Revenue Increased 45% YOY to $221.0 million; GAAP Diluted EPS of $0.56 and Non-GAAP Diluted EPS of $0.741
Royalty Revenue Increased 31% YOY to Record
$111.7 million
Raised 2023 Non-GAAP Diluted EPS Guidance to
$2.65-$2.75
Updated Revenue Guidance to $825-$845 million,
Representing 25-28% YOY Growth, and EBITDA Guidance to $420-$440 million,
Representing >30% YOY
Growth1
SAN
DIEGO, Aug. 8, 2023 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme" or the "Company")
today reported its financial and operating results for the second
quarter ended June 30, 2023 and provided an update on its
recent corporate activities and outlook.
"Our strong second quarter results with record revenue of
$221 million and non-GAAP EPS of
$0.74 were complemented with
significant commercial and clinical advancements with our ENHANZE
product pipeline," said Dr. Helen
Torley, president and chief executive officer of Halozyme.
"The FDA approval for argenx's VYVGART Hytrulo with ENHANZE for
generalized myasthenia gravis expanded our commercialized partnered
products to six products generating royalty revenue. In addition,
argenx's VYVGART Hytrulo achieved positive data in a second
indication for CIDP and Roche's SC ocrelizumab with ENHANZE met the
phase 3 study primary and secondary endpoints, which support the
near-term additional opportunities for growth. We expect our
commercialized partnered products to further expand with the
potential FDA approval of Roche's SC atezolizumab later this year.
We also look forward to late-stage clinical data from argenx for
ITP and pemphigus, which will support our future growth trajectory.
We are well positioned for another record year with our updated
guidance."
Recent Partner Highlights:
- In July 2023, argenx reported
positive data from the ADHERE study evaluating VYVGART®
Hytrulo with ENHANZE® in adults with chronic
inflammatory demyelinating polyneuropathy ("CIDP"). The study met
its primary endpoint resulting in a 61% reduction in risk of
relapse compared to placebo.
- In July 2023, Roche announced
that the Phase III OCARINA II trial evaluating OCREVUS®
(ocrelizumab) with ENHANZE® as a twice a year 10-minute
subcutaneous injection met its primary and secondary endpoints in
patients with relapsing forms of multiple sclerosis ("MS") or
primary progressive MS ("RMS" or "PPMS").
- In June 2023, argenx received
U.S. Food and Drug Administration ("FDA") approval for
VYVGART® Hytrulo injection with ENHANZE® for
SC use for the treatment of generalized myasthenia gravis in adult
patients who are anti-acetylcholine receptor ("AChR") antibody
positive and in July 2023,
VYVGART® Hytrulo was made available to patients,
triggering $33.0 million in milestone
payments and the right to receive royalties on net product
sales.
- In June 2023, Takeda announced
positive results from a pivotal Phase 3 trial evaluating
HYQVIA® for maintenance treatment of chronic
inflammatory demyelinating polyneuropathy ("CIDP") and confirmed
regulatory applications were under review in the U.S. and European
Union.
- In April 2023, Takeda announced
that the FDA approved a supplemental Biologics License Application
("sBLA") to expand the use of HYQVIA® to treat primary
immunodeficiency in children.
Second Quarter 2023 Financial Highlights:
- Revenue in the second quarter was $221.0
million compared to $152.4
million in the second quarter of 2022. The 45%
year-over-year increase was driven by growth in ENHANZE®
revenue streams with an increase in royalty revenue and an increase
in milestone revenue due to the approval and launch of
VYVGART® Hytrulo as well as the addition of product
sales as a result of the Antares Pharma acquisition. Revenue for
the quarter included $111.7 million
in royalties, an increase of 31% compared to $85.3 million in the prior year period, primarily
attributable to subcutaneous DARZALEX®
(daratumumab).
- Cost of sales in the second quarter was $50.1 million, compared to $33.9 million in the second quarter of 2022. The
increase was driven by an increase in product sales as a result of
the Antares Pharma acquisition and amortization of inventory
step-up associated with purchase accounting for the Antares Pharma
acquisition.
