Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the
“Company”) today announced financial results for the three and nine
months ended September 30, 2022.
Business and Recent Highlights:
- Submitted an IND application to FDA
for CAL02, a novel first-in-class broad-spectrum anti-virulence
agent for the treatment of severe community-acquired bacterial
pneumonia (“SCABP”). The IND filing includes a protocol for an
adequately powered global Phase 2 study to evaluate the efficacy
and safety of CAL02 when added to standard of care therapy in
patients with SCABP.
- Acquired an equity stake in, with
an option to purchase, Enalare Therapeutics Inc. (“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;
community drug overdose; and Apnea of Prematurity, a common
condition in preterm infants. The Company believes this investment
strengthens Eagle’s position as a diversified pharmaceutical
company and a leader in hospital/anesthesia.
- Enalare secured a contract for up
to $50.3 million from the Biomedical Advanced Research and
Development Authority (“BARDA”), part of the Administration for
Strategic Preparedness and Response in the U.S. Department of
Health and Human Services (contract number 75A50122C00072). In
partnership with BARDA, ENA-001 is being developed in an
intramuscular (“IM”) formulation for potential use in patients
experiencing community drug overdose and as a potential medical
countermeasure for mass casualty events.
- FDA granted Orphan Drug Designation
(“ODD”) to ENA-001 for the treatment of Apnea of Prematurity
(“AoP”). AoP is a development disorder attributed to immaturity of
the pulmonary system characterized by either cessation of breathing
for more than 20 seconds or cessation of breathing that lasts less
than 20 seconds but is accompanied by either bradycardia or
hypoxemia.
- Received favorable ruling in
vasopressin litigation. The U.S. Court of Appeals for the Federal
Circuit affirmed the U.S. District Court for the District of
Delaware’s decision that Eagle’s vasopressin product does not
infringe on any of the patents asserted by Par Pharmaceutical,
Inc.
- Appointed pharmaceutical industry
veteran, Debra M. Hussain, as Senior Vice President, Head of
Commercial, with responsibility for FDA-approved new chemical
entities, BARHEMSYS® and BYFAVO®, acquired as part of the
acquisition of Acacia Pharma Group plc (“Acacia”).
- Amended and restated its credit
agreement providing for a three-year $100 million revolving credit
facility and $50 million term loan facility and repaid all other
debt.
Financial Highlights
Third Quarter 2022
- Total revenue for Q3 2022 was $65.9
million, compared to $39.9 million in Q3 2021.
- Q3 2022 net loss was $(3.5)
million, or $(0.27) per basic and diluted share, compared to net
loss of $(5.6) million, or $(0.43) per basic and diluted share, in
Q3 2021.
- Q3 2022 adjusted non-GAAP net
income was $14.9 million, or $1.13 per basic and $1.12 per diluted
share, compared to adjusted non-GAAP net income of $7.5 million, or
$0.57 per basic and $0.56 per diluted share, in Q3 2021.
- Cash and cash equivalents were
$15.4 million, net accounts receivable was $96.9 million, and debt
was $59.3 million, as of September 30, 2022.
- Recorded a $3.8 million milestone
payment from SymBio on TREAKISYM® in Q3 2022, $1.2 million ($0.07
per basic and diluted share) less than anticipated due to currency
declines of the Japanese Yen.
“It was another strong quarter for Eagle, and we are pleased
that the earnings growth has continued. We are posting record
earnings this year, as evidenced by the fact that in the first nine
months of the year, we have already earned $6.69 per share, topping
our previous best full year ever,” stated Scott Tarriff, President
and Chief Executive Officer of Eagle Pharmaceuticals.
“We expect another strong year in 2023 and anticipate deploying
the cash from our earnings and strong balance sheet not only to
fund our key clinical initiatives but also to potentially make an
accretive acquisition to round out our portfolio. Between business
development activities and our own R&D engine, we believe Eagle
can grow significantly larger as it transitions into a branded
pharmaceutical company with a diversified portfolio of assets,”
concluded Tarriff.
Third Quarter 2022 Financial Results
Total revenue for the three months ended September 30, 2022 was
$65.9 million, as compared to $39.9 million for the three months
ended September 30, 2021.
