2019 to $1.71 billion for the three months ended June 30, 2020. Cost of sales was primarily impacted by purchase accounting related amortization of acquired intangible assets and other special items, which are described further in the section titled Use of Non-GAAP Financial Measures. Gross profit for the three months ended June 30, 20192020 was $932.6 million$1.03 billion and gross margins were 33%38%. For the three months ended June 30, 2018,2019, gross profit was $962.5 million$0.93 billion and gross margins were 34%33%. Gross margins were negativelypositively impacted by lower amortization expense from acquired intangible assets and intangible asset impairment charges realized in the incremental amortization from product acquisitions and by expenses related to the recall of Valsartan products, each of which decreased gross margins by approximately 50 basis points. Gross margins were also negatively impacted as a result of lower gross profit for sales of existing products partially offset by the impact from new product sales.prior year period. In addition, gross margins were negatively affectedpositively impacted by approximately 25 basis points as a resulthigher gross profit from net sales of incremental manufacturing expenses, site remediation expenses and incremental restructuring charges incurred during the current period principally as a resultexisting products in North America, primarily driven by gross profit from sales of the activities atWixelaTM InhubTM, and lower restructuring expenses in North America. These items were partially offset by lower gross margins from the Company’s Morgantown plant.net sales of existing products in the Rest of World segment, including in China. Adjusted gross margins were 54% for the three months ended June 30, 2019,2020, compared to 53%54% for the three months ended June 30, 2018.2019. Adjusted gross margins were positively impacted by higher gross profit from net sales of existing products in North America, primarily driven by gross profit from sales of the Wixela
TM InhubTM. This impact was partially offset by lower gross margins from the net sales of existing products in the Rest of World segment, primarily in China and emerging markets.
A reconciliation between cost of sales, as reported under U.S. GAAP, and adjusted cost of sales and adjusted gross margin for the three months ended June 30, 20192020 compared to the three months ended June 30, 20182019 is as follows:
| | | Three Months Ended | | Three Months Ended | |
| June 30, | | June 30, | |
(In millions) | 2019 | | 2018 | (In millions) | 2020 | | 2019 |
U.S. GAAP cost of sales | $ | 1,918.9 |
| | $ | 1,845.8 |
| U.S. GAAP cost of sales | $ | 1,705.5 | | | $ | 1,918.9 | |
Deduct: | | | | Deduct: | |
Purchase accounting amortization and other related items | (440.0 | ) | | (427.4 | ) | Purchase accounting amortization and other related items | (351.8) | | | (440.0) | |
Acquisition related items | (1.6 | ) | | (0.8 | ) | Acquisition related items | (1.3) | | | (1.6) | |
Restructuring and related costs | (46.3 | ) | | (41.0 | ) | Restructuring and related costs | (4.1) | | | (46.3) | |
Share-based compensation expense | (0.5 | ) | | — |
| Share-based compensation expense | (0.4) | | | (0.5) | |
Other special items | (112.1 | ) | | (64.0 | ) | Other special items | (99.5) | | | (112.1) | |
Adjusted cost of sales | $ | 1,318.4 |
| | $ | 1,312.6 |
| Adjusted cost of sales | $ | 1,248.4 | | | $ | 1,318.4 | |
| | | | | | | |
Adjusted gross profit (a) | $ | 1,533.1 |
| | $ | 1,495.7 |
| Adjusted gross profit (a) | $ | 1,482.8 | | | $ | 1,533.1 | |
| | | | | | | |
Adjusted gross margin (a) | 54 | % | | 53 | % | Adjusted gross margin (a) | 54 | % | | 54 | % |
____________
| |
(a)(a)Adjusted gross profit is calculated as total revenues less adjusted cost of sales. Adjusted gross margin is calculated as adjusted gross profit divided by total revenues. | Adjusted gross profit is calculated as total revenues less adjusted cost of sales. Adjusted gross margin is calculated as adjusted gross profit divided by total revenues. |
Operating Expenses
Research & Development Expense
Research and development (“R&D”)&D expense for the three months ended June 30, 20192020 was $147.6$156.3 million, compared to $206.7 million for the comparable prior year period, a decrease of $59.1 million. This decrease was primarily due to lower expenditures related to the reprioritization of global programs, and higher payments in the prior year period related to licensing arrangements for products in development.
Selling, General & Administrative Expense
Selling, general and administrative (“SG&A”) expense for the current quarter was $668.6 million, compared to $623.3$147.6 million for the comparable prior year period, an increase of $45.3$8.7 million. This increase was primarily due to a $30 million milestone payment due to Revance Therapeutics, Inc. (“Revance”) for the continuation of the development program for a biosimilar to the branded biologic product (onabotulinumtoxinA) marketed as BOTOX® in the current year period, partially offset by lower expenditures related to the reprioritization of global programs.
Selling, General & Administrative Expense
SG&A expense for the current quarter was $719.4 million, compared to $668.6 million for the comparable prior year period, an increase of $50.8 million. The increase was primarily duethe result of higher consulting fees and other expenses primarily related to continued investments in selling and marketing activities. Also impacting the quarter was higher share-based compensation expense due to a reduction ofpending Combination totaling approximately $23.5$120.0 million in the second quarter of 2018 related to certain performance-based awards and a decrease in bad debt expense ofcurrent year period, including approximately $28.5$85.0 million related to obligations to reimburse Pfizer for certain financing costs under the Business Combination Agreement and Separation Agreement (the “Combination Agreements”). Partially offsetting this increase were lower selling and promotional expenses, including through our active management and certain lower expenses as a special business interruption event for one customer in the prior year period.result of COVID-19.
Litigation Settlements and Other Contingencies, Net
During the three months ended June 30, 20192020 and 2018,2019, the Company recorded a net charge of $20.9$15.8 million and $46.4$20.9 million, respectively.
The following table includes the losses/(gains) recognized in litigation settlements and other contingencies, net during the three months ended June 30, 20192020 and June 30, 2018:2019:
| | | | | | | | | | | |
| Three Months Ended | | |
| June 30, | | |
(In millions) | 2020 | | 2019 |
Respiratory delivery platform contingent consideration adjustment | $ | 12.1 | | | $ | (24.8) | |
Litigation settlements, net | 3.7 | | | 45.7 | |
Total litigation settlements and other contingencies, net | $ | 15.8 | | | $ | 20.9 | |
|
| | | | | | | |
| Three Months Ended |
| June 30, |
(In millions) | 2019 | | 2018 |
Respiratory delivery platform contingent consideration adjustment | $ | (24.8 | ) | | $ | (32.7 | ) |
Litigation settlements | 45.7 |
| | (13.7 | ) |
Total litigation settlements and other contingencies, net | $ | 20.9 |
| | $ | (46.4 | ) |
During the three months ended June 30, 2020, the Company recorded a $12.1 million loss for fair value adjustments related to Pfizer’s proprietary dry powder inhaler delivery platform (the “respiratory delivery platform”) contingent consideration and a net charge of approximately $3.7 million related to a number of litigation matters. During the three months ended June 30, 2019, the Company recognized expense of approximately $18.0 million for a settlement in principle related to the modafinil antitrust matter, approximately $30.0 million for a settlement in principle with the SEC in connection with the SEC staff's investigation of the Company's public disclosures regarding its 2016 settlement with the Department of Justice concerning the EpiPen Medicaid Drug Rebate Program, which remains subject to SEC approval. For the three months ended June 30, 2018, the net gains primarilyProgram. These charges were partially offset by a gain of $24.8 million for fair value adjustments related to the resolution of certain patent infringement matters.respiratory delivery platform contingent consideration.
Interest Expense
Interest expense for the three months ended June 30, 20192020 totaled $131.2$116.2 million, compared to $139.2$131.2 million for the three months ended June 30, 2018,2019, a decrease of $8.0$15.0 million. The decrease is primarily due to lower average long-term debt balances during the current quarter as compared to the prior year period including the impact of the redemption of the 2018 Senior Notes in the prior year period.
Other (Income) Expense, Net
Other expense,income, net, was $16.4$2.0 million for the three months ended June 30, 2019,2020, compared to $21.0expense of $16.4 million for the comparable prior year period. Other (income) expense, net includes losses from equity affiliates, foreign exchange gains and losses and interest and dividend income. Other (income) expense, net was comprised of the following for the three months ended June 30, 20192020 and 2018,2019, respectively:
| | | | | | | | | | | |
| Three Months Ended | | |
| June 30, | | |
(In millions) | 2020 | | 2019 |
Losses from equity affiliates, primarily clean energy investments | $ | 17.2 | | | $ | 16.2 | |
Foreign exchange losses, net | 3.8 | | | 0.4 | |
| | | |
| | | |
| | | |
Other gains, net | (23.0) | | | (0.2) | |
Other (income) expense, net | $ | (2.0) | | | $ | 16.4 | |
|
| | | | | | | |
| Three Months Ended |
| June 30, |
(In millions) | 2019 | | 2018 |
Losses from equity affiliates, primarily clean energy investments | $ | 16.2 |
| | $ | 22.9 |
|
Foreign exchange losses/(gains), net | 0.4 |
| | (2.0 | ) |
Other (gains)/losses, net | (0.2 | ) | | 0.1 |
|
Other expense, net | $ | 16.4 |
| | $ | 21.0 |
|
Included in other gains for the three months ended June 30, 2020 was a $16.5 million gain for a fair value adjustment related to a non-marketable investment which the Company holds.Income Tax (Benefit) Provision (Benefit)
For the three months ended June 30, 2019,2020, the Company recognized an income tax provisionbenefit of $116.4$19.4 million, compared to an income tax benefitprovision of $18.8$116.4 million for the comparable prior year period, an increase of $135.2$135.8 million. During the current quarter, the Company recognized a benefit as a result of changes in the assessment of the realizability of deferred tax assets. During the three months ended June 30, 2019, the Company reached a settlement in principle with the Internal Revenue Service ("IRS")IRS to resolve federal tax matters related to the February 27, 2015 EPD Business Acquisition,acquisition by Mylan N.V. of Mylan Inc. and Abbott Laboratories’ non-U.S. developed markets specialty and branded generics business, including adjusting the interest rates used for intercompany loans and confirming our status as a non-U.S. corporation for U.S. federal income tax purposes. We are currently in the process of memorializing our closing agreement with the IRS, which we expect to enter into in the third quarter. In the prior year period, income tax benefitspurposes, and recorded a reserve of approximately $31.0$140.0 million were recognized upon revaluationsas part of certain deferred tax items upon statutory rate changes in certain non-U.S. jurisdictions. Partially offsetting this benefit was a net increase in the reserveits liability for uncertain tax benefitspositions, with a net impact to the income tax provision of approximately $11.0 million.$129.9 million related to this matter. Also impacting the current year income tax benefit was the changing mix of income earned in jurisdictions with differing tax rates.
