Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the
“Company”) today announced financial results for the three and six
months ended June 30, 2023.
“We delivered a strong second quarter with impressive earnings
and revenue, continuing the positive trajectory from an outstanding
18 months of business performance,” stated Scott Tarriff, President
and Chief Executive Officer of Eagle Pharmaceuticals. “Our marketed
drugs across oncology and our hospital business are performing
well. We’re particularly excited with the revenue ramp for
Barhemsys and Byfavo; our share of the commercial U.S. pemetrexed
market has more than tripled since the end of 2022, and Bendeka and
Belrapzo continue to outperform. In light of these and other
positive factors, which we believe reflect a broader continuation
of strength, we recently raised our full-year 2023 guidance and
resumed our share repurchase program.”
“Our expectation is that the growth that began in 2022 will
continue, and we have confidence that 2023 will be another great
year for Eagle,” stated Tarriff. “Going forward, we intend to build
on our sales momentum and also to leverage our commercial
infrastructure and working capital position to add complementary
products, either through R&D or acquisition.”
Recent Business Highlights:
- An estimated 19,000 patients were
dosed with Barhemsys or Byfavo during the second quarter of 2023,
and 275 health care facilities purchased the products out of a
total targeted market of approximately 4,000.2 Combined sales of
Barhemsys and Byfavo were $1.2 million, representing approximately
30% sequential growth for the last two quarters. A summary of the
sequential quarter sales growth for Barhemsys and Byfavo is
provided below:
- The Company completed the expansion
of its hospital and oncology commercial teams. Eagle believes the
new commercial infrastructure of approximately 80 people enables
the Company to bring in additional products, through R&D or
acquisition, with minimal additional commercialization costs.
- Eagle is scheduled to have a Type C
meeting with the U.S. Food and Drug Administration (FDA) in August
2023 for EA-114, its estrogen receptor antagonist product candidate
for the treatment of HR+/HER- advanced breast cancer.
- FDA granted Qualified Infectious
Disease Product (QIDP) Designation and Fast Track Designation for
CAL02, a novel first-in-class anti-toxin drug candidate, being
developed to treat severe community-acquired bacterial pneumonia
(SCABP) as an adjunctive therapy to standard of care, entitling
Eagle to an additional five years of marketing exclusivity upon
approval.
- First patients were randomized in a
multi-center adaptive, randomized, double-blind, placebo-controlled
Phase 2 study designed to assess the efficacy and safety of CAL02
administered intravenously in addition to standard of care in
patients with SCABP. The study plans to enroll approximately 276
patients at more than 100 sites in over 20 countries worldwide,
with 100 sites expected to be up by year-end in time for the
northern hemisphere’s pneumonia season. Depending upon recruitment
rates, Eagle anticipates having its 50% interim report around the
first half of 2024.
Second Quarter 2023 Financial Results
Total revenue for the second quarter of 2023, was $64.6 million,
as compared to $74.1 million for the second quarter of 2022.
Second quarter 2023 royalty revenue was $21.7 million, compared
to $24.9 million in the prior year quarter.
A summary of total revenue is outlined below:
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
(unaudited) |
|
(unaudited) |
|
(unaudited) |
|
(unaudited) |
|
Revenue (in thousands): |
|
|
|
|
|
|
|
|
Product sales, net |
$ |
42,993 |
|
|
$ |
49,201 |
|
|
$ |
89,214 |
|
|
$ |
139,289 |
|
Royalty revenue |
|
21,653 |
|
|
|
24,935 |
|
|
|
41,737 |
|
|
|
50,721 |
|
Total revenue |
$ |
64,646 |
|
|
$ |
74,136 |
|
|
$ |
130,951 |
|
|
$ |
190,010 |
|
|
|
|
|
|
|
|
|
|
Gross margin was 74% during the second quarter of 2023, compared
to 68% in the second quarter of 2022.
R&D expense was $9.8 million for the second quarter of 2023,
compared to $11.4 million for the second quarter of 2022. The
decrease was primarily due to lower spend on the Company’s EA-114
program, which was in a large-scale study during the second quarter
of 2022.
SG&A expenses in the second quarter of 2023 were $27.7
million compared to $36.8 million in the second quarter of 2022.
This decrease was driven largely by the non-recurrence of
Acacia-related acquisition costs and severance, partially offset by
higher personnel related costs given the Company’s expanded
hospital and oncology sales teams as well as higher selling and
marketing costs for Barhemsys and Byfavo.
Net income for the second quarter of 2023 was $5.2 million, or
$0.39 per basic and diluted share, compared to net loss of $(9.5)
million, or $(0.74) per basic and diluted share, in the second
quarter of 2022, primarily as a result of the factors discussed
above.
Adjusted non-GAAP net income for the second quarter of 2023 was
$15.5 million, or $1.18 per basic and diluted share, compared to
adjusted non-GAAP net income of $20.3 million, or $1.58 per basic
and $1.56 per diluted share, in the second quarter of 2022.
Adjusted non-GAAP EBITDA for the second quarter of 2023 was
$20.7 million, compared to adjusted non-GAAP EBITDA of $25.9
million in the second quarter of 2022.
2023 Full-Year Guidance
The Company reiterated its recently announced raised guidance as
follows:
- Adjusted non-GAAP EBITDA of $78.0-$84.0 million
- Adjusted non-GAAP earnings per share of $4.40-$4.70
- Adjusted non-GAAP R&D expense of $41.0-$45.0 million
- Adjusted non-GAAP SG&A expense of $86.0-$90.0 million
Liquidity
As of June 30, 2023, Eagle had $15.4 million in cash and cash
equivalents, $115.1 million in accounts receivable, net, and $71.3
million in outstanding debt on the Company’s $150.0 million credit
facility with JPMorgan. As of June 30, 2023, the Company had drawn
$25.0 million on its $100.0 million revolving credit facility,
which is included in outstanding debt.