Q3 2022 RYANODEX® net product sales were $7.6 million, compared
to $4.5 million in the third quarter of 2021.
Q3 2022 BELRAPZO net product sales were $8.5 million, compared
to $4.9 million in the third quarter of 2021.
Q3 2022 PEMFEXY® net product sales were $1.7 million and
vasopressin net product sales were $13.8 million.
A summary of total revenue is outlined below:
|
Three Months Ended September 30, |
|
|
|
2022 |
|
|
2021 |
|
|
(unaudited) |
|
(unaudited) |
|
Revenue (in thousands): |
|
|
|
|
Product sales, net |
$ |
38,086 |
|
$ |
12,124 |
|
Royalty revenue |
|
24,007 |
|
|
27,729 |
|
License and other revenue |
|
3,808 |
|
|
— |
|
Total
revenue |
$ |
65,901 |
|
$ |
39,853 |
|
Gross margin was 64% during the third quarter of 2022, as
compared to 79% in the third quarter of 2021. The decrease in gross
margin was driven by a change in the revenue mix, including the
launch of PEMFEXY and vasopressin and amortization expense related
to BARHEMSYS and BYFAVO.
R&D expense was $9.3 million for the third quarter of 2022,
compared to $23.3 million for the third quarter of 2021. The
decrease was primarily due to lower spend of $6.6 million on CAL02
and $4.8 million on landiolol due to the upfront license fees paid
in Q3 2021 and non-recurrence of development costs of $2.1 million
on vasopressin and $1.4 million on PEMFEXY. This was partially
offset by an increase in spend on fulvestrant of $0.9 million
compared to Q3 2021.
SG&A expenses in the third quarter of 2022 totaled $23.5
million compared to $18.5 million in the third quarter of 2021.
This increase was primarily related to $1.1 million of external
sales and marketing and $1.2 million of headcount costs for
BARHEMSYS and BYFAVO re-launches, $1.1 million of financial and
other professional fees, $0.6 million of severance related to the
integration of Acacia, $0.5 million of external legal costs, and
$0.2 million of sales and marketing costs for PEMFEXY, partially
offset by lower general and administrative head count costs.
Net loss for the third quarter of 2022 was $(3.5) million, or
$(0.27) per basic and diluted share, compared to net loss of $(5.6)
million, or $(0.43) per basic and diluted share, in the third
quarter of 2021, primarily as a result of the factors discussed
above.
Adjusted non-GAAP net income for the third quarter of 2022 was
$14.9 million, or $1.13 per basic and $1.12 per diluted share,
compared to adjusted non-GAAP net income of $7.5 million, or $0.57
per basic and $0.56 per diluted share, in the third quarter of
2021.
2022 Full Year Expense Guidance
- Adjusted non-GAAP R&D expense
for the full year 2022 is expected to be less than $40 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 $64
million to $68 million, as compared to $54.9 million in 2021.
Liquidity
As of September 30, 2022, Eagle had $15.4 million in cash and
cash equivalents and $96.9 million in net accounts receivable, and
$59.3 million in outstanding debt. Therefore, as of September 30,
2022, Eagle had cash plus net receivables of $112.3 million.
In the third quarter of 2022, Eagle repurchased $10 million of
its common stock as part of its current $160 million Share
Repurchase Program. From August 2016 through September 30, 2022,
Eagle has repurchased $246.1 million of its common stock.
Conference Call
As previously announced, Eagle management will host its third
quarter 2022 conference call as follows:
Date |
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November 7, 2022 |
Time |
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8:30 A.M. ET |
Toll free (U.S.) |
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800-343-4849 |
International |
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|
785-424-1699 |
Webcast (live and
replay) |
|
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|
|
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 800-934-4548 (U.S.) or
402-220-1175 (International) and entering conference call ID
EGRXQ322. The webcast will be archived for 30 days at the
aforementioned URL.
Investor Day Registration Information
Eagle will host an Investor Day on Tuesday, December 6, 2022, at
the Lotte New York Palace Hotel, at 8:00am ET.