Six Months Ended June 30, 20192020 Compared to Six Months Ended June 30, 20182019
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Six Months Ended | | | | | | | | | | |
| June 30, | | | | | | | | | | |
(In millions) | 2020 | | 2019 | | % Change | | 2020 Currency Impact (1) | | 2020 Constant Currency Revenues | | Constant Currency % Change (2) |
Net sales | | | | | | | | | | | |
North America | $ | 1,994.5 | | | $ | 1,946.3 | | | 2 | % | | $ | 3.3 | | | $ | 1,997.8 | | | 3 | % |
Europe | 1,956.9 | | | 1,884.9 | | | 4 | % | | 54.6 | | | 2,011.5 | | | 7 | % |
Rest of World | 1,332.7 | | | 1,447.6 | | | (8) | % | | 74.0 | | | 1,406.7 | | | (3) | % |
Total net sales | 5,284.1 | | | 5,278.8 | | | — | % | | 131.9 | | | 5,416.0 | | | 3 | % |
| | | | | | | | | | | |
Other revenues (3) | 66.3 | | | 68.2 | | | (3) | % | | 0.2 | | | 66.5 | | | (2) | % |
Consolidated total revenues (4) | $ | 5,350.4 | | | $ | 5,347.0 | | | — | % | | $ | 132.1 | | | $ | 5,482.5 | | | 3 | % |
____________
(1)Currency impact is shown as unfavorable (favorable).
|
| | | | | | | | | | | | | | | | | | | | | |
| Six Months Ended |
| June 30, |
(In millions) | 2019 | | 2018 | | % Change | | 2019 Currency Impact (1) | | 2019 Constant Currency Revenues | | Constant Currency % Change (2) |
Net sales | | | | | | | | | | | |
North America | $ | 1,946.3 |
| | $ | 1,986.1 |
| | (2 | )% | | $ | 4.9 |
| | $ | 1,951.2 |
| | (2 | )% |
Europe | 1,884.9 |
| | 2,029.0 |
| | (7 | )% | | 137.0 |
| | 2,021.9 |
| | — | % |
Rest of World | 1,447.6 |
| | 1,390.8 |
| | 4 | % | | 83.7 |
| | 1,531.3 |
| | 10 | % |
Total net sales | 5,278.8 |
| | 5,405.9 |
| | (2 | )% | | 225.6 |
| | 5,504.4 |
| | 2 | % |
| | | | | | | | | | | |
Other revenues (3) | 68.2 |
| | 86.9 |
| | (22 | )% | | 1.6 |
| | 69.8 |
| | (20 | )% |
Consolidated total revenues (4) | $ | 5,347.0 |
| | $ | 5,492.8 |
| | (3 | )% | | $ | 227.2 |
| | $ | 5,574.2 |
| | 1 | % |
(2)____________The constant currency percentage change is derived by translating net sales or revenues for the current period at prior year comparative period exchange rates, and in doing so shows the percentage change from 2020 constant currency net sales or revenues to the corresponding amount in the prior year. | |
(1)(3)For the six months ended June 30, 2020, other revenues in North America, Europe, and Rest of World were approximately $34.4 million, $7.7 million, and $24.2 million, respectively. For the six months ended June 30, 2019, other revenues in North America, Europe, and Rest of World were approximately $41.2 million, $8.5 million, and $18.5 million, respectively. (4)Amounts exclude intersegment revenue that eliminates on a consolidated basis. | Currency impact is shown as unfavorable (favorable). |
| |
(2)
| The constant currency percentage change is derived by translating net sales or revenues for the current period at prior year comparative period exchange rates, and in doing so shows the percentage change from 2019 constant currency net sales or revenues to the corresponding amount in the prior year. |
| |
(3)
| For the six months ended June 30, 2019, other revenues in North America, Europe, and Rest of World were approximately $41.2 million, $8.5 million, and $18.5 million, respectively. |
| |
(4)
| Amounts exclude intersegment revenue that eliminates on a consolidated basis. |
Total Revenues
For the six months ended June 30, 2019,2020, Mylan reported total revenues of $5.35 billion, compared to $5.49$5.35 billion for the comparable prior year period, representing a decreasean increase of $145.8$3.4 million, or 3%less than 1%. Total revenues include both net sales and other revenues from third parties. Net sales for the six months ended June 30, 20192020 were $5.28 billion, compared to $5.41$5.28 billion for the comparable prior year period, representing a decreasean increase of $127.1$5.3 million, or 2%less than 1%. Other revenues for the six months ended June 30, 20192020 were $68.2$66.3 million, compared to $86.9$68.2 million for the comparable prior year period.
The decreaseincrease in net sales included a decreasewas primarily the result of an increase in net sales in the Europe segment of 7%4% and an increase in net sales in the North America segment of 2%. These decreases, which were partially offset by an increasea decrease in net sales in the Rest of World segment of 4%8%. Mylan’s net sales were unfavorably impacted by the effect of foreign currency translation, primarily reflecting changes in the U.S. Dollar as compared to the currencies of Mylan’s subsidiaries in India, Australia, and the European Union.Union, India and Australia. The unfavorable impact of foreign currency translation on current year net sales was approximately $225.6$131.9 million, or 4%3%. On a constant currency basis, the increase in net sales was approximately $98.5$137.2 million, or 2%3% for the six months ended June 30, 2019.2020. This increase was primarily driven by higher volumes of existing products, and to a lesser extent, new product sales, partially offset by a decrease inlower pricing on sales of existing products. We have estimated that the net impact of the COVID-19 pandemic decreased total net sales from existing products as a result of lower volumes and to a lesser extent, pricing.consolidated total revenues during the six months ended June 30, 2020 by approximately 2%.
From time to time, a limited number of our products may represent a significant portion of our net sales, gross profit and net earnings. Generally, this is due to the timing of new product introductions and the amount, if any, of additional competition in the market. Our top ten products in terms of net sales, in the aggregate, represented approximately 24% and 19%24% for the six months ended June 30, 20192020 and 2018,2019, respectively. This percentage may fluctuate based upon the timing of new product launches, seasonality and the timing of the discontinuation of products.
Net sales are derived from our three geographic reporting segments: North America, Europe and Rest of World. The graph below shows net sales by segment for the six months ended June 30, 20192020 and 20182019 and the net change period over period:
North America Segment
Net sales from North America decreasedincreased by $39.8$48.2 million or 2% during the six months ended June 30, 20192020 when compared to the prior year period. This decreaseincrease was due primarily to lowerhigher volumes on sales of existing products, and to a lesser extent, new product sales. The higher volumes on sales of existing products were primarily driven by the expected growth of WixelaTM InhubTM and Yupelri® partially due to the launch timing of each product when compared to the prior year period. The increase in net sales was partially offset by lower net sales of existing products as a result of lower pricing. Lower pricing on sales of existing products was driven by changes in the competitive environment, and the impact of the Morgantown plant remediation activities, and to a lesser extent pricing. These decreases were partially offset by new product sales, including WixelaTM InhubTM and Fulphila™ (biosimilar to Neulasta®).for Levothyroxine Sodium. The impact of foreign currency translation on current period net sales was insignificant within North America.
Europe Segment
Net sales from Europe decreased by $144.1 million or 7% during the six months ended June 30, 2019 when compared to the prior year period. This decrease was primarily the result of the unfavorable impact of foreign currency translation of approximately $137.0 million or 7%. Sales of existing products were negatively impacted by lower pricing and, to a lesser extent, volumes, partially offset by new product sales. Constant currency net sales decreased by approximately $7.1 million when compared to the prior year period.
Rest of World Segment
Net sales from Rest of World increased by $56.8$72.0 million or 4% during the six months ended June 30, 20192020 when compared to the prior year period. This increase was primarily the result of new producthigher net sales primarily in Australia and emerging markets, and higher volumes of existing products. Increased volumes of existing products, as a result of increased volumes, and to a lesser extent new product sales. Volumes of existing products increased by approximately $40.0 million due to the resolution of supply disruptions encountered in the prior year period. The remainder of the increase in net sales was primarily driventhe result of expected net sales growth in the region partially offset by the Company’s anti-retroviral therapy franchise. Thisnegative impact of COVID-19. The increase in net sales was partially offset primarily by theunfavorable impact of foreign currency translation of approximately $54.6 million or 3%, and to a lesser extent by lower pricing on sales of existing products. Constant currency net sales increased by approximately $126.6 million, or 7%, when compared to the prior year period.
Rest of World Segment
Net sales from Rest of World decreased by $114.9 million or 8% during the six months ended June 30, 2020 when compared to the prior year period. The decrease was primarily due to the unfavorable impact of foreign currency translation and lower volumes on net sales of existing products related to the estimated negative impact from COVID-19 in China, Russia, Brazil and other emerging markets. The decrease in net sales of existing products were also impacted by lower pricing, primarily driven by government price cuts in Australia and Japan. Partially offsetting lower net sales of existing products were new product sales, primarily in Australia. Overall, net sales from Rest of World were unfavorably impacted by the effect of foreign currency translation of approximately $83.7$74.0 million, or 6%5%. Constant currency net sales increaseddecreased by approximately $140.5$40.9 million, or 10%3%, when compared to the prior year period.
Cost of Sales and Gross Profit
Cost of sales increaseddecreased from $3.55 billion for the six months ended June 30, 2018 to $3.61 billion for the six months ended June 30, 2019.2019 to $3.42 billion for the six months ended June 30, 2020. Cost of sales was primarily impacted by purchase accounting related amortization of acquired intangible assets and other special items, which are described further in the section titled Use of Non-GAAP Financial Measures. Gross profit for the six months ended June 30, 2020 was $1.93 billion and gross margins were 36%. For the six months ended June 30, 2019, gross profit was $1.74 billion and gross margins were 33%. ForGross margins were positively impacted by lower amortization expense from acquired intangible assets and intangible asset impairment charges realized in the six months ended June 30, 2018, gross profit was $1.95 billion andprior year period. In addition, gross margins were 35%. Gross margins were negatively affected by approximately 140 basis pointspositively impacted as a result of incremental manufacturing expenses, site remediation expenseshigher gross profit from sales of WixelaTM InhubTM, Yupelri®, sales of new products in North America and, incremental restructuring charges incurred during the current period principally asto a resultlesser extent, sales of the activities at the Company’s Morgantown plant. In addition, grossexisting products in Europe. Gross margins were negatively impacted as a result of lower gross profit forfrom sales of existing products partially offset by the impact from new product sales. Grossin Rest of World and North America. In addition, gross margins were also negatively impacted by approximately 50 basis points related toincremental costs incurred as a result of the incremental amortization from product acquisitions and by approximately 30 basis pointsCOVID-19 pandemic, including a special bonus for expenses related to the recall of Valsartan products.plant employees. Adjusted gross margins were 54% for the six months ended June 30, 2019,2020, compared to 53%54% for the six months ended June 30, 2018.2019.
