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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

_____________________

 

Form 8-K

_____________________

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event Reported): September 10, 2019

 

Akorn, Inc.

(Exact Name of Registrant as Specified in Charter)

 

Louisiana 001-32360 72-0717400
(State or Other Jurisdiction of Incorporation) (Commission File Number) (I.R.S. Employer Identification Number)

 

1925 W. Field Court, Suite 300, Lake Forest, Illinois 60045

(Address of Principal Executive Offices) (Zip Code)

 

(847) 279-6100

(Registrant’s telephone number, including area code)

 

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

  ¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
  ¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
  ¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
  ¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class Trading Symbol(s) Name of each exchange on which registered
Common Stock, No Par Value AKRX The NASDAQ Global Select Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). 

Emerging growth company ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 

 

 

  

 

Item 7.01 Other Events.

 

Akorn, Inc. (“Akorn” or the “Company”) intends to use the materials furnished herewith as Exhibit 99.1 in one or more investor presentations beginning as early as September 11, 2019. The investor presentation is incorporated herein by reference. The Company has also made available a copy of the investor presentation under the “Events and Presentations” tab in the “Investor Relations” section of the Company’s website, located at www.akorn.com.

 

The information in this report, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

  

Item 9.01. Exhibits.

 

(d) Exhibits

  

Exhibit Number Description
   
99.1 Akorn, Inc., September 2019 Investor Presentation.
   
104 Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 

 

 

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    Akorn, Inc.  
       
Date: September 10, 2019 By: /s/ Duane A. Portwood  
    Duane A. Portwood  
    Chief Financial Officer  

 

 

 

Exhibit 99.1

 

 

INVESTOR PRESENTATION September 2019

 

 

 

Cautionary Note Regarding Forward - Looking Statements This presentation contains forward - looking statements, including statements regarding our stabilization, transformation, return to profitability, higher value opportunities, R&D investment targets, completion of cGMP improvements, quality systems and compliance activitie s, cost reduction initiatives, improved operational performance, financial guidance, margin improvement, future growth, financial results, business operations, products, and prospects. When used in this document, the words “will,” “target,” “expect,” “continue,” “believe,” “anticipate ,” “estimate,” “intend,” “could,” “would,” “strives” and similar expressions are generally intended to identify forward - looking statements. These stateme nts are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Secur iti es Exchange Act of 1934, as amended. A number of important factors could cause actual results of the Company and its subsidiaries to differ mate ria lly from those indicated by such forward - looking statements. These factors include, but are not limited to: ( i ) the effect of the Delaware Court of Chancery’s October 1, 2018 decision against the Company and the Delaware Supreme Court’s December 7, 2018 order affirming the Chancery C our t’s decision on the Company’s ability to retain and hire key personnel, its ability to maintain relationships with its customers, supplier s a nd others with whom it does business, or its operating results and business generally, (ii) the risk that ongoing or future litigation against the d efe ndants or related to the court’s decision may result in significant costs of defense, indemnification and/or liability, (iii) the outcome of the inves tig ation conducted by the Company, with the assistance of outside consultants, into alleged breaches of FDA data integrity requirements relating to pro duc t development at the Company and any actions taken by the Company, third parties or the FDA as a result of such investigations, (iv) the diffi cul ty of predicting the timing or outcome of product development efforts, including FDA and other regulatory agency approvals and actions, if any, (v ) t he timing and success of product launches, (vi) difficulties or delays in manufacturing, (vii) the Company’s increased indebtedness and obl iga tion to comply with certain covenants and other obligations under its standstill agreement with its first lien term loan lenders (the “Standstill Ag reement”), (viii) the Company’s obligation under the Standstill Agreement to enter into a comprehensive amendment that is satisfactory in form and sub stance to the first lien term loan lenders, (ix) the risk that the holders of a significant number of shares may opt out of and elect not t o p articipate in or be bound by the Securities Class Action Settlement Agreement, (x) the risk that the Securities Class Action Settlement Agreement may n ot obtain the necessary approval by the court or may be terminated in accordance with its terms, (xi) the risk that insurance proceeds, common shares or other consideration contemplated to be exchanged pursuant to the proposed settlement is not available at the appropriate time and ( xii ) such other risks and uncertainties outlined in the risk factors detailed in Part I, Item 1A, “Risk Factors,” of the Company’s Annual Report on Fo rm 10 - K for the fiscal year ended December 31, 2018 (as filed with the Securities and Exchange Commission (“ SEC ”) on March 1, 2019) and in Part II, Item 1A, “Risk Factors,” of the Company’s Quarterly Reports on Form 10 - Q for the fiscal quarters ended March 31, 2019 (as filed with the SEC on May 9, 2019) and June 30, 2019 (as filed with the SEC on August 2, 2019) and other risk factors identified from time to time in the Company’s fil ings with the SEC. Readers should carefully review these risk factors, and should not place undue reliance on the Company’s forward - looking stateme nts. These forward - looking statements are based on information, plans and estimates at the date of this presentation. The Company undertake s no obligation to update any forward - looking statements to reflect changes in underlying assumptions or factors, new information, future events or other changes. Non - GAAP Measures In this presentation, we refer to Adjusted EBITDA, which is a non - GAAP financial measure the Company believes is helpful in evaluating the performance of its business. Please see “Appendix” for important disclosures regarding Adjusted EBITDA. 2

