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MarketScreener Homepage  >  Equities  >  Nasdaq  >  Arrowhead Pharmaceuticals, Inc.    ARWR

ARROWHEAD PHARMACEUTICALS, INC.

(ARWR)
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ARROWHEAD PHARMACEUTICALS : MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (form 10-K)

11/23/2020 | 04:37pm EST

Description of Business


Unless otherwise noted, (1) the term "Arrowhead" refers to Arrowhead
Pharmaceuticals, Inc., a Delaware corporation, (2) the terms "Company," "we,"
"us," and "our," refer to the ongoing business operations of Arrowhead and its
Subsidiaries, whether conducted through Arrowhead or a subsidiary of Arrowhead,
(3) the term "Subsidiaries" refers to Arrowhead Madison Inc. ("Arrowhead
Madison"), and Arrowhead Australia Pty Ltd ("Arrowhead Australia"), (4) the term
"Common Stock" refers to Arrowhead's Common Stock, (5) the term "Preferred
Stock" refers to Arrowhead's Preferred Stock and (6) the term "Stockholder(s)"
refers to the holders of Arrowhead Common Stock.

Overview


Arrowhead Pharmaceuticals, Inc. develops medicines that treat intractable
diseases by silencing the genes that cause them. Using a broad portfolio of RNA
chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA
interference mechanism to induce rapid, deep and durable knockdown of target
genes. RNA interference, or RNAi, is a mechanism present in living cells that
inhibits the expression of a specific gene, thereby affecting the production of
a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural
pathway of gene silencing. The Company's pipeline includes ARO-APOC3 for
hypertriglyceridemia, ARO-ANG3 for dyslipidemia, ARO-HSD for liver disease,
ARO-ENaC for cystic fibrosis, ARO-HIF2 for renal cell carcinoma, ARO-LUNG2 as a
candidate to treat chronic obstructive pulmonary disorder ("COPD") and ARO-COV
for treatment for the current novel coronavirus that causes COVID-19 and other
possible future pulmonary-borne pathogens. ARO-JNJ1, ARO-JNJ2 and ARO-JNJ3 are
being developed for undisclosed liver-expressed targets under a collaboration
agreement with Janssen Pharmaceuticals, Inc. ("Janssen"). ARO-AAT for liver
disease associated with alpha-1 antitrypsin deficiency ("AATD") was out-licensed
to Takeda Pharmaceuticals U.S.A., Inc. ("Takeda") in October 2020. ARO-HBV
(JNJ-3989) for chronic hepatitis B virus was out-licensed to Janssen in October
2018. ARO-LPA (AMG 890) for cardiovascular disease was out-licensed to Amgen
Inc. ("Amgen") in 2016.

Arrowhead operates lab facilities in Madison, Wisconsin and San Diego, California, where the Company's research and development activities, including the development of RNAi therapeutics, are based. The Company's principal executive offices are located in Pasadena, California.


Arrowhead has focused its resources on therapeutics that exclusively utilize the
Company's Targeted RNAi Molecule (TRiMTM) platform technology. Therapeutics
built on the TRiMTM platform have demonstrated high levels of pharmacologic
activity in multiple animal models spanning several therapeutic areas. TRiMTM
enabled therapeutics offer several potential advantages over prior generation
and competing technologies, including: simplified manufacturing and reduced
costs; multiple routes of administration including subcutaneous injection and
inhaled administration; the ability to target multiple tissue types including
liver, lung and tumors; and the potential for improved safety and reduced risk
of intracellular buildup, because there are less metabolites from smaller,
simpler molecules.

During fiscal year 2020, the Company has continued to develop its pipeline and
partnered candidates. Regarding the Company's wholly-owned pipeline candidates,
the Company dosed its first patients in three of its pipeline candidate studies:
ARO-HSD1001, a phase 1/2 clinical study of ARO-HSD; ARO-ENaC1001, a phase 1/2
clinical study of ARO-ENaC and ARO-HIF21001, a phase 1b study of ARO-HIF2. The
Company also presented new clinical data on its two cardiometabolic candidates,
ARO-APOC3 and ARO-ANG3, at multiple medical meetings, including the European
Society of Cardiology Congress and the American Heart Association Scientific
Sessions. Finally, the Company is also progressing ARO-LUNG2 toward entering
clinical trials and is continuing to perform discovery work to identify new
candidates.

The Company's partnered candidates under its collaboration agreements also
continue to progress. Janssen began dosing patients in a phase 2b triple
combination study called REEF-1, designed to enroll up to 450 patients with
chronic hepatitis B infection, and in connection with the start of this study
Arrowhead earned a $25.0 million milestone payment under the License Agreement
("Janssen License Agreement"). The Company is currently performing discovery,
optimization and preclinical research and development for ARO-JNJ1, ARO-JNJ2 and
ARO-JNJ3 for Janssen as part of the Research Collaboration and Option Agreement
("Janssen Collaboration Agreement"). Under the terms of the Janssen agreements
taken together, the Company has received $175.0 million as an upfront payment,
$75.0 million in the form of an equity investment by JJDC in Arrowhead common
stock, two $25.0 million milestone payments and may receive up to $1.6 billion
in development and sales milestones payments for the Janssen License Agreement,
and up to $1.9 billion in development and sales milestone payments for the three
additional targets covered under the Janssen Collaboration Agreement. The
Company is further eligible to receive tiered royalties up to mid-teens under
the Janssen License Agreement and up to low teens under the Janssen
Collaboration Agreement on product sales. The Company's collaboration agreement
with Amgen for Olpasiran (formerly referred to as AMG 890 or ARO-LPA), (the
"Second Collaboration and License Agreement" or "Olpasiran Agreement"),
continues to progress. In July 2020, Amgen initiated a Phase 2 clinical study,
which resulted in a $20.0 million milestone payment to the Company. The Company
has received $35.0 million in upfront payments, $21.5 million in

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the form of an equity investment by Amgen in the Company's Common Stock, $30.0
million in milestone payments, and may receive up to an additional $400.0
million in remaining development, regulatory and sales milestone payments. The
Company is eligible to receive up to low double-digit royalties for sales of
products under the Olpasiran Agreement. On October 7, 2020, the Company entered
into an Exclusive License and Co-Funding Agreement (the "Takeda License
Agreement") with Takeda. Under the Takeda License Agreement, Takeda and the
Company will co-develop the Company's ARO-AAT program. Within the United States,
ARO-AAT, if approved, will be co-commercialized under a 50/50 profit sharing
structure. Outside the United States, Takeda will lead the global
commercialization strategy and receive an exclusive license to commercialize
ARO-AAT with the Company eligible to receive tiered royalties of 20 to 25% on
net sales. The Company will receive $300.0 million as an upfront payment and is
eligible to receive potential development, regulatory and commercial milestones
of up to $740.0 million.

