Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the
“Company”) today announced financial results for the three and six
months ended June 30, 2022.
Business and Recent Highlights:
- Completed the acquisition of Acacia
on June 9, 2022, providing Eagle with two currently marketed, acute
care, hospital products, both of which are new chemical entities
(“NCEs”) with strong patent protection:
- BARHEMSYS®4 is the first and only antiemetic approved by
the FDA for rescue treatment of postoperative nausea and vomiting
despite prophylaxis5
- BYFAVO®6 for injection is indicated for the induction and
maintenance of procedural sedation in adults undergoing procedures
lasting 30 minutes or less, with an estimated total addressable
market in procedural sedation of more than $0.4 billion per
year7 in the U.S.
- Combined addressable market is an estimated $3.1 billion per
year8
- Projected annual peak sales of $275
million9 in the United States
- Acquired an equity stake in, with
an option to purchase, Enalare, adding a portfolio of novel NCEs
with strong intellectual property protection, from the mid-2030s
into the 2040s, including composition of matter patents. Enalare’s
lead compound, ENA-001 is an investigational, one-of-a-kind NCE
being developed as an agnostic respiratory stimulant for multiple
patient populations experiencing acute respiratory depression. The
initial targeted indications include: post-operative respiratory
depression, the most advanced development program; community drug
overdose; and Apnea of Prematurity, a common condition in preterm
infants. The Company believes this acquisition strengthens Eagle’s
position as a diversified pharmaceutical company and a leader in
hospital/anesthesia.
- Supported AOP’s submission of new
drug application (“NDA”) for landiolol, an ultra-selective Beta-1
Adrenergic Blocker, seeking approval for the short-term reduction
of ventricular rate in patients with supraventricular tachycardia,
including atrial fibrillation and atrial flutter. FDA decision with
respect to approval is expected mid-2023, and enrollment of the
study of pediatric patients with supraventricular tachycardia is
underway in Europe.
- Appointed pharmaceutical industry
veteran, Debra M. Hussain, as Senior Vice President, Head of
Commercial.
Financial Highlights
Second Quarter 2022
- Total revenue for Q2 2022 was $74.1
million, compared to $48.1 million in Q2 2021, primarily reflecting
product sales of vasopressin and PEMFEXY.
- Q2 2022 net loss was $(9.5)
million, or $(0.74) per basic and diluted share, compared to net
income of $3.6 million, or $0.28 per basic and $0.27 diluted share,
in Q2 2021.
- Q2 2022 adjusted non-GAAP net
income was $20.3 million, or $1.58 per basic and $1.56 per diluted
share, compared to adjusted non-GAAP net income of $12.4 million,
or $0.95 per basic and $0.93 diluted share, in Q2 2021.
- Cash and cash equivalents were
$36.6 million, net accounts receivable was $85.9 million, and debt
was $50.0 million, as of June 30, 2022.
________________________
4 https://bynder.acaciapharma.com/m/5d7c2cd0d58865f7/original/Barhemsys-Prescribing-Information.pdf5 FDA
labels for other recommended treatments do not include treatment
after failed
prophylaxis.6 https://bynder.acaciapharma.com/m/403e8c343b2922de/original/Byfavo-PI.pdf7 These
estimates are the result of market research performed by or for
Eagle Pharmaceuticals.8 These estimates are the result of
market research performed by or for Eagle
Pharmaceuticals.9 These estimates are the result of market
research performed by or for Eagle Pharmaceuticals.
“Our 2022 results to date are bearing out the vision that we
have been articulating for Eagle for some time. It’s only midyear,
and we have already turned in the best earnings performance in the
history of our company. Our first-half earnings per share are more
than twice our full-year 2021 numbers. As we look to sustain and
accelerate this growth, we continue to support our commercial
launches and broaden our portfolio through acquisitions, such as
Acacia and the potential to acquire Enalare, both of which
enhance our position in hospitals and critical care,” stated Scott
Tarriff, President and Chief Executive Officer of Eagle
Pharmaceuticals.