 

  

 

 

 

Akorn is executing a significant turnaround 3 Initial steps have been taken to stabilize the business and focus on long - term profitable growth ▪ Strengthening the foundation and improving operational results ▪ Improving financial results and cash flow generation ▪ Increasing R&D efficiency and bolstering new product pipeline Growth Phase Business Headwinds Stabilization Transformation and Return to Profitability 2012 - 2016 2017 - 2018 2019 2020+

 

 

Akorn Today 4 Lake Forest, Illinois Company headquarters Diversified portfolio of generic, branded, over - the - counter (OTC) and animal health products Strong pipeline of pending ANDAs ~1800 employees globally 4 manufacturing facilities Product mix focused on alternate dosage forms Akorn is a leading specialty pharma player in attractive niche markets

 

 

Experienced Leadership Team 5 Douglas Boothe President and CEO 18 years in pharma. Prior experience: Impax, Perrigo, Actavis Duane Portwood EVP and CFO 4 years at Akorn . Prior experience: Home Depot, Wrigley, PwC Joseph Bonaccorsi EVP and General Counsel 17 years in healthcare, 10 at Akorn. Prior experience: Option Care, Walgreens Jonathan Kafer Chief Commercial Officer 26 years in pharma, 4 at Akorn . Prior experience: Allergan, Teva, Xanodyne Christopher Young EVP, Global Operations 25 years in pharma. Prior experience: Alvogen , Actavis, Alpharma Dandy Dorado - Boladeres EVP, Global Quality 21 years in pharma. Prior experience: American Regent, Allergan, Teva, Actavis Jennifer Bowles SVP, Corporate Strategy and IR 13 years in pharma, 7 at Akorn. Prior experience: Wockhardt , Atofina , ExxonMobil Bill Ostrowski SVP, Chief Information Officer 18 years in pharma. Prior experience: Pernix , Actavis, Fujitsu Industry veterans focused on quality, compliance, and long - term profitable growth

 

 

Foundation For Success 6 Fundamental strengths provide a growth platform upon which to build Diversified Product Portfolio Strong Growth Potential Operational Efficiencies Experienced Management Team Strong Product Pipeline and R&D Capabilities Favorable Market Dynamics

 

 

Generic Prescription Branded Ophthalmics Consumer Health Animal Health ▪ Broad and diverse portfolio of ~150 products ▪ Products across variety of alternative dosage forms ▪ High barriers to entry ▪ Strong presence in both retail and institutional markets ▪ Portfolio of OTC brands ▪ Flagship brand: TheraTears ® provides a complete system of dry eye relief products ▪ Long history and strong reputation in ophthalmology ▪ ~45 field sales representatives ▪ Cost efficient outsourced infrastructure ▪ Leverages and deepens customer relationships ▪ Portfolio of acquired branded products as well as internally developed animal health generics ▪ Proprietary line of sedatives and reversal agents ▪ Strong relationships with vet distributors Retail Retail Retail Retail Diversified product lines with high barriers to entry provide strong foundation and multiple avenues for growth 7 Diverse Spec Pharma Offering

