Q1 2021 Earnings Call: Strategic Priorities and Financial Results
Q1 2021 Earnings Call: Strategic Priorities and Financial Results
Q1 2021 Earnings Call: Strategic Priorities and Financial Results
Earnings Call
Strategic
Priorities and
Financial
Results
May 7, 2021
Safe Harbor Statement
Certain statements contained in this presentation, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-
looking statements include statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, including among other things: discussions of future operations; expected operating results
and financial performance; impact of planned acquisitions and dispositions; the Company’s strategy for growth; product development; regulatory approvals; market position and expenditures. Words such as “plans,”
“expects,” “will,” “anticipates,” “estimates” and similar words are intended to identify estimates and forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These forward-looking
statements are based on current expectations of future events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the
expectations and projections of the Company. Such risks and uncertainties include, but are not limited to: the impact of the COVID-19 pandemic; the impact of global economic conditions; our ability to successfully develop,
license, acquire and commercialize new products on a timely basis; our ability to obtain exclusive marketing rights for our products; the competition we face in the pharmaceutical industry from brand and generic drug product
companies, and the impact of that competition on our ability to set prices; our ability to manage our growth through acquisitions and otherwise; our dependence on the sales of a limited number of products for a substantial
portion of our total revenues; the risk of product liability and other claims against us by consumers and other third parties; risks related to changes in the regulatory environment, including U.S. federal and state laws related
to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to FDA product approval requirements; risks related to federal regulation of arrangements between manufacturers of
branded and generic products; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; the continuing trend of consolidation of certain
customer groups; our reliance on certain licenses to proprietary technologies from time to time; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods; our
dependence on third-party agreements for a portion of our product offerings; our ability to identify and make acquisitions of or investments in complementary businesses and products on advantageous terms; legal,
regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; the significant amount of resources we expend on research and development; our substantial amount of
indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; and the high concentration of ownership of our Class A
Common Stock and the fact that we are controlled by the Amneal Group. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the
Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K.
Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Forward-looking statements included herein speak only as of the date hereof and
we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.
2
Non-GAAP Financial Measures
This release includes certain non-GAAP financial measures, including adjusted EBITDA, adjusted net income, adjusted net income per diluted share, adjusted gross profit, adjusted gross margin, adjusted operating income
adjusted cost of goods sold, adjusted selling general and administrative expense, and adjusted research and development expense, which are intended as supplemental measures of the Company’s performance that are
not required by or presented in accordance with U.S. General Accepted Accounting Principles (“GAAP”). The calculation of non-GAAP adjusted diluted earnings per share assumes the conversion of all outstanding shares
of Class B Common Stock to shares of Class A Common Stock.
Management uses these non-GAAP measures internally to evaluate and manage the Company’s operations and to better understand its business because they facilitate a comparative assessment of the Company's
operating performance relative to its performance based on results calculated under GAAP. These non-GAAP measures also isolate the effects of some items that vary from period to period without any correlation to core
operating performance and eliminate certain charges that management believes do not reflect the Company's operations and underlying operational performance. The compensation committee of the Company’s board of
directors also uses certain of these measures to evaluate management's performance and set its compensation. The Company believes that these non-GAAP measures also provide useful information to investors
regarding certain financial and business trends relating to the Company’s financial condition and operating results facilitates an evaluation of the financial performance of the Company and its operations on a consistent
basis. Providing this information therefore allows investors to make independent assessments of the Company’s financial performance, results of operation and trends while viewing the information through the eyes of
management.
These non-GAAP measures are subject to limitations. The non-GAAP measures presented in this release may not be comparable to similarly titled measures used by other companies because other companies may not
calculate one or more in the same manner. Additionally, the non-GAAP performance measures exclude significant expenses and income that are required by GAAP to be recorded in the Company’s financial statements;
do not reflect changes in, or cash requirements for, working capital needs; and do not reflect interest expense, or the requirements necessary to service interest or principal payments on debt. Further, our historical
adjusted results are not intended to project our adjusted results of operations or financial position for any future period. To compensate for these limitations, management presents and considers these non-GAAP measures
in conjunction with the Company’s GAAP results; no non-GAAP measure should be considered in isolation from or as alternatives to net income, diluted earnings per share, gross profit, gross margin, operating income,
cost of goods sold, selling general and administrative expense, research and development expense or any other measure determined in accordance with GAAP. Readers should review the reconciliations included below,
and should not rely on any single financial measure to evaluate the Company’s business.