“The addition of BARHEMSYS and BYFAVO, the planned launch of
landiolol next year, if approved, CAL02, and now our investment in
Enalare, puts us well on our way to becoming a diverse
pharmaceutical company. We are pleased that we have delivered on
our previously stated aspirations and believe we are well
positioned to use 2022 as a springboard for further growth,”
concluded Tarriff.
Second Quarter 2022 Financial Results
Total revenue for the three months ended June 30, 2022 was 74.1
million, as compared to $48.1 million for the three months ended
June 30, 2021.
Q2 2022 PEMFEXY product sales were $16.5 million and vasopressin
product sales were $11.3 million.
Q2 2022 RYANODEX® product sales were $8.8 million, compared to
$7.9 million in the second quarter of 2021.
Q2 2022 BELRAPZO® product sales were $8.1 million, compared to
$7.6 million in the second quarter of 2021.
Royalty revenue was $24.9 million in the second quarter of 2022,
compared to $28.5 million in the second quarter of 2021. BENDEKA
royalties were $23.0 million in the second quarter of 2022,
compared to $27.8 million in the second quarter of 2021.
A summary of total revenue is outlined below:
|
Three Months Ended June 30, |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
(unaudited) |
|
(unaudited) |
|
Revenue (in thousands): |
|
|
|
|
Product sales, net |
$ |
49,201 |
|
|
$ |
19,621 |
|
|
Royalty revenue |
|
24,935 |
|
|
|
28,503 |
|
|
Total
revenue |
$ |
74,136 |
|
|
$ |
48,124 |
|
|
|
|
|
|
|
Gross margin was 68% during the second quarter of 2022, as
compared to 78% in the second quarter of 2021. The decrease in
gross margin was driven by revenue mix, primarily the launch of
PEMFEXY and vasopressin.
R&D expense was $11.4 million for the second quarter of
2022, compared to $9.9 million for the second quarter of 2021. The
increase was primarily due to clinical expense for fulvestrant and
spend on CAL02. Excluding stock-based compensation and other
non-cash and non-recurring items, adjusted non-GAAP R&D expense
during the second quarter of 2022 was $10.8 million.
SG&A expenses in the second quarter of 2022 totaled $36.8
million compared to $16.6 million in the second quarter of 2021.
This increase was primarily related to external legal spend for the
acquisition of Acacia, severance costs, and sales and marketing
expenses associated with the launch of PEMFEXY. Excluding
stock-based compensation and other non-cash and non-recurring
items, second quarter 2022 adjusted non-GAAP SG&A expense was
$15.2 million.
Net loss for the second quarter of 2022 was $(9.5) million, or
$(0.74) per basic and diluted share, compared to net income of $3.6
million, or $0.28 per basic and $0.27 per diluted share, in the
second quarter of 2021, as a result of the factors discussed
above.
Adjusted non-GAAP net income for the second quarter of 2022 was
$20.3 million, or $1.58 per basic and $1.56 per diluted share,
compared to adjusted non-GAAP net income of $12.4 million, or $0.95
per basic and $0.93 diluted share, in the second quarter of
2021.
2022 Full Year Expense Guidance
- Adjusted non-GAAP R&D expense
for the full year 2022 is expected to be in the range of $46
million to $50 million, as compared to $32.5 million in 2021.
- Adjusted non-GAAP SG&A expense
for the full year 2022 is expected to be in the range of $62
million to $66 million, as compared to $54.9 million in 2021.
Liquidity
As of June 30, 2022, Eagle had $36.6 million in cash and cash
equivalents and $85.9 million in net accounts receivable, and $50.0
million in outstanding debt. Therefore, as of June 30, 2022, Eagle
had cash plus net receivables of $122.5 million.