 

 

= Number of ANDAs Strong R&D Pipeline 36 pending ANDAs 1 represent a total market opportunity of ~$5.6B with significant diversification by dosage form 8 $72 $313 $1,109 $4,144 Topical Other Injectable Ophthalmic 17 9 6 4 • Development areas of focus: • High value ophthalmic suspensions and injectables • Animal health generics (ANADAs) • Focused on pursuing higher value opportunities rather than higher quantity of filings • R&D investment target of approximately 5 - 6% of sales annually Market Value ($ millions) of Pending ANDAs by S pecialty R&D Investment ($ millions) Pending ANDAs as of 7/31/19. The market value of pending ANDAs, shown in millions, is the market size estimate based on IQVIA data for the trailing 12 months ended May 2019 and excludes any trade and customary allowances and discounts. The IQVIA market size is not a forecast of our future sales. 0 10 20 30 40 50 2016 2017 2018 3.5% 5.3% 6.8% $ 39 $ 45 $ 47 R&D Spending % of Revenue 1

 

 

Favorable market dynamics with multiple tailwinds Source: Company Management and IQVIA Loss of exclusivity of b rands driving generic opportunities 5 6 Generic substitution rates and prescription volume both steadily increasing 3 Savings to the US healthcare system from generics will continue to drive substitution 2 Aging US population driving demand for more medicine 1 Portfolio optimization provides opportunities for remaining suppliers Customer consolidation trends have normalized 4 9

 

 

10 Invest in New Product Development and Pipeline Stabilize and Improv e Operations • Stabilize and improve manufacturing, quality, and compliance while limiting new operational risks • Complete cGMP improvements across facilities • Target reductions in third - party spending • Increase level of service to customers to continue to build trust • Improve product availability to better serve customers and minimize failure to supply penalties • Prioritize development efforts on high - value products • Explore in - licensing and other business development activities Optimize In - Line Portfolio Performance Invest in New Product Development and Pipeline Focus is on stabilizing the business and restoring sustainable growth Near - Term Priorities

 

 

Operational Initiatives Begin to Yield Value 11 Early wins with operational performance and improved customer service Increased Product Availability Improved Operational Performance 4 Product Approvals 1 Expanded Organizational Capabilities Progressing with FDA Action Items at Decatur and Somerset 5 Product Launches 1 1 Product approvals and launches as of YTD September 2019

 

 

Facility Progress Update Decatur Facility ▪ April / May 2018 FDA inspection resulted in OAI status ▪ Warning letter received in January 2019 x FDA Compliance related activities expected to be substantially complete in early 2020 ▪ Ongoing activities include: ▪ Comprehensive, independent assessments of processes and systems, CAPAs Somerset Facility ▪ July / August 2018 FDA inspection resulted in OAI status ▪ Warning letter received in June 2019 x FDA Compliance related activities expected to reach essentially full completion by end of 2019 ▪ Ongoing activities include : ▪ Third party verification targeted for late 2019 / early 2020 Other Facilities Recent inspections at other sites have had satisfactory outcomes x Amityville: FDA inspection conducted in January and February 2019; VAI status x Hettlingen : Last FDA inspection conducted in December 2017; VAI status FDA Compliance Activities QSCAP 1 program implemented to coordinate, harmonize, and complete the various quality - related reviews, corrective actions and deliverables Quality Systems Corrective Action Plan (QSCAP) 12 1

 

 

Financial Overview

 

 