A reconciliation between cost of sales, as reported under U.S. GAAP, and adjusted cost of sales and adjusted gross margin for the six months ended June 30, 20192020 compared to the six months ended June 30, 20182019 is as follows:
| | | | | | | | | | | |
| Six Months Ended | | |
| June 30, | | |
(In millions) | 2020 | | 2019 |
U.S. GAAP cost of sales | $ | 3,418.6 | | | $ | 3,609.2 | |
Deduct: | | | |
Purchase accounting amortization and other related items | (704.0) | | | (875.4) | |
Acquisition related items | (2.1) | | | (2.1) | |
Restructuring and related costs | (8.9) | | | (60.8) | |
Share-based compensation expense | (0.7) | | | (0.5) | |
Other special items | (215.7) | | | (197.2) | |
Adjusted cost of sales | $ | 2,487.2 | | | $ | 2,473.2 | |
| | | |
Adjusted gross profit (a) | $ | 2,863.2 | | | $ | 2,873.8 | |
| | | |
Adjusted gross margin (a) | 54 | % | | 54 | % |
|
| | | | | | | |
| Six Months Ended |
| June 30, |
(In millions) | 2019 | | 2018 |
U.S. GAAP cost of sales | $ | 3,609.2 |
| | $ | 3,546.0 |
|
Deduct: | | | |
Purchase accounting amortization and other related items | (875.4 | ) | | (848.3 | ) |
Acquisition related items | (2.1 | ) | | (1.0 | ) |
Restructuring and related costs | (60.8 | ) | | (45.4 | ) |
Share-based compensation expense | (0.5 | ) | | — |
|
Other special items | (197.2 | ) | | (74.0 | ) |
Adjusted cost of sales | $ | 2,473.2 |
| | $ | 2,577.3 |
|
| | | |
Adjusted gross profit (a) | $ | 2,873.8 |
| | $ | 2,915.5 |
|
| | | |
Adjusted gross margin (a) | 54 | % | | 53 | % |
____________(a)____________Adjusted gross profit is calculated as total revenues less adjusted cost of sales. Adjusted gross margin is calculated as adjusted gross profit divided by total revenues.
| |
(a)
| Adjusted gross profit is calculated as total revenues less adjusted cost of sales. Adjusted gross margin is calculated as adjusted gross profit divided by total revenues. |
Operating Expenses
Research & Development Expense
R&D expense for the six months ended June 30, 20192020 was $320.2$270.5 million, compared to $411.6$320.2 million for the comparable prior year period, a decrease of $91.4$49.7 million. This decrease was primarily due to lower expenditures related to the reprioritization of global programs, and higher payments in the prior year period related to licensing arrangements for products in development.
Selling, General & Administrative Expense
SG&A expense for the six months ended June 30, 20192020 was $1.28$1.32 billion, compared to $1.23$1.28 billion for the comparable prior year period, an increase of $45.7$48.3 million. ThisThe increase was due primarily due to continued investment in selling and marketing activities. Also impactinghigher consulting fees along with other expenses primarily related to the six-month period was higher share-based compensation expense due to a reduction ofpending Combination totaling approximately $23.5$138.7 million in the second quarter of 2018 related to certain performance-based awards and a decrease in bad debt expense ofcurrent year period, including approximately $23.3$85.0 million related to obligations to reimburse Pfizer for certain financing costs under the Combination Agreements. Partially offsetting this increase were lower selling and promotional expenses, including through our active management and certain lower expenses as a special business interruption event for one customer in the prior year period.result of COVID-19.
Litigation Settlements and Other Contingencies, Net
During the six months ended June 30, 2020 and 2019, the Company recorded a net charge of $17.6 million and $21.6 million, respectively.
The following table includes the losses/(gains) recognized in litigation settlements and other contingencies, net during the six months ended June 30, 20192020 and June 30, 2018:2019:
| | | | | | | | | | | |
| Six Months Ended | | |
| June 30, | | |
(In millions) | 2020 | | 2019 |
Respiratory delivery platform contingent consideration adjustment | $ | 18.7 | | | $ | (28.9) | |
Litigation settlements, net | (1.1) | | | 50.5 | |
Total litigation settlements and other contingencies, net | $ | 17.6 | | | $ | 21.6 | |
|
| | | | | | | |
| Six Months Ended |
| June 30, |
(In millions) | 2019 | | 2018 |
Respiratory delivery platform contingent consideration adjustment | $ | (28.9 | ) | | $ | (30.0 | ) |
Litigation settlements | 50.5 |
| | (0.2 | ) |
Total litigation settlements and other contingencies, net | $ | 21.6 |
| | $ | (30.2 | ) |
During the six months ended June 30, 2019,2020, the Company recognized litigationrecorded a $18.7 million loss for fair value adjustments related chargesto respiratory delivery platform contingent consideration. Partially offsetting this item was a net gain of approximately $50.5$1.1 million primarily related to the matters settled during the second quartera number of 2019.litigation matters. Litigation settlements for the six months ended June 30, 2018,2019, consisted primarily of a gainlitigation related charges of approximately $14.7$50.5 million related tofor a favorable litigation settlement,number of matters, primarily those settled during the second quarter of 2019, which was partially offset by litigation related chargesa gain of approximately $13.3$28.9 million for fair value adjustments related to an anti-trust and a patent infringement matter.the respiratory delivery platform contingent consideration.
Interest Expense
Interest expense for the six months ended June 30, 20192020 totaled $262.4$236.1 million, compared to $270.9$262.4 million for the six months ended June 30, 2018,2019, a decrease of $8.5$26.3 million. The decrease is primarily due to lower average long-term debt balances during the current quarter as compared to the prior year period including the impact of the redemption of the 2018 Senior Notes in the prior year period.year.
Other (Income) Expense, Net
Other expense, net was $23.7$32.1 million for the six months ended June 30, 2019,2020, compared to $34.5$23.7 million for the comparable prior year period. Other expense, net includes losses from equity affiliates, foreign exchange gains and losses and interest and dividend income. Other expense, net was comprised of the following for the six months ended June 30, 20192020 and 2018,2019, respectively:
| | | | | | | | | | | |
| Six Months Ended | | |
| June 30, | | |
(In millions) | 2020 | | 2019 |
Losses from equity affiliates, primarily clean energy investments | $ | 34.5 | | | $ | 33.2 | |
Foreign exchange losses/(gains), net | 17.4 | | | (4.0) | |
| | | |
| | | |
| | | |
Other gains, net | (19.8) | | | (5.5) | |
Other expense, net | $ | 32.1 | | | $ | 23.7 | |
|
| | | | | | | |
| Six Months Ended |
| June 30, |
(In millions) | 2019 | | 2018 |
Losses from equity affiliates, primarily clean energy investments | $ | 33.2 |
| | $ | 46.0 |
|
Foreign exchange gains, net | (4.0 | ) | | (17.6 | ) |
Other (gains)/losses, net | (5.5 | ) | | 6.1 |
|
Other expense, net | $ | 23.7 |
| | $ | 34.5 |
|
Included in other gains for the six months ended June 30, 2020 was a $16.5 million gain for a fair value adjustment relate to a non-marketable investment which the Company holds.Income Tax (Benefit) Provision (Benefit)
For the six months ended June 30, 2019,2020, the Company recognized an income tax provisionbenefit of $26.9$9.5 million, compared to a benefittax provision of $95.4$26.9 million for the comparable prior year period, an increase of $122.3$36.4 million. During the six months ended June 30, 2020, the Company recognized a benefit as a result of changes in the assessment of the realizability of deferred tax assets. During the six months ended June 30, 2019, primarily due to the settlement in principle reached with the IRS and the expiration of federal and foreign statutes of limitations, the Company increased its net liability for unrecognized tax benefits by
approximately $46.1 million. In the prior year period, as a result of federal and state audits and settlements and expirations of certain state, federal, and foreign statutes of limitations, the Company reduced its liability for unrecognized tax benefits by approximately $86.0 million, which resulted in a net benefit to the income tax provision of approximately $53.0 million. Also impacting the current year income tax benefitexpense was the changing mix of income earned in jurisdictions with differing tax rates and deferred tax revaluations for statutory rate changes in certain jurisdictions.rates.
Use of Non-GAAP Financial Measures
Whenever the Company uses non-GAAP financial measures, we provide a reconciliation of the non-GAAP financial measures to their most directly comparable U.S. GAAP financial measure. Investors and other readers are encouraged to review the related U.S. GAAP financial measures and the reconciliation of non-GAAP measures to their most directly comparable U.S. GAAP measure and should consider non-GAAP measures only as a supplement to, not as a substitute for or as a superior measure to, measures of financial performance prepared in accordance with U.S. GAAP. Additionally, since these are not measures determined in accordance with U.S. GAAP, non-GAAP financial measures have no standardized meaning across companies, or as prescribed by U.S. GAAP and, therefore, may not be comparable to the calculation of similar measures or measures with the same title used by other companies.
Management uses these measures internally for forecasting, budgeting, measuring its operating performance, and incentive-based awards. Primarily due to acquisitions and other significant events which may impact comparability of our periodic operating results, we believe that an evaluation of our ongoing operations (and comparisons of our current operations with historical and future operations) would be difficult if the disclosure of our financial results was limited to financial measures prepared only in accordance with U.S. GAAP. We believe that non-GAAP financial measures are useful supplemental information for our investors and when considered together with our U.S. GAAP financial measures and the reconciliation to the most directly comparable U.S. GAAP financial measure, provide a more complete understanding of the factors and trends affecting our operations. The financial performance of the Company is measured by senior management, in part, using adjusted metrics as described below, along with other performance metrics. Management’sBeginning in 2020, management’s annual incentive compensation is derived, in part, based on the adjusted EPSEBITDA (as defined below) metric..
Adjusted Cost of Sales and Adjusted Gross Margin
We use the non-GAAP financial measure “adjusted cost of sales” and the corresponding non-GAAP financial measure “adjusted gross margin.” The principal items excluded from adjusted cost of sales include restructuring, acquisition related and other special items and purchase accounting amortization and other related items, which are described in greater detail below.
Adjusted Net Earnings and Adjusted EPS
Adjusted net earnings is a non-GAAP financial measure and provides an alternative view of performance used by management. Management believes that, primarily due to acquisition activity and other significant events, an evaluation of the Company’s ongoing operations (and comparisons of its current operations with historical and future operations) would be difficult if the disclosure of its financial results were limited to financial measures prepared only in accordance with U.S. GAAP. Management believes that adjusted net earnings and adjusted net earnings per diluted share (“adjusted EPS”) are two of the mostis an important internal financial metricsmetric related to the ongoing operating performance of the Company, and are therefore useful to investors and that their understanding of our performance is enhanced by these adjusted measures.this measure. Actual internal and forecasted operating results and annual budgets used by management include adjusted net earningsearnings.
EBITDA and Adjusted EBITDA
EBITDA and adjusted EPS.EBITDA are non-GAAP financial measures that the Company believes are appropriate to provide additional information to investors to demonstrate the Company’s ability to comply with financial debt covenants and assess the Company’s ability to incur additional indebtedness. The Company also believes that adjusted EBITDA better focuses management on the Company’s underlying operational results and true business performance and, beginning in 2020, is used, in part, for management’s incentive compensation. We calculate “EBITDA” as U.S. GAAP net earnings (loss) adjusted for net contribution attributable to equity method investments, income tax provision (benefit), interest expense and depreciation and amortization. EBITDA is further adjusted for share-based compensation expense, litigation settlements and other contingencies, net, and restructuring and other special items to determine “adjusted EBITDA”. These adjustments are permitted under our credit agreement in calculating Adjusted EBITDA for determining compliance with our debt covenants.
