Eagle Pharmaceuticals Reports Third Quarter 2021 Results
Eagle Pharmaceuticals reported a Q3 2021 net loss of $5.6 million, or $0.43 per share, a decline from a net income of $7.1 million in Q3 2020. Total revenue decreased to $39.9 million, down from $49.9 million year-over-year, primarily due to lower sales of BELRAPZO and BENDEKA. Adjusted non-GAAP net income was $7.5 million, down from $16.1 million in the previous year. Eagle is preparing for key product launches, including vasopressin and PEMFEXY, and secured a worldwide licensing agreement for CAL02, an antitoxin agent ready for Phase 2b/3 development.
- Entered into a worldwide licensing agreement for CAL02, ready for Phase 2b/3 development.
- Received favorable court decision confirming no patent infringement for vasopressin product.
- Expected product launches for vasopressin and PEMFEXY within the next 90 days could boost revenue.
- Gross margin improved to 79% from 76% year-over-year despite revenue decline.
- Total revenue for Q3 2021 decreased by 20% compared to Q3 2020.
- Net loss of $5.6 million in Q3 2021 compared to net income of $7.1 million in Q3 2020.
- Adjusted non-GAAP net income significantly decreased, down to $7.5 million from $16.1 million year-over-year.
- R&D expenses surged to $23.3 million compared to $4.8 million in Q3 2020, affecting profitability.
-
Q3 2021 net loss was
per basic and diluted share and adjusted non-GAAP net income was$0.43 per basic and$0.57 per diluted share$0.56 -
Expect to receive approval for Abbreviated New Drug Application (“ANDA”) for vasopressin;
December 15, 2021 GDUFA date - Received favorable district court decision that Eagle’s proposed vasopressin product does not infringe any of the patents Par asserted against Eagle
- Entered into worldwide licensing agreement for CAL02, a novel first-in-class antitoxin agent ready for Phase 2b/3 development for the treatment of severe bacterial pneumonia
-
Licensed
U.S. commercial rights to landiolol, a beta-1 adrenergic blocker, a leading hospital emergency use product inEurope andJapan
Business and Recent Highlights:
- Entered into a worldwide licensing agreement for the commercial rights to CAL02, a novel first-in-class antitoxin agent ready for Phase 2b/3 development for the treatment of severe bacterial pneumonia in combination with traditional antibacterial drugs.
-
Vasopressin updates:
-
In
August 2021 , received favorable decision from theU.S. District Court for the District of Delaware that Eagle’s proposed vasopressin product does not infringe any of the patentsPar Pharmaceutical, Inc. asserted against Eagle. -
U.S. Food and Drug Administration (“FDA”) maintained Priority Review for the Company’s ANDA withDecember 15, 2021 GDUFA date. -
Received a 30-day information request from the FDA; Eagle fully responded to the request on
September 20, 2021 , and there are no other review requests outstanding.
-
In
-
Granted
U.S. Patent No. 11,103,483, “Formulations of Bendamustine,” which has been listed in the FDA Orange Book for BENDEKA® and BELRAPZO®. -
Entered into a licensing agreement for the
U.S. commercial rights to landiolol, a leading hospital emergency use product inEurope andJapan . Landiolol is currently approved inEurope for the treatment of non-compensatory sinus tachycardia and tachycardic supraventricular arrhythmias. Eagle will support the submission of a new drug application to the FDA seeking approval for landiolol for the short-term reduction of ventricular rate in patients with supraventricular tachycardia, including atrial fibrillation and atrial flutter.
Financial Highlights
Third Quarter 2021
-
Total revenue for Q3 2021 was
, compared to$39.9 million in Q3 2020, primarily reflecting lower product sales of BELRAPZO and BENDEKA, partially offset by higher product sales of TREAKISYM.$49.9 million -
Q3 2021 net loss was
, or$5.6 million per basic and diluted share, compared to net income of$0.43 , or$7.1 million per basic and$0.52 diluted share in Q3 2020.$0.51 -
Q3 2021 adjusted non-GAAP net income was
, or$7.5 million per basic and$0.57 per diluted share, compared to adjusted non-GAAP net income of$0.56 , or$16.1 million per basic and$1.19 per diluted share, in Q3 2020.$1.17 -
Cash and cash equivalents were
, net accounts receivable was$99.7 million , and debt was$45.3 million as of$28.0 million September 30, 2021 .