Stabilizing Financial Performance 14 $ in millions 2019E revenue reflects guidance range provided on 8/1/19 in 2019 Q2 release. Revenue Revenue Guidance • Growth predominately driven by market exclusivity of e phedrine sulfate injection • Operating performance negatively impacted by: • Increased competition for key products • Customer consolidation • Fresenius merger termination • cGMP enhancement expenses • Business stabilization driven by executing operations, quality systems and compliance initiatives • Focused on measuring and driving improvement in key performance metrics • Already demonstrating results related to improved product availability, lower backorders, and reduced failure to supply • Cost reduction initiatives initially focused on discretionary spending items and procurement activities 2015 - 2016 2019 2017 - 2018 $985 2015 $1,117 2016 $841 2017 $694 2018 $710 2019E 1 $690 1

 

 

Recent Earnings Summary In both Q1 and Q2 2019, Akorn has demonstrated sequential improvement in operating results Q4’18 Q1’19 Q2’19 15 Adjusted EBITDA, as defined by the Company, is calculated as follows: net (loss) income, (minus) plus: ( i ) interest income (expense), net (ii) provision (benefit) for income taxes (ii) depreciation and amortization, (iv) non - cash expenses, such as impairment of long - lived assets, share - based compensation expense, and amortizatio n of deferred financing costs, and (iv) other adjustments, such as legal settlements, restatement expenses and various merger and acquisition - related expenses, employee retention expense, refinancing a dvisory fees, fixed asset impairment, executive termination expenses, data integrity investigations and assessment, gain on disposal of fixed assets, and Fresenius transaction and litig ati on. Please see “Appendix” for important disclosures regarding Adjusted EBITDA. Revenue growth $153M $166M $178M Gross Margin % 38% 16% 32% Adjusted EBITDA 1 - $20M $10M $22M Operating Cash Flow - $32M $ - 30M $1M 1 FTI12

 

 

LONGER TERM • Continued growth and margin improvement • Meaningful annualized cost reductions Longer term 2020 • Normalized Earnings power • Adjusted EBITDA 2 at least doubling from 2019 Confidence in Business Turnaround Drives Guidance 1 16 Net Loss : ($273) to ($258) million Net Revenue : $690 to $710 million 2020 Adjusted EBITDA : $71 to $86 million Capital Expenditures : ~ $40 million FDA Compliance & Data Integrity Expenditures: ~ $50 million FY 2019 Guidance 1 As of 8/1/2019 Please see “Appendix” for important disclosures regarding Adjusted EBITDA. 2

 

 

Investment Highlights Akorn is a leading specialty pharma player in attractive niche markets Diversified Product Portfolio Majority of Sales Are for Alternate Dosage Forms Strong Product Pipeline and R&D Capabilities Strong Growth Potential Experienced Management Team • Diversified portfolio not reliant on a single product reduces vulnerability to competitive pressures • Specialty generics business is focused on alternate dosage forms (e.g. injectables, ophthalmics, respiratory, liquids) which have higher barriers to entry and generally lower competition • Strong presence in attractive niche markets including branded and OTC ophthalmics • Majority of Akorn’s business is focused on alternate dosage forms such as injectables, ophthalmics, topicals, liquids • More complex, higher barrier to entry products provide higher value potential • Strong pipeline of 36 pending ANDAs with $5.6 billion combined addressable market value • Focused on high value alternate dosage form development opportunities • Company is executing a turnaround and targeting significant growth • Priority is on executing cGMP plan initiatives, with related expenses expected to diminish in 2020 • Company is executing on significant operational improvement opportunities • CEO Douglas Boothe joined in January 2019 • Previously held senior positions at Impax , Perrigo, and Actavis • Recent management changes include EVP of Global Operations, EVP of Global Quality, and Chief Information Officer • Deep bench with significant industry and functional experience 17

 

 

Appendix

 

 