- Amortization of intangibles expense in the second quarter was
$17.8 million, due to the Antares
Pharma acquisition, in which Halozyme acquired intangible assets
that are amortized over a useful life related to the auto injector
technology platform, XYOSTED® and
TLANDO®.
- Research and development expense in the second quarter was
$19.7 million, compared to
$15.5 million in the second quarter
of 2022. The increase is primarily due to an increase in
compensation expense related to the ongoing combined larger
workforce as a result of the Antares Pharma acquisition, which
added device platform resources in regulatory, quality and
manufacturing, as well as planned investments in
ENHANZE®.
- Selling, general and administrative expense in the second
quarter was $38.9 million, compared
to $57.5 million in the second
quarter of 2022. The decrease was primarily due to one-time
transaction costs in the prior year, partially offset by an
increase in compensation expense related to the ongoing combined
larger workforce, including the addition of commercial resources in
sales and marketing for the testosterone replacement therapy
products.
- Operating income in the second quarter was $94.5 million, compared to operating income of
$34.1 million in the second quarter
of 2022. Net Income in the second quarter was $74.8 million, compared with net income of
$22.7 million in the second quarter
of 2022. EBITDA in the second quarter was $115.1 million, compared with EBITDA of
$46.6 million in the second quarter
of 2022. Adjusted EBITDA in the second quarter was $115.1 million, compared with Adjusted EBITDA of
$87.8 million in the second quarter
of 2022.
- Earnings per Share: On a GAAP basis in the second quarter of
2023, diluted earnings per share was $0.56, compared with $0.16 in the second quarter of 2022. On a
non-GAAP basis, diluted earnings per share was $0.74, compared with diluted earnings per share
of $0.53 in the second quarter of
2022.1
- Cash, cash equivalents and marketable securities were
$348.3 million on June 30, 2023, compared to $362.8 million on December
31, 2022. The decrease was primarily due to the repurchase
of common stock for $150.0 million in
the first quarter of 2023.
Financial Outlook for 2023
The Company is increasing the lower end of revenue and EBITDA
guidance ranges to reflect strong second quarter results. In
addition, the Company is increasing non-GAAP diluted earnings per
share guidance to reflect the impact of share repurchases that
occurred earlier in the year. For the full year 2023, the Company
now expects:
- Total revenue of $825 million to
$845 million, representing growth of
25% to 28% over 2022 total revenue primarily driven by continued
strength in Wave 2 products, including DARZALEX® SC
(daratumumab) and Phesgo® (pertuzumab, trastuzumab and
hyaluronidase) utilizing ENHANZE®, as well as full year
auto-injector royalty and product contribution. The Company expects
revenue from royalties of $445
million to $455 million,
representing growth of 23% to 26%.
- EBITDA of $420 million to
$440 million, representing growth of
>30% over 2022. EBITDA excludes the impact of amortization costs
related to the Antares Pharma acquisition.1
- Non-GAAP diluted earnings per share of $2.65 to $2.75,
representing growth of 20% over 20221. The Company's
earnings per share guidance does not consider the impact of
potential future share repurchases.
Table 1. 2023 Financial Guidance
|
|
Guidance
Range
|
|
Previous Guidance
Range
|
Total
Revenue
|
|
$825 to $845
million
|
|
$815 to $845
million
|
Royalty
Revenue
|
|
$445 to $455
million
|
|
$445 to $455
million
|
EBITDA
|
|
$420 to $440
million
|
|
$415 to $440
million
|
Non-GAAP Diluted
EPS
|
|
$2.65 to
$2.75
|
|
$2.50 to
$2.65
|
Webcast and Conference Call
Halozyme will host its Quarterly Update Conference Call for the
second quarter ended June 30, 2023 today, Tuesday,
August 8, 2023 at 4:30 p.m.
ET/1:30 p.m. PT. The
conference call may be accessed live with pre-registration via this
link: https://conferencingportals.com/event/QfiVLXsr. The call
will also be webcast live through the "Investors" section of
Halozyme's corporate website and a recording will be made available
following the close of the call. To access the webcast and
additional documents related to the call, please visit the
"Investors" section of www.halozyme.com.