The revenue recognition for these collaboration agreements is discussed further in Note 2 Notes to Consolidated Financial Statements of Part IV, Item 15. Exhibits and Financial Statement Schedules.


The Company continues to develop other clinical candidates for future clinical
trials. Clinical candidates are tested internally and through GLP toxicology
studies at outside laboratories. Drug materials for such studies and clinical
trials are either contracted to third-party manufactures or manufactured
internally. The Company engages third-party contract research organizations
("CROs") to manage clinical trials and works cooperatively with such
organizations on all aspects of clinical trial management, including plan
design, patient recruiting, and follow up. These outside costs, relating to the
preparation for and administration of clinical trials, are referred to as
"candidate costs." If the clinical candidates progress through human testing,
candidate costs will increase.

The Company is actively monitoring the COVID-19 pandemic. The financial results
for the year ended September 30, 2020 were not significantly impacted by
COVID-19. The Company had temporarily paused enrollment in its two ARO-AAT
studies, SEQUOIA and the ARO-AAT 2002 study, but resumed the process of
screening and enrolling patients during the year ended September 30,
2020. During the pause in enrollment, patients already enrolled in these studies
continued to be dosed per protocol and continued to come in for their follow up
visits. Additional delays have occurred in the Company's earlier stage programs,
but Company does not expect a material impact to any program's anticipated
timelines. Several of the Company's other clinical candidates are in the
start-up stage (ARO-HSD, ARO-HIF2 and ARO-ENaC), during which significant
clinical costs will continue to be incurred. Additionally, the Company's
operations at its research and development facilities in Madison, Wisconsin and
San Diego, California, as well as its corporate headquarters in Pasadena,
California have continued to operate with limited impact, other than for
enhanced safety measures, including work from home policies. However, the
Company cannot predict the impact of the progression of COVID-19 will have on
future financial results due to a variety of factors including the ability of
the Company's clinical sites to continue to enroll subjects, the ability of the
Company's suppliers to continue to operate, the continued good health and safety
of the Company's employees, and ultimately the length of the COVID-19 pandemic.

Net losses were $84.6 million for the year ended September 30, 2020 as compared
to net income of $68.0 million for the year ended September 30, 2019 and net
losses of $54.5 million for the year ended September 30, 2018. Net losses per
share - diluted were $0.84 for the year ended September 30, 2020 as compared to
net income per share-diluted of $0.69 for the year ended September 30, 2019 and
net losses per share-diluted of $0.65 for the year ended September 30, 2018. An
increase in research and development and general and administrative expenses
coupled with a decrease in revenue from the license and collaboration agreements
with Janssen were the drivers of the increase in net losses and net losses per
share for the year ended September 30, 2020, as discussed further below.

The Company has strengthened its liquidity and financial position through
upfront and milestone payments received under its collaboration agreements, as
well as equity financings. Under the terms of the Company's agreements with
Janssen taken together, the Company has received $175.0 million as an upfront
payment, $75.0 million in the form of an equity investment by JJDC in Arrowhead
Common Stock, and two $25.0 million milestone payments. Under the terms of the
Company's agreements with Amgen, the Company has received $35.0 million in
upfront payments, $21.5 million in the form of an equity investment by Amgen in
the Company's Common Stock and $30.0 million in milestone payments. The
Company's October 2020 licensing agreement with Takeda will result in a $300.0
million upfront payment expected to be collected in the first fiscal quarter of
2021. Additionally, in December 2019, the Company completed a securities
offering which generated approximately $250.5 million in net cash proceeds.
These cash proceeds secure the funding needed to continue to advance our
pipeline candidates. The Company had $143.6 million of cash and cash
equivalents, $85.0 million of marketable securities, $86.9 million in short-term
investments, $137.5 million of long term investments and $522.5 million of total
assets as of September 30, 2020, as compared to $221.8 million, $0, $36.9
million, $44.2 million and $349.8 million as of September 30, 2019,
respectively. Based upon the Company's current cash and investment resources and
operating plan, the Company expects to have sufficient liquidity to fund
operations for at least the next twelve months.

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Critical Accounting Policies and Estimates


Management makes certain judgments and uses certain estimates and assumptions
when applying accounting principles generally accepted in the United States
("GAAP") in the preparation of our Consolidated Financial Statements. We
evaluate our estimates and judgments on an ongoing basis and base our estimates
on historical experience and on assumptions that we believe to be reasonable
under the circumstances. Our experience and assumptions form the basis for our
judgments about the carrying value of assets and liabilities that are not
readily apparent from other sources. Actual results may vary from what we
anticipate and different assumptions or estimates about the future could change
our reported results. We believe the following accounting policies are the most
critical to us, in that they require our most difficult, subjective or complex
judgments in the preparation of our consolidated financial statements. For
further information, see Note 1, Organization and Significant Accounting
Policies, to our Consolidated Financial Statements, which outlines our
application of significant accounting policies.

Principles of Consolidation-The Consolidated Financial Statements include the
accounts of Arrowhead and its Subsidiaries. Arrowhead's primary operating
subsidiary is Arrowhead Madison, which is located in Madison, Wisconsin, where
the Company's research and development facility is located. All significant
intercompany accounts and transactions are eliminated in consolidation.