The program will provide an opportunity for an in-depth look at
the Company’s hospital-based products and product candidates,
including CAL02, BARHEMSYS and BYFAVO, landiolol, and Enalare’s
ENA-001. Featured speakers include Scott Tarriff, President and
Chief Executive Officer, senior members of Eagle’s clinical and
commercial teams, and noteworthy Key Opinion Leaders, who will
discuss the scientific rationale and potential unmet medical needs
for each pipeline asset and commercial product.
Advance registration is required for this event. Institutional
investors and analysts are kindly requested to RSVP through this
link to attend.
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 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,” “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 with respect to: the development of, potential benefits
of and potential FDA submission for ENA-001, including a potential
IM formulation that could potentially enable more rapid deployment
in emergency situations and the potential to develop an innovative
and rapid treatment for respiratory depression in a variety of
settings; expectations with respect to the BARDA award providing
funding to Enalare to accelerate the development of ENA-001; the
achievement of milestones and deliverables; the potential further
investment by the Company in Enalare and the Company’s development
programs, products and pipeline; the potential use of ENA-001 to
help preterm infants with respiratory conditions; the ability of
ENA-001 and other products and product candidates to address unmet
clinical needs, including for patients with post-operative
respiratory depression and in combatting community drug overdose;
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 the
Company’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 the Company’s long-term growth possibilities, if
acquired; expected continued earnings growth in 2023 and 2024,and
anticipated deployment of cash to fund clinical development and
potential strategic transactions to round out the Company's
portfolio; the potential for the Company to grow significantly
larger as it transitions into a diversified pharmaceutical company
with a portfolio of branded, first-in-class assets; expectations
for earnings to grow in 2023 and 2024; 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 are not realized; the ability of Enalare to
achieve milestones and deliverables under the BARDA agreement and
otherwise accelerate and achieve successful results in the
development of ENA-001; 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, the Company’s Quarterly Report on Form 10-Q for the
quarter ended June 30, 2022, filed with the SEC on August 9, 2022
and its other subsequent filings with the SEC, including the
Company’s Quarterly Report on Form 10-Q for the quarter ended
September 30, 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, expense of acquired in-process
research & development, severance, acquisition related costs,
legal settlement, non-cash interest expense, fair value adjustments
on equity investment, convertible promissory note related
adjustments, fair value adjustments related to derivative
instruments, foreign currency exchange loss, inventory step-up and
the tax effect of these adjustments.