Conference Call
As previously announced, Eagle management will host its second
quarter 2022 conference call as follows:
Date |
|
August 9, 2022 |
Time |
|
8:30 A.M. ET |
Toll free (U.S.) |
|
800-445-7795 |
International |
|
203-518-9843 |
Webcast (live and replay) |
|
www.eagleus.com, under the “Investor + News” section |
A replay of the conference call will be available for two weeks
after the call's completion by dialing 800-938-0997 (U.S.) or
402-220-1541 (International) and entering conference call ID
EGRXQ222. 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 vasopressin, 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 information within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, and other securities laws. Forward-looking
statements are statements that are not historical facts. Words and
phrases such as “anticipated,” “forward,” “will,” “would,” “could,”
“should,” “may,” “remain,” “potential,” “prepare,” “expected,”
“believe,” “plan,” “near future,” “belief,” “guidance,” “estimate,”
and similar expressions are intended to identify forward-looking
statements. These statements include, but are not limited to,
statements regarding future events such as: the Company’s financial
projections and guidance, including anticipated financial
performance for 2022, including expected R&D and SG&A
expense; any further investments in Enalare and Enalare’s
development programs; the potential exercise of Eagle’s option to
acquire all of Enalare’s outstanding shares; the potential benefits
and commercial opportunity of Enalare’s product candidates; the
potential of Enalare product candidates to immediately expand
Eagle’s long-term growth possibilities, if acquired; statements
regarding expectations with respect to whether and when the Acacia
acquisition may be earnings accretive; expectations with respect to
synergies; expectations that the acquisition of Acacia Pharma will
help improve the care of patients undergoing medical treatments,
solidify the Company's leadership position in the hospital and
oncology space and bring long-term value to the Company's
shareholders; the estimated addressable market size and estimated
sales figures for BARHEMSYS and BYFAVO and other products or
product candidates; the ability of BARHEMSYS and BYFAVO, as well as
the Company’s investment in Enalare, serve to diversify and
complement its revenue streams and strengthen its advantage in
acute care; the ability of Enalare to advance global development
and future commercialization of ENA001 and the Company’s potential
acquisition of Enalare in the future, subject to the completion of
certain milestones; the Company’s ability to pursue additional
potential transactions to further diversify its product portfolio
and pipeline on favorable terms or at all; the Company’s ability to
obtain and maintain regulatory approval of its products and product
candidates; the Company's clinical development plan for its product
candidates, including the number and timing of development
initiatives or new indications for the Company’s product
candidates; the Company’s timing and ability to enroll patients in
upcoming clinical trials, including for CAL02; the timing, scope or
likelihood and timing of regulatory filings and approvals from the
FDA for the Company’s product candidates, including landiolol and
its fulvestrant product; the progress and success of the Company’s
launch of any products, including vasopressin and PEMFEXY; the
addressable market size for, and the ability of the Company to
successfully commercialize, its product candidates, including
vasopressin and PEMFEXY; the ability of vasopressin to benefit
providers and patients as an alternative to Vasostrict; the ability
of BARHEMSYS, BYFAVO, landiolol and other products and product
candidates to address unmet clinical needs; the potential market
opportunity for the Company’s products or product candidates,
including for BARHEMSYS, BYFAVO and landiolol; the period of
marketing exclusivity for any of the Company’s products or product
candidates, including vasopressin; the resolution of patent
litigation and all related settlement terms, including the date of
market entry and the potential for earlier market entry under
certain circumstances; the timing, scope or likelihood and timing
of regulatory filings and approvals from the FDA for the Company’s
product candidates and the Company’s ability to maintain regulatory
approval of its products and product candidates; the Company's
clinical development plan for the product candidates in its
portfolio; the implementation of certain healthcare reform
measures; the ability of the Company to obtain and maintain
coverage and adequate reimbursement for its products; the success
of the Company's collaborations with its strategic partners and the
timing and results of these partners’ preclinical studies and
clinical trials, and the Company’s potential earnings potential
through such collaborations; the ability of the Company’s executive
team to execute on the Company’s strategy and to utilize its cash
and other assets to increase shareholder value; and the ability of
the Company’s product candidates to deliver value to stockholders;