Basis of Presentation and Use of Estimates-The preparation of financial
statements in conformity with accounting principles generally accepted in the
United States requires management to make estimates and assumptions that affect
the reported amounts of assets and liabilities and disclosure of contingent
assets and liabilities at the date of the financial statements and the reported
amounts of revenues and expenses during the reporting period. Actual results
could materially differ from those estimates. Additionally, certain
reclassifications have been made to prior period financial statements to conform
to the current period presentation.

Cash and Cash Equivalents-The Company considers all liquid debt instruments
purchased with a maturity of three months or less to be cash
equivalents. Included within Cash and cash equivalents on the Consolidated
Balance Sheets is $1.8 million and $1.0 restricted cash at September 30, 2020
and September 30, 2019, respectively. Amounts included in restricted cash are
primarily held as collateral associated with a letter of credit for the
Company's lease for its corporate headquarters in Pasadena, California.

Concentration of Credit Risk-The Company maintains several bank accounts
primarily at two financial institutions for its operations. These accounts are
insured by the Federal Deposit Insurance Corporation (FDIC) for up to $250,000
per institution. Management believes the Company is not exposed to significant
credit risk due to the financial position of the depository institutions in
which these deposits are held.

Investments-The Company may invest excess cash balances in short-term and
long-term marketable debt securities and equity securities. Investments may
consist of certificates of deposit, money market accounts, government-sponsored
enterprise securities, corporate bonds and/or commercial paper. The Company
accounts for its investment in debt securities in accordance with Financial
Accounting Standards Board ("FASB") Accounting Standards Codification ("ASC")
320, Investments - Debt and Equity Securities, which requires debt securities to
be classified into three categories:

Held-to-maturity-Debt securities that the entity has the positive intent and ability to hold to maturity are reported at amortized cost.


Trading Securities-Debt securities that are bought and held primarily for the
purpose of selling in the near term are reported at fair value, with unrealized
gains and losses included in earnings.

Available-for-Sale-Debt securities not classified as either securities held-to-maturity or trading securities are reported at fair value with unrealized gains or losses excluded from earnings and reported as a separate component of shareholders' equity.


The Company classifies its investments in marketable debt securities based on
the facts and circumstances present at the time of purchase of the securities.
During the years ended September 30, 2020, 2019 and 2018, all of the Company's
debt securities were classified as held-to-maturity. Held-to-maturity
investments are measured and recorded at amortized cost on the Company's
Consolidated Balance Sheet. Discounts and premiums to par value of the debt
securities are amortized to interest income/expense over the term of the
security. No gains or losses on investment securities are realized until they
are sold or a decline in fair value is determined to be other-than-temporary.

During the year ended September 30, 2020, the Company purchased shares of mutual
funds that invest in marketable debt securities such as U.S. government bonds,
U.S. government agency bonds, corporate bonds, and other asset backed debt
securities. The Company accounts for these securities using the guidance from
FASB ASC 321, Investments-Equity Securities. These securities are recorded on
the Company's Consolidated Balance Sheet as "marketable securities" and recorded
at fair value. All unrealized gains/losses associated with these securities are
recorded in the Company's Consolidated Statement of Operations and Comprehensive
Income (Loss).

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Property and Equipment-Property and equipment are recorded at cost, which may
equal fair market value in the case of property and equipment acquired in
conjunction with a business acquisition. Depreciation of property and equipment
is recorded using the straight-line method over the respective useful lives of
the assets ranging from three to seven years. Leasehold improvements are
amortized over the lesser of the expected useful life or the remaining lease
term. Long-lived assets, including property and equipment are reviewed for
impairment whenever events or circumstances indicate that the carrying amount of
these assets may not be recoverable.

Intangible Assets Subject to Amortization-Intangible assets subject to
amortization include certain patents and license agreements. Intangible assets
subject to amortization are reviewed for impairment whenever events or
circumstances indicate that the carrying amount of these assets may not be
recoverable and are also reviewed annually to determine whether any impairment
is necessary.

Contingent Consideration-The consideration for the Company's acquisitions may
include future payments that are contingent upon the occurrence of a particular
event. For example, milestone payments might be based on the achievement of
various regulatory approvals or future sales milestones, and royalty payments
might be based on drug product sales levels. The Company records a contingent
consideration obligation for such contingent payments at fair value on the
acquisition date. The Company estimates the fair value of contingent
consideration obligations through valuation models designed to estimate the
probability of such contingent payments based on various assumptions and
incorporating estimated success rates. Estimated payments are discounted using
present value techniques to arrive at an estimated fair value at the balance
sheet date. Changes in the fair value of the contingent consideration
obligations are recognized within the Company's Consolidated Statements of
Operations and Comprehensive Income (Loss). Changes in the fair value of the
contingent consideration obligations can result from changes to one or multiple
inputs, including adjustments to the discount rates, changes in the amount or
timing of expected expenditures associated with product development, changes in
the amount or timing of cash flows from products upon commercialization, changes
in the assumed achievement or timing of any development milestones, changes in
the probability of certain clinical events and changes in the assumed
probability associated with regulatory approval. These fair value measurements
are based on significant inputs not observable in the market. Substantial
judgment is employed in determining the appropriateness of these assumptions as
of the acquisition date and for each subsequent period. Accordingly, changes in
assumptions could have a material impact on the amount of contingent
consideration expense the Company records in any given period. The Company
determined the fair value of its contingent consideration obligation to be $0 at
September 30, 2020 and September 30, 2019.

Revenue Recognition- On October 1, 2018, the Company adopted FASB Topic 606 -
Revenue for Contracts from Customers which amended revenue recognition
principles and provides a single, comprehensive set of criteria for revenue
recognition within and across all industries. The Company's adoption of the new
revenue standard did not have a material impact on its Consolidated Financial
Statements. The Company has not yet achieved commercial sales of its drug
candidates to date, however, the new standard is applicable to the Company's
ongoing licensing and collaboration agreements, including those with Amgen,
Janssen and Takeda, and the analysis of the impact of this guidance on those
agreements is discussed further in Note 2 of Notes to Consolidated Financial
Statements of Part IV, Item 15. Exhibits and Financial Statement Schedules.