A reconciliation of each historical non-GAAP measure to the most directly comparable GAAP measure is set forth below.
3
Agenda
3 Closing Remarks
Chirag Patel, Co-CEO
4 Q&A
4
Amneal 2.0:
Positioned For Chirag and
Chintu Patel
The Next Phase Co-CEOs
of Growth
5
Executing on Our Strategic Priorities
Q1 2021 performance demonstrates our sound Amneal 2.0 Strategy and solid execution
6
Expand Product Mix and End Markets
• Leverage our broad commercial presence to grow market share
• Increase speed of innovation of complex generics, including Injectables,
Inhalants, Ophthalmics and Biosimilars
• Margin expansion through new product launches and operational efficiencies
• Leverage portfolio to out-license ex-US geographies through partnerships 7
Complementing portfolio & adding new growth drivers
Proven Track Record Across Complex Dosage Forms
Inserts / Implants / Vaginal
Transdermal Patches Oral Liquids/ Topicals Nasal Sprays Injectables OSDs
Ring
• EluRyng (Etonogestrel + • Estradiol Transdermal • Sucralfate Suspension • Mometasone Nasal • Triamcinolone • Aspirin + Dipyridamole
EE Vaginal Ring) Patch • Atovaquone Suspension spray Suspension ER
• Yuvafem (Estradiol • Buprenorphine Patch • Oxcarbazepine • Azelastine Nasal Spray Methylprednisolone • Methylphenidate ER,
Vaginal Insert) • Rivastigmine Patch Suspension Acetate Suspension Paliperidone ER,
• Lidocaine Patch • Diclofenac Topical Gel • Cyclophosphamide Amphetamine Salts ER,
• Norelgestromin + EE • Testosterone Gel Dexmethylphenidate ER
patch • Fluphenazine Tabs
$314
$72 $78
$45 $100 $168
$23 $25 $32
Single Source: One active player other than RLD / RS
FTM: First to market (No IP/ No Generic)
PIV FTM LOA Day 1 eFTF FTM LOA Day 1 PIV LOA High Value eFTF
PIV: Paragraph IV certification
LOA: Launch upon approval
eFTF: exclusive first to file
High Value: large size opportunity for Amneal
9
Note: Addressable sales are approximate IQVIA MAT February 2021 sales ($ in millions).
Expand product mix & end markets: Key focus areas
Complex Generics Biosimilars
10
*Pre-filled syringe
Drive organic and inorganic growth
• Leverage commercial expertise in Neurology and Endocrinology to drive growth of Rytary
and Unithroid
• Advance our two R&D Neurology programs of IPX-203 and K-127 and maximize Kashiv’s
proprietary drug delivery technologies to ensure long term sustainable organic growth
• Pursue accretive BD or M&A that leverage our commercial infrastructure
11
Driving growth in our Specialty Business
K-114
$13
$16 K-127
K-128
Rytary Unithroid
Q1 2020 Q1 2021
12
IPX203 Phase IIb Results
IPX203 decreased “off” time and increased good “on” time compared with IR CD/LD
IPX203 decreased “off” time by 2.3 hours IPX203 increased good “on” time by 1.9 hours
compared with IR CD/LD compared with IR CD/LD
IR CD/LD
Baseline: 5.2 hr IPX203
Day 15: 5.5 hours Baseline: 5.2 hr
Day 15: 3.2 hr
0.3
2.1*
2.0*
Improved
Improved
0.2
IR CD/LD IPX203
Baseline: 10.0 hours Baseline: 10.0 hours
Day 15: 10.2 hours Day 15: 12.1 hours
Primary Endpoint:
Change from baseline in “Good on” time in hours per day at end of double-blind treatment
period (Visit 7 or early termination):
• "Good on" time is defined as the sum of “On” time without dyskinesia and “On” time with
non-troublesome dyskinesia
Secondary Endpoints:
• Change from baseline in “Off” time in hours per day
• Proportion of subjects with either “much improved” or “very much improved” in PGI-C scores
• Change from baseline in the MDS-UPDRS Part III score
• Change from baseline in sum of MDS-UPDRS Parts II and III scores
Note: MDS-UPDRS stands for Movement Disorder Society - Unified Parkinson’s Disease Rating Scale 14
https://clinicaltrials.gov/ct2/show/NCT03670953
IPX203 is an investigational product that is not approved by the FDA.