The significant items excluded from adjusted cost of sales, adjusted net earnings, EBITDA and adjusted EPSEBITDA include:
Purchase Accounting Amortization and Other Related Items
The ongoing impact of certain amounts recorded in connection with acquisitions of both businesses and assets is excluded from adjusted cost of sales, adjusted net earnings, EBITDA and adjusted EPS.EBITDA. These amounts include the amortization of intangible assets, inventory step-up and intangible asset impairment charges, including for in-process research and development. For the acquisition of businesses accounted for under the provisions of the Financial Accounting Standards Board Accounting Standards Codification (“ASC”) Topic 805, these purchase accounting impacts are excluded regardless of the financing method used for the acquisitions, including the use of cash, long-term debt, the issuance of ordinary shares, contingent consideration or any combination thereof.
Upfront and Milestone-Related R&D Expenses
These expenses and payments are excluded from adjusted net earnings and adjusted EPSEBITDA because they generally occur at irregular intervals and are not indicative of the Company’s ongoing operations.
Accretion of Contingent Consideration Liability and Other Fair Value Adjustments
The impact of changes to the fair value of contingent consideration and accretion expense are excluded from adjusted net earnings and adjusted EPSEBITDA because they are not indicative of the Company’s ongoing operations due to the variability of the amounts and the lack of predictability as to the occurrence and/or timing and management believes their exclusion is helpful to understanding the underlying, ongoing operational performance of the business.
Share-based Compensation Expense
Beginning in 2019, share-basedShare-based compensation expense is excluded from adjusted net earnings and adjusted EPS.EBITDA. Our share-based compensation programs have become increasingly weighted toward performance-based compensation, which leads to variability and to a lack of predictability as to the occurrence and/or timing of amounts incurred. As such, management believes the exclusion of such amounts on an ongoing basis is helpful to understanding the underlying operational performance of the business. The impact of share-based compensation was insignificant to the financial results for the year ended December 31, 2018 due primarily to this variability.
Restructuring, Acquisition Related and Other Special Items
Costs related to restructuring, acquisition and integration activities and other actions are excluded from adjusted cost of sales, adjusted net earnings and adjusted EPS,EBITDA, as applicable. These amounts include items such as:
•Costs related to formal restructuring programs and actions, including costs associated with facilities to be closed or divested, employee separation costs, impairment charges, accelerated depreciation, incremental manufacturing variances, equipment relocation costs and other restructuring related costs;
•Certain acquisition related remediation and integration and planning costs, as well as other costs associated with acquisitions such as advisory and legal fees and certain financing related costs, and other business transformation and/or optimization initiatives, which are not part of a formal restructuring program, including employee separation and post-employment costs;
•The pre-tax loss of the Company’s clean energy investments, whose activities qualify for income tax credits under the U.S. Internal Revenue Code of 1986, as amended; only included in adjusted net earnings and adjusted EPS is the net tax effect of the entity’s activities;
The pre-tax mark-to-market gains and losses of the Company’s investments in marketable equity securities historically accounted for as available for sale securities; only included in adjusted net earnings and adjusted EPS are cumulative realized gains and losses;
•Other costs, incurred from time to time, related to certain special events or activities that lead to gains or losses, including, but not limited to, incremental manufacturing variances, asset write-downs, or liability adjustments;
•Certain costs to further develop and optimize our global enterprise resource planning systems, operations and supply chain; and
•The impact of changes related to uncertain tax positions is excluded from adjusted net earnings. In addition, tax adjustments to adjusted earnings are recorded to present items on an after-tax basis consistent with the presentation of adjusted net earnings and adjusted EPS.earnings.
The Company has undertaken restructurings and other optimization initiatives of differing types, scope and amount during the covered periods and, therefore, these charges should not be considered non-recurring; however, management excludes these amounts from adjusted net earnings and adjusted EPSEBITDA because it believes it is helpful to understanding the underlying, ongoing operational performance of the business.
Litigation Settlements, Net
Charges and gains related to legal matters, such as those discussed in Note 2018 Litigation included in Part I, Item 1 of this Form 10-Q are generally excluded from adjusted net earnings and adjusted EPS.EBITDA. Normal, ongoing defense costs of the Company made in the normal course of our business are not excluded.
Reconciliation of U.S. GAAP Net Earnings to Adjusted Net Earnings and U.S. GAAP EPS to Adjusted EPS
A reconciliation between net earnings and diluted earnings per share,(loss) as reported under U.S. GAAP, and adjusted net earnings and adjusted EPS for the periods shown follows:
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | Six Months Ended June 30, |
(In millions, except per share amounts) | 2019 | | 2018 | | 2019 | | 2018 |
U.S. GAAP net (loss) earnings and U.S. GAAP EPS | $ | (168.5 | ) | | $ | (0.33 | ) | | $ | 37.5 |
| | $ | 0.07 |
| | $ | (193.5 | ) | | $ | (0.38 | ) | | $ | 124.6 |
| | $ | 0.24 |
|
Purchase accounting related amortization (primarily included in cost of sales) (a) | 440.0 |
| | | | 430.3 |
| | | | 875.4 |
| | | | 853.7 |
| | |
Litigation settlements and other contingencies, net | 20.9 |
| | | | (46.4 | ) | | | | 21.6 |
| | | | (30.2 | ) | | |
Interest expense (primarily clean energy investment financing and accretion of contingent consideration) | 6.9 |
| | | | 9.2 |
| | | | 14.2 |
| | | | 18.9 |
| | |
Clean energy investments pre-tax loss | 16.2 |
| | | | 23.0 |
| | | | 33.2 |
| | | | 46.0 |
| | |
Acquisition related costs (primarily included in SG&A) (b) | 5.5 |
| | | | 10.2 |
| | | | 13.6 |
| | | | 12.5 |
| | |
Restructuring related costs (c) | 57.6 |
| | | | 76.1 |
| | | | 77.5 |
| | | | 121.5 |
| | |
Share-based compensation expense (d) | 16.8 |
| | | | — |
| | | | 34.8 |
| | | | — |
| | |
Other special items included in: | | | | | | | | | | | | | | | |
Cost of sales (e) | 112.1 |
| | | | 64.0 |
| | | | 197.2 |
| | | | 74.0 |
| | |
Research and development expense (f) | 27.1 |
| | | | 50.5 |
| | | | 60.2 |
| | | | 97.1 |
| | |
Selling, general and administrative expense | 10.8 |
| | | | 32.1 |
| | | | 24.7 |
| | | | 33.9 |
| | |
Other expense, net (g) | — |
| | | | 6.8 |
| | | | — |
| | | | 24.2 |
| | |
Tax effect of the above items and other income tax related items (h) | (12.6 | ) | | | | (141.8 | ) | | | | (204.2 | ) | | | | (329.1 | ) | | |
Adjusted net earnings and adjusted EPS | $ | 532.8 |
| | $ | 1.03 |
| | $ | 551.5 |
| | $ | 1.07 |
| | $ | 954.7 |
| | $ | 1.85 |
| | $ | 1,047.1 |
| | $ | 2.03 |
|
Weighted average diluted ordinary shares outstanding | 516.3 |
| | | | 516.3 |
| | | | 516.5 |
| | | | 516.6 |
| | |
____________ | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | | | | | | | Six Months Ended June 30, | | |
(In millions) | 2020 | | | | 2019 | | | | 2020 | | 2019 |
U.S. GAAP net earnings (loss) | $ | 39.4 | | | | | $ | (168.5) | | | | | $ | 60.2 | | | $ | (193.5) | |
Purchase accounting related amortization (primarily included in cost of sales) | 351.8 | | | | | 440.0 | | | | | 704.0 | | | 875.4 | |
Litigation settlements and other contingencies, net | 15.8 | | | | | 20.9 | | | | | 17.6 | | | 21.6 | |
Interest expense (primarily clean energy investment financing and accretion of contingent consideration) | 5.5 | | | | | 6.9 | | | | | 11.3 | | | 14.2 | |
Clean energy investments pre-tax loss | 17.2 | | | | | 16.2 | | | | | 34.5 | | | 33.2 | |
| | | | | | | | | | | |
Acquisition related costs (primarily included in SG&A) (a) | 122.7 | | | | | 5.5 | | | | | 145.9 | | | 13.6 | |
| | | | | | | | | | | |
Restructuring related costs (b) | 23.6 | | | | | 57.6 | | | | | 32.5 | | | 77.5 | |
Share-based compensation expense | 15.3 | | | | | 16.8 | | | | | 34.7 | | | 34.8 | |
Other special items included in: | | | | | | | | | | | |
Cost of sales (c) | 99.5 | | | | | 112.1 | | | | | 215.7 | | | 197.2 | |
Research and development expense (d) | 40.4 | | | | | 27.1 | | | | | 42.1 | | | 60.2 | |
Selling, general and administrative expense | 9.1 | | | | | 10.8 | | | | | 5.4 | | | 24.7 | |
Other expense, net | (16.1) | | | | | — | | | | | (16.4) | | | — | |
Tax effect of the above items and other income tax related items | (149.9) | | | | | (12.6) | | | | | (246.0) | | | (204.2) | |
Adjusted net earnings | $ | 574.3 | | | | | $ | 532.8 | | | | | $ | 1,041.5 | | | $ | 954.7 | |
| | | | | | | | | | | |
Significant items include the following:
(a) Acquisition related costs consist primarily of transaction costs including legal and consulting fees and integration activities. The increase for the three and six months ended June 30, 2020 relates to transaction costs for the pending Combination, including approximately $85.0 million related to the Company’s obligation to reimburse Pfizer for certain financing costs under the Combination Agreements.
(b) For the three months ended June 30, 2020, charges of approximately $4.1 million are included in cost of sales, approximately $0.2 million is included in R&D, and approximately $19.3 million is included in SG&A. For the six months ended June 30, 2020, charges of approximately $8.9 million are included in cost of sales, approximately $0.4 million is included in R&D, and approximately $23.2 million is included in SG&A. Refer to Note 15 Restructuring included in Part I, Item 1 of this Form 10-Q for additional information.