The new revenue standard provides a five-step framework for recognizing revenue
as control of promised goods or services is transferred to a customer at an
amount that reflects the consideration to which the entity expects to be
entitled in exchange for those goods or services. To determine revenue
recognition for arrangements that the Company determines are within the scope of
the new revenue standard, the Company performs the following five steps: (i)
identify the contract; (ii) identify the performance obligations; (iii)
determine the transaction price; (iv) allocate the transaction price to the
performance obligations in the contract; and (v) recognize revenue when (or as)
the Company satisfies a performance obligation. At contract inception, the
Company assesses whether the goods or services promised within each contract are
distinct and, therefore, represent a separate performance obligation, or whether
they are not distinct and are combined with other goods and services until a
distinct bundle is identified. The Company then determines the transaction
price, which typically includes upfront payments and any variable consideration
that the Company determines is probable to not cause a significant reversal in
the amount of cumulative revenue recognized when the uncertainty associated with
the variable consideration is resolved. The Company then allocates the
transaction price to each performance obligation and recognizes the associated
revenue when (or as) each performance obligation is satisfied.

The Company recognizes the transaction price allocated to upfront license
payments as revenue upon delivery of the license to the customer and resulting
ability of the customer to use and benefit from the license, if the license is
determined to be distinct from the other performance obligations identified in
the contract. These other performance obligations are typically to perform
research and development services for the customer, often times relating to the
candidate that the customer is licensing. If the license is not considered to be
distinct from other performance obligations, the Company assesses the nature of
the combined performance obligation to determine whether the combined
performance obligation is satisfied at a point in time or over time. If the
performance obligation is satisfied over time, the Company then determines the
appropriate method of measuring progress for purposes of recognizing revenue
from license payments. The Company evaluates the measure of progress each
reporting period and, if necessary, adjusts the related revenue recognition.

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Typically, the Company's collaboration agreements entitle it to additional
payments upon the achievement of milestones or royalties on sales. The
milestones are generally categorized into three types: development milestones,
generally based on the initiation of toxicity studies or clinical trials;
regulatory milestones, generally based on the submission, filing or approval of
regulatory applications such as a Clinical Trial Application ("CTA") or a New
Drug Application ("NDA") in the United States; and sales-based milestones,
generally based on meeting specific thresholds of sales in certain geographic
areas. The Company evaluates whether it is probable that the consideration
associated with each milestone or royalty will not be subject to a significant
reversal in the cumulative amount of revenue recognized. Amounts that meet this
threshold are included in the transaction price using the most likely amount
method, whereas amounts that do not meet this threshold are excluded from the
transaction price until they meet this threshold. At the end of each subsequent
reporting period, the Company re-evaluates the probability of a significant
reversal of the cumulative revenue recognized for our milestones and royalties,
and, if necessary, adjusts its estimate of the overall transaction price. Any
such adjustments are recorded on a cumulative catch-up basis, which would affect
revenues and net income in our Consolidated Statements of Operations and
Comprehensive Income (Loss).  Typically, milestone payments and royalties are
achieved after the Company's performance obligations associated with the
collaboration agreements have been completed and after the customer has assumed
responsibility for the respective clinical or pre-clinical program. Milestones
or royalties achieved after the Company's performance obligations have been
completed are recognized as revenue in the period the milestone or royalty was
achieved. If a milestone payment is achieved during the performance period, the
milestone payment would be recognized as revenue to the extent performance had
been completed at that point, and the remaining balance would be recorded as
deferred revenue.

The new revenue standard requires the Company to assess whether a significant
financing component exists in determining the transaction price. The Company
performs this assessment at the onset of its licensing or collaboration
agreements. Typically, a significant financing component does not exist because
the customer is paying for a license or services in advance with an upfront
payment. Additionally, future royalty payments are not substantially within the
control of the Company or the customer.

The new revenue standard requires the Company to allocate the arrangement
consideration on a relative standalone selling price basis for each performance
obligation after determining the transaction price of the contract and
identifying the performance obligations to which that amount should be
allocated. The relative standalone selling price is defined in the new revenue
standard as the price at which an entity would sell a promised good or service
separately to a customer. If other observable transactions in which the Company
has sold the same performance obligation separately are not available, the
Company estimates the standalone selling price of each performance obligation.
Key assumptions to determine the standalone selling price may include forecasted
revenues, development timelines, reimbursement rates for personnel costs,
discount rates and probabilities of technical and regulatory success.

Whenever the Company determines that goods or services promised in a contract
should be accounted for as a combined performance obligation over time, the
Company determines the period over which the performance obligations will be
performed and revenue will be recognized. Revenue is recognized using the
proportional performance method. Labor hours or costs incurred are typically
used as the measure of performance. Significant management judgment is required
in determining the level of effort required under an arrangement and the period
over which the Company is expected to complete its performance obligations. If
the Company determines that the performance obligation is satisfied over time,
any upfront payment received is initially recorded as deferred revenue on the
Company's Consolidated Balance Sheets.

Certain judgments affect the application of the Company's revenue recognition
policy. For example, the Company records short-term and long-term deferred
revenue based on its best estimate of when such revenue will be recognized.
Short-term deferred revenue consists of amounts that are expected to be
recognized as revenue in the next 12 months, and long-term deferred revenue
consists of amounts that the Company does not expect will be recognized in the
next 12 months. This estimate is based on the Company's current operating plan
and, if the Company's operating plan should change in the future, the Company
may recognize a different amount of deferred revenue over the next 12-month
period.

Allowance for Doubtful Accounts-The Company accrues an allowance for doubtful
accounts based on estimates of uncollectible revenues by analyzing historical
collections, accounts receivable aging and other factors. Accounts receivable
are written off when all collection attempts have failed.

Research and Development-Costs and expenses that can be clearly identified as
research and development are charged to expense as incurred in accordance with
FASB ASC 730-10. Included in research and development costs are operating costs,
facilities, supplies, external services, clinical trial and manufacturing costs,
overhead directly related to the Company's research and development operations,
and costs to acquire technology licenses.