Adjusted non-GAAP R&D expense excludes stock-based
compensation expense, depreciation expense, severance and expense
of acquire in-process research & development.
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) |
|
|
|
|
|
|
|
|
|
September 30, 2022 |
|
December 31, 2021 |
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
15,384 |
|
|
$ |
97,659 |
|
Accounts receivable, net |
|
96,932 |
|
|
|
41,149 |
|
Inventories |
|
63,855 |
|
|
|
21,908 |
|
Prepaid expenses and other current assets |
|
8,875 |
|
|
|
11,890 |
|
Total current assets |
|
185,046 |
|
|
|
172,606 |
|
Property and equipment, net |
|
1,297 |
|
|
|
1,636 |
|
Intangible assets, net |
|
108,785 |
|
|
|
10,671 |
|
Goodwill |
|
41,794 |
|
|
|
39,743 |
|
Deferred tax asset, net |
|
23,541 |
|
|
|
18,798 |
|
Other assets |
|
29,604 |
|
|
|
10,278 |
|
Total assets |
$ |
390,067 |
|
|
$ |
253,732 |
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
13,215 |
|
|
$ |
16,431 |
|
Accrued expenses and other liabilities |
|
73,652 |
|
|
|
32,338 |
|
Current debt |
|
34,961 |
|
|
|
25,607 |
|
Total current liabilities |
|
121,828 |
|
|
|
74,376 |
|
Long-term debt |
|
26,431 |
|
|
|
— |
|
Deferred tax liability |
|
4,536 |
|
|
|
— |
|
Other long-term liabilities |
|
1,874 |
|
|
|
2,903 |
|
Total liabilities |
|
154,669 |
|
|
|
77,279 |
|
Commitments and Contingencies |
|
|
|
Stockholders' equity: |
|
|
|
Preferred stock, 1,500,000 shares authorized and no shares issued
or outstanding as of September 30, 2022 and December 31, 2021 |
|
— |
|
|
|
— |
|
Common stock, $0.001 par value; 50,000,000 shares authorized;
17,568,586 and 16,903,034 shares issued as of September 30, 2022
and December 31, 2021, respectively |
|
18 |
|
|
|
17 |
|
Additional paid in capital |
|
362,161 |
|
|
|
325,779 |
|
Accumulated other comprehensive income (loss) |
|
9,377 |
|
|
|
(94 |
) |
Retained earnings |
|
106,957 |
|
|
|
75,862 |
|
Treasury stock, at cost, 4,552,730 and 4,111,622 shares as of
September 30, 2022 and December 31, 2021, respectively |
|
(243,115 |
) |
|
|
(225,111 |
) |
Total stockholders' equity |
|
235,398 |
|
|
|
176,453 |
|
Total liabilities and stockholders' equity |
$ |
390,067 |
|
|
$ |
253,732 |
|
EAGLE PHARMACEUTICALS, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED) |
(In thousands, except share and per share
amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales, net |
$ |
38,086 |
|
|
$ |
12,124 |
|
|
$ |
177,375 |
|
|
$ |
48,865 |
|
Royalty revenue |
|
24,007 |
|
|
|
27,729 |
|
|
|
74,728 |
|
|
|
80,361 |
|
License and other revenue |
|
3,808 |
|
|
|
— |
|
|
|
3,808 |
|
|
|
— |
|
Total revenue |
|
65,901 |
|
|
|
39,853 |
|
|
|
255,911 |
|
|
|
129,226 |
|
Operating expenses: |
|
|
|
|
|
|
|
Cost of product sales |
|
20,869 |
|
|
|
5,486 |
|
|
|
67,216 |
|
|
|
21,835 |
|
Cost of royalty revenue |
|
2,782 |
|
|
|
2,773 |
|
|
|
7,854 |
|
|
|
8,036 |
|
Research and development |
|
9,326 |
|
|
|
23,289 |
|
|
|
26,871 |
|
|
|
47,488 |
|
Selling, general and administrative |
|
23,462 |
|
|
|
18,482 |
|
|
|
82,476 |
|
|
|
54,997 |
|
Total operating expenses |
|
56,439 |
|
|
|
50,030 |
|
|
|
184,417 |
|
|
|
132,356 |
|
Income (loss) from operations |
|
9,462 |
|
|
|
(10,177 |
) |
|
|
71,494 |
|
|
|
(3,130 |
) |
Interest income |
|
(444 |
) |
|
|
197 |
|
|
|
(46 |
) |
|
|
395 |
|
Interest expense |
|
(1,147 |
) |
|