(c) Costs incurred during the three and six months ended June 30, 2020 include incremental manufacturing variances and site remediation activities as a result of the activities at the Company’s Morgantown plant of approximately $63.0 million and $121.8 million, respectively. In addition, the three and six months ended June 30, 2020 includes incremental manufacturing variances incurred as a result of the COVID-19 pandemic of approximately $15.0 million and $22.0 million, respectively. Also, the six months ended June 30, 2020 includes $25.0 million related to a special bonus for plant employees as a result of the COVID-19 pandemic. The three months ended June 30, 2019 includeincludes costs related to the following:
| |
(a)Valsartan product recall, the termination of a contract and certain other inventory write-offs. Charges for the six months ended June 30, 2019 primarily related to certain incremental manufacturing variances and site remediation activities as a result of the activities at the Company’s Morgantown plant and the items also impacting the change for the three-month period.
| The increase in purchase accounting related amortization is primarily due to amortization expense related to certain product rights acquisitions which occurred in 2018 and 2019. |
| |
(b)
| Acquisition related costs consist primarily of transaction costs including legal and consulting fees and integration activities. |
| |
(c)
| For the three months ended June 30, 2019, approximately $46.3 million is included in cost of sales and $11.3 million is included in SG&A. For the six months ended June 30, 2019, approximately $60.8 million is included in cost of sales, approximately $0.1 million is included in R&D, and approximately $16.6 million is included in SG&A. Refer to Note 17 Restructuring included in Part I, Item 1 of this Form 10-Q for additional information.
|
| |
(d)
| Beginning in 2019, share-based compensation expense is excluded from adjusted net earnings and adjusted EPS. The full year impact for the year ended December 31, 2018 was insignificant. As such, the three and six months ended June 30, 2018 amounts were not added back to U.S. GAAP net earnings. |
| |
(e)
| The three months ended June 30, 2019 increased $48.1 million primarily related to the impact of the Valsartan product recall, the termination of a contract and certain other inventory write-offs. The six months ended June 30, 2019 increased $123.2 million for certain incremental manufacturing variances and site remediation activities as a result of the activities at the Company’s Morgantown plant and the items also impacting the change for the three-month period. |
| |
(f)
| R&D expense for the three months ended June 30, 2019 consists primarily of payments for product development arrangements of approximately $23.4 million, which includes $18.4 million related to the expansion of the YUPELRI®
|
(d) R&D expense for the three and six months ended June 30, 2020 consists primarily of amounts for product development arrangements, including with Revance, of approximately $39.4 million and $41.0 million, respectively. R&D expense for the three months ended June 30, 2019 consists primarily of payments for product development
arrangements of approximately $23.4 million, which includes $18.4 million related to the expansion of the Yupelri® agreement with Theravance Biopharma Inc., and the remaining expense relates to on-going collaboration agreements. R&D expense for the six months ended June 30, 2019 consists primarily of payments for product development arrangements of approximately $46.7 million, including $18.4 million for the expansion of the YUPELRI®Yupelri® agreement and $23.3 million related to non-refundable upfront licensing amounts for a product in development. The remaining expense relates to on-going development collaborations. Refer
Reconciliation of U.S. GAAP Net Earnings to Note 4 AcquisitionsEBITDA and Other Transactions included in Part I, Item 1Adjusted EBITDA
Below is a reconciliation of this Form 10-Q for additional information. R&D expenseU.S. GAAP net earnings (loss) to EBITDA and adjusted EBITDA for the three months ended June 30, 2018 includes two non-refundable upfront payments totaling approximately $30.5 million for development agreements entered into during the quarter, and the remaining expense relates to on-going collaboration agreements, including Momenta Pharmaceuticals, Inc. For the six months ended June 30, 2018, R&D expense includes $73.5 million related2020 compared to four non-refundable upfront payments for development agreements entered into during the prior year period.period:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | | | Six Months Ended June 30, | | |
(In millions) | 2020 | | 2019 | | 2020 | | 2019 |
U.S. GAAP net earnings (loss) | $ | 39.4 | | | $ | (168.5) | | | $ | 60.2 | | | $ | (193.5) | |
Add / (deduct) adjustments: | | | | | | | |
Clean energy investments pre-tax loss | 17.2 | | | 16.2 | | | 34.5 | | | 33.2 | |
Income tax (benefit) provision | (19.4) | | | 116.4 | | | (9.5) | | | 26.9 | |
Interest expense (a) | 116.2 | | | 131.2 | | | 236.1 | | | 262.4 | |
Depreciation and amortization (b) | 415.7 | | | 501.4 | | | 830.7 | | | 1,001.9 | |
EBITDA | $ | 569.1 | | | $ | 596.7 | | | $ | 1,152.0 | | | $ | 1,130.9 | |
Add / (deduct) adjustments: | | | | | | | |
Share-based compensation expense | 15.3 | | | 16.8 | | | 34.7 | | | 34.8 | |
Litigation settlements and other contingencies, net | 15.8 | | | 20.9 | | | 17.6 | | | 21.6 | |
Restructuring, acquisition related and other special items (c) | 278.4 | | | 213.0 | | | 425.0 | | | 370.3 | |
Adjusted EBITDA | $ | 878.6 | | | $ | 847.4 | | | $ | 1,629.3 | | | $ | 1,557.6 | |
(a) Includes clean energy investment financing and accretion of contingent consideration.
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(g)(b) Includes purchase accounting related amortization. (c) See items detailed in the Reconciliation of U.S. GAAP Net Earnings to Adjusted Net Earnings.
| The 2018 amount primarily related to mark-to-market losses of investments in equity securities historically accounted for as available-for-sale securities and the cumulative realized gains on such investments. |
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(h)
| The impact of changes related to uncertain tax positions is excluded from adjusted earnings. |
Liquidity and Capital Resources
Our primary source of liquidity is net cash provided by operating activities, which was $629.2$670.6 million for the six months ended June 30, 2019.2020. We believe that net cash provided by operating activities and available liquidity will continue to allow us to meet our needs for working capital, capital expenditures and interest and principal payments on debt obligations. Nevertheless, our ability to satisfy our working capital requirements and debt service obligations, or fund planned capital expenditures, will substantially depend upon our future operating performance (which will be affected by prevailing economic conditions), and financial, business and other factors, some of which are beyond our control.
Operating Activities
Net cash provided by operating activities decreasedincreased by $422.8$41.4 million to $629.2$670.6 million for the six months ended June 30, 2019,2020, as compared to net cash provided by operating activities of $1.05 billion$629.2 million for the six months ended June 30, 2018.2019. Net cash provided by operating activities is derived from net (loss) earnings adjusted for non-cash operating items, gains and losses attributed to investing and financing activities and changes in operating assets and liabilities resulting from timing differences between the receipts and payments of cash, including changes in cash primarily reflecting the timing of cash collections from customers, payments to vendors and employees and tax payments in the ordinary course of business.
The net decreaseincrease in net cash provided by operating activities was principally due to the following:
a decrease•an increase in net earnings of approximately $318.1$253.7 million, principally as a result of a decreasean increase in earnings from operations;
•a net decrease in non-cash expenses of $140.9 million;
a net decrease in the amount of cash provided by accounts receivable of $280.1 million, reflecting the timing of sales and cash collections; and
a net increase of $46.1$51.0 million in the amount of cash used through changes in inventory balances.balances;
•a net increase in the amount of cash provided by changes in income taxes of $144.1 million as a result of the level and timing of estimated tax payments made during the current period; and
These items were partially offset by the following:
•a net increase in the amount of cash provided by changes in other operating assets and liabilities of $275.3 million;$27.6 million.
These items were partially offset by the following:
•a net decrease in the amount of cash provided by accounts receivable of $76.3 million, reflecting the timing of sales and cash collections;
•a net increase in the amount of cash used through changes in trade accounts payable of $59.0$162.9 million as a result of the timing of cash payments; and
•a net decrease in the amountnon-cash impact of cash used through changes in income taxesdepreciation and amortization of $28.1 million as a result of the level and timing of estimated tax payments made during the current period.$171.2 million.
Investing Activities
Net cash used in investing activities was $220.1 million for the six months ended June 30, 2020, as compared to $234.0 million for the six months ended June 30, 2019, as compared to $732.7 million for the six months ended June 30, 2018, a net decrease of $498.7$13.9 million.
In 2020, significant items in investing activities included the following:
•payments for product rights and other, net totaling approximately $76.4 million, primarily related to deferred non-contingent purchase payments for the acquisition of intellectual property rights and marketing authorizations in prior periods;
•purchase of marketable securities and other investments of $90.2 million; and
•capital expenditures, primarily for equipment and facilities, totaling approximately $87.9 million. While there can be no assurance that current expectations will be realized, capital expenditures for the 2020 calendar year are expected to be approximately $250 million to $350 million.
In 2019, significant items in investing activities included the following:
•payments for product rights and other, net totaling approximately $129.5 million primarily related to the acquisitions of intellectual property rights and marketing authorizations; and
•capital expenditures, primarily for equipment and facilities, totaling approximately $97.2 million. While there can be no assurance that current expectations will be realized, capital expenditures for the 2019 calendar year are expected to be approximately $250 million to $400 million.
In 2018, significant items in investing activities included the following:
cash paid for acquisitions, net totaling approximately $63.3 million related to deferred non-contingent purchase price payments for the acquisition of Apicore, Inc.;
payments for product rights and other, net totaling approximately $614.4 million, which included payments of approximately $575.0 million related to commercialized product rights, primarily related to Betadine in certain European markets and other products in certain rest of world markets; and
capital expenditures, primarily for equipment and facilities, totaling approximately $75.9 million.
Financing Activities
Net cash used in financing activities was $609.1 million for the six months ended June 30, 2020, as compared to $571.9 million for the six months ended June 30, 2019, as compared to $289.9 million for the six months ended June 30, 2018, a net increase of $282.0$37.2 million.
In 2020, significant items in financing activities included the following:•long-term debt payments of approximately $589.0 million consisting primarily of the redemption of $555.2 million principal amount of the 2020 Floating Rate Euro Notes; and
•payments totaling approximately $43.6 million (of the $52.3 million) in milestone payments related to the respiratory delivery platform contingent consideration. The remaining payments related to the respiratory delivery platform contingent consideration are included as a component of other operating assets and liabilities, net within net cash from operating activities.
In 2019, significant items in financing activities included the following:
•long-term debt payments of approximately $555.5 million consisting primarily of the redemption of $550.0 million principal amount of 2.500% Senior Notes due 2019;
•payments totaling approximately $38.8 million (ofof the $67.5 million)million in milestone payments related to Pfizer Inc.’s proprietary dry powder inhaler delivery platform (“the respiratory delivery platform”)platform contingent consideration. The remaining payments related to the respiratory delivery platform contingent consideration are included as a component of other operating assets and liabilities, net within net cash from operating activities; and
•a net increase in short-term borrowings of $24.3 million.
In 2018, significant items in financing activities included the following:71
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• | the Company repurchased 9.8 million ordinary shares at a cost of approximately $432.0 million completingthe previously authorized share repurchase program;
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long-term debt proceeds of approximately $2.58 billion primarily related to borrowings of approximately $496.5 million under the 2016 Revolving Facility, proceeds from the April 2018 Senior Notes offering of approximately $1.50 billion and proceeds from the May 2018 Euro Senior Notes offering of approximately €500.0 million;
long-term debt payments of approximately $2.60 billion consisting primarily of repayments of borrowings of approximately $496.5 million under the 2016 Revolving Facility, redemptions of $1.50 billion principal amount of senior notes in connection with the April 2018 Senior Notes offering and redemptions of $600.0 million principal amount of senior notes in connection with the May 2018 Euro Senior Notes offering; and
a net increase in short-term borrowings of $179.0 million.
Capital Resources
Our cash and cash equivalents totaled $211.5$323.6 million at June 30, 2019,2020, and the majority of these funds are held by our non-U.S. subsidiaries. The Company anticipates having sufficient liquidity, including existing borrowing capacity under the 2018its Revolving Credit Facility, the Commercial Paper Program, the Receivables Facility and the Note Securitization Facility (each as defined below other than the 2018 Revolving Facility and the Commercial Paper Program, which(which are each defined in Note 132 Revenue Recognition and Accounts Receivable or Note 12 Debt in Part I, Item 1 of this Form 10-Q) combined with cash to be generated from operations, to fund foreseeable cash needs without requiring the repatriation of non-U.S. cash.