As of June 30, 2023, Eagle had working capital of $100.6
million, after significant direct investment in R&D to fund the
Company’s promising product candidates, the acquisition of Acacia
Pharma Inc.’s outstanding shares and debt in 2022, and the purchase
of an equity stake in and option to acquire Enalare Therapeutics
Inc.
Conference Call
As previously announced, Eagle management will host its second
quarter 2023 conference call as follows:
Date |
Tuesday,
August 8, 2023 |
Time |
8:30 a.m. ET |
Toll free (U.S.) |
800-343-4136 |
International |
203-518-9814 |
Webcast (live and replay) |
www.eagleus.com, under the “Investor Relations” section |
A replay of the conference call will be available for two weeks
after the call's completion by dialing 800-839-9409 (U.S.) or
402-220-6088 (International) and entering conference call ID
EGRXQ223. The webcast will be archived for 30 days at the
aforementioned URL.
About Eagle Pharmaceuticals, Inc.
Eagle is a fully integrated pharmaceutical company with research
and development, clinical, manufacturing and commercial expertise.
Eagle is committed to developing innovative medicines that result
in meaningful improvements in patients’ lives. Eagle’s
commercialized products include PEMFEXY®, RYANODEX®, BENDEKA®,
BELRAPZO®, TREAKISYM® (Japan), and Byfavo® and Barhemsys® through
its wholly owned subsidiary Acacia Pharma Inc. Eagle’s oncology and
CNS/metabolic critical care pipeline includes product candidates
with the potential to address underserved therapeutic areas across
multiple disease states. Additional information is available on
Eagle’s website at www.eagleus.com.
Forward-Looking Statements This press release
contains “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995, as amended, and
other securities law. Forward-looking statements are statements
that are not historical facts. Words and phrases such as
“anticipated,” “forward,” “will,” “would,” “could,” “may,”
“remain,” “potential,” “prepare,” “expected,” “believe,” “plan,”
“near future,” “belief,” “guidance,” and similar expressions are
intended to identify forward-looking statements. These statements
include, but are not limited to, statements regarding the Company’s
financial projections and guidance, including anticipated financial
performance for 2023, including expected adjusted EBITDA, adjusted
non-GAAP earnings per share, adjusted non-GAAP R&D expense and
adjusted non-GAAP SG&A expense; the Company’s expectations for
the design and timing of clinical trials and studies, including
with respect to enrollment, site selection, data meetings with
regulatory agencies, and the timing thereof; statements regarding
potential regulatory exclusivity; statements regarding the
Company’s expectations with respect to building on its sales
momentum leveraging its commercial infrastructure and working
capital position to add complementary products, either through
R&D or acquisition; and the potential of the Company’s pipeline
and product candidates to address underserved therapeutic areas
across multiple disease states. All of such statements are subject
to certain risks and uncertainties, many of which are difficult to
predict and generally beyond the Company’s control, that could
cause actual results to differ materially from those expressed in,
or implied or projected by, the forward-looking information and
statements. Such risks and uncertainties include, but are not
limited to: the impacts of the post- COVID-19 environment and
geopolitical factors such as the conflict in Ukraine; delay in or
failure to obtain regulatory approval of the Company's or its
partners’ product candidates and successful compliance with FDA,
European Medicines Agency and other governmental regulations
applicable to product approvals; changes in the regulatory
environment; the uncertainties and timing of the regulatory
approval process; whether the Company can successfully market and
commercialize its product candidates; the success of the Company's
relationships with its partners; the outcome of litigation
involving any of its products or that may have an impact on any of
its products; the strength and enforceability of the Company’s
intellectual property rights or the rights of third parties;
competition from other pharmaceutical and biotechnology companies
and the potential for competition from generic entrants into the
market; unexpected safety or efficacy data observed during clinical
trials; clinical trial site activation or enrollment rates that are
lower than expected; the risks inherent in drug development and in
conducting clinical trials; unanticipated factors in addition to
the foregoing that may impact the Company’s financial and business
projections and guidance and may cause the Company’s actual results
and outcomes to materially differ from its projections and
guidance; and those risks and uncertainties identified in the “Risk
Factors” sections of the Company's Annual Report on Form 10-K for
the year ended December 31, 2022, filed with the Securities and
Exchange Commission (the “SEC”) on March 23, 2023, the Company’s
Quarterly Reports on Form 10-Q for the quarter ended March 31, 2023
and its other subsequent filings with the SEC, including the
Company’s Quarterly Report on Form 10-Q for the quarter ended June
30, 2023. Readers are cautioned not to place undue reliance on
these forward-looking statements. All forward-looking statements
contained in this press release speak only as of the date on which
they were made. Except to the extent required by law, the Company
undertakes no obligation to update such statements to reflect
events that occur or circumstances that exist after the date on
which they were made.
Non-GAAP Financial Performance Measures
In addition to financial information prepared in accordance with
U.S. GAAP, this press release contains non-GAAP financial measures,
including adjusted non-GAAP net income, adjusted non-GAAP EBITDA,
adjusted non-GAAP earnings per share, adjusted non-GAAP gross
margin, adjusted non-GAAP gross profit, adjusted non-GAAP R&D
expense and adjusted non-GAAP SG&A expense. The Company
believes these measures provide investors and management with
supplemental information relating to operating performance and
trends that facilitate comparisons between periods and with respect
to projected information.
Adjusted non-GAAP net income and related earnings per share
information excludes amortization expense, stock-based compensation
expense, depreciation expense, severance expense, non-cash interest
expense, fair value adjustments on equity investment, fair value
adjustments related to derivative instruments, foreign currency
exchange gain or loss, amortization of inventory step-up,
acquisition related costs, legal settlement, convertible promissory
note related adjustments, and the tax effect of these
adjustments.
Adjusted non-GAAP EBITDA excludes interest expense net of
interest income, income tax provision, depreciation and
amortization expense, stock-based compensation expense, fair value
adjustments on equity investment, convertible promissory note
related adjustments, fair value adjustments related to derivative
instruments, foreign currency exchange gain or loss, gain on Euro
debt, legal settlement, acquisition related costs, debt issuance
cost, and severance expense.
