Q1 2024 Earnings Call

May 3, 2024

Cautionary Statement on Forward Looking Statements

Certain statements contained herein, 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, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as "plans," "expects," "will," "anticipates," "estimates," and similar words, or the negatives thereof, 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, including with respect to future market conditions, company performance and financial results, operational investments, business prospects, new strategies and growth initiatives, the competitive environment, and other 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: our ability to successfully develop, license, acquire and commercialize new products on a timely basis; 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 obtain exclusive marketing rights for our products; our revenues are derived from the sales of a limited number of products, a substantial portion of which are through a limited number of customers; the impact of a prolonged business interruption within our supply chain; the continuing trend of consolidation of certain customer groups; 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; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; our dependence on information technology systems and infrastructure and the potential for cybersecurity incidents; our ability to attract, hire and retain highly skilled personnel; risks related to federal regulation of arrangements between manufacturers of branded and generic products; our reliance on certain licenses to proprietary technologies from time to time; the significant amount of resources we expend on research and development; the risk of claims brought against us by 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 Food and Drug Administration product approval requirements; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; our dependence on third- party agreements for a portion of our product offerings; 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; our potential expansion into additional international markets subjecting us to increased regulatory, economic, social and political uncertainties, including recent events affecting the financial services industry; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; the impact of global economic, political or other catastrophic events; our obligations under a tax receivable agreement may be significant; 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.

Non-GAAP Financial Measures

This release includes certain non-GAAP financial measures, including EBITDA, adjusted EBITDA, adjusted net income, and adjusted diluted EPS, which are intended as supplemental measures of the Company's performance that are not required by or presented in accordance with GAAP. Adjusted diluted EPS reflects diluted earnings per share based on adjusted net income, which is net loss adjusted to (A) exclude (i) non-cash interest, (ii) GAAP provision for income taxes, (iii) amortization, (iv) stock-based compensation, (v) acquisition, site closure expenses, and idle facility expenses, (vi) restructuring and other charges, (vii) charges related to certain legal matters, including interest, net, (viii) asset impairment charges, (ix) change in fair value of contingent consideration, (x) increase in tax receivable agreement liability, (xi) system implementation expense, (xii) other and (xiii) net income attributable to non-controlling interests not associated with Class B common stock, and (B) include non-GAAP provision for income taxes. Non-GAAP adjusted diluted EPS for the three months ended March 31, 2024 was calculated assuming the weighted average diluted shares outstanding of Class A common stock. Non-GAAP adjusted diluted EPS for the three months ended March 31, 2023 was calculated assuming (i) the weighted average diluted shares outstanding of Class A common stock and (ii) as if all shares of Class B common stock were converted to shares of Class A common stock as of January 1, 2023. 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 operations 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 any measure determined in accordance with GAAP.

2

Q1 2024 Earnings Call

Agenda

1

Strategy & Business Update

Chirag and Chintu Patel,

Co-founders and Co-CEOs

2

Financial Results

Tasos Konidaris, EVP & CFO

3

Q&A

Chirag Patel,

Chintu Patel,

Tasos Konidaris,

Co-CEO and President

Co-CEO

EVP & CFO

Andy Boyer,

Joe Renda,

Jason Daly, SVP

EVP - Generics

SVP - Specialty

& Chief Legal Officer

3

Q1 2024 key highlights

Strong start

to 2024

  • Q1 net revenue of $659M, up +18%, and adjusted EBITDA of $152M, up +31%, reflects double-digit top-linegrowth in all 3 segments, combined with strong gross margins driven by the complexity of the portfolio

Affirming full year

2024 outlook

  • Continue to expect 2024 net revenue of $2.55-$2.65B,reflecting +7%-11%growth, and adjusted EBITDA of $580-$620M,reflecting high-singledigit growth

Continued

Reduced net leverage to 4.6x in Q1, down from 4.8x at 2023 year-end; higher

deleveraging

profitability and cash generation allow for gross debt reduction over time

4

Executing on Amneal's four pillars of value creation

Key Pillar

Metric

2019

2023

LTM(2) Q1 2024

#1

Increased

OSD(1) Gx % of

53%

25%

25%

diversification

revenue

#2

Strong financial

Revenues

$1.6B

$2.4B

$2.5B

performance

Adjusted EBITDA

$339M

$558M

$594M

#3

Cash generation

Operating Cash Flow

$2M

$346M

$201M

#4

Deleveraging

Net Leverage

7.4x

4.8x

4.6x

at 12/31/19

at 12/31/23

at 3/31/24

Growth projection(3)

<20% of revenue by 2027

High single-digit growth Meaningful acceleration

Sustained higher levels of cash flow generation

  • 4x in 2025, < 3x thereafter
  1. OSD = Oral Solid. AvKARE sales of Amneal label products, royalty income and international revenues are included within Generics Non-OSD consistent with how the Company manages its portfolio. Projection excludes select high-

value OSD products that are highly complex with limited competition.