|
(396 |
) |
|
|
(2,065 |
) |
|
|
(1,240 |
) |
Other expense |
|
(7,916 |
) |
|
|
(2,284 |
) |
|
|
(17,636 |
) |
|
|
(1,797 |
) |
Total other expense, net |
|
(9,507 |
) |
|
|
(2,483 |
) |
|
|
(19,747 |
) |
|
|
(2,642 |
) |
(Loss)
income before income tax (provision) benefit |
|
(45 |
) |
|
|
(12,660 |
) |
|
|
51,747 |
|
|
|
(5,772 |
) |
Income tax (provision) benefit |
|
(3,468 |
) |
|
|
7,038 |
|
|
|
(20,652 |
) |
|
|
3,341 |
|
Net
(loss) income |
$ |
(3,513 |
) |
|
$ |
(5,622 |
) |
|
$ |
31,095 |
|
|
$ |
(2,431 |
) |
(Loss) earnings per share attributable to common stockholders: |
|
|
|
|
|
|
|
Basic |
$ |
(0.27 |
) |
|
$ |
(0.43 |
) |
|
$ |
2.41 |
|
|
$ |
(0.19 |
) |
Diluted |
$ |
(0.27 |
) |
|
$ |
(0.43 |
) |
|
$ |
2.38 |
|
|
$ |
(0.19 |
) |
Weighted average number of common shares outstanding: |
|
|
|
|
|
|
|
Basic |
|
13,166,931 |
|
|
|
13,077,298 |
|
|
|
12,906,235 |
|
|
|
13,103,203 |
|
Diluted |
|
13,166,931 |
|
|
|
13,077,298 |
|
|
|
13,051,311 |
|
|
|
13,103,203 |
|
EAGLE PHARMACEUTICALS, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED) |
(In thousands) |
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
|
2022 |
|
|
|
2021 |
|
Cash flows from operating activities: |
|
|
|
Net income (loss) |
$ |
31,095 |
|
|
$ |
(2,431 |
) |
Adjustments to reconcile net income (loss) to net cash provided by
operating activities: |
|
|
|
Deferred income taxes |
|
(4,743 |
) |
|
|
(2,533 |
) |
Depreciation expense |
|
508 |
|
|
|
575 |
|
Non-cash operating lease expense related to right-of-use
assets |
|
917 |
|
|
|
768 |
|
Amortization expense of intangible assets |
|
5,886 |
|
|
|
2,118 |
|
Fair value adjustments on equity investment |
|
(410 |
) |
|
|
1,900 |
|
Stock-based compensation expense |
|
12,332 |
|
|
|
14,873 |
|
Convertible promissory note related credit losses |
|
— |
|
|
|
150 |
|
Amortization of debt issuance costs |
|
354 |
|
|
|
354 |
|
Fair value adjustments related to derivative instruments |
|
962 |
|
|
|
(254 |
) |
Accretion of discount on convertible promissory note |
|
— |
|
|
|
(102 |
) |
Loss on foreign currency exchange rates |
|
7,309 |
|
|
|
— |
|
Loss on write-off of convertible promissory note |
|
4,444 |
|
|
|
— |
|
Changes in operating assets and liabilities which provided
(used) cash: |
|
|
|
Accounts receivable |
|
(55,325 |
) |
|
|
5,343 |
|
Inventories |
|
(15,006 |
) |
|
|
(1,240 |
) |
Prepaid expenses and other current assets |
|
(831 |
) |
|
|
(8,821 |
) |
Accounts payable |
|
(3,824 |
) |
|
|
6,449 |
|
Accrued expenses and other liabilities |
|
33,888 |
|
|
|
3,897 |
|
Other assets and other long-term liabilities, net |
|
(4,412 |
) |
|
|
(908 |
) |
Net cash provided by operating activities |
|
13,144 |
|
|
|
20,138 |
|
Cash flows from investing activities: |
|
|
|
Purchase of Acacia, net of cash acquired |
|
(74,153 |
) |
|
|
— |
|
Purchase of equity investment security |
|
(12,500 |
) |
|
|
— |
|
Purchase of property and equipment |
|
(168 |
) |
|
|
(274 |
) |
Purchase of convertible promissory note |
|
— |
|
|
|
(5,000 |
) |
Net cash used in investing activities |
|
(86,821 |
) |
|
|
(5,274 |
) |
Cash flows from financing activities: |
|
|
|
Proceeds from common stock option exercises |
|
1,747 |
|
|
|
1,841 |
|
Proceeds from existing revolving credit facility |
|
15,000 |
|
|
|
— |
|