the Company's ability to deliver value in 2022 and over the long
term; the Company’s ability to sustain and accelerate this growth;
the Company’s ability to utilize its cash and other assets to
increase shareholder value; the Company’s ability to effectively
manage and control expenses in line with its budget; and the
Company's plans and ability to advance the products in its
pipeline; potential opportunities for, and the Company’s ability to
complete, business development transactions, in a timely manner, on
favorable terms to the Company, or at all; the sufficiency of the
Company’s cash flows and capital resources; and the Company’s
ability to achieve expected future financial performance and
results. 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 risk that the
anticipated benefits of the Company’s recently completed
transaction with Acacia Pharma are not realized; the impacts of the
COVID-19 pandemic and geopolitical events such as the conflict in
Ukraine, including disruption or impact in the sales of the
Company's marketed products, interruptions or other adverse effects
to clinical trials, delays in regulatory review, manufacturing and
supply chain interruptions, adverse effects on healthcare systems,
disruption in the operations of the Company's third party partners
and disruption of the global economy, and the overall impact of the
COVID-19 pandemic or other events on the Company's business,
financial condition and results of operations; macroeconomic
conditions, including rising inflation and uncertain credit and
financial markets; whether the Company will incur unforeseen
expenses or liabilities or other market factors; whether the
Company will successfully implement its development plan for
its product candidates; delay in or failure to obtain
regulatory approval of the Company's or its partners’ product
candidates; whether the Company can successfully market and
commercialize its product candidates; the success of the Company's
relationships with its partners; the availability and pricing of
third party sourced products and materials; the outcome of
litigation involving any of its products or that may have an impact
on any of our products; successful compliance with the FDA and
other governmental regulations applicable to product approvals,
manufacturing facilities, products and/or businesses; general
economic conditions, including the potential adverse effects of
public health issues, including the COVID-19 pandemic and
geopolitical events, on economic activity and the performance of
the financial markets generally; 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; the risks inherent in the early stages of drug
development and in conducting clinical trials; and factors in
addition to the foregoing that may impact the Company’s financial
projects and guidance, including among other things, any potential
business development transactions, acquisitions, restructurings or
legal settlements, in addition to any unanticipated factors, that
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, 2021, filed with the Securities and Exchange Commission (the
“SEC”) on March 8, 2022, the Company’s Quarterly Report on Form
10-Q for the quarter ended March 31, 2022, filed with the SEC on
May 9, 2022, and its other subsequent filings with the SEC,
including the Company’s Quarterly Report on Form 10-Q for the
quarter ended June 30, 2022, which the Company expects to file with
the SEC on August 9, 2022. 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 also contains adjusted non-GAAP net
income, adjusted non-GAAP earnings per share attributable to Eagle,
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, acquisition related
costs, legal settlement, non-cash interest expense, fair value
adjustments on equity investment, convertible promissory note
related credit losses, fair value adjustments related to derivative
instruments, accretion of discount on convertible promissory note,
foreign currency exchange loss and the tax effect of these
adjustments.
Adjusted non-GAAP R&D expense excludes stock-based
compensation expense and depreciation expense.
Adjusted non-GAAP SG&A expense excludes stock-based
compensation expense, amortization expense, depreciation expense,
severance, legal settlement and acquisition related costs.
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.
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. Reconciliations of the
components of projected adjusted non-GAAP R&D and adjusted
non-GAAP SG&A to their most comparable GAAP financial measures
is not provided because the quantification of projected GAAP
R&D and SG&A and the reconciling items between projected
GAAP to adjusted non-GAAP R&D and SG&A cannot be reasonably
calculated or predicted at this time without unreasonable efforts.
For example, with respect to GAAP R&D and SG&A, 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 R&D and SG&A would vary significantly
from projected GAAP and adjusted non-GAAP R&D and adjusted
non-GAAP SG&A.
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. 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.