The Company has access to $2.0 billion under the 2018 Revolving Credit Facility which matures in 2023. Up to $1.65 billion of the 2018 Revolving Credit Facility may be used to support borrowings under our Commercial Paper Program.
In addition to the 2018 Revolving Facility, Mylan Pharmaceuticals Inc., a wholly owned subsidiary of the Company, has a $400 million receivables facility (the “Receivables Facility”). On April 25, 2019, the Company entered into an amendment to the Receivables Facility to extend its expiration date to April 22, 2022. As of June 30, 2019,2020, the Company had no amounts outstanding under the Commercial Paper Program.
The Company has the $400 million Receivables Facility.
OnFacility which expires in April 25, 2019, we entered into an additional facility for borrowings up to2022. The Company also has the $200 million (the “Note Securitization Facility”). Under the terms of each of the Receivables Facility and Note Securitization Facility certain of our accounts receivable secure the amounts borrowed and cannot be used to pay our other debts or liabilities. The amount that we may
borrow at a given point in time is determined basedwhich expires on the amount of qualifying accounts receivable that are present at such point in time.August 30, 2021. Borrowings outstanding under the Receivables Facility bear interest at a commercial paper rate plus 0.775%0.925% and under the Note Securitization Facility at London Interbank Offered Rate or LIBORa rate per annum quoted from time to time by MUFG Bank, Ltd. plus 0.75%1.00% and are included as a component of short-term borrowings, while the accounts receivable securing these obligations remain as a component of accounts receivable, net, in our condensed consolidated balance sheets. In addition, the agreements governing the Receivables Facility and Note Securitization Facility contain various customary affirmative and negative covenants, and customary default and termination provisions.provisions with which the Company was compliant as of June 30, 2020. As of June 30, 2020, the Company had no amounts outstanding under the Receivables Facility or the Note Securitization Facility.
We have entered into accounts receivable factoring agreements with financial institutions to sell certain of our non-U.S. accounts receivable. These transactions are accounted for as sales and result in a reduction in accounts receivable because the agreements transfer effective control over and risk related to the receivables to the buyers. Our factoring agreements do not allow for recourse in the event of uncollectibility, and we do not retain any interest in the underlying accounts receivable once sold. We derecognized $131.9 million and $90.1 million of accounts receivable as of June 30, 2020 and December 31, 2019, respectively, under these factoring arrangements.
At June 30, 2019,2020, our long-term debt, including the current portion, totaled $13.26$12.14 billion, as compared to $13.82$12.67 billion at December 31, 2018.2019. Total long-term debt is calculated net of deferred financing fees which were $67.6$54.7 million and $74.6$60.5 million at June 30, 20192020 and December 31, 2018,2019, respectively.
For additional information regarding our debt and debt agreements refer to Note 1312 Debt in Part I, Item 1 of this Form 10-Q.
Long-term Debt Maturity
Mandatory minimum repayments remaining on the outstanding notional amount of long-term debt at June 30, 20192020 was as follows for each of the periods ending December 31:
The Company’s 2016 Term Facility (as defined in Note 13 Debt in Part I, Item 1 of this Form 10-Q) and 2018 Revolving Facility each contains customary affirmative covenants for facilities of this type, including among others, covenants pertaining to the delivery of financial statements, notices of default and certain material events, maintenance of corporate existence and rights, property, and insurance and compliance with laws, as well as customary negative covenants for facilities of this type, including limitations on the incurrence of subsidiary indebtedness, liens, mergers and certain other fundamental changes, investments and loans, acquisitions, transactions with affiliates, payments of dividends and other restricted payments and changes in our lines of business.The 2016 TermCompany has a $2.0 billion revolving credit facility which is scheduled to expire in July 2023. The Revolving Credit Facility and 2018 Revolving Facility containcontains a maximum consolidated leverage ratio financial covenant requiring maintenance of a maximum ratio of 3.75 to 1.00 for consolidated total indebtedness as of the end of any quarter to consolidated EBITDA for the trailing four quarters as defined in the related credit agreements (“maximum leverage ratio”).
On February 22, 2019, the Company, as a guarantor, and Mylan Inc., as borrower, entered into an amendment (the "Revolving Loan Amendment") to the 2018 Revolving Facility. In addition, on February 22, 2019,June 16, 2020 the Company entered into an amendment (the "Term Loan Amendment") to the 2016 Term Facility. The Revolving Loan Amendment andCredit Facility to temporarily increase the Term Loan Amendment extended themaximum leverage ratio covenant ofto 4.25 to 1.00 after the March
31, 2020 reporting period through the December 31, 20192020 reporting period.period with a maximum leverage ratio of 3.75 to 1.00 thereafter. The Company is in compliance at June 30, 20192020 and expects to remain in compliance for the next twelve months.
Collaboration and Licensing Agreements
We periodically enter into collaboration and licensing agreements with other pharmaceutical companies for the development, manufacture, marketing and/or sale of pharmaceutical products. Our significant collaboration agreements are primarily focused on the development, manufacturing, supply and commercialization of multiple, high-value generic biologic compounds, insulin analog products and respiratory products, among other complex products. Under these agreements, we have future potential milestone payments and co-development expenses payable to third parties as part of our licensing, development and co-development programs. Payments under these agreements generally become due and are payable upon the satisfaction or achievement of certain developmental, regulatory or commercial milestones or as development expenses are incurred on defined projects. Milestone payment obligations are uncertain, including the prediction of timing and the occurrence of events triggering a future obligation and are not reflected as liabilities in the condensed consolidated balance sheets, except for milestone and royalty obligations reflected as acquisition related contingent consideration. Refer to Note 1211 Financial Instruments and Risk Management in Part I, Item of this Form 10-Q for additional information. Our potential maximum development milestones not accrued for at June 30, 20192020 totaled approximately $476.0 million, which includes the new agreements entered into during 2019.$391 million. We estimate that the amounts that may be paid inthrough the next twelve monthsend of 2020 to be approximately $79.0$73 million. These agreements may also include potential sales-based milestones and call for us to pay a percentage of amounts earned from the sale of the product as a royalty or a profit share. The amounts disclosed do not include sales-based milestones or royalty or profit share obligations on future sales of product as the timing and amount of future sales levels and costs to produce products subject to these obligations is not reasonably estimable. These sales-based milestones or royalty or profit share obligations may be significant depending upon the level of commercial sales for each product.
We are contractually obligated to make potential future development, regulatory and commercial milestone, royalty and/or profit sharing payments in conjunction with acquisitions we have entered into with third parties. The most significant of these relates to the potential future consideration related to the respiratory delivery platform. These payments are contingent upon the occurrence of certain future events and, given the nature of these events, it is unclear when, if ever, we may be required to pay such amounts. The amount of the contingent consideration liabilities was $266.7$223.2 million at June 30, 2019.2020. In addition, the Company expects to incur approximately $15$10 million to $20$15 million of non-cash accretion expense related to the increase in the net present value of the contingent consideration liabilities in 2020.
Supplemental Guarantor Financial Information
Mylan N.V. is the issuer of the 3.750% Senior Notes due 2020, 3.150% Senior Notes due 2021, 3.950% Senior Notes due 2026 and 5.250% Senior Notes due 2046 (collectively, the “Mylan N.V. Senior Notes”), which are fully and unconditionally guaranteed on a senior unsecured basis by Mylan Inc. Mylan Inc. is the issuer of the 3.125% Senior Notes due 2023, 4.200% Senior Notes due 2023, 4.550% Senior Notes due 2028, 5.400% Senior Notes due 2043 and 5.200% Senior Notes due 2048 (collectively, the “Mylan Inc. Senior Notes” and, together with the Mylan N.V. Senior Notes, the “Senior Notes”), which are fully and unconditionally guaranteed on a senior unsecured basis by Mylan N.V.
The respective obligations of Mylan N.V. and Mylan Inc. as guarantors of the Senior Notes, as applicable, are senior unsecured obligations of the applicable guarantor and rank pari passu in right of payment with all of such guarantor’s existing and future senior unsecured obligations that are not expressly subordinated to such guarantor’s guarantee of the applicable series of Senior Notes, rank senior in right of payment to any future obligations of such guarantor that are expressly subordinated to such guarantor’s guarantee of the applicable series of Senior Notes, and are effectively subordinated to such guarantor’s existing and future secured obligations to the extent of the value of the collateral securing such obligations. The respective obligations of Mylan N.V. and Mylan Inc. as guarantors of the Senior Notes, as applicable, are structurally subordinated to all of the existing and future liabilities, including trade payables, of the existing and future subsidiaries of such guarantor that do not guarantee the applicable series of Senior Notes.
The guarantees by Mylan Inc. of the Mylan N.V. Senior Notes will terminate under the following customary circumstances: (1) a sale or disposition of Mylan Inc. in a transaction that complies with the applicable indenture such that Mylan Inc. ceases to be a subsidiary of Mylan N.V.; (2) legal defeasance or covenant defeasance, each as described in the applicable indenture, or if Mylan N.V.’s obligations under the applicable indenture are discharged; or (3) the earlier to occur of (i) the release of Mylan N.V.’s guarantee under all applicable Mylan Inc. debt and (ii) Mylan Inc. no longer having any obligations in respect of any Mylan Inc. debt.
The guarantee obligations of Mylan N.V. and Mylan Inc. under the Senior Notes are subject to certain limitations and terms similar to those applicable to other guarantees of similar instruments, including that (i) the guarantees are subject to fraudulent transfer and conveyance laws and (ii) each guarantee is limited in amount to an amount not to exceed the maximum amount that can be guaranteed by the applicable guarantor without rendering the guarantee, as it relates to such guarantor, voidable under applicable fraudulent transfer and conveyance laws or similar laws affecting the rights of creditors generally. In addition, Dutch and English insolvency laws to which Mylan N.V. is or may be subject may not be as favorable to holders of Senior Notes as United States or other insolvency laws, and, because it is a Dutch company, it may be more difficult for holders of Senior Notes to obtain or enforce judgments against Mylan N.V.
Because Mylan N.V. is a holding company, its only material assets are its ownership interests in its subsidiaries, and those subsidiaries conduct substantially all of its operations. As a result, Mylan N.V.’s ability to make payments on its obligations under the Senior Notes will depend on its subsidiaries’ cash flow and their ability to make payments to Mylan N.V., which will depend on their earnings, applicable covenants in debt and other agreements, business and tax considerations and applicable law (including local law regulating payments of dividends and distributions).
In March 2020, the SEC amended Rule 3-10 of Regulation S-X regarding the financial disclosure requirements for guarantors and issuers of guaranteed securities registered or being registered. Among other things, the amendments narrow the circumstances that require separate financial statements of subsidiary issuers and guarantors and streamline the alternative disclosures required in lieu of those financial statements. The effective date of the amendment is January 4, 2021 with earlier voluntary compliance permitted. We have chosen to voluntarily comply with the amended rules effective during the three months ended March 31, 2020.