Advancing new product development candidates – IPX-203
For treatment of Parkinson’s Disease – a neurodegenerative disorder that affects dopamine-producing neurons in the brain
that affect movement
Expected Benefits of IPX-203
Developed with innovative technology containing immediate and sustained-release granules
Indication
Myasthenia Gravis Sialorrhea & Movement Disorders Hypothyroidism (T4 sub-indication)
(Therapeutic Parkinson’s Disease
(CNS) (CNS) (Endo)
Area)
Total Addressable
~1.0mm(1) ~60k(1) ~1.2mm(1) ~2.4mm(1)
Patient Population
• Delivers fast-acting and longer • Utilizes proprietary GRANDE • Controlled release pellets that • Utilizes proprietary GRANDE
lasting motor symptom control technology provide therapeutic release over technology
extended period
• Gives patients significantly better • Improved tolerability with reduced • Potential to maintain steady level of
“on” time compared to IR CD/LD morning symptoms / muscle fatigue • Potential to improve tolerability by T3 in therapeutic ranges through
Product
in the evening and constant blood reducing side effects associated continuous and sustained-release
Differentiation • Offers convenient dosing – Can be
levels without peaks and troughs with peak plasma concentration over 24 hours
taken 2 or 3 times per day
with immediate release products
• Once-daily dosing ensuring 24-hour • Potentially reduces side effects
symptom control • Once-daily dosing ensuring 24-hour associated with abnormal levels of
symptom control T3
Increases total addressable market with higher value indications and provides lower risk of approval through 505(b)(2)
Extended drug release: Tablet is retained in the stomach for Modifies drug kinetics to mimic physiological patterns and targets
12-24 hours of constant drug delivery chronological release when required
Applications: 1) Weekly basic drugs to improve absorption & variability; 2) drugs Applications: Disorders requiring symptom control in the early morning hours for
requiring local effect in stomach; 3) pH dependent poorly to highly soluble drugs improved functioning e.g. ADHD, Excessive Sleep Disorders, Epilepsy, Cardiovascular
(prevent early morning HA) & Arthritis (morning stiffness)
18
Financial
Tasos
Review Konidaris
EVP & CFO
Q1 2021 Results
Adjusted Results(1)
Favorable product mix and operational efficiencies drive margin
Variance expansion
$ in millions Q1 2021 Q1 2020 Q4 2020 YOY Sequential
Revenue 493.1 498.5 510.0 (5.4) (16.9) • Revenue reflects mild flu and cold season, higher purchases last year
at the onset of the COVID-19 pandemic as well as generic price
Gross Profit 231.1 225.1 207.0 6.0 24.1 deflation. These dynamics were partially offset by new generic product
growth, our Rytary and Unithroid specialty brands and AvKARE(2)
Gross Margin 46.9% 45.1% 40.6% 180 Bps 630 Bps • Gross margin reflects growth across all three of our operating
segments driven by favorable product mix, reduced certain material
R&D Expense (3)
39.7 35.1 45.0 (4.6) 5.3 costs and operational efficiencies
• R&D reflects timing of project spend and filing fees
SG&A Expense 79.6 69.2 70.7 (10.4) (8.9)
• SG&A reflects a discrete expense item in the current quarter as well as
Adjusted EBITDA 126.1 134.4 107.4 (8.3) 18.7 investments to grow our sales force footprint
• EPS reflects Adjusted EBITDA and mostly lower interest expense
Diluted EPS 0.20 0.20 0.14 - 0.06
• Operating Cash Flow is inherently variable mostly due to timing of
collections, and taxes. Current quarter reflects robust underlined
Operating Cash Flow 148.1 49.0 106.0 99.1 42.1
collections as well as favorable timing of certain cash receipts and
payments as well
(1) Please see the language under the heading "Non-GAAP Financial Measures” in our press release dated May 7, 2021 for a discussion of these Non-GAAP measures and the Appendix to
this presentation for a reconciliation thereof to the most directly comparable GAAP measures. 20
(2) AvKARE amounts exclude net revenues, cost of goods sold and gross profit from sales of Amneal products. Those results are included within the Generics segment.