Wilson In-Site
Communications, Inc. T: 212-452-2793 E: lwilson@insitecony.com
-- Financial tables follow --
EAGLE PHARMACEUTICALS, INC. |
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED) |
(In thousands, except share amounts) |
|
|
|
|
|
June 30, 2022 |
|
December 31, 2021 |
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
36,562 |
|
|
$ |
97,659 |
|
Accounts receivable, net |
|
85,920 |
|
|
|
41,149 |
|
Inventories |
|
57,712 |
|
|
|
21,908 |
|
Prepaid expenses and other current assets |
|
14,262 |
|
|
|
11,890 |
|
Total current assets |
|
194,456 |
|
|
|
172,606 |
|
Property and equipment, net |
|
1,459 |
|
|
|
1,636 |
|
Intangible assets, net |
|
112,474 |
|
|
|
10,671 |
|
Goodwill |
|
43,057 |
|
|
|
39,743 |
|
Deferred tax asset, net |
|
23,244 |
|
|
|
18,798 |
|
Other assets |
|
7,066 |
|
|
|
10,278 |
|
Total assets |
$ |
381,756 |
|
|
$ |
253,732 |
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
19,971 |
|
|
$ |
16,431 |
|
Accrued expenses and other liabilities |
|
67,150 |
|
|
|
32,338 |
|
Current debt |
|
21,843 |
|
|
|
25,607 |
|
Total current liabilities |
|
108,964 |
|
|
|
74,376 |
|
Long-term debt |
|
28,018 |
|
|
|
— |
|
Deferred tax liability |
|
4,536 |
|
|
|
— |
|
Other long-term liabilities |
|
2,256 |
|
|
|
2,903 |
|
Total liabilities |
|
143,774 |
|
|
|
77,279 |
|
Commitments and Contingencies |
|
|
|
Stockholders' equity: |
|
|
|
Preferred stock, 1,500,000 shares authorized and no shares issued
or outstanding as of June 30, 2022 and December 31, 2021 |
|
— |
|
|
|
— |
|
Common stock, $0.001 par value; 50,000,000 shares authorized;
17,549,023 and 16,903,034 shares issued as of June 30, 2022 and
December 31, 2021, respectively |
|
18 |
|
|
|
17 |
|
Additional paid in capital |
|
358,377 |
|
|
|
325,779 |
|
Accumulated other comprehensive income (loss) |
|
2,281 |
|
|
|
(94 |
) |
Retained earnings |
|
110,470 |
|
|
|
75,862 |
|
Treasury stock, at cost, 4,278,831 and 4,111,622 shares as of June
30, 2022 and December 31, 2021, respectively |
|
(233,164 |
) |
|
|
(225,111 |
) |
Total stockholders' equity |
|
237,982 |
|
|
|
176,453 |
|
Total liabilities and stockholders' equity |
$ |
381,756 |
|
|
$ |
253,732 |
|
|
|
|
|
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, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Revenue: |
|
|
|
|
|
|
|
Product sales, net |
$ |
49,201 |
|
|
$ |
19,621 |
|
|
$ |
139,289 |
|
|
$ |
36,741 |
|
Royalty revenue |
|
24,935 |
|
|
|
28,503 |
|
|
|
50,721 |
|
|
|
52,632 |
|
Total revenue |
|
74,136 |
|
|
|
48,124 |
|
|
|
190,010 |
|
|
|
89,373 |
|
Operating expenses: |
|
|
|
|
|
|
|
Cost of product sales |
|
21,171 |
|
|
|
7,907 |
|
|
|
46,347 |
|
|
|
16,349 |
|
Cost of royalty revenue |
|
2,493 |
|
|
|
2,850 |
|
|
|
5,072 |
|
|
|
5,263 |
|
Research and development |
|
11,437 |
|
|
|
9,911 |
|
|
|
17,545 |
|
|
|
24,199 |
|
Selling, general and administrative |
|
36,832 |