Net Income (Loss) per Share-Basic net income (loss) per share is computed using
the weighted-average number of common shares outstanding during the period.
Diluted net income (loss) per share is computed using the weighted-average
number of common shares and dilutive potential common shares outstanding during
the period. Dilutive potential common shares primarily consist of stock options
and restricted stock units issued to employees. During the years ended September
30, 2020, 2019 and 2018, the calculation of the effect of dilutive stock options
and restricted stock units was 0 shares, 4,748,958 shares, and 0 shares,
respectively. During the year ended September 30, 2020, the calculation of the
effect of dilutive stock option and restricted stock units excluded all

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stock options and restricted stock units granted and outstanding during the
period due to their anti-dilutive effect. During the year ended September 30,
2019, the calculation of the effect of dilutive stock options and restricted
stock units excluded 1,007,500 stock options and 11,500 restricted stock units
granted and outstanding during the period due to their anti-dilutive
effect. During the year ended September 30, 2018, the calculation of the effect
of dilutive stock option and restricted stock units excluded all stock options
and restricted stock units granted and outstanding during the period due to
their anti-dilutive effect.

Stock-Based Compensation-The Company accounts for share-based compensation
arrangements in accordance with FASB ASC 718, which requires the measurement and
recognition of compensation expense for all share-based payment awards to be
based on estimated fair values. The Company uses the Black-Scholes option
valuation model to estimate the fair value of its stock options at the date of
grant. The Black-Scholes option valuation model requires the input of subjective
assumptions to calculate the value of stock options. For restricted stock units,
the value of the award is based on the Company's stock price at the grant
date. For performance-based restricted stock unit awards, the value of the award
is based on the Company's stock price at the grant date, with consideration
given to the probability of the performance condition being achieved. The
Company uses historical data and other information to estimate the expected
price volatility for stock option awards and the expected forfeiture rate for
all awards. Expense is recognized over the vesting period for all awards and
commences at the grant date for time-based awards and upon the Company's
determination that the achievement of such performance conditions is probable
for performance-based awards. This determination requires significant judgment
by management.

Income Taxes-The Company accounts for income taxes under the liability method,
which requires the recognition of deferred income tax assets and liabilities for
the expected future tax consequences of events that have been included in the
financial statements or tax returns. Under this method, deferred income taxes
are recognized for the tax consequences in future years of differences between
the tax bases of assets and liabilities and their financial reporting amounts at
each period end based on enacted tax laws and statutory tax rates applicable to
the periods in which the differences are expected to affect taxable income.
Valuation allowances are established, when necessary, to reduce deferred income
tax assets to the amount expected to be realized. The provision for income
taxes, if any, represents the tax payable for the period and the change in
deferred income tax assets and liabilities during the period.

Leases - The Company determines whether a contract is, or contains, a lease at
inception. The Company classifies each of its leases as operating or financing
considering factors such as the length of the lease term, the present value of
the lease payments, the nature of the asset being leased, and the potential for
ownership of the asset to transfer during the lease term. Leases with terms
greater than one-year are recognized on the Consolidated Balance Sheets as
Right-of-use assets and Lease liabilities and are measured at the present value
of the fixed payments due over the expected lease term minus the present value
of any incentives, rebates or abatements expected to be received from the
lessor. Options to extend a lease are typically excluded from the expected lease
term as the exercise of the option is typically not reasonably certain. The
interest rate implicit in lease contracts is typically not readily determinable.
As such, the Company utilizes the appropriate incremental borrowing rate, which
is the rate incurred to borrow on a collateralized basis an amount equal to the
lease payments over a similar term and in a similar economic environment. The
Company records expense to recognize fixed lease payments on a straight-line
basis over the expected lease term. Costs determined to be variable and not
based on an index or rate are not included in the measurement of the lease
liability and are expensed as incurred.

Results of Operations


The following data summarizes our results of operations for the following
periods indicated:



                                                  Years ended September 30,
                                          2020              2019              2018
Revenues                              $  87,992,066$ 168,795,577$  16,142,321
Operating Income (loss)               $ (93,158,803 )$  61,190,634$ (55,936,235 )
Net Income (loss)                     $ (84,553,226 )$  67,974,849$ (54,450,478 )
Net Income (Loss) per share-Diluted   $       (0.84 )$        0.69$       (0.65 )





The decrease in revenue for the year ended September 30, 2020 compared to the
year ended September 30, 2019 was driven by the timing of the recognition of the
$252.6 million initial transaction price associated with our agreements with
Janssen and JJDC as we achieved progress toward completing our performance
obligation under those agreements. The increase in Net Losses during the year
ended September 30, 2020 was driven by this decrease in Revenue and also
increases in Research and Development and General and Administrative Expenses as
our pipeline of clinical candidates has continued to increase.

                                       53

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Revenue


Total revenue for the years ended September 30, 2020, 2019, and 2018 was
$87,992,066, $168,795,577 and $16,142,321, respectively. Revenue in the current
period is primarily related to the recognition of a portion of the $252.6
million initial transaction price associated with our agreements with Janssen
and JJDC as we achieved progress towards completing our performance obligation
under those agreements. In addition, revenue in the current period consisted of
a $20 million milestone payment from Amgen for the initiation of phase 2
clinical study for AMG 890 (ARO-LPA). Revenue for the year ended September 30,
2019, was also primarily related to the recognition of a portion of the $252.6
million initial transaction price associated with our agreements with Janssen
and JJDC. A higher proportion of performance activity was ongoing during the
prior period than the current, which resulted in the higher revenue recognized
in the prior period. Revenue for the year ended September 30, 2018, was
primarily related to a $10 million milestone payment received from Amgen in
August 2018, which was earned following the administration of the first does of
AMG 890 (ARO-LPA).

Amgen Inc.

