Amneal Pharmaceuticals, Inc. · NASDAQ:AMRX
Amneal Pharmaceuticals — FY2018 Earnings Presentation
40 slides from Amneal Pharmaceuticals's earnings presentation, Feb 28, 2019
Slide 1: Q4 and Full Year 2018 Earnings Call
“We make healthy possible” Q4 and Full Year 2018 Earnings Call Financial Results and Business Update February 28, 2019
Slide 2: Safe Harbor Statement
Safe Harbor Statement Safe Harbor Statement Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the Private Securities Litigation Reform Act of 1995). Such forward- looking statements include statements regarding mana
Slide 3: Non-GAAP Financial Measures
Non-GAAP Financial Measures This presentation includes certain Non-GAAP financial measures, including adjusted EBITDA, adjusted net income, adjusted net income per diluted share, adjusted gross profit, adjusted gross margin and adjusted operating income, are intended as supplemental measures of the
Slide 4: Agenda
Agenda Q4 and Full Year 2018 Highlights 1 Rob Stewart, President & CEO Financial Results Review 2 Todd Branning, SVP & CFO 2019 Outlook 3 Rob Stewart 4 Q&A 4
Slide 5: Performance and Highlights
Performance and Highlights Rob Stewart President & CEO
Slide 6: Significant Achievements in 2018
Significant Achievements in 2018 Led U.S. generics industry in both approvals and launches Operational Excellence 62 ANDAs approved 10 tentative approvals 42 new products launched Strong growth from Specialty products Rytary® and Unithroid® R&D activity: 31 ANDAs submitted; initiated Pha
Slide 7: 2018 Financial Results
2018 Financial Results Strategic investments, accelerated synergy capture, new product launches and base business performance drove combined adjusted EBITDA(1) growth in 2018 Non-GAAP Non-GAAP Non-GAAP Combined Net Revenue(1) Combined Adjusted EBITDA(1) Combined Adjusted Diluted EPS(1) +0.2% +16% $1
Slide 8: Q4 '18 Financial Results
Q4 ’18 Financial Results Delivered solid financial and operational performance in fourth quarter 2018 Non-GAAP Non-GAAP Non-GAAP Combined Net Revenue(1) Combined Adjusted EBITDA(1) Combined Adjusted Diluted EPS(1) Sequential +4% Sequential +15% Sequential YOY +2% YOY +34% +22% $487 $476 $498 15% $46
Slide 9: Strong Generic Pipeline Execution in 2018
Strong Generic Pipeline Execution in 2018 Led U.S. Generic Industry in ANDA Approvals $171 Million in Net Revenue from New Product Launches(1) 62 10 42 ANDAs Approved Tentative ANDAs New Products Approved Launched in 2018 2018 ANDAs Approved 62 37% injectable, topical or liquid products 15 46 44 40
Slide 10: Continuing to Diversify Amneal's Generic Pipeline to Drive Future Growth
Continuing to Diversify Amneal’s Generic Pipeline to Drive Future Growth Amneal’s Submitted Pipeline(1) Submitted % 2018 U.S. Dosage Form Sales(2) Products Portfolio 65% of ANDAs submitted in 2018 $ billions were non-oral solid products Tablets 48 41% $34.2 Injectable 19 16% $8.9 Capsules 15 13% $16
Slide 11: Focused on Complex, High-Value Products
Focused on Complex, High-Value Products Amneal’s Development Pipeline(1) R&D investments targeting valuable 2018 U.S. % and durable product opportunities Dosage Form Development Portfolio Sales(2) $ billions Injectable 25 26% $6.5 Capsules 17 18% $7.5 Tablets 16 16% $4.7 Ophthalmic 12 12% $1.1 Topic
Slide 12: Specialty CNS Franchises Delivered Solid Growth in 2018
Specialty CNS Franchises Delivered Solid Growth in 2018 2018 Results 2018 Results Net sales growth of 43% over 2017 Net sales growth of 11% over 2017 Hit all-time high TRx/week in December of 4,237(1) Overcame managed care headwinds Added ~12MM new covered Med-D lives through new 2019 Focu
Slide 13: Implementing Strategies to Deliver Growth in 2019
Implementing Strategies to Deliver Growth in 2019 2018 Results 2018 Results Net sales growth of 39% over 2017 Net sales declined 4% versus 2017 Hit all time high TRx of 6,621/week in December(1) 2019 Focus Double-digit growth in TRx and NRx in 2018 Action plan underway to increase patient
Slide 14: Initiated Phase 3 Study for IPX203 in 2018
Initiated Phase 3 Study for IPX203 in 2018 IPX203 is an investigational extended-release capsule formulation of carbidopa-levodopa (CD- LD) for oral administration Investigator meeting and patient enrollment began Q4 2018 Topline data expected first half 2020 NDA filing expected in 2021 14
Slide 15: Financial Review
Financial Review Todd Branning SVP & CFO
Slide 16: Generic Segment Results