Adjusted non-GAAP Gross Profit excludes amortization expense and
amortization of inventory step-up.
Adjusted non-GAAP R&D expense excludes stock-based
compensation expense, depreciation expense and severance
expense.
Adjusted non-GAAP SG&A expense excludes stock-based
compensation expense, depreciation expense, severance expense,
acquisition related costs, and legal settlement.
The Company believes the use of non-GAAP financial measures
helps indicate underlying trends in the Company’s business and are
important in comparing current results with prior period results
and understanding projected operating performance. Non-GAAP
financial measures provide the Company and its investors with an
indication of the Company’s baseline performance before items that
are considered by the Company not to be reflective of the Company’s
ongoing results. See the attached reconciliation tables for details
of the amounts excluded and included to arrive at certain of the
non-GAAP financial measures for historical periods.
Investors should note that reconciliations of the
forward-looking or projected non-GAAP financial measures included
in this press release to their most comparable GAAP financial
measures cannot be provided because the Company cannot do so
without unreasonable efforts due to the unavailability of
information needed to calculate the reconciling items and the
variability, complexity, and limited visibility of comparable GAAP
measures, and the reconciling items that would be excluded from the
non-GAAP financial measures in the future. Likewise, the Company is
unable to provide projected GAAP financial measures. GAAP
projections and reconciliations of the components of projected
adjusted non-GAAP EBITDA, adjusted non-GAAP R&D expenses,
adjusted non-GAAP SG&A expenses and adjusted non-GAAP earning
per share to their most comparable GAAP financial measures are not
provided because the quantification of projected GAAP R&D
expenses, SG&A expenses, net income and earnings per share and
the reconciling items between projected GAAP to adjusted non-GAAP
EBITDA, adjusted non-GAAP R&D expenses, adjusted non-GAAP
SG&A expenses and adjusted non-GAAP earnings per share cannot
be reasonably calculated or predicted at this time without
unreasonable efforts. For example, with respect to GAAP net income
and R&D Expense, the Company is not able to calculate the
favorable or unfavorable expenses related to the fair value
adjustments on equity investments and derivative instruments
primarily due to nature of these transactions. Such unavailable
information could be significant such that actual GAAP net income,
R&D expenses, SG&A expenses and earnings per share would
vary significantly from projected GAAP and adjusted non-GAAP
EBITDA, adjusted non-GAAP R&D expenses, adjusted non-GAAP
SG&A expenses and adjusted non-GAAP earnings per share.
These non-GAAP financial measures should be considered in
addition to, but not as a substitute for, the information prepared
in accordance with U.S. GAAP. 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 has
ceased, and may in the future cease, to exclude items that it has
historically excluded for purposes of its non-GAAP financial
measures. For example, commencing in 2023, the Company no longer
excludes expense of acquired in-process research & development
from the Company’s adjusted non-GAAP net income or adjusted
non-GAAP EBITDA, their line item components, and non-GAAP earnings
per share. For purposes of comparability, non-GAAP adjusted
financial measures for the three and six months ended June 30, 2022
have been updated to reflect this change. Accordingly, such
expenses are not excluded from the Company’s non-GAAP financial
measures for the three and six months ended June 30, 2023 and 2022,
as detailed in the reconciliation tables that follow, or from 2023
non-GAAP adjusted net income and adjusted non-GAAP earnings per
share guidance. Likewise, the Company may determine to modify the
nature of its adjustments to arrive at its non-GAAP financial
measures. The Company strongly encourages investors to review its
consolidated financial statements and publicly-filed reports in
their entirety and cautions investors that the non-GAAP financial
measures used by the Company may differ from similar measures used
by other companies, even when similar terms are used to identify
such measures.
Investor Relations for Eagle Pharmaceuticals,
Inc.:
Lisa M. WilsonIn-Site Communications, Inc. T: 212-452-2793 E:
lwilson@insitecony.com
Public Relations for Eagle Pharmaceuticals,