About Halozyme
Halozyme is a biopharmaceutical company bringing disruptive
solutions to significantly improve patient experiences and outcomes
for emerging and established therapies. As the innovators of the
ENHANZE® technology with the proprietary enzyme rHuPH20,
Halozyme's commercially-validated solution is used to facilitate
the delivery of injected drugs and fluids in order to reduce the
treatment burden to patients. Having touched more than 700,000
patient lives in post-marketing use in six commercialized products
across more than 100 global markets, Halozyme has licensed its
ENHANZE® technology to leading pharmaceutical and
biotechnology companies including Roche, Takeda, Pfizer, AbbVie,
Eli Lilly, Bristol-Myers Squibb, Alexion, argenx, Horizon
Therapeutics, ViiV Healthcare and Chugai Pharmaceutical.
Halozyme also develops, manufactures and commercializes, for
itself or with partners, drug-device combination products using its
advanced auto-injector technology that are designed to provide
commercial or functional advantages such as improved convenience
and tolerability, and enhanced patient comfort and adherence. The
Company has a commercial portfolio of proprietary products
including XYOSTED®, TLANDO® and
NOCDURNA® and partnered commercial products and ongoing
product development programs with several pharmaceutical companies
including Teva Pharmaceuticals and Idorsia Pharmaceuticals.
Halozyme is headquartered in San
Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations
facility.
For more information visit www.halozyme.com and connect with us
on LinkedIn and Twitter.
Note Regarding Use of Non-GAAP Financial Measures
In addition to disclosing financial measures prepared in
accordance with U.S. generally accepted accounting principles
(GAAP), this press release and the accompanying tables contain
certain Non-GAAP financial measures. The Company reports earnings
before interest, taxes, depreciation, and amortization (EBITDA),
adjusted EBITDA and Non-GAAP diluted earnings per share, and
guidance with respect to those measures, in addition to, and not as
a substitute for, or superior to, financial measures calculated in
accordance with GAAP. The Company calculates Non-GAAP diluted
earnings per share excluding share-based compensation expense,
amortization of debt discount, intangible asset amortization,
transaction costs for business combinations, realized gains or
losses on marketable security sales and certain adjustments to
income tax expense. The Company calculates EBITDA excluding
interest, taxes, depreciation and amortization. The Company
calculates adjusted EBITDA excluding transaction costs for business
combinations. Reconciliations between GAAP and Non-GAAP financial
measures are included at the end of this press release. The Company
does not provide reconciliations of forward-looking adjusted
measures to GAAP due to the inherent difficulty in forecasting and
quantifying certain amounts that are necessary for such
reconciliation, including adjustments that could be made for
changes in contingent liabilities, share-based compensation expense
and the effects of any discrete income tax items. The Company
evaluates other items of income and expense on an individual basis
for potential inclusion in the calculation of Non-GAAP financial
measures and considers both the quantitative and qualitative
aspects of the item, including (i) its size and nature, (ii)
whether or not it relates to the Company's ongoing business
operations and (iii) whether or not the Company expects it to occur
as part of the Company's normal business on a regular basis.
Non-GAAP financial measures do not have any standardized meaning
and are therefore unlikely to be comparable to similarly titled
measures presented by other companies. These Non-GAAP financial
measures are not meant to be considered in isolation and should be
read in conjunction with the Company's consolidated financial
statements prepared in accordance with GAAP; and are not prepared
under any comprehensive set of accounting rules or principles. In
addition, from time to time in the future there may be other items
that the Company may exclude for purposes of its Non-GAAP financial
measures; and the Company may in the future cease to exclude items
that it has historically excluded for purposes of its Non-GAAP
financial measures. The Company considers these Non-GAAP financial
measures to be important because they provide useful measures of
the operating performance of the Company, exclusive of factors that
do not directly affect what the Company considers to be its core
operating performance, as well as unusual events. The Non-GAAP
measures also allow investors and analysts to make additional
comparisons of the operating activities of the Company's core
business over time and with respect to other companies, as well as
assessing trends and future expectations. The Company uses Non-GAAP
financial information in assessing what it believes is a meaningful
and comparable set of financial performance measures to evaluate
operating trends, as well as in establishing portions of our
performance-based incentive compensation programs.