On September 28, 2016, the Company entered into two collaboration and license
agreements, and a common stock purchase Agreement with Amgen Inc., a Delaware
corporation ("Amgen"). Under one of the license agreements (the "Second
Collaboration and License Agreement" or "Olpasiran Agreement"), Amgen has
received a worldwide, exclusive license to Arrowhead's novel, RNAi Olpasiran
program. These RNAi molecules are designed to reduce elevated lipoprotein(a),
which is a genetically validated, independent risk factor for atherosclerotic
cardiovascular disease. Under the other collaboration and license agreement (the
"First Collaboration and License Agreement" or "ARO-AMG1 Agreement"), Amgen
received an option to a worldwide, exclusive license for ARO-AMG1, an RNAi
therapy for an undisclosed genetically validated cardiovascular target. In both
agreements, Amgen is wholly responsible for clinical development and
commercialization. Under the terms of the agreements taken together, the Company
has received $35.0 million in upfront payments, $21.5 million in the form of an
equity investment by Amgen in the Company's Common Stock, and $30.0 million in
milestone payments, and may receive up to an additional $400.0 million in
remaining development, regulatory and sales milestone payments. The Company is
further eligible to receive up to low double-digit royalties for sales of
products under the Olpasiran Agreement. In July 2019, Amgen informed the Company
that it would not be exercising its option for an exclusive license for
ARO-AMG1, and as such, there will be no further milestone or royalty payments
under the ARO-AMG1 Agreement.

The Company substantially completed its performance obligations under the
Olpasiran Agreement and the ARO-AMG1 Agreement. Future milestones and royalties
achieved will be recognized in their entirety when earned. In July 2020, Amgen
initiated a Phase 2 clinical study, which resulted in a $20.0 million milestone
payment to the Company. During the years ended September 30, 2020, 2019 and
2018, the Company recognized $20.1 million, $0.3 million, and $16.1 million of
Revenue associated with its agreements with Amgen, respectively. As of September
30, 2020, there were $0 million in contract assets recorded as accounts
receivable and $0 contract liabilities recorded as current deferred revenue on
the Company's Consolidated Balance Sheets.

Janssen Pharmaceuticals, Inc.


On October 3, 2018, the Company entered into a License Agreement ("Janssen
License Agreement") and a Research Collaboration and Option Agreement ("Janssen
Collaboration Agreement") with Janssen Pharmaceuticals, Inc. ("Janssen") part of
the Janssen Pharmaceutical Companies of Johnson & Johnson. The Company also
entered into a Stock Purchase Agreement ("JJDC Stock Purchase Agreement") with
Johnson & Johnson Innovation-JJDC, Inc. ("JJDC"), a New Jersey
corporation. Under the Janssen License Agreement, Janssen has received a
worldwide, exclusive license to the Company's JNJ-3989 (ARO-HBV) program, the
Company's third-generation subcutaneously administered RNAi therapeutic
candidate being developed as a potentially curative therapy for patients with
chronic hepatitis B virus infection. Beyond the Company's Phase 1 / 2 study of
JNJ-3989 (ARO-HBV), Janssen is wholly responsible for clinical development and
commercialization. Under the Janssen Collaboration Agreement, Janssen will be
able to select three new targets against which Arrowhead will develop clinical
candidates. These candidates are subject to certain restrictions and do not
include candidates that already were in the Company's pipeline. The Company will
perform discovery, optimization and preclinical research and development,
entirely funded by Janssen, which on its own or in combination with Janssen
development work, is sufficient to allow the filing of a U.S. Investigational
New Drug application or equivalent, at which time Janssen will have the option
to take an exclusive license. If the option is exercised, Janssen will be wholly
responsible for clinical development and commercialization of each optioned
candidate. Under the terms of the agreements taken together, the Company has
received $175.0 million as an upfront payment, $75.0 million in the form of an
equity investment by JJDC in Arrowhead Common Stock, two $25.0 million milestone
payments and may receive up to $1.6 billion in development and sales milestones
payments for the Janssen License Agreement, and up to $1.9 billion in
development and sales milestone payments for the three additional targets
covered under the Janssen Collaboration Agreement. The Company is further
eligible to receive tiered royalties up to mid-teens under the Janssen License
Agreement and up to low teens under the Janssen Collaboration Agreement on
product sales.

The Company has evaluated these agreements in accordance with the new revenue
recognition requirements that became effective for the Company on October 1,
2018. The adoption of the new revenue standard did not have a material impact on
the

                                       54
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balances reported when evaluated under the superseded revenue standard. At the
inception of these agreements, the Company has identified one distinct
performance obligation. Regarding the Janssen License Agreement, the Company
determined that the key deliverables included the license and certain R&D
services including the Company's responsibility to complete the Phase 1/2 study
of JNJ-3989 (ARO-HBV) and the Company's responsibility to ensure certain
manufacturing of ARO-HBV drug product is completed and delivered to Janssen (the
"Janssen R&D Services"). Due to the specialized and unique nature of these
Janssen R&D Services, and their direct relationship with the license, the
Company determined that these deliverables represent one distinct bundle and
thus, one performance obligation. The Company also determined that Janssen's
option to require the Company to develop up to three new targets is not a
material right, and thus, not a performance obligation at the onset of the
agreement. The consideration for this option will be accounted for if and when
it is exercised.

The Company determined the transaction price totaled approximately $252.6
million which includes the upfront payment, the premium paid by JJDC for its
equity investment in the Company, the two $25 million milestone payments earned
and estimated payments for reimbursable Janssen R&D Services to be
performed. The Company has allocated the total $252.6 million initial
transaction price to its one distinct performance obligation for the JNJ-3989
(ARO-HBV) license and the associated Janssen R&D Services. This revenue will be
recognized using a proportional performance method (based on actual labor hours
versus estimated total labor hours) beginning in October 2018 and ending as the
Company's efforts in overseeing the phase 1/2 clinical trial are
completed. During the years ended September 30, 2020 and 2019, the Company
recognized approximately $65.0 million and $167.5 million of Revenue associated
with this performance obligation, respectively. As of September 30, 2020, there
were $0 in contract assets recorded as accounts receivable and $19.3 million of
contract liabilities recorded as current deferred revenue on the Company's
Consolidated Balance Sheets. The $19.3 million of current deferred revenue is
driven by the upfront payment, the premium paid by JJDC for its equity
investment in the Company, and the two $25.0 million milestone payments earned,
net of revenue recognized to date.