Inc.:Faith Pomeroy-WardT: 817-807-8044E:
faith@eagleus.com
EAGLE
PHARMACEUTICALS, INC. |
|
CONDENSED
CONSOLIDATED BALANCE SHEETS (UNAUDITED) |
|
(In
thousands, except share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2023 |
|
December 31, 2022 |
|
ASSETS |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
$ |
15,354 |
|
|
$ |
55,321 |
|
|
Accounts
receivable, net |
|
115,140 |
|
|
|
72,439 |
|
|
Inventories |
|
42,482 |
|
|
|
47,794 |
|
|
Prepaid
expenses and other current assets |
|
14,274 |
|
|
|
13,200 |
|
|
Total current assets |
|
187,250 |
|
|
|
188,754 |
|
|
Property and
equipment, net |
|
1,013 |
|
|
|
1,168 |
|
|
Intangible
assets, net |
|
107,406 |
|
|
|
118,327 |
|
|
Goodwill |
|
45,033 |
|
|
|
45,033 |
|
|
Deferred tax
asset, net |
|
30,715 |
|
|
|
27,146 |
|
|
Other
assets |
|
33,405 |
|
|
|
25,732 |
|
|
Total assets |
$ |
404,822 |
|
|
$ |
406,160 |
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts
payable |
$ |
15,843 |
|
|
$ |
18,993 |
|
|
Accrued
expenses and other liabilities |
|
62,490 |
|
|
|
85,844 |
|
|
Short-term
debt, net |
|
8,297 |
|
|
|
6,250 |
|
|
Total current liabilities |
|
86,630 |
|
|
|
111,087 |
|
|
Long-term
debt, net |
|
61,896 |
|
|
|
56,216 |
|
|
Other
long-term liabilities |
|
4,256 |
|
|
|
5,297 |
|
|
Total liabilities |
|
152,782 |
|
|
|
172,600 |
|
|
Commitments and Contingencies |
|
|
|
|
Stockholders' equity: |
|
|
|
|
Preferred
stock, 1,500,000 shares authorized and no shares issued or
outstanding as of June 30, 2023 and December 31, 2022 |
|
— |
|
|
|
— |
|
|
Common
stock, $0.001 par value; 50,000,000 shares authorized; 17,647,390
and 17,569,375 shares issued as of June 30, 2023 and December 31,
2022, respectively |
|
18 |
|
|
|
18 |
|
|
Additional
paid in capital |
|
373,831 |
|
|
|
366,265 |
|
|
Accumulated
other comprehensive (loss) |
|
(1,112 |
) |
|
|
(1,112 |
) |
|
Retained
earnings |
|
122,418 |
|
|
|
111,504 |
|
|
Treasury
stock, at cost, 4,552,730 and 4,552,730 shares as of June 30, 2023
and December 31, 2022, respectively |
|
(243,115 |
) |
|
|
(243,115 |
) |
|
Total stockholders' equity |
|
252,040 |
|
|
|
233,560 |
|
|
Total liabilities and stockholders' equity |
$ |
404,822 |
|
|
$ |
406,160 |
|
|
|
|
|
|
|
EAGLE
PHARMACEUTICALS, INC. |
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) |
|
(In
thousands, except share and per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
Six Months Ended June 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales, net |
$ |
42,993 |
|
|
$ |
49,201 |
|
|
$ |
89,214 |
|
|
$ |
139,289 |
|
|
Royalty revenue |
|
21,653 |
|
|
|
24,935 |
|
|
|
41,737 |
|
|
|
50,721 |
|
|
Total revenue |
|
64,646 |
|
|
|
74,136 |
|
|
|
130,951 |
|
|
|
190,010 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product sales |
|
16,858 |
|
|
|
21,171 |
|
|
|
34,158 |
|
|
|
46,347 |
|
|
Cost of royalty revenue |
|
— |
|
|
|
2,493 |
|
|
|
— |
|
|
|
5,072 |
|
|
Research and development |
|
9,833 |
|
|
|
11,437 |
|
|
|
19,105 |
|
|
|
17,545 |
|
|
Selling, general and administrative |
|
27,651 |
|
|
|
36,832 |
|
|
|
55,611 |
|
|
|
59,014 |
|
|
Total operating expenses |
|
54,342 |
|
|
|
71,933 |
|
|
|
108,874 |
|
|
|
127,978 |
|
|
Income from operations |
|
10,304 |
|
|
|
2,203 |
|
|
|
22,077 |
|
|
|
62,032 |
|
|
Interest income |
|
195 |
|
|
|
244 |
|
|
|
407 |
|
|
|
398 |
|
|
Interest expense |
|
(1,448 |
) |
|
|
(552 |
) |
|
|
(2,964 |
) |
|
|
(918 |
) |
|
Other income (expense), net |
|
247 |
|
|
|
(7,763 |
) |
|
|
9 |
|
|
|
(9,720 |
) |
|
Total other expense, net |
|
(1,006 |
) |
|
|
(8,071 |
) |
|
|
(2,548 |
) |
|
|
(10,240 |
) |
|
Income (loss) before income tax provision |
|
9,298 |
|
|
|
(5,868 |
) |
|
|
19,529 |
|
|
|
51,792 |
|
|
Income tax provision |
|
(4,134 |
) |
|
|
(3,582 |
) |
|
|
(8,615 |
) |
|
|
(17,184 |
) |
|
Net income (loss) |
$ |
5,164 |
|
|
$ |
(9,450 |
) |
|
$ |
10,914 |
|
|
$ |
34,608 |
|
|
Earnings (loss) per share attributable to common stockholders: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
$ |
0.39 |
|
|
$ |
(0.74 |
) |
|
$ |
0.83 |
|
|
$ |
2.71 |
|
|
Diluted |
$ |
0.39 |
|
|
$ |
(0.74 |
) |
|
$ |
0.83 |
|
|
$ |
2.67 |
|
|
Weighted average number of common shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
13,090,852 |
|
|
|
12,836,116 |
|
|
|
13,075,090 |
|
|
|
12,773,727 |
|
|
Diluted |
|
13,154,599 |
|
|
|
12,836,116 |
|
|
|
13,151,107 |
|
|
|
12,951,788 |
|
|
|
|
|
|
|
|
EAGLE
PHARMACEUTICALS, INC. |
|
RECONCILIATION OF GAAP NET INCOME (LOSS) TO ADJUSTED
NON-GAAP NET INCOME AND |
|
GAAP
EARNINGS PER SHARE TO ADJUSTED NON-GAAP EARNINGS PER SHARE