|
|
|
16,636 |
|
|
|
59,014 |
|
|
|
36,515 |
|
Total operating expenses |
|
71,933 |
|
|
|
37,304 |
|
|
|
127,978 |
|
|
|
82,326 |
|
Income from operations |
|
2,203 |
|
|
|
10,820 |
|
|
|
62,032 |
|
|
|
7,047 |
|
Interest income |
|
244 |
|
|
|
163 |
|
|
|
398 |
|
|
|
198 |
|
Interest expense |
|
(552 |
) |
|
|
(422 |
) |
|
|
(918 |
) |
|
|
(844 |
) |
Other (expense) income |
|
(7,763 |
) |
|
|
(5,013 |
) |
|
|
(9,720 |
) |
|
|
487 |
|
Total other (expense) income, net |
|
(8,071 |
) |
|
|
(5,272 |
) |
|
|
(10,240 |
) |
|
|
(159 |
) |
(Loss) income before income tax provision |
|
(5,868 |
) |
|
|
5,548 |
|
|
|
51,792 |
|
|
|
6,888 |
|
Income tax provision |
|
(3,582 |
) |
|
|
(1,936 |
) |
|
|
(17,184 |
) |
|
|
(3,697 |
) |
Net (loss) income |
$ |
(9,450 |
) |
|
$ |
3,612 |
|
|
$ |
34,608 |
|
|
$ |
3,191 |
|
(Loss) earnings per share attributable to common stockholders: |
|
|
|
|
|
|
|
Basic |
$ |
(0.74 |
) |
|
$ |
0.28 |
|
|
$ |
2.71 |
|
|
$ |
0.24 |
|
Diluted |
$ |
(0.74 |
) |
|
$ |
0.27 |
|
|
$ |
2.67 |
|
|
$ |
0.24 |
|
Weighted average number of common shares outstanding: |
|
|
|
|
|
|
|
Basic |
|
12,836,116 |
|
|
|
13,108,998 |
|
|
|
12,773,727 |
|
|
|
13,116,370 |
|
Diluted |
|
12,836,116 |
|
|
|
13,262,164 |
|
|
|
12,951,788 |
|
|
|
13,293,920 |
|
|
|
|
|
|
|
|
|
EAGLE PHARMACEUTICALS, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED) |
(In thousands) |
|
|
|
|
|
Six Months Ended June 30, |
|
|
2022 |
|
|
|
2021 |
|
Cash flows from operating activities: |
|
|
|
Net income |
$ |
34,608 |
|
|
$ |
3,191 |
|
Adjustments to reconcile net income to net cash provided by
operating activities: |
|
|
|
Deferred income taxes |
|
(4,445 |
) |
|
|
1,119 |
|
Depreciation expense |
|
345 |
|
|
|
378 |
|
Noncash operating lease expense related to right-of-use assets |
|
593 |
|
|
|
508 |
|
Amortization expense of intangible assets |
|
2,197 |
|
|
|
1,412 |
|
Fair value adjustments on equity investment |
|
3,230 |
|
|
|
(400 |
) |
Stock-based compensation expense |
|
8,795 |
|
|
|
10,789 |
|
Convertible promissory note related credit losses |
|
62 |
|
|
|
100 |
|
Amortization of debt issuance costs |
|
236 |
|
|
|
236 |
|
Fair value adjustments related to derivative instrument |
|
620 |
|
|
|
(188 |
) |
Accretion of discount on convertible promissory note |
|
(91 |
) |
|
|
(56 |
) |
Loss on foreign currency exchange rates |
|
1,281 |
|
|
|
— |
|
Changes in operating assets and liabilities which provided
(used) cash: |
|
|
|
Accounts receivable |
|
(44,312 |
) |
|
|
(1,981 |
) |
Inventories |
|
(8,862 |
) |
|
|
(219 |
) |
Prepaid expenses and other current assets |
|
(6 |
) |
|
|
(1,802 |
) |
Accounts payable |
|
2,931 |
|
|
|
4,868 |
|
Accrued expenses and other liabilities |
|
29,006 |
|
|
|
1,710 |
|
Other assets and other long-term liabilities, net |
|
193 |
|
|
|
(594 |
) |
Net cash provided by operating activities |
|
26,381 |
|
|
|