The Company has begun to conduct its discovery, optimization and preclinical
research and development of ARO-JNJ1, ARO-JNJ2 and ARO-JNJ3 under the Janssen
Collaboration Agreement. All costs and labor hours spent by the Company will be
entirely funded by Janssen.  During the years ended September 30, 2020 and 2019,
the Company recognized $2.9 million and $1.0 million of Revenue associated with
these efforts, respectively. As of September 30, 2020, there were $0.8 million
of contract assets recorded as accounts receivable and $0 of contract
liabilities recorded as current deferred revenue on the Company's Consolidated
Balance Sheets.

Operating Expenses

The analysis below details the operating expenses and discusses the expenditures
of the Company within the major expense categories. Certain reclassifications
have been made to prior-period operating expense categories to conform to the
current period presentation. For purposes of comparison, the amounts for the
years ended September 30, 2020 and 2019 are shown in the tables below.

Research and Development Expenses


R&D expenses are related to the Company's research and development efforts, and
related program costs which are comprised primarily of outsourced costs related
to the manufacturing of clinical supplies, toxicity/efficacy studies and
clinical trial expenses. Internal costs primarily relate to operations at our
research facilities in Madison, Wisconsin and San Diego, California, including
facility costs and laboratory-related expenses. Salaries and stock compensation
expense consist of salary, bonuses, payroll taxes and related benefits and stock
compensation for our R&D personnel. Depreciation and amortization expense
relates to

                                       55

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depreciation on lab equipment and leasehold improvements at our research facilities. The following table provides details of research and development expenses for the periods indicated:


(table below in thousands)



                               Twelve                         Twelve
                               Months          % of           Months          % of
                                Ended         Expense         Ended          Expense          Increase (Decrease)
                              September                     September
                              30, 2020       Category        30, 2019       Category           $                %
Salaries                     $    26,300            20 %   $     15,502            19 %   $     10,798             70 %
Facilities related                 4,136             3 %          2,649             3 %          1,487             56 %
Candidate costs                   60,638            47 %         47,062            58 %         13,576             29 %
R&D discovery costs               16,192            13 %          7,901            10 %          8,291            105 %
Total research and
development expense,
excluding non-cash expense   $   107,266            83 %   $     73,114            90 %   $     34,152             47 %
Stock compensation                16,277            13 %          3,515             4 %         12,762            363 %
Depreciation/amortization          5,332             4 %          4,420             6 %            912             21 %
Total research and
development expense          $   128,875           100 %   $     81,049           100 %   $     47,826             59 %




Salaries expense increased by $10,798,000 from $15,502,000 during the year ended
September 30, 2019 to $26,300,000 during the current period. This increase is
primarily due to an increase in R&D headcount that has occurred as the Company
has expanded its pipeline of candidates.

Facilities expense increased by $1,487,000 from $2,649,000 during the year ended
September 30, 2019 to $4,136,000 during the current period. This category
includes rental costs for our research and development facilities in Madison,
Wisconsin and San Diego, California. This increase is primarily due the
commencement of our sublease in San Diego, California in April 2020.

Candidate costs increased by $13,576,000 from $47,062,000 during the year ended
September 30, 2019 to $60,638,000 during the current period. This increase is
primarily due to the progression of our pipeline candidates into and through
clinical trials, which results in higher outsourced clinical trial, toxicity
study and manufacturing costs. We anticipate these expenses to continue to
increase as our pipeline of candidates grows and progresses to later phase
clinical trials.

R&D discovery costs increased by $8,291,000 from $7,901,000 during the year
ended September 30, 2019 to $16,192,000 in the current period. This increase is
due to the growth of our discovery efforts, including the addition of our
research facility in San Diego. We anticipate this expense to continue to
increase as we increase headcount to support our discovery efforts to identify
new drug candidates.

Stock compensation expense, a non-cash expense, increased by $12,762,000 from
$3,515,000 during the year ended September 30, 2019 to $16,277,000 during the
current period. Stock compensation expense is based upon the valuation of stock
options and restricted stock units granted to employees, directors, and certain
consultants. Many variables affect the amount expensed, including the Company's
stock price on the date of the grant, as well as other assumptions. The increase
in the expense is primarily due to the increased headcount discussed above and a
mix of higher grant date fair values of awards amortizing during the periods due
to the Company's stock price at the time of the grants.

Depreciation and amortization expense, a non-cash expense, increased by $912,000
from $4,420,000 during the year ended September 30, 2019 to $5,332,000 during
the current period. The majority of depreciation and amortization expense
relates to depreciation on lab equipment and leasehold improvements at our
Madison research facility.

                                       56

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General & Administrative Expenses


The following table provides details of our general and administrative expenses
for the periods indicated:

(table below in thousands)



                                Twelve                         Twelve
                                Months          % of           Months          % of
                                Ended          Expense         Ended          Expense         Increase (Decrease)
                              September                      September
                               30, 2020       Category        30, 2019       Category           $               %
Salaries                     $     11,781            23 %   $      8,288            31 %   $      3,493            42 %
Professional/outside
services                            7,342            14 %          5,605            21 %          1,737            31 %
Facilities related                  2,203             4 %          1,434             5 %            769            54 %
Other G&A                           3,232             6 %          2,332             9 %            900            39 %
Total general &
administrative expense,
excluding non-cash expense   $     24,558            47 %   $     17,659            67 %   $      6,899            39 %
Stock compensation                 27,106            52 %          8,878            33 %         18,228           205 %
Depreciation/amortization             611             1 %             19             0 %            592          3116 %
Total general &
administrative expense       $     52,275           100 %   $     26,556           100 %   $     25,719            97 %




Salaries expense increased by $3,493,000 from $8,288,000 during the year ended
September 30, 2019 to $11,781,000 during the current period. The increase is
primarily driven by annual merit increases, performance bonuses and increased
headcount.

Professional/outside services include legal, accounting, consulting, patent
expenses, business insurance expenses and other outside services retained by the
Company. Professional/outside services expense increased by $1,737,000 from
$5,605,000 during the year ended September 30, 2019 to $7,342,000 during the
current period. The increases is primarily related to certain patent-related
expenses.

Facilities-related expense increased by $769,000 from $1,434,000 during the year
ended September 30, 2019 to $2,203,000 during the current period. This category
primarily includes rental costs for our corporate headquarters in Pasadena,
California. The increase in the expense is primarily related to costs incurred
as we moved into our new corporate headquarters during the current period.