(UNAUDITED) |
|
(In
thousands, except share and per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
Net income (loss) - GAAP |
$ |
5,164 |
|
|
$ |
(9,450 |
) |
|
$ |
10,914 |
|
|
$ |
34,608 |
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments: |
|
|
|
|
|
|
|
|
Cost of product revenues: |
|
|
|
|
|
|
|
|
|
Amortization
expense |
|
5,459 |
|
|
|
1,466 |
|
|
|
10,901 |
|
|
|
2,197 |
|
|
|
Amortization
of inventory step-up |
|
416 |
|
|
|
— |
|
|
|
736 |
|
|
|
— |
|
|
Research and development: |
|
|
|
|
|
|
|
|
|
Stock-based
compensation expense |
|
527 |
|
|
|
601 |
|
|
|
1,214 |
|
|
|
1,244 |
|
|
|
Depreciation
expense |
|
32 |
|
|
|
44 |
|
|
|
62 |
|
|
|
92 |
|
|
|
Severance |
|
44 |
|
|
|
— |
|
|
|
44 |
|
|
|
— |
|
|
Selling, general and administrative: |
|
|
|
|
|
|
|
|
|
Stock-based
compensation expense |
|
3,665 |
|
|
|
3,899 |
|
|
|
7,617 |
|
|
|
7,551 |
|
|
|
Depreciation
expense |
|
77 |
|
|
|
124 |
|
|
|
157 |
|
|
|
253 |
|
|
|
Severance |
|
154 |
|
|
|
7,742 |
|
|
|
197 |
|
|
|
7,791 |
|
|
|
Acquisition
related costs |
|
— |
|
|
|
9,849 |
|
|
|
— |
|
|
|
11,339 |
|
|
|
Legal
settlement |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
300 |
|
|
Other: |
|
|
|
|
|
|
|
|
|
Non-cash
interest expense |
|
115 |
|
|
|
278 |
|
|
|
237 |
|
|
|
396 |
|
|
|
Fair value
adjustments on equity investment |
|
(210 |
) |
|
|
700 |
|
|
|
193 |
|
|
|
3,230 |
|
|
|
Convertible
promissory note related adjustments |
|
— |
|
|
|
(19 |
) |
|
|
— |
|
|
|
(28 |
) |
|
|
Fair value
adjustments related to derivative instruments |
|
— |
|
|
|
6,239 |
|
|
|
(77 |
) |
|
|
5,631 |
|
|
|
Foreign
currency exchange (gain) loss |
|
(35 |
) |
|
|
798 |
|
|
|
(125 |
) |
|
|
798 |
|
|
Tax effect of the non-GAAP adjustments |
|
91 |
|
|
|
(1,956 |
) |
|
|
(35 |
) |
|
|
(2,935 |
) |
|
Adjusted non-GAAP net income |
$ |
15,499 |
|
|
$ |
20,315 |
|
|
$ |
32,035 |
|
|
$ |
72,467 |
|
|
|
|
|
|
|
|
|
|
|
|
Earnings (loss) per share: |
|
|
|
|
|
|
|
|
Basic |
$ |
0.39 |
|
|
$ |
(0.74 |
) |
|
$ |
0.83 |
|
|
$ |
2.71 |
|
|
Diluted |
$ |
0.39 |
|
|
$ |
(0.74 |
) |
|
$ |
0.83 |
|
|
$ |
2.67 |
|
|
Weighted average number of common shares outstanding: |
|
|
|
|
|
|
|
|
Basic |
|
13,090,852 |
|
|
|
12,836,116 |
|
|
|
13,075,090 |
|
|
|
12,773,727 |
|
|
Diluted |
|
13,154,599 |
|
|
|
12,836,116 |
|
|
|
13,151,107 |
|
|
|
12,951,788 |
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted non-GAAP earnings per share: |
|
|
|
|
|
|
|
|
Basic |
$ |
1.18 |
|
|
$ |
1.58 |
|
|
$ |
2.45 |
|
|
$ |
5.67 |
|
|
Diluted |
$ |
1.18 |
|
|
$ |
1.56 |
|
|
$ |
2.44 |
|
|
$ |
5.60 |
|
|
Weighted average number of common shares outstanding: |
|
|
|
|
|
|
|
|
Basic |
|
13,090,852 |
|
|
|
12,836,116 |
|
|
|
13,075,090 |
|
|
|
12,773,727 |
|
|
Diluted |
|
13,154,599 |
|
|
|
12,997,602 |
|
|
|
13,151,107 |
|
|
|
12,951,788 |
|
|
|
|
|
|
|
|
|
|
|
|
EAGLE
PHARMACEUTICALS, INC. |
|
RECONCILIATION OF GAAP NET INCOME (LOSS) TO ADJUSTED
NON-GAAP EBITDA (UNAUDITED) |
|
(In
thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
Twelve Months Ended June 30, |
|
Twelve Months Ended December 31, |
|
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
2023 |
|
|
|
2022 |
|
|
Net income (loss) - GAAP |
$ |
5,164 |
|
|
$ |
(9,450 |
) |
|
$ |
10,914 |
|
|
$ |
34,608 |
|
$ |
11,948 |
|
|
$ |
35,642 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Add back: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
expense, net of interest income |
|
1,253 |
|
|
|
308 |
|
|
|
2,557 |
|
|
|
520 |
|
|
5,811 |
|
|
|
3,774 |
|
|
|
Income tax
provision |
|
4,134 |
|
|
|
3,582 |
|
|
|
8,615 |
|
|
|
17,184 |
|
|
17,222 |
|
|
|
25,791 |
|
|
|
Depreciation
and amortization expense |
|
5,984 |
|
|
|
1,634 |
|
|
|
11,856 |
|
|
|
2,542 |
|
|
21,884 |
|
|
|
12,570 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Add back: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation expense |
|
4,192 |
|
|
|
4,500 |
|
|
|
8,831 |
|
|
|
8,795 |
|
|
16,487 |
|
|
|
16,451 |
|
|
|
Fair value
adjustments on equity investment |
|
(210 |
) |
|
|
700 |
|
|
|
193 |
|
|
|
3,230 |
|
|
1,420 |
|
|
|
4,457 |
|
|
|
Convertible
promissory note related adjustments |
|
— |
|
|
|
26 |
|
|
|
— |
|
|
|
62 |
|
|
4,180 |
|
|
|
4,242 |
|
|
|
Fair value
adjustments related to derivative instrument |
|
— |
|
|
|
6,239 |
|
|
|
(77 |
) |
|
|
5,631 |
|
|
2,257 |
|
|
|
7,965 |
|
|
|
Foreign
currency exchange (gain) loss |
|
(35 |
) |
|
|
798 |
|
|
|
(125 |
) |
|
|
798 |
|
|
(1,570 |
) |
|
|
(647 |
) |
|
|
Gain on euro
debt |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