The following table presents unaudited summarized financial information of Mylan N.V. and Mylan Inc. on a combined basis as of and for the Three Months Ended June 30, 2020 and as of and for the year ended December 31, 2019. All intercompany balances have been eliminated in consolidation. This unaudited combined summarized financial information is presented utilizing the equity method of accounting.
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| Combined Summarized Balance Sheet Information of Mylan N.V. and Mylan Inc. | | |
(In millions) | June 30, 2020 | | December 31, 2019 |
ASSETS | | | |
Current assets | $ | 90.1 | | | $ | 152.2 | |
Non-current assets | 38,981.9 | | | 41,602.4 | |
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LIABILITIES AND EQUITY | | | |
Current liabilities | 18,258.3 | | | 15,414.9 | |
Non-current liabilities | 9,067.5 | | | 14,455.9 | |
| | | | | | | | | | | |
| Combined Summarized Statement of Operations Information of Mylan N.V. and Mylan Inc. | | |
(In millions) | Six Months Ended June 30, 2020 | | Year Ended December 31, 2019 |
Revenues | $ | — | | | $ | — | |
Gross Profit | — | | | — | |
Loss from Operations | (485.9) | | | (790.3) | |
Net earnings | 60.2 | | | 16.8 | |
Other Commitments
The Company is involved in various disputes, governmental and/or regulatory inquiries, investigations and proceedings, tax proceedings and litigation matters, both in the U.S. and abroad, that arise from time to time, some of which could result in losses, including damages, fines and/or civil penalties, and/or criminal charges against the Company. These matters are often complex and have outcomes that are difficult to predict. The Company is also party to certain proceedings and litigation matters for which it may be entitled to indemnification under the respective sale and purchase agreements relating to the acquisitions of the former Merck Generics business, Agila Specialties Private Limited, the EPD Business,Abbott Laboratories’ non-U.S. developed markets specialty and branded generics business, and certain other acquisitions. We have approximately $107.0$42.5 million accrued for legal contingencies at June 30, 2019.2020.
While the Company believes that it has meritorious defenses with respect to the claims asserted against it and intends to vigorously defend its position, the process of resolving these matters is inherently uncertain and may develop over a long period of time, and so it is not possible to predict the ultimate resolution of any such matter. It is possible that an unfavorable resolution of any of the ongoing matters or the inability or denial of Merck KGaA, Strides Arcolab Limited, Abbott Laboratories, or another indemnitor or insurer to pay an indemnified claim, could have a material adverse effect on the Company’s business, financial condition, results of operations, cash flows and/or ordinary share price.
In the normal course of business, Mylan periodically enters into employment, legal settlement and other agreements which incorporate indemnification provisions. While the maximum amount to which Mylan may be exposed under such agreements cannot be reasonably estimated, the Company maintains insurance coverage, which management believes will effectively mitigate the Company’s obligations under these indemnification provisions. No amounts have been recorded in the condensed consolidated financial statements with respect to the Company’s obligations under such agreements.
The Company has also entered into employment and other agreements with certain executives and other employees that provide for compensation retirement and certain other benefits. These agreements provide for severance payments under certain circumstances. Additionally, the Company has split-dollar life insurance agreements with certain retired executives.
We are continuously evaluating the potential acquisition of products, as well as companies, as a strategic part of our future growth. Consequently, we may utilize current cash reserves or incur additional indebtedness to finance any such acquisitions, which could impact future liquidity. In addition, on an ongoing basis, we review our operations including the
evaluation of potential divestitures of products and businesses as part of our future strategy. Any divestitures could impact future liquidity.
Application of Critical Accounting Policies
There have been no changes to the Critical Accounting Policies disclosed in our 20182019 Annual Report on Form 10-K.10-K, as amended. The following discussion supplements our Critical Accounting Policy for Acquisitions, Intangible Assets, Goodwill and Contingent Consideration as it relates to our annualthe goodwill impairment test.tests performed as of March 31, 2020 and April 1, 2020.
Goodwill and intangible assets, including IPR&D, are reviewed The Company reviews goodwill for impairment annually and/on April 1st or whenmore frequently if events or other changes in circumstances indicate that the carrying amountvalue of the assetsgoodwill may not be recoverable. Impairment of goodwill and indefinite-lived intangibles, including IPR&D, is determined to exist when the fair value is less than the carrying valueAs a result of the net assets being tested, with any impairment charge being equal todecline in the difference. ImpairmentCompany’s share price during the first quarter of finite-lived intangibles is determined to exist when undiscounted cash flows related to2020, and the assets are less thangeneral uncertainty and volatility in the carrying valueeconomic environments in which the Company operates, including the impacts of the assets being tested. Future events and decisions may lead to assetCOVID-19 pandemic, the Company performed an interim goodwill impairment and/or related costs.
Goodwill is allocated and evaluated for impairment at the reporting unit level, which is definedtest as an operating segment or one level below an operating segment.of March 31, 2020. The Company performed the annual goodwill impairment test as of April 1, 2020. There were no significant changes from the interim goodwill test performed at March 31, 2020 and the results were consistent with the interim goodwill impairment test.
The Company has performed both the interim goodwill impairment test and its annual goodwill impairment test on a quantitative basis for its four reporting units, North America Generics, North America Brands, Europe and Rest of World. As of April 1, 2019, the date of our most recent annual impairment test, the allocation of the Company’s total goodwill was as follows: North America Generics $2.67 billion, North America Brands $0.65 billion, Europe $4.56 billion and Rest of World $1.72 billion.
The Company performed a quantitative impairment analysis for all of its reporting units as of April 1, 2019. The impairment analysis consists of a comparison of the estimated fair value of the individual reporting units with their carrying amount, including goodwill. In estimating each reporting unit’s fair value, wethe Company performed an extensive valuation analysis, utilizing both income and market-based approaches, in our goodwill assessment process. We utilized an average of the two methods in estimating the fair value of the individual reporting units, except for the North America Brands reporting unit where the fair value was estimated utilizing the income approach. The following describesdetermination of the valuation methodologies used to derive the estimated fair value of the reporting units.
Income Approach: Under this approach,units requires the Company to determine fair value, we discountedmake significant estimates and assumptions that affect the reporting unit’s expected future cash flows of each reporting unit. We used aflows. These estimates and assumptions, utilizing Level 3 inputs, primarily include, but are not limited to, market multiples, control premiums, the discount rate, which reflectedterminal growth rates, operating income before depreciation and amortization, and capital expenditures forecasts.
As of March 31, 2020 and April 1, 2020, the overall level of inherent risk and the rate of return an outside investor would have expected to earn. To estimate cash flows beyond the final year of our model, we used a terminal value approach. Under this approach, we used EBITDA in the final year of our model, adjusted to estimate a normalized cash flow, applied a perpetuity growth assumption, and discounted by a perpetuity discount factor to determine the terminal value. We incorporated the present valueallocation of the resulting terminal value into our estimateCompany’s total goodwill was as follows: North America Generics $2.60 billion, North America Brands $0.65 billion, Europe $4.43 billion and Rest of fair value.
Market-Based Approach: The Company also utilizes a market-based approach to estimate fair value, principally utilizing the guideline company method which focuses on comparing our risk profile and growth prospects to a select group of publicly traded companies with reasonably similar guidelines.World $1.65 billion.
As of March 31, 2020 and April 1, 2019,2020, the Company determined that the fair value of the North America Generics, North America Brands and Rest of World reporting units was substantially in excess of the respective unit’s carrying value.value. However, when compared to the prior year,April 1, 2019 test, the fair value of our overall business declined because of our recent operating results, future forecasts and the decline in our share price, including activity subsequent to April 1, 2019.price.
For the Europe reporting unit, the estimated fair value exceeded its carrying value by approximately $900.0 million$1.3 billion or 7.0%.11.0% for both the interim and annual goodwill impairment test. The excess fair value for the Europe reporting unit is consistent with the result of the Company’s 20182019 annual impairment test. As it relates to the income approach for the Europe reporting unit at March 31, 2020 and April 1, 2019,2020, the Company forecasted cash flows for the next 5 years. During the forecast period, the revenue compound annual growth rate was approximately 6.5%7.5%. A terminal year value year was calculated with a 2.0% revenue growth rate applied. The discount rate utilized was 10.5%11.0% and the estimated tax rate was 24.0%25.5%. Under the market-based approach, we utilized an estimated range of market multiples of 8.0 to 9.5 times EBITDA plus a control premium of 15.0%. If all other assumptions are held constant, a reduction in the terminal value growth rate by 2.0%3.5% or an increase in discount rate by 1.5%3.5% would result in an impairment charge for the Europe reporting unit.
The determination of the fair value of the reporting units requires us to make significant estimates and assumptions that affect the reporting unit’s expected future cash flows. These estimates and assumptions primarily include, but are not limited to, market multiples, control premiums, the discount rate, terminal growth rates, operating income before depreciation
and amortization, and capital expenditures forecasts. Due to the inherent uncertainty involved in making these estimates, actual results could differ from those estimates. In addition, changes in underlying assumptions, especially as it relates to the key assumptions detailed, could have a significant impact on the fair value of the reporting units.
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ITEM 3. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
For a discussion of the Company’s market risk, see “Item 7A. Quantitative and Qualitative Disclosures about Market Risk” in Mylan N.V.’s Annual Report filed on Form 10-K for the year ended December 31, 2018,2019, as amended.
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ITEM 4. | CONTROLS AND PROCEDURES |
ITEM 4. CONTROLS AND PROCEDURES
An evaluation was performed under the supervision and with the participation of the Company’s management, including the Principal Executive Officer and the Principal Financial Officer, of the effectiveness of the design and operation of the Company’s disclosure controls and procedures as of June 30, 2019.2020. Based upon that evaluation, the Principal Executive Officer and the Principal Financial Officer concluded that the Company’s disclosure controls and procedures were effective.
Management has not identified any changes in the Company’s internal control over financial reporting that occurred during the second quarter of 20192020 that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.
PART II — OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
For information regarding legal proceedings, refer to Note 2018 Litigation, in the accompanying Notes to interim financial statements in this Form 10-Q.
ITEM 1A. RISK FACTORS
Except as set forth below, there have been no material changes in the Company’s risk factors from those disclosed in Mylan’s Annual Report on Form 10-K for the year ended December 31, 2018,2019, as amended.
Mylan, Pfizer
The COVID-19 pandemic has had and Upjohncould continue to have a material adverse effect on our business operations, results of operations, cash flows and financial position.
A novel strain of coronavirus (COVID-19) was first reported in December 2019 and has since spread to over 200 countries and territories, including every state in the United States. On March 11, 2020 the World Health Organization declared COVID-19 a pandemic, and on March 13, 2020 the United States declared a national emergency with respect to COVID-19. We continue to closely monitor the impact of the COVID-19 pandemic on all aspects of our business, including its impact on our workforce, suppliers, vendors, business partners, distribution channels, customers and patients. As the rate of infection continues to accelerate in many countries and as the number of cases increases in certain states in the U.S., attempts continue to be made to reduce the spread of COVID-19, including quarantines, government restrictions on movement, business closures and suspensions, canceled events and activities, self-isolation, and other voluntary and/or mandated changes in behavior. Both the outbreak of the disease and actions to slow its spread have created significant uncertainty and economic volatility and disruption, which have impacted and may continue to impact our business operations and have materially adversely affected and may continue to materially adversely affect our workforce and business operations as well as our results of operations, cash flows and financial performance.