5

(2)

LTM = Last Twelve Months

(3)

Growth projection reflects the potential outcomes of delivering our long-term strategy and is based on the current macro environment and expected product pipeline launches, among other assumptions.

Global diversified pharmaceutical company with a clear strategy for sustainable growth

Business area

Net Revenue

LTM Q1 2024

Retail

Generics

Injectables

$1.519B

Biosimilars

International

Strategy for growth

Growth projection(1)

Grow #4 U.S. Generics portfolio of ~240 products with new

Low-single digit growth

launches and shift to complex dosage forms

Expand portfolio of 30+ institutional products through new launches

$300M+ revenue by 2025

and leverage new capacity to be Top 5 in U.S. and a global player

High-single

Drive initial portfolio and add more biosimilars to the pipeline to be

$200M+ peak U.S. sales by

digit growth

Top 5 in U.S. and a global player

2025 from 1st 3 biosimilars(2)

Market expansion in India, Europe, China and rest of the world -

Add $50-100M revenue by 2027

either direct or through licensing

Specialty

$404M

Grow branded portfolio with focus on Neurology and Endocrinology

$500M+ revenue by 2027 reflecting

high-single digit growth

AvKARE

$572M

Grow across government, institutional and distribution channels

$650M+ by 2025 reflecting

double-digit growth

(1)

Growth projection reflects the potential outcomes of delivering our long-term strategy and is based on the current macro environment and expected product pipeline launches, among other assumptions.

6

(2)

Represents the total peak U.S. sales for our first three oncology biosimilars (filgrastim, pegfilgrastim and bevacizumab).

Recent and upcoming growth catalysts across portfolio

Retail

Injectables

Biosimilars

Specialty

International

Achieved

Launched: Naloxone nasal spray,

Launched: Ropivacaine (IV bag),

Driving uptake of:

Launched:

Launched:

in 2024

Fluorometholone acetate, Carvedilol ER,

PEMRYDI RTUTM(1) 505(b)(2),

ALYMSYS® (bevacizumab),

ONGENTYS®

India: Ophthalmics, Oncology

Darunavir, Ciprofloxacin and

Atropine Sulfate (PFS(2))

RELUEKO® (filgrastim), &

Dexamethasone Otic Suspension

FYLNETRA® (peg-filgrastim)

(Parkinson's Disease

and Diagnostics

Approved: Methylprednisolone

adjunctive therapy)

Partnerships established:

Approved: Lacosamide oral solution,

acetate, Foscarnet sodium

Finalized partnerships in ~40

Fosfomycin Tromethamine granules for oral

solution, Ofloxacin ophthalmic solution,

countries in Middle East,

Pitavastain

Africa, Latin America, and

Southeast Asia

Expected

2024: Mesalamine, Gx ProAir®, Gx QVAR®,

2024: 2 505(b)(2) RTU products:

Added Q1:2 peg-filgrastim

8/7/24 goal date: IPX203

Register products with our

2024/2025

Estradiol Gel, Bromfenac opthalmic solution,

FOCINVEZTM (vial) and Potassium

programs (On-Body injector &

(Parkinson's Disease)

European and other

launches

Bupropion, Clindamycin phosphate topical,

phosphate (IV bag), Exenatide pen

Prefilled autoinjector); BLA(5)

1H 2025: DHE

distribution partners

and key

Everolimus, Isotretinoin, Loteprednol etabonate

injector, Propofol emulsion,

filing expected in Q1 2025

autoinjector (migraine

Execute additional global

ophthalmic, Timolol maleate opthalmic,

Edaravone, Sodium phosphate,

activities

BLA filing of:2 denosumab

and cluster headache)

partnership agreements

Scopolamine

Labetalol, Nicardipine, Phytonadione

biosimilar pipeline candidates

2025: Gx Restasis®, Gx Pred-Forte®,

2025: Gx Copaxone®, Gx Risperdal

(for Prolia® and XGEVA®)

Eltrombopag, Memantine/Donepezil ER;

Consta®, Epinephrine (MDV(3) & SDV(4)

Look to in-license1-2 biosimilar

Additional pipeline opportunities not disclosed

vials and PFS(2)), Hydrocortisone

sodium succinate (vial), Sodium

opportunities per year

bicarbonate (vial) and 2-3505(b)(2)

RTU products including

Phenylephrine (IV bag)

Potential high-value opportunities

(1) RTU = Ready-to-use; (2) PFS = Prefilled Syringe; (3) MDV = Multiple-dose vial; (4) SDV = Single-dose vial; (5) BLA = Biologics License Application

7

Note: All trademarks are the property of their respective owners.