Recent Product Launches Generic Name (Strength) Brand Reference Market $ M 1 Current # of Competitors Launched Ropivacaine Injection (0.2%) Naropin® $41 3 Jan - 19 TheraTears ® Sterilid ® Antimicrobial Sterilid ® n/a - Apr - 19 Dicyclomine Injection (10mg/mL) Bentyl® $18 4 Jun - 19 Loteprednol Etabonate Ophthalmic Suspension (0.5%) Lotemax ® $92 1 Jun - 19 Diclofenac Sodium Topical Gel (1%) Voltaren® $333 5 Sep - 19 Trademarks mentioned are the property of their respective owners The market value, shown in millions, is the market size estimate based on IQVIA data for the trailing 12 months ended July 2019 a nd excludes any trade and customary allowances and discounts. The IQVIA market size is not a forecast of our sales. 1

 

 

Reconciliation of GAAP Net (Loss) to Non - GAAP EBITDA and Adjusted EBITDA 1 20 Six Months Ended Three Months Ended Year Ended June 30, June 30, March 31, December 31, December 31, $ in thousands 2019 2019 2019 2018 2018 ($193,780) ($111,599) ($82,181) ($215,038) ($401,909) Depreciation expense 15,108 7,423 7,685 8,217 29,333 Amortization expense 21,015 9,950 11,065 13,487 53,472 Interest expense, net 31,668 17,341 14,327 13,569 45,900 Income tax (benefit) provision 2,902 1,482 1,420 5,678 (36,273) ($123,087) ($75,403) ($47,684) ($174,087) ($309,477) Merger and acquisition-related expenses 6 9 (3) 22 121 Employee retention expense 3,343 1,585 1,612 – Data integrity investigations & assessment 7,833 3,179 4,199 6,021 28,420 Fresenius transaction & litigation 3,631 1,940 2,147 8,303 43,305 Refinancing advisory fees 10,038 4,290 5,748 – – Non-cash stock compensation expense 10,308 5,588 4,720 4,304 21,503 Impairment of goodwill 15,955 – 15,955 – – Impairment of intangible assets 10,748 394 10,354 118,088 231,086 Loss (Gain) from asset sales – – – – (201) Amortization of deferred financing costs 6,959 5,655 1,304 1,304 5,216 Restatement expenses (26) – (26) (273) (1,018) Executive termination expenses 835 – 835 6,455 6,455 Impairment of fixed assets and other 10,227 138 10,089 6,081 6,058 Loss (Gain) on disposal of fixed assets (29) 2 (31) – – Litigation rulings and settlements 74,879 74,469 410 3,870 17,814 $31,620 $21,846 $9,629 ($19,912) $49,282 ADJUSTED EBITDA NON-CASH AND OTHER NON-RECURRING INCOME AND EBITDA ADJUSTMENTS TO ARRIVE AT EBITDA: NET (LOSS) Adjusted EBITDA, as defined by the Company, is calculated as follows: net (loss) income, (minus) plus: ( i ) interest income (expense), net (ii) provision (benefit) for income taxes (ii) depreciation and amortization, (iv) non - cash expenses, such as impairment of long - lived assets, share - based compensation expense, and amortizatio n of deferred financing costs, and (iv) other adjustments, such as legal settlements, restatement expenses and various merger and acquisition - related expenses, employee retention expense, refinancing a dvisory fees, fixed asset impairment, executive termination expenses, data integrity investigations and assessment, gain on disposal of fixed assets, and Fresenius transaction and litig ati on. Please see “Appendix” for important disclosures regarding Adjusted EBITDA. 1

 

 

Reconciliation of GAAP Net (Loss) to Non - GAAP EBITDA and Adjusted EBITDA 1 21 $ in millions Adjusted EBITDA, as defined by the Company, is calculated as follows: net (loss) income, (minus) plus: ( i ) interest income (expense), net (ii) provision (benefit) for income taxes (ii) depreciation and amortization, (iv) non - cash expenses, such as impairment of long - lived assets, share - based compensation expense, and amortizatio n of deferred financing costs, and (iv) other adjustments, such as legal settlements, restatement expenses and various merger and acquisition - related expenses, employee retention expense, refinancing a dvisory fees, fixed asset impairment, executive termination expenses, data integrity investigations and assessment, gain on disposal of fixed assets, and Fresenius transaction and litig ati on. Please see “Appendix” for important disclosures regarding Adjusted EBITDA. 1