19,071 |
|
Cash flows from investing activities: |
|
|
|
Purchase of Acacia, net of cash acquired |
|
(75,416 |
) |
|
|
— |
|
Purchase of property and equipment |
|
(168 |
) |
|
|
(269 |
) |
Purchase of convertible promissory note |
|
— |
|
|
|
(5,000 |
) |
Net cash used in investing activities |
|
(75,584 |
) |
|
|
(5,269 |
) |
Cash flows from financing activities: |
|
|
|
Proceeds from common stock option exercises |
|
1,500 |
|
|
|
1,608 |
|
Employee withholding taxes related to stock-based awards |
|
(1,341 |
) |
|
|
(1,551 |
) |
Payment of debt |
|
(4,000 |
) |
|
|
(4,000 |
) |
Repurchases of common stock |
|
(8,053 |
) |
|
|
(4,297 |
) |
Net cash used in financing activities |
|
(11,894 |
) |
|
|
(8,240 |
) |
Net (decrease) increase in cash and cash
equivalents |
|
(61,097 |
) |
|
|
5,562 |
|
Cash and cash equivalents at beginning of
period |
|
97,659 |
|
|
|
103,155 |
|
Cash and cash equivalents at end of period |
$ |
36,562 |
|
|
$ |
108,717 |
|
Supplemental disclosures of cash flow
information: |
|
|
|
Cash paid during the period for: |
|
|
|
Income taxes, net |
$ |
10,570 |
|
|
$ |
4,300 |
|
Interest |
|
525 |
|
|
|
625 |
|
|
|
|
|
EAGLE PHARMACEUTICALS, INC. |
RECONCILIATION OF GAAP TO ADJUSTED NON-GAAP NET INCOME
AND |
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, |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Net (loss) income - GAAP |
$ |
(9,450 |
) |
|
$ |
3,612 |
|
|
$ |
34,608 |
|
|
$ |
3,191 |
|
|
|
|
|
|
|
|
|
|
Adjustments: |
|
|
|
|
|
|
|
Cost of product revenues: |
|
|
|
|
|
|
|
|
Amortization expense |
|
1,466 |
|
|
|
301 |
|
|
|
2,197 |
|
|
|
602 |
|
Research and development: |
|
|
|
|
|
|
|
|
Stock-based compensation expense |
|
601 |
|
|
|
641 |
|
|
|
1,244 |
|
|
|
1,536 |
|
|
Depreciation expense |
|
44 |
|
|
|
54 |
|
|
|
92 |
|
|
|
107 |
|
|
Severance |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
274 |
|
Selling, general and administrative: |
|
|
|
|
|
|
|
|
Stock-based compensation expense |
|
3,899 |
|
|
|
3,640 |
|
|
|
7,551 |
|
|
|
9,253 |
|
|
Depreciation expense |
|
124 |
|
|
|
134 |
|
|
|
253 |
|
|
|
271 |
|
|
Severance |
|
7,742 |
|
|
|
28 |
|
|
|
7,791 |
|
|
|
334 |
|
|
Acquisition related costs |
|
9,849 |
|
|
|
- |
|
|
|
11,339 |
|
|
|
- |
|
|
Amortization expense |
|
- |
|
|
|
405 |
|
|
|
- |
|
|
|
810 |
|
|
Legal settlement |
|
- |
|
|
|
- |
|
|
|
300 |
|
|
|
- |
|
Other: |
|
|
|
|
|
|
|
|
Non-cash interest expense |
|
278 |
|
|
|
118 |
|
|
|
396 |
|
|
|
236 |
|
|
Fair value adjustments on equity investment |
|
700 |
|
|
|
5,200 |
|
|
|
3,230 |
|
|
|
(400 |
) |
|
Convertible promissory note related credit losses |
|
26 |
|
|
|
- |
|
|
|
62 |
|
|
|
100 |
|
|
Fair value adjustments related to derivative instrument |
|
6,239 |
|
|
|
(188 |
) |
|
|
5,631 |
|
|
|
(188 |
) |
|
Accretion of discount on convertible promissory note |
|
(45 |
) |
|
|
(56 |
) |
|
|
(90 |
) |
|
|
(56 |