Safe Harbor Statement
In addition to historical information, the statements set forth
in this press release include forward-looking statements including,
without limitation, statements concerning the Company's financial
performance (including the Company's financial outlook for 2023)
and expectations for future growth, achieving operational goals,
profitability, revenues (including royalty, milestone and product
sales revenue), EBITDA and non-GAAP diluted earnings-per-share and
potential share repurchase under its share repurchase program.
Forward-looking statements regarding the Company's
ENHANZE® drug delivery technology may include the
possible benefits and attributes of ENHANZE®, its
potential application to aid in the dispersion and absorption of
other injected therapeutic drugs and facilitating more rapid
delivery and administration of higher volumes of injectable
medications through subcutaneous delivery. Forward-looking
statements regarding the Company's business may include
potential growth and receipt of royalty and milestone payments
driven by our partners' development and commercialization efforts,
potential new clinical trial study starts and clinical data,
regulatory submissions and product launches, the size and growth
prospects of our partners' drug franchises, potential new or
expanded collaborations and collaborative targets and regulatory
review and potential approvals of new partnered or
proprietary products. These forward-looking statements are
typically, but not always, identified through use of the words
"believe," "enable," "may," "will," "could," "intends," "estimate,"
"anticipate," "plan," "predict," "probable," "potential,"
"possible," "should," "continue," and other words of similar
meaning and involve risk and uncertainties that could cause actual
results to differ materially from those in the forward-looking
statements. Actual results could differ materially from the
expectations contained in these forward-looking statements as a
result of several factors, including unexpected levels of revenues,
expenditures and costs, unexpected delays in the execution of the
Company's share repurchase program, unexpected results or delays in
the growth of the Company's business, or in the development,
regulatory review or commercialization of the Company's partnered
or proprietary products, regulatory approval requirements,
unexpected adverse events or patient outcomes and competitive
conditions. These and other factors that may result in differences
are discussed in greater detail in the Company's most recent Annual
Report on Form 10-K and Quarterly Report on Form 10-Q filed with
the Securities and Exchange Commission.
Contacts:
Tram Bui
VP, Investor Relations and Corporate Communications
609-359-3016
tbui@halozyme.com
Dawn Schottlandt
Argot Partners
212-600-1902
Halozyme@argotpartners.com
Footnotes:
1. Reconciliations between GAAP reported
and non-GAAP financial information and adjusted guidance measures
are provided at the end.
Halozyme
Therapeutics, Inc
Consolidated
Statements of Operations
(Unaudited)
(In thousands,
except per share amounts)
|
|
|
|
|
|
Three Months
Ended
June
30,
|
|
Six Months
Ended
June
30,
|
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Revenues:
|
|
|
|
|
|
|
|
|
Royalties
|
|
$ 111,740
|
|
$
85,340
|
|
$
211,380
|
|
$ 154,945
|
Product sales,
net
|
|
73,889
|
|
46,300
|
|
134,683
|
|
68,440
|
Revenues under