“We are preparing for two significant product launches, vasopressin and PEMFEXY™, expected within the next ninety days that we believe will meaningfully increase the revenue and profitability of Eagle. With the recent licensing of CAL02 and landiolol, our expectation going forward is that we will utilize our cash and possibly the balance sheet to further strengthen the pipeline and portfolio,” stated
Third Quarter 2021 Financial Results
Total revenue for the three months ended
Q3 2021 BELRAPZO product sales were
Q3 2021 RYANODEX® product sales were
Royalty revenue was
Three Months Ended |
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2021 |
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2020 |
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(unaudited) | (unaudited) | ||||
Revenue (in thousands): | |||||
Product sales, net | $ |
12,124 |
$ |
17,317 |
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Royalty revenue |
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27,729 |
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27,611 |
|
License and other revenue |
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— |
|
5,000 |
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Total revenue | $ |
39,853 |
$ |
49,928 |
|
Gross Margin was
R&D expense was
SG&A expenses in the third quarter of 2021 totaled
Net loss for the third quarter of 2021 was
Adjusted non-GAAP net income for the third quarter of 2021 was
2021 Expense Guidance
-
R&D spend in 2021, on a non-GAAP basis, is expected to be
, as compared to$34 -$38 million in 2020.$27.8 million -
SG&A spend in 2021, on a non-GAAP basis, is expected to be
, as compared to$52 -$56 million in 2020.$50.9 million - The guidance provided in this section represents forward-looking information, and actual results may vary. Please see the risks and assumptions referred to in the Forward-Looking Statements section of this press release.
Liquidity
As of
In the third quarter of 2021, the Company purchased
Conference Call
As previously announced, Eagle management will host its third quarter 2021 conference call as follows:
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Toll free ( |
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866-342-8591 |
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International |
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203-518-9822 |
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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 one week after the call's completion by dialing 800-839-8292 (US) or 402-220-6069 (International) and entering conference call ID EGRXQ321. The webcast will be archived for 30 days at the aforementioned URL.
About
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 RYANODEX®, BENDEKA®, BELRAPZO®, and its 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,” “may,” “remain,” “potential,” “prepare,” “expected,” “believe,” “plan,” “near future,” “belief,” “guidance,” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding future events such as: the number and timing of potential product launches, development initiatives or new indications for the Company’s product candidates; the period of market exclusivity for any of the Company’s product candidates; potential future revenue or earnings of the Company, including resulting from potential product launches of vasopressin and PEMFEXY; the Company's clinical development plan for the product candidates in its portfolio; the ability of the Company’s executive team to execute on the Company’s strategy and build stockholder value; 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 potential timing of the Company’s commercial launch of PEMFEXY, vasopressin or landiolol, if ever; the Company’s plans for and ability to support the commercial launch of landiolol in
Non-GAAP Financial Performance Measures
In addition to financial information prepared in accordance with
Adjusted non-GAAP net income excludes stock-based compensation expense, depreciation expense, expense of acquired in-process research and development expense, amortization expense, severance, non-cash interest expense, expense related to collaboration with Tyme, fair value adjustments on equity investment, fair value adjustments related to derivative instrument, convertible promissory note related credit losses, accretion of discount on convertible promissory note and the tax effect of these adjustments. The Company believes these non-GAAP financial measures help 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 of GAAP to Adjusted Non-GAAP Net Income and Adjusted Non-GAAP Earnings per Share and Reconciliation of GAAP to Adjusted Non-GAAP EBITDA for details of the amounts excluded and included to arrive at adjusted non-GAAP net income, adjusted non-GAAP earnings per share amounts, and adjusted non-GAAP EBITDA amounts, respectively.