Generic Segment Results Key Drivers: Combined Adjusted(1) Results Combined Adjusted(1) Sequentially: Revenue Up 5% Variance 15 new product launches in Q418 including Levothyroxine Lower sales of Yuvafem®, Aspirin Dipyridamole and Diclofenac Q4 18 Q3 18 Q4 17 Sequential YOY 1% due to new competit
Slide 17: Specialty Segment Results
Specialty Segment Results Combined Adjusted(1) Key Drivers: Combined Adjusted(1) Results Variance Sequentially: Revenue Up 2% Year-Over-Year: Revenue Up 7% Q4 18 Q3 18 Q4 17 Sequential YOY Higher sales of Rytary®, Zomig® and Unithroid® $ millions Lower sales of Albenza® due to loss of exclusivit
Slide 18: Balance Sheet and Cash Flow Information
Balance Sheet and Cash Flow Information Q4 Q3 Q4 ’18 Sources of Cash Variance 2018 2018 $ millions Cash flow from operations of $260MM Cash and Cash Equivalents $213 $165 $48 $25MM from sale of Hayward buildings and certain equipment Accounts Receivable $481 $641 ($160) Current Portion and Long-
Slide 19: 2019 Outlook
2019 Outlook Rob Stewart President & CEO Amneal’s full year 2019 estimates are based on management's current expectations, including with respect to prescription trends, pricing levels, inventory levels, and the anticipated timing of future product launches and events. The Company cannot provide a r
Slide 20: 2019 Outlook Assumptions
2019 Outlook Assumptions(1) Generics Segment: • Revenues expected to increase driven by the full year impact of 2018 product launches and up to 50 product launches in 2019 including gNuvaring® • Partially offset by declines on key products Yuvafem®, Aspirin/Dipyridamole, Oseltamivir, Diclofenac Ge
Slide 21: 2019 Financial Outlook
2019 Financial Outlook 2018 Combined 2019 Outlook Adjusted(1) Adjusted Gross Margin 52% 47% - 50% Adjusted R&D as a % of net revenues 12% 9% - 10% Adjusted SG&A as a % of net revenues 14% 11% - 12% Adjusted EBITDA $584 million $600 million - $650 million Adjusted Diluted EPS $0.98 $0.94 - $1.04 Adju
Slide 22: Near-Term Priorities to Build from Position of Strength
Near-Term Priorities to Build from Position of Strength OUR GOALS Capitalize on Organic Growth Continue to leverage industry leading approvals and on-time launch performance Drive for double-digit Drive Operational Excellence earnings growth Maintain superior customer service and highest level of qu
Slide 23: Long-Term Priorities to Drive For Double-Digit Earnings Growth
Long-Term Priorities to Drive For Double-Digit Earnings Growth OUR PORTFOLIO Continue to Drive Organic Growth FOCUS Ongoing investment in Generic and Specialty R&D Generics Pursue Creative Business Development Tuck-in acquisitions as well as larger transactions to Specialty strengthen key portfolios
Slide 24: Appendix
2 amneal Appendix
Slide 25: Reconciliation of Net (Loss) Income to Combined Adjusted Net Income
Reconciliation of Net (Loss) Income to Combined Adjusted Net Income and Calculation of Adjusted Diluted EPS (Unaudited; In thousands, except per share amounts) Year ended December 31, 2018 Year ended December 31, 2017 (Non-GAAP) (Non-GAAP) Add: Add: Actual Impax/ Gemini Combined Actual Impax/ Gemini
Slide 26: Reconciliation of Net (Loss) Income to EBITDA and Combined Adjusted EBITDA
Reconciliation of Net (Loss) Income to EBITDA and Combined Adjusted EDITBA (Unaudited; In thousands) Year ended December 31, 2018 Year ended December 31, 2017 (Non-GAAP) (Non-GAAP) Add: Add: Impax/ Impax/ Actual Gemini Combined Actual Gemini Combined Net (loss) income $ (201,303) $ (150,155) $ (351,
Slide 27: Reconciliation of Non-GAAP Combined Revenue
Reconciliation of Non-GAAP Combined Revenue (Unaudited: In thousands) Year ended December 31, 2018 Year ended December 31, 2017 (Non-GAAP) (Non-GAAP) Three months ended Sept. 30, 2018 Add: Add: Add: Impax/ Impax/ Actual Gemini Combined Actual Gemini Combined Impax/ Actual Gemini Combined Net revenue
Slide 28: Reconciliation of Net (Loss) Income to EBITDA and Combined Adjusted EBITDA
Reconciliation of Net (Loss) Income to EBITDA and Combined Adjusted EBITDA (Unaudited: In thousands) Three months ended December 31, 2018 Three months ended December 31, 2017 Three months ended Sept. 30, 2018 (Non-GAAP) (Non-GAAP) Add: Add: Add: Impax/ Impax/ Actual Gemini Combined Actual Gemini Com
Slide 29: Reconciliation of Net (Loss) Income to EBITDA and Combined Adjusted EBITDA