While our business operations are currently considered essential based on current government guidelines throughout the world due to the important role pharmaceutical manufacturers play within the global healthcare system, many of our administrative offices have been operating under work from home protocols. Extended changes in work conditions, including work from home protocols, could strain our business continuity plans, reduce productivity and morale, or introduce operational risk, including but not limited to increased cybersecurity risk. For example, remote working environments may be unableless secure and more susceptible to satisfyhacking attacks, including phishing and social engineering attempts that seek to exploit the conditionsCOVID-19 pandemic.
Additionally, we have taken extra precautions at our manufacturing facilities to aid in the protection of site personnel and operations, including the implementation of social distancing guidelines, daily health assessments of on-site personnel and split shifts where feasible. If we experience an increase in reported illnesses or obtainquarantining at any of our facilities, including critical manufacturing sites, it is possible that such facilities may need to close for an extended period of time, which could negatively affect our ability to produce, ship, and supply products to our customers and would impact our business and financial results.
In addition, customer-facing field operations have moved to a remote engagement model and global restrictions have been placed on travel and in-person meetings. A remote engagement model may not be as successful as in-person meetings and could result in lower sales of products, particularly new products. We have also taken steps to protect the approvals requiredsafety of study participants, employees and staff at clinical trial sites while continuing to completeensure regulatory compliance and scientific integrity of trial data.
COVID-19 and related responsive measures have also made, and may continue to make, it difficult for us, our partners or suppliers to source and manufacture products in, and to export our products from, certain affected areas. In addition, we have faced, and may continue to face, delays or difficulty sourcing certain products or raw materials, including active pharmaceutical ingredients. Even if we are able to find alternate sources for such products or raw materials, they may cost more. In addition, we have experienced and may continue to experience increased shipping and freight costs , as well as delays in shipping. These factors have and could continue to materially adversely affect our ability to produce, ship, and supply products, which could negatively impact our customer relationships, business, results of operations and financial results, or result in negative publicity and reputational harm.
Lower retail pharmacy demand, as well as some patients, doctors and hospitals delaying or foregoing routine doctor and hospital visits and elective medical procedures, has led and could continue to lead to decreased demand for certain of our products, which has negatively impacted our sales, results of operations and financial results. At the same time, we have experienced unpredictable increases in demand for certain of our products, which could exceed our capacity to meet such demand and negatively impact our customer relationships, business and results of operation.
Health regulatory agencies globally may also experience disruptions in their operations and greater regulatory uncertainty as a result of the COVID-19 pandemic. For instance, the FDA has announced its intention to temporarily postpone certain inspections of domestic and foreign manufacturing facilities. The FDA and comparable foreign regulatory agencies may have slower response times or reduced resources and, as a result, review of regulatory submissions, inspections, approval of
new products and other timelines important to our business may be materially impacted, which could delay our new product launches and have a material adverse effect on our business.
In addition, our continued access to external sources of liquidity depends on multiple factors, including the condition of debt capital markets, our operating performance, and maintaining strong credit ratings. Also, the continuing impact of the COVID-19 pandemic could lead to our customers or suppliers having liquidity problems that could negatively impact our ability to collect cash on our receivables and/or negatively impact our ability to get inventory and materials. If the impacts of the pandemic create further disruptions or turmoil in the financial markets or customer or supplier liquidity issues, or if rating agencies lower our credit ratings, it could adversely affect our ability to access the debt markets, our cost of funds, and other terms for new debt, which could negatively impact our results of operations and financial position.
In addition, the ongoing challenges posed by the COVID-19 pandemic have already delayed the anticipated timing for completion of the Combination and regulatory agencies may delay or impose conditions on approval of the Combination, which may diminish the anticipated benefits of the Combination. Failure to complete the Combination could adversely impact the market price of Mylan shares as well as Mylan’s business and operating results.
The consummation of the Combination is subject to numerous conditions, including the receipt by Pfizer of an IRS ruling and tax opinion of its tax counselcreate additional uncertainties with respect to the Combination, the receipt of Mylan shareholder approvalexpected timetable for the Combination and other customary conditions. Mylan cannot make any assurances that the Combination will be consummated on the terms or timeline currently contemplated, or at all.
Completion of the Combination is also conditioned upon the receipt of required government consents and approvals, including required approvals from foreign regulatory agencies. While Mylan, Pfizer and Upjohn intend to pursue vigorously all required governmental approvals and do not know of any reason why they would not be able to obtain the necessary approvals in a timely manner, the requirement to receive these approvals before the consummation of the Combination could delay the completion of the Combination, possibly for a significant period of time after Mylan shareholders have approved the Combination. Any further delay in the contemplated timing for the completion of the Combination could diminish the anticipated benefits of the Combination to the combined company or result in additional transaction costs, loss of revenue or opportunities for Mylan or the combined company, or have other negative effects associated with uncertainty about the Combination.
ToThe extent to which the extentCOVID-19 pandemic will continue to impact us depends on numerous evolving factors and future developments that the market price of Mylan ordinary shares reflects positive market assumptions that the Combination will be consummated, the price of Mylan ordinary shares may decline if the Combinationwe are not consummated for any reason or in a timely manner. Mylancurrently able to predict and may also be subject to additionalexacerbate other risks if the Combination are not consummated, including:
dependingdiscussed in Item 1A. Risk Factors in our Annual Report on the reasons for terminationForm 10-K, any of the Business Combination Agreement, the requirement that Mylan pay Pfizer a termination fee of $322 million, or in the situation where Mylan’s shareholders do not approve the Combination and the transaction is terminated, up to $96 million to reimburse Pfizer for its costs;
the fact that substantial costs related to the Combination, such as legal, accounting, filing, financial advisory and financial printing fees, must be paid regardless of whether the Combination are completed; and
possible negative reactions from our customers, regulators and employees.
The pendency of the Combination could adversely affect Mylan’s business and operations.
Whether the Combination is ultimately consummated or not, its pendencywhich could have a number of negative effects on our current business, including potentially disrupting our regular operations, diverting the attention of our workforce and management team, or increasing workforce turnover. The completion of the Combination, including for example, obtaining regulatory approvals, will require significant time and attention from Mylan management and may divert attention from the day-to-day operations of our business. Any uncertainty over the ability of Pfizer, Mylan and Upjohn to complete the Combination could make it more difficult for Mylan to retain key employees or attract new talent, or to pursue business strategies.
Parties with which we have business relationships, either contractual or operational, may experience uncertainty as to the future or desirability of such relationships and may delay or defer certain business decisions, seek alternative relationships with third parties or seek to alter their present business relationships with us. Parties with whom we otherwise may have sought to establish business relationships may seek alternative relationships with third parties. Additionally, we have contracts with
certain customers, suppliers, vendors, distributors, lenders, and other business partners, and these contracts may require us to obtain consent from these other parties in connection with the Combination. Obtaining such consents may be difficult and could impose costs on us, including renegotiating such contracts on terms less favorable to Mylan, which in turn may result in us suffering a loss of potential future revenue, incurring contractual liabilities or losing rights that are material to our business.
The Business Combination Agreement subjects us to restrictions on our business activities and obligates us to generally operate our business in the ordinary course in all material respects consistent with past practice prior to completion of the Combination. These restrictions could prevent us from pursuing attractive business opportunities that arise prior to the completion of the Combination and are outside the ordinary course of business, or otherwise have an adverse effect on us, our business operations, results of operations, cash flows and financial position. The Business Combination Agreement also subjects us
ITEM 5. OTHER INFORMATION
As previously reported in the Company’s Current Report on Form 8-K filed with the SEC on July 29, 2019, Kenneth S. Parks, currently Chief Financial Officer of Mylan, has agreed to restrictionsdepart the Company upon the close of the Combination. Mr. Parks advised the Company on our ability to pursue alternatives to the Combination and so we might have to forego another strategic transactionAugust 4, 2020 that would otherwise have been favorable to Mylan and our shareholders.he will be stepping down from his position as Chief Financial Officer effective September 1, 2020.
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ITEM 6. EXHIBITS |
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| Amendment No. 1, dated as of May 29, 2020, to the Business Combination Agreement, dated as of July 29, 2019, by and among Pfizer Inc., Upjohn Inc., Utah Acquisition Sub Inc., Mylan N.V., Mylan I B.V. and Mylan II B.V., filed as Exhibit 2.1 to the Report on Form 8-K filed with the SEC on June 1, 2020, and incorporated herein by reference.^ |
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| Amendment No. 2, dated as of May 29, 2020, to the Separation and Distribution Agreement, dated as of July 29, 2019, by and between Pfizer Inc. and Upjohn Inc.,filed as Exhibit 2.2 to the Report on Form 8-K filed with the SEC on June 1, 2020, and incorporated herein by reference.^ |
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| Amendment No. 2, dated as of June 16, 2020, to the Revolving Credit Agreement dated as of July 27, 2018 among Mylan Inc., as borrower, Mylan N.V., as guarantor, the lenders and issuing banks from time to time party thereto and Bank of America, N.A., as administrative agent, filed as Exhibit 10.1 to the Report on Form 8-K filed with the SEC on June 17, 2020, and incorporated herein by reference. |
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| Executive Employment Agreement, entered into on April 15, 2020, by and between Mylan N.V., Mylan Inc.and Robert J.Coury, filed as Exhibit 10.3 to the Form 10-Q for the quarter ended March 31, 2020, and incorporated herein by reference.* |
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| List of Subsidiary Guarantors and Issuers of Guaranteed Securities, filed as Exhibit 22 to the Form 10-Q for the quarter ended March 31, 2020, and incorporated herein by reference. |
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| Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
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| Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
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| Certification of Principal Executive Officer and Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
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101.INS | Inline XBRL Instance Document |
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101.SCH | Inline XBRL Taxonomy Extension Schema |
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101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase |
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101.DEF | Inline XBRL Taxonomy Definition Linkbase |
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101.LAB | Inline XBRL Taxonomy Extension Label Linkbase |
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101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase |
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104 | Cover Page Interactive Data File - the cover page interactive data file does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document (included in Exhibit 101). |
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* | Denotes management contract or compensatory plan or arrangement. |
^ | Annexes, schedules and/or exhibits have been omitted pursuant to Item 601(b)(2) of Regulation S-K. Mylan agrees to furnish supplementally a copy of any omitted attachment to the SEC on a confidential basis upon request. |
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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 thereunto duly authorized.
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| | Mylan N.V. (Registrant) |
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| By: | Mylan N.V.
(Registrant)
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| By: | /s/ HEATHER BRESCH |
| | Heather Bresch |
| | Chief Executive Officer |
| | (Principal Executive Officer) |
July 29, 2019
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| | /s/ KENNETH S. PARKS |
| | Kenneth S. Parks |
| | Chief Financial Officer |
| | (Principal Financial Officer) |
July 29, 2019
August 6, 2020