These adjusted measures are non-GAAP and should be considered in addition to, but not as a substitute for, the information prepared in accordance with
-- Financial tables follow --
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) | |||||||
(In thousands, except share amounts) | |||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ |
99,741 |
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$ |
103,155 |
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Accounts receivable, net |
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45,335 |
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|
50,678 |
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Inventories |
|
9,315 |
|
|
8,075 |
|
|
Prepaid expenses and other current assets |
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17,303 |
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|
4,157 |
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Total current assets |
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171,694 |
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166,065 |
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Property and equipment, net |
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1,775 |
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|
2,077 |
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Intangible assets, net |
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10,799 |
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12,917 |
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39,743 |
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39,743 |
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Deferred tax asset, net |
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17,713 |
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15,180 |
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Other assets |
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14,537 |
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17,208 |
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Total assets | $ |
256,261 |
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$ |
253,190 |
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LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ |
12,717 |
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$ |
6,268 |
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Accrued expenses and other liabilities |
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27,714 |
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23,817 |
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Current portion of long-term debt |
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8,000 |
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8,000 |
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Total current liabilities |
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48,431 |
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38,085 |
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Other long-term liabilities |
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3,048 |
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3,959 |
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Long-term debt, less current portion |
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19,489 |
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25,135 |
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Total liabilities |
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70,968 |
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67,179 |
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Commitments and Contingencies | |||||||
Stockholders' equity: | |||||||
Preferred stock, 1,500,000 shares authorized and no shares issued or outstanding as of |
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— |
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— |
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Common stock, |
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17 |
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17 |
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Additional paid in capital |
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320,566 |
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305,403 |
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Accumulated other comprehensive loss |
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(882 |
) |
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— |
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Retained earnings |
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82,058 |
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84,489 |
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(216,466 |
) |
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(203,898 |
) |
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Total stockholders' equity |
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185,293 |
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186,011 |
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Total liabilities and stockholders' equity | $ |
256,261 |
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$ |
253,190 |
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) | |||||||||||||||
(In thousands, except share and per share amounts) | |||||||||||||||
Three Months Ended |
Nine Months Ended |
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2021 |
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2020 |
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2021 |
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2020 |
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Revenue: | |||||||||||||||
Product sales, net | $ |
12,124 |
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$ |
17,317 |
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$ |
48,865 |
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$ |
49,387 |
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Royalty revenue |
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27,729 |
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27,611 |
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80,361 |
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83,499 |
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License and other revenue |
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— |
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5,000 |
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— |
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5,000 |
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Total revenue |
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39,853 |
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49,928 |
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129,226 |
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137,886 |
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Operating expenses: | |||||||||||||||
Cost of product sales |
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5,486 |
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8,726 |
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21,835 |
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23,804 |
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Cost of royalty revenue |
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2,773 |
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3,260 |
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8,036 |
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9,120 |
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Research and development |
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23,289 |
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4,828 |
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47,488 |
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21,390 |
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Selling, general and administrative |
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18,482 |
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17,697 |
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54,997 |
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60,411 |
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Total operating expenses |
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50,030 |
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34,511 |
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132,356 |
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114,725 |
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(Loss) income from operations |
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(10,177 |
) |
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15,417 |
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(3,130 |
) |
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23,161 |
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Interest income |
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197 |
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46 |
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|
395 |
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542 |