(264 |
) |
|
|
(264 |
) |
|
|
Legal
settlement |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
300 |
|
|
— |
|
|
|
300 |
|
|
|
Acquisition
related costs |
|
— |
|
|
|
9,849 |
|
|
|
— |
|
|
|
11,339 |
|
|
1,783 |
|
|
|
13,122 |
|
|
|
Debt
issuance cost |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
258 |
|
|
|
258 |
|
|
|
Severance |
|
198 |
|
|
|
7,742 |
|
|
|
241 |
|
|
|
7,791 |
|
|
901 |
|
|
|
8,451 |
|
|
Adjusted Non-GAAP EBITDA |
$ |
20,680 |
|
|
$ |
25,928 |
|
|
$ |
43,005 |
|
|
$ |
92,800 |
|
$ |
82,317 |
|
|
$ |
132,112 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EAGLE
PHARMACEUTICALS, INC. |
RECONCILIATION OF GAAP RESEARCH AND DEVELOPMENT
AND |
SELLING,
GENERAL AND ADMINISTRATIVE TO ADJUSTED NON-GAAP
RESEARCH |
AND
DEVELOPMENT AND SELLING, GENERAL AND ADMINISTRATIVE
(UNAUDITED) |
(In
thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Research and development - GAAP |
$ |
9,833 |
|
$ |
11,437 |
|
$ |
19,105 |
|
$ |
17,545 |
|
Add back: |
|
|
|
|
|
|
|
|
Stock-based
compensation expense |
|
527 |
|
|
601 |
|
|
1,214 |
|
|
1,244 |
|
|
Depreciation
expense |
|
32 |
|
|
44 |
|
|
62 |
|
|
92 |
|
|
Severance |
|
44 |
|
|
— |
|
|
44 |
|
|
— |
|
Research and development - Non-GAAP |
$ |
9,230 |
|
$ |
10,792 |
|
$ |
17,785 |
|
$ |
16,209 |
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Selling, general and administrative - GAAP |
$ |
27,651 |
|
$ |
36,832 |
|
$ |
55,611 |
|
$ |
59,014 |
|
Add back: |
|
|
|
|
|
|
|
|
Stock-based
compensation expense |
|
3,665 |
|
|
3,899 |
|
|
7,617 |
|
|
7,551 |
|
|
Depreciation
expense |
|
77 |
|
|
124 |
|
|
157 |
|
|
253 |
|
|
Severance |
|
154 |
|
|
7,742 |
|
|
197 |
|
|
7,791 |
|
|
Acquisition
related costs |
|
— |
|
|
9,849 |
|
|
— |
|
|
11,339 |
|
|
Legal
settlement |
|
— |
|
|
— |
|
|
— |
|
|
300 |
|
Selling, general and administrative - Non-GAAP |
$ |
23,755 |
|
$ |
15,218 |
|
$ |
47,640 |
|
$ |
31,780 |
|
|
|
|
|
|
|
|
|
|
EAGLE
PHARMACEUTICALS, INC. |
|
RECONCILIATION OF GAAP GROSS PROFIT TO |
|
ADJUSTED
NON-GAAP GROSS PROFIT (UNAUDITED) |
|
(In
thousands) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenue: |
|
|
|
|
|
|
|
|
Product sales, net |
$ |
42,993 |
|
$ |
49,201 |
|
$ |
89,214 |
|
$ |
139,289 |
|
Royalty revenue |
|
21,653 |
|
|
24,935 |
|
|
41,737 |
|
|
50,721 |
|
Total revenue |
$ |
64,646 |
|
$ |
74,136 |
|
$ |
130,951 |
|
$ |
190,010 |
|
Cost of product sales |
|
16,858 |
|
|
21,171 |
|
|
34,158 |
|
|
46,347 |
|
Cost of royalty revenue |
|
— |
|
|
2,493 |
|
|
— |
|
|
5,072 |
|
Gross Profit |
$ |
47,788 |
|
$ |
50,472 |
|
$ |
96,793 |
|
$ |
138,591 |
|
Adjustments: |
|
|
|
|
|
|
|
|
Cost of
product revenues: |
|
|
|
|
|
|
|
|
Amortization expense |
|
5,459 |
|
|
1,466 |
|
|
10,901 |
|
|
2,197 |
|
Amortization of inventory step-up |
|
416 |
|
|
— |
|
|
736 |
|
|
— |
|
Adjusted Non-GAAP Gross Profit |
$ |
53,663 |
|
$ |
51,938 |
|
$ |
108,430 |
|
$ |
140,788 |
|
|
|
|
|
|
|
|
|
|
EAGLE
PHARMACEUTICALS, INC. |
|
RECONCILIATION OF GAAP ONCOLOGY GROSS PROFIT
TO |
|
ADJUSTED
ONCOLOGY NON-GAAP GROSS PROFIT (UNAUDITED) |
|
(In
thousands) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenue: |
|
|
|
|
|
|
|
|
PEMFEXYTM |
$ |
19,400 |
|
$ |
16,504 |
|
$ |
42,348 |
|
$ |
53,686 |
|
BELRAPZO® |
|
6,848 |
|
|
8,131 |
|
|
13,198 |
|
|
14,080 |
|
BENDEKA® |
|
3,780 |
|
|
3,497 |
|
|
6,174 |
|
|
8,050 |
|
TREAKISYM |
|
728 |
|
|
812 |
|
|
2,083 |
|
|
2,266 |
|
Oncology product sales, net |
$ |
30,756 |
|
$ |
28,944 |
|
$ |
63,803 |
|
$ |
78,082 |
|
|
|
|
|
|
|
|
|
|
BENDEKA® |
|
20,485 |
|
|
22,969 |
|
|
39,380 |
|
|
46,792 |
|
TREAKISYM |
|
1,168 |
|
|
1,966 |
|
|
2,357 |
|
|
3,929 |
|
Oncology royalty revenue |
$ |
21,653 |
|
$ |
24,935 |
|
$ |
41,737 |
|
$ |
50,721 |
|
|
|
|
|
|
|
|
|
|
Oncology Total Revenue |
$ |
52,409 |
|
$ |
53,879 |
|
$ |
105,540 |
|
$ |
128,803 |
|
|
|
|
|
|
|
|
|
|
Oncology cost of product sales |
|
10,466 |
|
|
12,653 |
|
|
20,146 |
|
|
25,340 |
|
Oncology cost of royalty revenue |
|
— |
|
|
2,493 |
|
|
— |
|
|
5,072 |
|
Oncology Gross Profit |
$ |
41,943 |
|
$ |
38,733 |
|
$ |
85,394 |
|
$ |
98,391 |
|
Adjustments: |
|
|
|
|
|
|
|
|
Oncology cost of product revenues: |
|
|
|
|
|
|
|
|
Oncology amortization expense |
|
1,867 |
|
|
— |
|
|
3,714 |
|
|
— |
|
Adjusted Oncology Non-GAAP Gross Profit |
$ |
43,810 |
|
$ |
38,733 |
|
$ |
89,108 |
|
$ |
98,391 |
|
|
|
|
|
|
|
|
|
|
Important Safety Information for
BARHEMSYS®
(amisulpride)4
Injection
Contraindication
BARHEMSYS is contraindicated in patients with known
hypersensitivity to amisulpride.