collaborative agreements
|
|
35,409
|
|
20,725
|
|
37,118
|
|
46,259
|
Total
revenues
|
|
221,038
|
|
152,365
|
|
383,181
|
|
269,644
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Cost of
sales
|
|
50,070
|
|
33,943
|
|
85,240
|
|
49,865
|
Amortization of
intangibles
|
|
17,835
|
|
11,403
|
|
35,670
|
|
11,403
|
Research and
development
|
|
19,727
|
|
15,483
|
|
37,706
|
|
27,336
|
Selling, general and
administrative
|
|
38,948
|
|
57,476
|
|
76,305
|
|
71,310
|
Total operating
expenses
|
|
126,580
|
|
118,305
|
|
234,921
|
|
159,914
|
Operating
income
|
|
94,458
|
|
34,060
|
|
148,260
|
|
109,730
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
Investment and other
(expense) income, net
|
|
3,192
|
|
(945)
|
|
6,171
|
|
(447)
|
Interest
expense
|
|
(4,494)
|
|
(3,104)
|
|
(9,037)
|
|
(4,863)
|
Net income before
income taxes
|
|
93,156
|
|
30,011
|
|
145,394
|
|
104,420
|
Income tax
expense
|
|
18,402
|
|
7,326
|
|
31,025
|
|
21,627
|
Net income
|
|
$
74,754
|
|
$
22,685
|
|
$
114,369
|
|
$
82,793
|
|
|
|
|
|
|
|
|
|
Net income per
share:
|
|
|
|
|
|
|
|
|
Basic
|
|
$
0.57
|
|
$
0.16
|
|
$
0.86
|
|
$
0.60
|
Diluted
|
|
$
0.56
|
|
$
0.16
|
|
$
0.84
|
|
$
0.58
|
|
|
|
|
|
|
|
|
|
Shares used in
computing net income per share:
|
|
|
|
|
|
|
|
|
Basic
|
|
131,730
|
|
137,937
|
|
133,369
|
|
137,798
|
Diluted
|
|
133,543
|
|
142,216
|
|
135,758
|
|
141,795
|
Halozyme
Therapeutics, Inc
Consolidated Balance
Sheets
(Unaudited)
(In
thousands)
|
|
|
|
June 30,
2023
|
|
December 31,
2022
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
221,165
|
|
$
234,195
|
Marketable securities,
available-for-sale
|
|
127,110
|
|
128,599
|
Accounts receivable,
net and contract assets
|
|
246,179
|
|
231,072
|
Inventories,
net
|
|
132,406
|
|
100,123
|
Prepaid expenses and
other current assets
|
|
38,885
|
|
45,024
|
Total current
assets
|
|
765,745
|
|
739,013
|
Property and equipment,
net
|
|
74,559
|
|
75,570
|
Prepaid expenses and
other assets
|
|
18,409
|
|
26,301
|
Goodwill
|
|
416,821
|
|
409,049
|
Intangible assets,
net
|
|
510,982
|
|
546,652
|
Deferred tax assets,
net
|
|
23,924
|
|
44,426
|
Restricted
cash
|
|
—
|
|
500
|
Total
assets
|
|
$ 1,810,440
|
|
$
1,841,511
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
10,120
|
|
$
17,693
|
Accrued
expenses
|
|
105,431
|
|
96,516
|
Deferred revenue,
current portion
|
|
842
|
|
3,246
|
Current portion of
long-term debt, net
|
|
—
|
|
13,334
|
Total current
liabilities
|
|
116,393
|
|
130,789
|
Deferred revenue, net
of current portion
|
|
2,253
|
|
2,253
|
Long-term debt,
net
|
|
1,495,998
|
|
1,492,766
|
Other long-term
liabilities
|
|
30,875
|
|
30,433
|
Contingent
liability
|
|
13,888
|
|
15,472
|
Total
liabilities
|
|
1,659,407
|
|
1,671,713
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
Common
stock
|
|
132
|
|
135
|
Additional paid-in
capital
|
|
12,068
|
|
27,368
|
Accumulated other
comprehensive loss
|
|
(1,615)
|
|
(922)
|
Retained earnings
(accumulated deficit)
|
|
140,448
|
|
143,217
|
Total stockholders'
equity
|
|
151,033
|
|
169,798
|
Total liabilities and
stockholders' equity
|
|
$ 1,810,440
|
|
$
1,841,511
|
Halozyme
Therapeutics, Inc
GAAP to Non-GAAP
Reconciliations
Net Income and
Diluted EPS
(Unaudited)
(In thousands,
except per share amounts)
|
|
|
|
Three Months
Ended
June
30,
|
|
|
2023
|
|
2022
|
GAAP Net
Income
|
|
$
74,754
|
|
$
22,685
|
Adjustments:
|
|
|
|
|
Share-based
compensation