(3) Includes Intellectual property legal development expense
Generics Segment Adjusted Results(1)
$ millions
Q1 21 Q1 20 Q4 20 Q1 21 Q1 20 Q4 20 Q1 21 Q1 20 Q4 20
▪ Year-over-year: ~$23 million relates to mild flu and ▪ Year-over-year: Favorable product mix, operating ▪ Year-over-year: $16 million reduction reflects $9 million
cold season. In addition, price deflation and Q1 20 efficiencies, improved pricing on certain materials in lower gross profit as a function of lower net revenue
benefit from COVID-19 related purchases were offset price deflation and improved gross margin as well as $7 million in
partially offset by products launched since January higher investments to drive long term growth
▪ Sequential: Favorable product mix, higher plant
2020 which contributed ~$36 million of growth and utilization, and improved pricing on certain materials ▪ Sequential: $7 million increase reflect $10 million
solid volume trends offset price deflation increase in gross margin as well as increased
▪ Sequential: Growth from new product introductions operating expenses driven by a discrete expense item
is offset by the mild flu and cold season as well as in the current quarter
certain customer seasonal trends
(1)
21
Please see the language under the heading "Non-GAAP Financial Measures” in our press release dated May 7, 2021 for a discussion of these Non-GAAP measures and the Appendix to this presentation for a reconciliation thereof to the most directly
comparable GAAP measures.
Specialty Segment Adjusted Results(1)
$ millions
Q1 21 Q1 20 Q4 20 Q1 21 Q1 20 Q4 20 Q1 21 Q1 20 Q4 20
▪ Year-over-year: Growth in Rytary and Unithroid as ▪ Year-over-year and Sequential: Favorable product mix ▪ Year-over-year and Sequential: Increased net
well as favorable gross to net driven in part by the decline in Zomig Nasal Spray and revenue and gross margin coupled with slight
favorable gross to net decreases in operating expenses
▪ Sequential: Growth in Emverm and Unithroid as
well as favorable gross to net offset lower Rytary
net revenue due to seasonality
(1) Please see the language under the heading "Non-GAAP Financial Measures” in our press release dated May 7, 2021 for a discussion of these Non-GAAP measures and the Appendix to this presentation for a reconciliation thereof to the most directly
comparable GAAP measures. 22
AvKARE Segment Adjusted Results(1)
$ millions
6.8
58.0 6.1
Q1 21 Q1 20 Q4 20 Q1 21 Q1 20 Q4 20 Q1 21 Q1 20 Q4 20
▪ Year-over-year increase: Q1 21 reflect three months ▪ Year-over-year and sequential: Reflects mix of ▪ Year-over-year and sequential: Higher net revenues
vs Q1 20 having two months due to acquisition’s business amongst different revenue channels as at higher gross margins
timing of close. well as a lower inventory related charges
▪ Sequential results are in line with prior period
(1) Please see the language under the heading "Non-GAAP Financial Measures” in our press release dated May 7 , 2021 for a discussion of these Non-GAAP measures and the Appendix to this presentation for a reconciliation thereof to the most directly
comparable GAAP measures. 23
Quarterly Trending Summary
Adjusted Results (1)
Q1 2021 Q4 2020 Q3 2020 Q2 2020 Q1 2020
(in $ millions except for Adjusted Diluted EPS)
(1) Please see the language under the heading "Non-GAAP Financial Measures” in our press release dated May 7, 2021 for a discussion of these Non-GAAP measures and the Appendix to
this presentation for a reconciliation thereof to the most directly comparable GAAP measures.
24
Balance Sheet and Liquidity
$ millions
(1) Includes “Current portion of long-term debt, net” and “Long-term debt, net”
(2) Includes restricted cash.
(3) Net debt = Current portion and long-term debt less cash and cash equivalents.
(4) Gross debt = Current portion and long-term debt.