) |
|
Foreign currency exchange loss |
|
798 |
|
|
|
- |
|
|
|
798 |
|
|
|
- |
|
Tax effect of the non-GAAP adjustments |
|
(1,956 |
) |
|
|
(1,489 |
) |
|
|
(2,935 |
) |
|
|
(403 |
) |
|
Adjusted non-GAAP net
income |
$ |
20,315 |
|
|
$ |
12,400 |
|
|
$ |
72,467 |
|
|
$ |
15,667 |
|
|
|
|
|
|
|
|
|
|
Adjusted non-GAAP earnings per share: |
|
|
|
|
|
|
|
Basic |
$ |
1.58 |
|
|
$ |
0.95 |
|
|
$ |
5.67 |
|
|
$ |
1.19 |
|
Diluted |
$ |
1.56 |
|
|
$ |
0.93 |
|
|
$ |
5.60 |
|
|
$ |
1.18 |
|
Weighted average number of common shares outstanding: |
|
|
|
|
|
|
|
Basic |
|
12,836,116 |
|
|
|
13,108,998 |
|
|
|
12,773,727 |
|
|
|
13,116,370 |
|
Diluted |
|
12,997,602 |
|
|
|
13,262,164 |
|
|
|
12,951,788 |
|
|
|
13,293,920 |
|
|
|
|
|
|
|
|
|
|
EAGLE PHARMACEUTICALS, INC. |
RECONCILIATION OF GAAP TO ADJUSTED NON-GAAP EBITDA
(UNAUDITED) |
(In thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
TwelveMonths EndedJune 30, |
|
TwelveMonths EndedDecember 31, |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income - GAAP |
$ |
(9,450 |
) |
|
$ |
3,612 |
|
|
$ |
34,608 |
|
$ |
3,191 |
|
|
$ |
22,790 |
|
|
$ |
(8,627 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Add back: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense, net of interest income |
|
308 |
|
|
|
259 |
|
|
|
520 |
|
|
646 |
|
|
|
949 |
|
|
|
1,075 |
|
|
Income tax provision |
|
3,582 |
|
|
|
1,936 |
|
|
|
17,184 |
|
|
3,697 |
|
|
|
17,566 |
|
|
|
4,079 |
|
|
Depreciation and amortization expense |
|
1,634 |
|
|
|
894 |
|
|
|
2,542 |
|
|
1,790 |
|
|
|
4,512 |
|
|
|
3,760 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Add back: |
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation expense |
|
4,500 |
|
|
|
4,281 |
|
|
|
8,795 |
|
|
10,789 |
|
|
|
17,561 |
|
|
|
19,555 |
|
|
Fair value adjustments on equity investment |
|
700 |
|
|
|
5,200 |
|
|
|
3,230 |
|
|
(400 |
) |
|
|
9,800 |
|
|
|
6,170 |
|
|
Expense of acquired in-process research & development |
|
- |
|
|
|
- |
|
|
|
- |
|
|
- |
|
|
|
15,339 |
|
|
|
15,339 |
|
|
Convertible promissory note related credit losses |
|
26 |
|
|
|
- |
|
|
|
62 |
|
|
100 |
|
|
|
720 |
|
|
|
758 |
|
|
Fair value adjustments related to derivative instrument |
|
6,239 |
|
|
|
(188 |
) |
|
|
5,631 |
|
|
(188 |
) |
|
|
5,133 |
|
|
|
(686 |
) |
|
Foreign currency exchange loss |
|
798 |
|
|
|
- |
|
|
|
798 |
|
|
- |
|
|
|
798 |
|
|
|
- |
|
|
Legal Settlement |
|
- |
|
|
|
- |
|
|
|
300 |
|
|
- |
|
|
|
300 |
|
|
|
- |
|
|
Acquisition related costs |
|
9,849 |
|
|
|
- |
|
|
|
11,339 |
|
|
- |
|
|
|
11,339 |
|
|
|
- |
|
|
Severance |
|
7,742 |
|
|
|
28 |
|
|
|
7,791 |
|
|
608 |
|
|
|
9,267 |
|
|
|
2,084 |
|
|
Adjusted Non-GAAP EBITDA |
$ |
25,928 |
|
|
$ |
16,022 |
|
|
$ |
92,800 |
|
$ |
20,233 |
|
|
$ |
116,074 |
|
|
$ |
43,507 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
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