Reconciliation of Net (Loss) Income to EBITDA and Combined Adjusted EBITDA (Unaudited: In thousands) Three months ended March 31, 2018 Three months ended June 30, 2018 Net loss $ (79,397) Add: Adjusted to add (deduct): GAAP Impax/ Gemini Combined Interest expense, net 34,743 Net loss $(250,090) $(23
Slide 30: Reconciliation of Net (Loss) Income to Combined Adjusted Net Income
Reconciliation of Net (Loss) Income to Combined Adjusted Net Income and Calculation of Adjusted Diluted EPS (Unaudited; In thousands, except per share amounts) Three months ended December 31, 2018 Three months ended December 31, 2017 (Non-GAAP) (Non-GAAP) Three months ended Sept. 30, 2018 Add: Add:
Slide 31: Reconciliation of Net (Loss) Income to Combined Adjusted Net Income
Reconciliation of Net (Loss) Income to Combined Adjusted Net Income and Calculation of Adjusted Diluted EPS (Unaudited; In thousands, except per share amounts) Three months ended March 31, 2018 Three months ended June 30, 2018 Add: Combined net loss $ (79,397) GAAP Impax/ Gemini Combined Adjusted to
Slide 32: Reconciliation of Generics Operating Income to Combined Operating Income
Reconciliation of Generics Operating Income to Generics Combined Operating Income (Unaudited; In thousands) Three months ended Sept. 30, 2018 Add: Generics Three months ended December 31, 2018 Three months ended December 31, 2017 Actual Impax Combined Add: (Non-GAAP) Add: (Non-GAAP) Impax/ Impax/ Ne
Slide 33: Reconciliation of Generics Cost of Goods Sold to Combined Adjusted
Reconciliation of Generics Cost of Goods Sold to Generics Combined Adjusted Cost of Goods Sold (Unaudited; In thousands) Generics Three months ended December 31, 2018 Three months ended December 31, 2017 Three months ended Sept. 30, 2018 (Non-GAAP) (Non-GAAP) Add: Add: Add: Impax/ Impax/ Actual Impa
Slide 34: Reconciliation of Generics Operating Income to Combined Adjusted Operating Income
Reconciliation of Generics Operating (Loss) Income to Generics Combined Adjusted Operating Income (Unaudited; In thousands) Generics Three months ended December 31, 2018 Three months ended December 31, 2017 Three months ended Sept. 30, 2018 (Non-GAAP) (Non-GAAP) Add: Add: Add: Impax/ Impax/ Actual I
Slide 35: Reconciliation of Specialty Operating Income to Combined Operating Income
Reconciliation of Specialty Operating Income to Specialty Combined Operating Income (Unaudited; In thousands) Specialty Three months ended December 31, 2018 Three months ended December 31, 2017 Three months ended Sept. 30, 2018 (Non-GAAP) (Non-GAAP) Add: Add: Add: Impax/ Impax/ Actual Impax/ Gemini
Slide 36: Reconciliation of Specialty Cost of Goods Sold to Combined Adjusted
Reconciliation of Specialty Cost of Goods Sold to Specialty Combined Adjusted Cost of Goods Sold (Unaudited; In thousands) Specialty Three months ended December 31, 2018 Three months ended December 31, 2017 (Non-GAAP) (Non-GAAP) Three months ended Sept. 30, 2018 Add: Add: Add: Impax/ Impax/ Actual G
Slide 37: Reconciliation of Specialty Operating Income to Combined Adjusted Operating Income
Reconciliation of Specialty Operating (Loss) Income to Specialty Combined Adjusted Operating Income (Unaudited; In thousands) Specialty Three months ended December 31, 2018 Three months ended December 31, 2017 Three months ended Sept. 30, 2018 (Non-GAAP) (Non-GAAP) Add: Add: Add: Impax/ Impax/ Actua
Slide 38: Reconciliation of Total Company Cost of Goods Sold to Combined Adjusted
Reconciliation of Total Company Cost of Goods Sold to Total Company Combined Adjusted Cost of Goods Sold (Unaudited; In thousands) Three months ended December 31, 2018 Three months ended December 31, 2017 (Non-GAAP) (Non-GAAP) Add: Add: Impax/ Impax/ Actual Gemini Combined Actual Gemini Combined Cos
Slide 39: Reconciliation of SG&A to Combined Adjusted SG&A
Reconciliation of SG&A to Combined Adjusted SG&A (Unaudited; In thousands) Three months ended December 31, 2018 Three months ended December 31, 2017 (Non-GAAP) (Non-GAAP) Add: Add: Impax/ Impax/ Actual Gemini Combined Actual Gemini Combined Selling, general and administrative expenses $ 71,236 $ — $
Slide 40: Reconciliation of Research and Development to Combined Adjusted R&D
Reconciliation of Research and Development to Combined Adjusted Research and Development (Unaudited; In thousands) Three months ended December 31, 2018 Three months ended December 31, 2017 (Non-GAAP) (Non-GAAP) Add: Add: Impax/ Impax/ Actual Gemini Combined Actual Gemini Combined Research and develo
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