Employee withholding taxes related to stock-based awards |
|
(1,341 |
) |
|
|
(1,551 |
) |
Payment of debt |
|
(6,000 |
) |
|
|
(6,000 |
) |
Repurchases of common stock |
|
(18,004 |
) |
|
|
(12,568 |
) |
Net cash used in financing activities |
|
(8,598 |
) |
|
|
(18,278 |
) |
Net decrease in cash and cash equivalents |
|
(82,275 |
) |
|
|
(3,414 |
) |
Cash and cash equivalents at beginning of
period |
|
97,659 |
|
|
|
103,155 |
|
Cash and cash equivalents at end of period |
$ |
15,384 |
|
|
$ |
99,741 |
|
Supplemental disclosures of cash flow
information: |
|
|
|
Cash paid during the period for: |
|
|
|
Income taxes, net |
$ |
18,855 |
|
|
$ |
6,303 |
|
Interest |
|
894 |
|
|
|
917 |
|
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 September 30, |
|
Nine Months Ended September 30, |
|
|
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
|
Net (loss) income - GAAP |
$ |
(3,513 |
) |
|
$ |
(5,622 |
) |
|
$ |
31,095 |
|
|
$ |
(2,431 |
) |
|
|
|
|
|
|
|
|
|
|
|
Adjustments: |
|
|
|
|
|
|
|
|
Cost of product revenues: |
|
|
|
|
|
|
|
|
|
Amortization expense |
|
3,689 |
|
|
|
301 |
|
|
|
5,886 |
|
|
|
903 |
|
|
Research and development: |
|
|
|
|
|
|
|
|
|
Stock-based compensation expense |
|
600 |
|
|
|
641 |
|
|
|
1,844 |
|
|
|
2,177 |
|
|
|
Depreciation expense |
|
42 |
|
|
|
57 |
|
|
|
134 |
|
|
|
164 |
|
|
|
Expense of acquired in-process research & development |
|
- |
|
|
|
15,000 |
|
|
|
- |
|
|
|
15,000 |
|
|
|
Severance |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
274 |
|
|
Selling, general and administrative: |
|
|
|
|
|
|
|
|
|
Stock-based compensation expense |
|
2,937 |
|
|
|
3,443 |
|
|
|
10,488 |
|
|
|
12,696 |
|
|
|
Depreciation expense |
|
121 |
|
|
|
140 |
|
|
|
374 |
|
|
|
411 |
|
|
|
Severance |
|
587 |
|
|
|
- |
|
|
|
8,378 |
|
|
|
334 |
|
|
|
Acquisition related costs |
|
1,498 |
|
|
|
- |
|
|
|
12,837 |
|
|
|
- |
|
|
|
Amortization expense |
|
- |
|
|
|
405 |
|
|
|
- |
|
|
|
1,215 |
|
|
|
Legal settlement |
|
- |
|
|
|
- |
|
|
|
300 |
|
|
|
- |
|
|
Other: |
|
|
|
|
|
|
|
|
|
Non-cash interest expense |
|
756 |
|
|
|
118 |
|
|
|
1,152 |
|
|
|
354 |
|
|
|
Fair value adjustments on equity investment |
|
(3,640 |
) |
|
|
2,300 |
|
|
|
(410 |
) |
|
|
1,900 |
|
|
|
Convertible promissory note related adjustments |
|
4,674 |
|
|
|
4 |
|
|
|
4,646 |
|
|
|
48 |
|
|
|
Fair value adjustments related to derivative instruments |
|
1,624 |
|
|
|
(66 |
) |
|
|
7,255 |
|
|
|
(254 |
) |
|
|
Foreign currency exchange loss |
|
5,751 |
|
|
|
- |
|
|
|
6,549 |
|
|
|
- |
|
|
|
Inventory step-up |
|
392 |
|
|
|
- |
|
|
|
392 |
|
|
|
- |
|
|
Tax effect of the non-GAAP adjustments |
|
(624 |
) |
|
|
(9,205 |
) |
|
|
(3,559 |
) |
|
|
(9,608 |
) |
|
Adjusted
non-GAAP net income |
$ |
14,894 |
|
|
$ |
7,516 |
|
|
$ |
87,361 |
|
|
$ |
23,183 |
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted non-GAAP earnings per share: |
|
|
|
|
|
|
|
|
Basic |
$ |
1.13 |
|
|
$ |
0.57 |
|
|
$ |
6.77 |
|
|
$ |
1.77 |
|
|
Diluted |
$ |
1.12 |
|
|
$ |
0.56 |
|
|
$ |
6.69 |
|
|
$ |
1.74 |
|
|
Weighted average number of common shares outstanding: |
|
|
|
|
|
|
|
|
Basic |
|
13,166,931 |
|
|
|
13,077,298 |
|
|
|
12,906,235 |
|
|
|
13,103,203 |
|
|
Diluted |
|
13,280,811 |
|
|
|
13,307,559 |
|
|
|
13,051,311 |
|
|
|
13,290,677 |
|
|
|
|
|
|
|
|
|
|
|
|
EAGLE PHARMACEUTICALS, INC. |