QT Prolongation
BARHEMSYS causes dose- and concentration-dependent prolongation
of the QT interval. The recommended dosage is 5 mg or 10 mg as a
single intravenous (IV) dose infused over 1 to 2 minutes.
Avoid BARHEMSYS in patients with congenital long QT syndrome and
in patients taking droperidol.
Electrocardiogram (ECG) monitoring is recommended in patients
with pre-existing arrhythmias/cardiac conduction disorders,
electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia),
congestive heart failure, and in patients taking other medicinal
products (e.g., ondansetron) or with other medical conditions known
to prolong the QT interval.
Adverse Reactions
Common adverse reactions reported in ≥ 2% of adult patients who
received BARHEMSYS 5 mg (n=748) and at a higher rate than placebo
(n=741) in clinical trials for the prevention of PONV were: chills
(4% vs. 3%), hypokalemia (4% vs. 2%), procedural hypotension (3%
vs. 2%), and abdominal distention (2% vs. 1%).
Serum prolactin concentrations were measured in one prophylaxis
study where 5% (9/176) of BARHEMSYS-treated patients had increased
blood prolactin reported as an adverse reaction compared with 1%
(1/166) of placebo-treated patients.
The most common adverse reaction, reported in ≥ 2% of adult
patients who received BARHEMSYS 10 mg (n=418) and at a higher rate
than placebo (n=416), in clinical trials for the treatment of PONV
was infusion site pain (6% vs. 4%).
Use in Specific Populations
Lactation
Amisulpride is present in human milk. There are no reports of
adverse effects on the breastfed child and no information on the
effects of amisulpride on milk production.
BARHEMSYS may result in an increase in serum prolactin levels,
which may lead to a reversible increase in maternal milk
production. In a clinical trial, serum prolactin concentrations in
females (n=112) increased from a mean of 10 ng/mL at baseline to 32
ng/mL after BARHEMSYS treatment and from 10 ng/mL to 19 ng/mL in
males (n=61). No clinical consequences due to elevated prolactin
levels were reported.
To minimize exposure to a breastfed infant, lactating women may
consider interrupting breastfeeding and pumping and discarding
breast milk for 48 hours after receiving a dose of BARHEMSYS.
Pediatric Use
Safety and effectiveness in pediatric patients have not been
established.
Geriatric Use
No overall differences in safety or effectiveness were observed
between these patients and younger patients, and other reported
clinical experience has not identified differences in responses
between the elderly and younger patients, but greater sensitivity
of some older individuals cannot be ruled out.
Renal Impairment
Avoid BARHEMSYS in patients with severe renal impairment
(estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73
m2). The pharmacokinetics of amisulpride in patients with severe
renal impairment have not been adequately studied in clinical
trials. Amisulpride is known to be substantially excreted by the
kidneys, and patients with severe renal impairment may have
increased systemic exposure and an increased risk of adverse
reactions.
No dosage adjustment is necessary in patients with mild to
moderate renal impairment
(eGFR ≥ 30 mL/min/1.73 m2).
Drug Interactions
- BARHEMSYS causes dose- and
concentration-dependent QT prolongation. To avoid potential
additive effects, avoid use of BARHEMSYS in patients taking
droperidol.
- ECG monitoring is recommended in
patients taking other drugs known to prolong the QT interval (e.g.,
ondansetron).
- Reciprocal antagonism of effects
occurs between dopamine agonists (e.g., levodopa) and BARHEMSYS.
Avoid using levodopa with BARHEMSYS.
Important Safety Information for
BYFAVO™ (remimazolam)5
Injection
Indications
BYFAVO is a benzodiazepine indicated for the induction and
maintenance of procedural sedation in adults undergoing procedures
lasting 30 minutes or less.
Important Safety Information
WARNING: PERSONNEL AND EQUIPMENT FOR MONITORING AND
RESUSCITATION AND RISKS FROM CONCOMITANT USE WITH OPIOID
ANALGESICS
Personnel and Equipment for Monitoring and
Resuscitation
- Only
personnel trained in the administration of procedural sedation, and
not involved in the conduct of the diagnostic or therapeutic
procedure, should administer BYFAVO.
-
Administering personnel must be trained in the detection
and management of airway obstruction, hypoventilation, and apnea,
including the maintenance of a patent airway, supportive
ventilation, and cardiovascular resuscitation.
- BYFAVO has
been associated with hypoxia, bradycardia, and hypotension.
Continuously monitor vital signs during sedation and during the
recovery period.
-
Resuscitative drugs, and age- and size-appropriate
equipment for bag-valve-mask–assisted ventilation must be
immediately available during administration of
BYFAVO.
Risks From Concomitant Use With Opioid Analgesics and
Other Sedative-Hypnotics
Concomitant use of benzodiazepines, including BYFAVO,
and opioid analgesics may result in profound sedation, respiratory
depression, coma, and death. The sedative effect of intravenous
BYFAVO can be accentuated by concomitantly administered CNS
depressant medications, including other benzodiazepines and
propofol. Continuously monitor patients for respiratory depression
and depth of sedation.