|
|
9,622
|
|
5,635
|
Amortization of debt
discount
|
|
1,817
|
|
1,112
|
Amortization of
intangible assets
|
|
17,835
|
|
11,403
|
Transaction costs for
business combinations(1)
|
|
—
|
|
18,593
|
Severance and
share-based compensation acceleration
expense(2)
|
|
—
|
|
22,552
|
Amortization of
inventory step-up at fair value(3)
|
|
763
|
|
4,454
|
Realized loss from
marketable securities(4)
|
|
—
|
|
1,727
|
Income tax effect of
above adjustments(5)
|
|
(6,355)
|
|
(12,432)
|
Non-GAAP Net
Income
|
|
$
98,436
|
|
$
75,729
|
|
|
|
|
|
GAAP Diluted
EPS
|
|
$
0.56
|
|
$
0.16
|
Adjustments:
|
|
|
|
|
Share-based
compensation
|
|
0.07
|
|
0.04
|
Amortization of debt
discount
|
|
0.01
|
|
0.01
|
Amortization of
intangible assets
|
|
0.13
|
|
0.08
|
Transaction costs for
business combinations(1)
|
|
—
|
|
0.13
|
Severance and
share-based compensation acceleration
expense(2)
|
|
—
|
|
0.16
|
Amortization of
inventory step-up at fair value(3)
|
|
0.01
|
|
0.03
|
Realized loss from
marketable securities(4)
|
|
—
|
|
0.01
|
Income tax effect of
above adjustments(5)
|
|
(0.05)
|
|
(0.09)
|
Non-GAAP Diluted
EPS
|
|
$
0.74
|
|
$
0.53
|
|
|
|
|
|
GAAP & Non-GAAP
Diluted Shares
|
|
133,543
|
|
142,216
|
|
Dollar amounts, as
presented, are rounded. Consequently, totals may not add
up.
|
(1)
|
Amount represents
incremental costs including legal fees, accounting fees and
advisory fees incurred for the Antares acquisition.
|
(2)
|
Amount represents
severance cost and acceleration of unvested equity awards as part
of the Antares merger agreement.
|
(3)
|
Amounts relate to
amortization of the inventory step-up associated with purchase
accounting for the Antares acquisition.
|
(4)
|
Amount represents the
realized loss from the sale of our marketable securities to finance
the acquisition of Antares.
|
(5)
|
Adjustments relate to
taxes for the reconciling items, as well as excess benefits or tax
deficiencies from stock-based compensation, and the quarterly
impact of other discrete items.
|
Halozyme
Therapeutics, Inc
GAAP to Non-GAAP
Reconciliations
EBITDA
(Unaudited)
(In
thousands)
|
|
|
|
Three Months
Ended
June
30,
|
|
|
2023
|
|
2022
|
GAAP Net
Income
|
|
$
74,754
|
|
$
22,685
|
Adjustments:
|
|
|
|
|
Investment and other
income
|
|
(3,192)
|
|
945
|
Interest
expense
|
|
4,494
|
|
3,104
|
Income tax
expense
|
|
18,402
|
|
7,326
|
Depreciation and
amortization
|
|
20,628
|
|
12,546
|
EBITDA
|
|
115,086
|
|
46,606
|
Adjustments:
|
|
|
|
|
Transaction costs for
business combinations
|
|
—
|
|
18,593
|
Severance and
share-based compensation acceleration expense
|
|
—
|
|
22,552
|
Adjusted
EBITDA
|
|
$
115,086
|
|
$
87,751
|
Halozyme
Therapeutics, Inc.
GAAP to Non-GAAP
Reconciliations
EBITDA
(Unaudited)
(In
millions)
|
|
|
|
Twelve Months
Ended
December 31,
2022
|
|
2023 Guidance
Range
|
|
Percentage
Change
|
GAAP Net
Income
|
|
$
202
|
|
|
|
|
Adjustments:
|
|
|
|
|
|
|
Investment and other
income
|
|
(1)
|
|
|
|
|
Interest
expense
|
|
17
|
|
|
|
|
Income tax
expense
|
|
47
|
|
|
|
|
Depreciation and
amortization
|
|
50
|
|
|
|
|
EBITDA
|
|
315
|
|
$420 -
$440
|
|
33% -
40%
|
Adjustments:
|
|
|
|
|
|
|
Transaction costs for
business combinations
|
|
22
|
|
|
|
|
Severance and
share-based compensation acceleration expense
|
|
23
|
|
|
|
|
Adjusted
EBITDA
|
|
$
360
|
|
$420 -
$440
|
|
17% -
22%
|
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SOURCE Halozyme Therapeutics, Inc.