Key near-term growth drivers

Retail & Injectables

Naloxone HCl

ALYMSYS®

IPX203

DHE Autoinjector

New Launches

Nasal Spray

Product type

Generics portfolio

Complex generics

Biosimilar

Specialty

Specialty

Therapeutic area

All areas

Anti-overdose

Oncology

Parkinson's Disease

Migraine and Cluster

Headache

Expected Launch

30+ each year

Q2 2024

Q4 2022

Q3 2024(3)

1H 2025

Expands and diversifies

Increases access to OTC(2)

Potential to achieve 1.55

Prefilled and ready-to-use

Importance

portfolio with complex

and affordable treatment as

Key oncology therapy

more hours of "Good On"

autoinjector for an easy-to-

products and drives

opioid crisis remains a U.S.

with growing market share

time per dose

use treatment option

continued growth

Public Health Emergency

Market

Expect $100M+ in new

Expect $30M+ sales in 2024;

Expect $100M+

Estimated ~$300M - $500M

Estimated ~$50M - $100M

opportunity

product revenue in 2024(1)

< 10M unit capacity in 2025

sales by 2025

U.S. sales opportunity

U.S. sales opportunity

  1. Reflects expected 2024 new launches and the impact of 2023 new launches annualizing. Note: This does not include naloxone, which is listed separately above.

(2) OTC = Over-the-Counter

8

(3) Pending successful CRL resolution and FDA approval.

Our portfolio continues to diversify - making growth sustainable

Purposeful mix shift towards a more complex portfolio

Generics net revenues mix ($'s)

Pipeline mix

(# of products)

6%

56%

52%

43%

41%

37%

65%

94%

44%

48%

57%

59%

63%

35%

2019

2020

2021

2022

2023

Pending

Pipeline

Actuals

Actuals

Actuals

Actuals

Actuals

ANDAs

Non-Oral Solid(1)

Oral Solid

Diversified revenues driving sustainable growth

Total company net revenues mix ($'s)

Specialty

Oral Solid

AvKARE

Generics

23%

20%

25%

Oral Solid

Generics

Non-Oral Solid

53%

Specialty

Generics

Non-Oral Solid

16%

28%

Generics

36%

2019

LTM Q1 2024

Note: Total may not add due to rounding. LTM = Last Twelve Months

9

(1) AvKARE sales of Amneal label products, royalty income and international revenues are included within Generics Non-OSD consistent with how the Company manages its portfolio.

Deep pipeline as our wheel of innovation keeps turning

~67 pipeline

Developing pipeline across increasingly complex dosage forms with 94% non-oralsolids

programs with

~$27B TAM

~86 pending

ANDA's with

~$50B TAM

270+

commercial

Retail &

Injectable

products

Pending

ANDA's

across

dosage forms

with 63% non-oralsolids

Oral Solids: 32

$27,362

$12,325

$1,334

$362

LOA

PIV/Day 181

Day 1

Single

Source

Topicals/Transdermal: 8

$455

$155

$97

LOA

PIV/Day 1

S. Source

Injectables: 27

$1,596

$797

$395

$200

$107

NDA

LOA

Day

PIV S. Source

1/FTM

Oral Liquids: 3

$613

$31

LOAPIV

Ophthalmics: 12

$2,653

$904

$6

57

eFTF

LOA PIV/D181 S.Source

Inh/Nasal: 4

$793

$254

eFTF/PIVLOA

Refreshing pipeline by filing 25-30ANDAs and launching 30+ new products each year

Note: Total Addressable market (TAM) are approximate IQVIA (brand + active generics) MAT February 2024 sales ($ in millions).

For ANDA charts, Single Source: One active player other than RLD / RS. FTM: First to market (No IP/ No Generic). PIV: Paragraph IV certification. LOA: Launch upon approval. eFTF: exclusive first to file. High Value: large size opportunity for Amneal. 10

Attachments

  • Original Link
  • Original Document
  • Permalink

Disclaimer

Amneal Pharmaceuticals Inc. published this content on 03 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 03 May 2024 10:24:09 UTC.