RECONCILIATION OF GAAP TO ADJUSTED NON-GAAP EBITDA
(UNAUDITED) |
(In thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
Twelve Months Ended September 30, |
|
Twelve Months Ended December 31, |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
2021 |
|
Net (loss) income - GAAP |
$ |
(3,513 |
) |
|
$ |
(5,622 |
) |
|
$ |
31,095 |
|
|
$ |
(2,431 |
) |
|
$ |
24,899 |
|
$ |
(8,627 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Add back: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense, net of interest income |
|
1,591 |
|
|
|
199 |
|
|
|
2,111 |
|
|
|
845 |
|
|
|
2,341 |
|
|
1,075 |
|
|
Income tax provision |
|
3,468 |
|
|
|
(7,038 |
) |
|
|
20,652 |
|
|
|
(3,341 |
) |
|
|
28,072 |
|
|
4,079 |
|
|
Depreciation and amortization expense |
|
3,852 |
|
|
|
903 |
|
|
|
6,394 |
|
|
|
2,693 |
|
|
|
7,461 |
|
|
3,760 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Add back: |
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation expense |
|
3,537 |
|
|
|
4,084 |
|
|
|
12,332 |
|
|
|
14,873 |
|
|
|
17,014 |
|
|
19,555 |
|
|
Fair value adjustments on equity investment |
|
(3,640 |
) |
|
|
2,300 |
|
|
|
(410 |
) |
|
|
1,900 |
|
|
|
3,860 |
|
|
6,170 |
|
|
Expense of acquired in-process research & development |
|
- |
|
|
|
15,000 |
|
|
|
- |
|
|
|
15,000 |
|
|
|
339 |
|
|
15,339 |
|
|
Convertible promissory note related adjustments |
|
4,180 |
|
|
|
50 |
|
|
|
4,242 |
|
|
|
150 |
|
|
|
4,850 |
|
|
758 |
|
|
Fair value adjustments related to derivative instrument |
|
1,624 |
|
|
|
(66 |
) |
|
|
7,255 |
|
|
|
(254 |
) |
|
|
6,823 |
|
|
(686 |
) |
|
Foreign currency exchange loss |
|
5,751 |
|
|
|
- |
|
|
|
6,549 |
|
|
|
- |
|
|
|
6,549 |
|
|
- |
|
|
Legal Settlement |
|
- |
|
|
|
- |
|
|
|
300 |
|
|
|
- |
|
|
|
300 |
|
|
- |
|
|
Acquisition related costs |
|
1,498 |
|
|
|
- |
|
|
|
12,837 |
|
|
|
- |
|
|
|
12,837 |
|
|
- |
|
|
Inventory step-up |
|
392 |
|
|
|
- |
|
|
|
392 |
|
|
|
- |
|
|
|
392 |
|
|
- |
|
|
Severance |
|
587 |
|
|
|
- |
|
|
|
8,378 |
|
|
|
608 |
|
|
|
9,854 |
|
|
2,084 |
|
Adjusted
Non-GAAP EBITDA |
$ |
19,327 |
|
|
$ |
9,810 |
|
|
$ |
112,127 |
|
|
$ |
30,043 |
|
|
$ |
125,591 |
|
$ |
43,507 |
|
Important Safety Information for
BARHEMSYS® (amisulpride)8
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)9 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 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 to their
most comparable GAAP financial measures, please see below and the
tables at the end of this press release.2
https://www.bendekahcp.com/globalassets/bendeka-hcp/prescribinginformation.pdf3
https://belrapzo.com/prescribing-information.pdf4
https://www.bendekahcp.com/globalassets/bendeka-hcp/resources-page/bendeka-treanda-product-characteristics.pdf5
IQVIA SMART-US monthly volume data for the months January and
September 2022.6 Gross profit includes all revenues generated by
bendamustine products and all associated costs of sales including
royalty expense on a GAAP basis, unaudited.7 Subject to the terms
of the Company’s agreement with Enalare, including achievement of
specified milestones.8
https://bynder.acaciapharma.com/m/5d7c2cd0d58865f7/original/Barhemsys-Prescribing-Information.pdf
9
https://bynder.acaciapharma.com/m/403e8c343b2922de/original/Byfavo-PI.pdf
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