(5) Please see the language under the heading "Non-GAAP Financial Measures” in our press release dated May 7, 2021 for a discussion of these Non-GAAP measures and the Appendix to this presentation for a reconciliation thereof to the
most directly comparable GAAP measures for Amneal. LTM EBITDA as of Dec 31, 2020 also includes the pro forma impact of the AvKARE acquisition. 25
(6) Access to borrowing base availability is subject to certain covenants
Maintaining 2021 Financial Outlook(1)
(in $ millions except for Adjusted Diluted EPS) 2020 2021 Guidance
(1) Amneal’s full year 2021 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. Please see the language under the headings “Cautionary Statement on Forward-Looking Statements” and “Non-GAAP Financial Measures” in our press release dated May 7, 2021 for
information regarding our expectations and use of Non-GAAP financial measures.
(2) EPS guidance reflects the current tax laws in effect as of May 7, 2021.
(3) Under the if-converted method, weighted average diluted shares outstanding consists of Class A and Class B shares.
(4) 2020 reported cash flows incudes a $110 million of discrete cash tax refund.
26
Key Takeaways
Strong operational and financial Starting 2021 with solid Amneal 2.0 driving our next
performance in Q1 momentum phase of growth
• Broad, relevant product portfolio • Solid revenue performance • Building on our recent success,
reflects the diversity and we continue to evolve our
• Improved profitability and Balance
relevancy of our product lines and generics business, grow our
Sheet
strength of R&D pipeline specialty franchise and
• Solid execution and driving operational strategically diversify the
• R&D pipeline revitalized;IPX-203
efficiencies business in support of our
top line data read out in 2H 2021
vision for Amneal 2.0
• Investments to drive long term value
• Kashiv Specialty integration
creation
enhances Generics and Specialty
long term prospects
2021 shall continue the positive momentum as we continue to focus on long-term sustainable growth 27
Appendix:
Non-GAAP
Reconciliations
Reconciliation of Net Income (Loss) to Adjusted Net Income and
Calculation of Adjusted Diluted EPS
29
Reconciliation of Net Income (Loss) to EBITDA and Adjusted
EBITDA
($) in millions Three months ended
March 31, 2021 December 31, 2020 September 30, 2020 June 30, 2020 March 31, 2020
30
Reconciliation of Generics Operating Income to Generics Adjusted
Operating Income
($) in millions Three Months Ended March 31, 2021 Three Months Ended March 31, 2020 Three Months Ended December 31, 2020
Cost of goods sold 185.3 (12.0) 173.3 218.9 (14.7) 204.2 227.6 (14.9) 212.7
Gross profit $ 127.2 $ 12.0 $ 139.2 $ 132.2 $ 16.2 $ 148.4 $ 114.5 $ 14.9 $ 129.4
Research and development 36.1 (4.4) 31.7 29.0 (0.4) 28.6 41.5 (7.1) 34.4
Operating income $ 68.7 $ 17.3 $ 86.0 $ 81.8 $ 20.7 $ 102.5 $ 54.5 $ 24.3 $ 78.8
31
Reconciliation of Specialty Operating Income to Specialty Adjusted
Operating Income
($) in millions Three Months Ended March 31, 2021 Three Months Ended March 31, 2020 Three Months Ended December 31, 2020
Cost of goods sold 48.2 (27.5) 20.7 47.8 (25.4) 22.4 47.1 (25.1) 22.0
Gross profit $ 47.7 $ 27.5 $ 75.2 $ 40.2 $ 25.4 $ 65.6 $ 38.4 $ 25.1 $ 63.5
Research and development 12.0 (7.6) 4.4 7.3 (2.1) 5.2 12.0 (5.1) 6.9
Operating income $ 15.8 $ 35.7 $ 51.5 $ 10.0 $ 29.3 $ 39.3 $ 7.5 $ 30.7 $ 38.2
32
Reconciliation of AvKARE Operating Income to AvKARE Adjusted
Operating Income
($) in millions Three Months Ended March 31, 2021 Three Months Ended March 31, 2020 Three Months Ended December 31, 2020
Acquisition, transaction-related
0.9 (0.9) — — — — 0.6 (0.6) —
and integration expenses
Operating income $ 2.0 $ 7.1 $ 9.1 $ 0.3 $ 6.5 $ 6.8 $ (3.2) $ 9.3 $ 6.1
33
Reconciliation of Selling, General & Administrative to Adjusted
Selling, General, & Administrative
Adjusted to deduct:
34