Other G&A expense increased by $900,000 from $2,332,000 during the year ended
September 30, 2019 to $3,232,000 during the current period. This category
consists primarily of travel, communication and technology, office expenses, and
franchise and property tax expenses. The increase in the expense was due to
increased communication and technology and office expenses associated with our
new corporate headquarters.

Stock compensation expense, a non-cash expense, increased by $18,228,000 from
$8,878,000 during the year ended September 30, 2019 to $27,106,000 during the
current period. Stock compensation expense is based upon the valuation of stock
options and restricted stock units granted to employees, directors, and certain
consultants. Many variables affect the amount expensed, including the Company's
stock price on the date of the grant, as well as other assumptions. The increase
in expense is primarily due to the timing of the achievement of certain
performance-based awards in each period and a mix of higher grant date fair
values of awards amortizing during the periods due to the Company's stock price
at the time of the grants.

Depreciation and amortization expense, a noncash expense, increased by $592,000
from $19,000 during the year ended September 30, 2019 to $611,000 during the
current period. The increase is primarily related to amortization of leasehold
improvements for our new corporate headquarters.

Other Income / Expense


Other income / expense was income of $6,957,768 during the year ended September
30, 2019 compared to income of $8,607,977 during the current period. Interest
income has increased in the current period as our investment holdings have
grown.

Liquidity and Cash Resources


Arrowhead has historically financed its operations through the sale of its
equity securities. Research and development activities have required significant
capital investment since the Company's inception and are expected to continue to
require significant cash expenditure in the future.

                                       57

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At September 30, 2020, the Company had cash on hand of approximately $143.6
million as compared to $221.8 million at September 30, 2019. Cash invested in
short-term fixed income securities and marketable securities was $171.9 million
at September 30, 2020, compared to $36.9 million at September 30, 2019. Cash
invested in long-term fixed income securities was $137.5 million at September
30, 2020, compared to $44.2 million at September 30, 2019. The Company also
entered into an Open Market Sale Agreement (the "ATM" agreement), pursuant to
which the Company may, from time to time, sell up to $250,000,000 in shares of
the Company's common stock through Jefferies LLC. As of the year ended September
30, 2020, no shares have been issued under the ATM agreement. The Company
believes its current financial resources are sufficient to fund its operations
through at least the next twelve months.

A summary of cash flows for the years ended September 30, 2020, 2019, and 2018
as follows:



                                                        Years ended September 30,
                                                   2020            2019            2018
Cash Flow from:
Operating Activities                          $  (95,391,570 )$ 173,034,923$ (47,223,417 )
Investing Activities                            (240,777,764 )   (47,746,007 )    (7,434,963 )
Financing Activities                             257,947,873      66,381,999      59,953,026
Net Increase (decrease) in cash and cash
equivalents                                      (78,221,461 )   191,670,915       5,294,646
Cash and cash equivalents at beginning of
period                                           221,804,128      

30,133,213 24,838,567 Cash and cash equivalents at end of period 143,582,667 221,804,128 30,133,213





During the year ended September 30, 2020, the Company used $95.4 million in cash
from operating activities, which was primarily related to the ongoing expenses
of the Company's research and development programs and general and
administrative expenses. Cash used in investing activities was $240.8 million,
which was primarily related to the purchase of investments of $279.0 million and
property and equipment of $12.0 million, partially offset by maturities of
fixed-income securities of $50.1 million. Cash provided by financing activities
of $257.9 million was driven by the securities financing in December 2019, which
generated $250.5 million in net cash proceeds, as well as $7.5 million in cash
received from stock option exercises.

During the year ended September 30, 2019, the Company generated $173.0 million
in cash from operating activities, which was primarily related to the $175.0
million upfront payment and the two $25.0 million milestone payments received
from Janssen, and the premium JJDC paid on the Company's common stock during the
period. These inflows were partially offset by approximately $66.5 million of
cash used for the ongoing expenses of the Company's research and development
programs and general and administrative expenses. Cash used in investing
activities was $47.7 million, which was primarily related to purchases of
fixed-income investments of $90.3 million partially offset by maturities of
fixed-income investments of $54.5 million. Cash provided by financing activities
of $66.4 million was driven by the equity investment the Company received from
JJDC during the period.

During the year ended September 30, 2018, the Company used $47.2 million in cash
from operating activities, which was primarily related to $57.2 million used for
the on-going expenses of its research and development programs and general and
administrative expenses, offset by the $10 million milestone payment for the AMG
890 (ARO-LPA) Agreement with Amgen. Cash used in investing activities was $7.4
million, which was primarily related to maturities of fixed-income investments
of $46.1 million offset by purchases of fixed-income securities of $52.1
million. Cash provided by financing activities of $60.0 million was driven by
the $56.6 million of cash generated from the underwritten public offering in
January 2018.

Contractual Obligations

In the table below, we set forth our enforceable and legally binding obligations
and future commitments at September 30, 2020 for the categories shown, as well
as obligations related to contracts in such categories that we are likely to
continue. Some of the figures that we include in this table are based on
management's estimates and assumptions about these obligations, including their
duration, the possibility of renewal, anticipated actions by third parties and
other factors. Because these estimates and assumptions are necessarily
subjective, the obligations we will actually pay in future periods may vary from
those reflected in the table. The following

                                       58

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table does not include any future obligations that may be owed under existing
license agreements, as the certainty of achieving the relevant milestones that
would trigger these payments is currently unknown.



                                                                     Payments due by Period
                                                                                                               More than  5
                                         Total          Less than 1 Year       1-3 Years        3-5 Years          Years
Long-Term Debt                                   -                      -                -               -                 -
Capital Leases                                   -                      -                -               -                 -
Operating Leases                        32,311,207              3,091,901        7,260,044       6,627,966        15,331,296
Unconditional Purchase Obligations      77,965,922             60,176,232       17,789,690               -                 -
Other Long-Term Liabilities                      -                      -                -               -                 -
Total                                $ 110,277,129$       63,268,133$ 25,049,734$ 6,627,966$  15,331,296

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements.

                                       59

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