Contraindication
BYFAVO is contraindicated in patients with a history of severe
hypersensitivity reaction to dextran 40 or products containing
dextran 40.
Personnel and Equipment for Monitoring and
Resuscitation
Clinically notable hypoxia, bradycardia, and hypotension were
observed in Phase 3 studies of BYFAVO. Continuously monitor vital
signs during sedation and through the recovery period. Only
personnel trained in the administration of procedural sedation, and
not involved in the conduct of the diagnostic or therapeutic
procedure, should administer BYFAVO. Administering personnel must
be trained in the detection and management of airway obstruction,
hypoventilation, and apnea, including the maintenance of a patent
airway, supportive ventilation, and cardiovascular resuscitation.
Resuscitative drugs, and age- and size-appropriate equipment for
bag-valve-mask–assisted ventilation must be immediately available
during administration of BYFAVO. Consider the potential for
worsened cardiorespiratory depression prior to using BYFAVO
concomitantly with other drugs that have the same potential (e.g.,
opioid analgesics or other sedative-hypnotics). Administer
supplemental oxygen to sedated patients through the recovery
period. A benzodiazepine reversal agent (flumazenil) should be
immediately available during administration of BYFAVO.
Risks From Concomitant Use With Opioid Analgesics and
Other Sedative-Hypnotics
Concomitant use of BYFAVO and opioid analgesics may result in
profound sedation, respiratory depression, coma, and death. The
sedative effect of IV BYFAVO can be accentuated when administered
with other CNS depressant medications (eg, other benzodiazepines
and propofol). Titrate the dose of BYFAVO when administered with
opioid analgesics and sedative-hypnotics to the desired clinical
response. Continuously monitor sedated patients for hypotension,
airway obstruction, hypoventilation, apnea, and oxygen
desaturation. These cardiorespiratory effects may be more likely to
occur in patients with obstructive sleep apnea, the elderly, and
ASA-PS class III or IV patients.
Hypersensitivity Reactions
BYFAVO contains dextran 40, which can cause hypersensitivity
reactions, including rash, urticaria, pruritus, and anaphylaxis.
BYFAVO is contraindicated in patients with a history of severe
hypersensitivity reaction to dextran 40 or products containing
dextran 40.
Neonatal Sedation
Use of benzodiazepines during the later stages of pregnancy can
result in sedation (respiratory depression, lethargy, hypotonia) in
the neonate. Observe newborns for signs of sedation and manage
accordingly.
Pediatric Neurotoxicity
Published animal studies demonstrate that anesthetic and
sedation drugs that block NMDA receptors and/or potentiate GABA
activity increase neuronal apoptosis in the developing brain and
result in long-term cognitive deficits when used for longer than 3
hours. The clinical significance of this is not clear. However, the
window of vulnerability to these changes is believed to correlate
with exposures in the third trimester of gestation through the
first several months of life but may extend out to approximately 3
years of age in humans.
Anesthetic and sedation drugs are a necessary part of the care
of children needing surgery, other procedures, or tests that cannot
be delayed, and no specific medications have been shown to be safer
than any other. Decisions regarding the timing of any elective
procedures requiring anesthesia should take into consideration the
benefits of the procedure weighed against the potential risks.
Adverse Reactions
The most common adverse reactions reported in >10% of
patients (N=630) receiving BYFAVO 5-30 mg (total dose) and
undergoing colonoscopy (two studies) or bronchoscopy (one study)
were: hypotension, hypertension, diastolic hypertension, systolic
hypertension, hypoxia, and diastolic hypotension.
Use in Specific Populations
Pregnancy
There are no data on the specific effects of BYFAVO on
pregnancy. Benzodiazepines cross the placenta and may produce
respiratory depression and sedation in neonates. Monitor neonates
exposed to benzodiazepines during pregnancy and labor for signs of
sedation and respiratory depression.
Lactation
Monitor infants exposed to BYFAVO through breast milk for
sedation, respiratory depression, and feeding problems. A lactating
woman may consider interrupting breastfeeding and pumping and
discarding breast milk during treatment and for 5 hours after
BYFAVO administration.
Pediatric Use
Safety and effectiveness in pediatric patients have not been
established. BYFAVO should not be used in patients less than 18
years of age.
Geriatric Use
No overall differences in safety or effectiveness were observed
between these subjects and younger subjects. However, there is a
potential for greater sensitivity (eg, faster onset, oversedation,
confusion) in some older individuals. Administer supplemental doses
of BYFAVO slowly to achieve the level of sedation required and
monitor all patients closely for cardiorespiratory
complications.
Hepatic Impairment
In patients with severe hepatic impairment, the dose of BYFAVO
should be carefully titrated to effect. Depending on the overall
status of the patient, lower frequency of supplemental doses may be
needed to achieve the level of sedation required for the procedure.
All patients should be monitored for sedation-related
cardiorespiratory complications.
Abuse and Dependence
BYFAVO is a federally controlled substance (CIV) because it
contains remimazolam which has the potential for abuse and physical
dependence.
1 Adjusted non-GAAP net income, adjusted non-GAAP earnings per
share, adjusted non-GAAP EBITDA, adjusted non-GAAP gross margin,
adjusted non-GAAP gross profit, adjusted non-GAAP R&D expense
and adjusted non-GAAP SG&A expense are non-GAAP financial
measures. For descriptions and reconciliations of these non-GAAP
financial measures for historical periods to their most comparable
GAAP financial measures, please see below and the tables at the end
of this press release. 2 Data on file.3 IQVIA SMART-US weekly
volume data for the second quarter of 2023.4
https://bynder.acaciapharma.com/m/5d7c2cd0d58865f7/original/Barhemsys-Prescribing-Information.pdf5
https://bynder.acaciapharma.com/m/403e8c343b2922de/original/Byfavo-PI.pdf
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/14a8361c-807d-4ff7-a73f-200b78f19bd4
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