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Interest expense |
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(396 |
) |
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(489 |
) |
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(1,240 |
) |
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(2,164 |
) |
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Other expense |
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(2,284 |
) |
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(6,049 |
) |
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(1,797 |
) |
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(10,249 |
) |
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Total other expense, net |
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(2,483 |
) |
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(6,492 |
) |
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(2,642 |
) |
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(11,871 |
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(Loss) income before income tax benefit (provision) |
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(12,660 |
) |
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8,925 |
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(5,772 |
) |
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11,290 |
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Income tax benefit (provision) |
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7,038 |
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(1,866 |
) |
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3,341 |
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(7,358 |
) |
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Net (loss) income | $ |
(5,622 |
) |
$ |
7,059 |
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$ |
(2,431 |
) |
$ |
3,932 |
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(Loss) earnings per share attributable to common stockholders: | |||||||||||||||
Basic | $ |
(0.43 |
) |
$ |
0.52 |
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$ |
(0.19 |
) |
$ |
0.29 |
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Diluted | $ |
(0.43 |
) |
$ |
0.51 |
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$ |
(0.19 |
) |
$ |
0.28 |
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Weighted average number of common shares outstanding: | |||||||||||||||
Basic |
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13,077,298 |
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13,531,372 |
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13,103,203 |
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13,620,981 |
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Diluted |
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13,077,298 |
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13,786,803 |
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13,103,203 |
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13,917,800 |
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CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) | |||||||
(In thousands) | |||||||
Nine Months Ended |
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2021 |
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2020 |
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Cash flows from operating activities: | |||||||
Net (loss) income | $ |
(2,431 |
) |
$ |
3,932 |
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Adjustments to reconcile net (loss) income to net cash provided by operating activities: | |||||||
Deferred income taxes |
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(2,533 |
) |
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(1,671 |
) |
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Depreciation expense |
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575 |
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656 |
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Noncash operating lease expense related to right-of-use assets |
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768 |
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|
980 |
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Amortization expense of intangible assets |
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2,118 |
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|
1,999 |
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Fair value adjustments on equity investment |
|
1,900 |
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|
7,700 |
|
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Stock-based compensation expense |
|
14,873 |
|
|
18,435 |
|
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Convertible promissory note related credit losses |
|
150 |
|
|
— |
|
|
Amortization of debt issuance costs |
|
354 |
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|
301 |
|
|
Fair value adjustments related to derivative instrument |
|
(254 |
) |
|
2,549 |
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Accretion of discount on convertible promissory note |
|
(102 |
) |
|
— |
|
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Changes in operating assets and liabilities which provided (used) cash: | |||||||
Accounts receivable |
|
5,343 |
|
|
(4,195 |
) |
|
Inventories |
|
(1,240 |
) |
|
(20 |
) |
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Prepaid expenses and other current assets |
|
(8,821 |
) |
|
(2,774 |
) |
|
Accounts payable |
|
6,449 |
|
|
7,606 |
|
|
Accrued expenses and other liabilities |
|
3,897 |
|
|
(3,916 |
) |
|
Other assets and other long-term liabilities, net |
|
(908 |
) |
|
(1,845 |
) |
|
Net cash provided by operating activities |
|
20,138 |
|
|
29,737 |
|
|
Cash flows from investing activities: | |||||||
Purchase of equity investment security |
|
— |
|
|
(17,500 |
) |
|
Purchase of property and equipment |
|
(274 |
) |
|
(577 |
) |
|
Purchase of convertible promissory note |
|
(5,000 |
) |
|
— |
|
|
Net cash used in investing activities |
|
(5,274 |
) |
|
(18,077 |
) |
|
Cash flows from financing activities: | |||||||
Proceeds from common stock option exercises |
|
1,841 |
|
|
555 |
|
|
Employee withholding taxes related to stock-based awards |
|
(1,551 |
) |
|
(1,310 |
) |
|
Proceeds from existing revolving credit facility |
|
— |
|
|
110,000 |
|
|
Repayment of existing revolving credit facility |
|
— |
|
|
(110,000 |
) |
|
Payment of debt |
|
(6,000 |
) |
|
(3,000 |
) |
|
Repurchases of common stock |
|
(12,568 |
) |
|
(27,999 |
) |
|
Net cash used in financing activities |
|
(18,278 |
) |
|
(31,754 |
) |
|
Net decrease in cash and cash equivalents |
|
(3,414 |
) |
|
(20,094 |
) |
|
Cash and cash equivalents at beginning of period |
|
103,155 |
|
|
109,775 |
|
|
Cash and cash equivalents at end of period | $ |
99,741 |
|
$ |
89,681 |
|
|
Supplemental disclosures of cash flow information: | |||||||
Cash paid during the period for: | |||||||
Income taxes, net | $ |
6,303 |
|
$ |
3,036 |
|
|
Interest |
|
917 |
|
|
1,878 |
|
|
Right-of-use asset obtained in exchange for lease obligation - lease amendment |
|
— |
|
|
842 |
|
|
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 |
Nine Months Ended |
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|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
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Net (loss) income - GAAP | $ |
(5,622 |
) |
$ |
7,059 |
|
$ |
(2,431 |
) |
$ |
3,932 |
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Adjustments: | ||||||||||||||||
Cost of product revenues: | ||||||||||||||||
Amortization expense |
|
301 |
|
|
261 |
|
|
903 |
|
|
784 |
|
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Research and development: | ||||||||||||||||
Stock-based compensation expense |
|
641 |
|
|
(514 |
) |
|
2,177 |
|
|
2,070 |
|
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Depreciation expense |
|
57 |
|
|
72 |
|
|
164 |
|
|
206 |
|
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Expense of acquired in-process research & development |
|
15,000 |
|
|
- |
|
|
15,000 |
|
|
- |
|
||||
Severance |
|
- |
|
|
- |
|
|
274 |
|
|
- |
|
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Selling, general and administrative: | ||||||||||||||||
Stock-based compensation expense |
|
3,443 |
|
|
5,236 |
|
|
12,696 |
|
|
16,365 |
|
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Expense related to collaboration with Tyme |
|
- |
|
|
- |
|
|
- |
|
|
2,500 |
|
||||
Amortization expense |
|
405 |
|
|
405 |
|
|
1,215 |
|
|
1,215 |
|
||||
Depreciation expense |
|
140 |
|
|
124 |
|
|
411 |
|
|
450 |
|
||||
Severance |
|
- |
|
|
- |
|
|
334 |
|
|
245 |
|
||||
Other: | ||||||||||||||||
Non-cash interest expense |
|
118 |
|
|
118 |
|
|
354 |
|
|
354 |
|
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Fair value adjustments on equity investment |
|
2,300 |
|
|
3,500 |
|
|
1,900 |
|
|
7,700 |
|
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Convertible promissory note related credit losses |
|
50 |
|
|
- |
|
|
150 |
|
|
- |
|
||||
Fair value adjustments related to derivative instrument |
|
(66 |
) |
|
2,549 |
|
|
(254 |
) |
|
2,549 |
|
||||
Accretion of discount on convertible promissory note |
|
(46 |
) |
|
- |
|
|
(102 |
) |
|
- |
|
||||
Tax effect of the non-GAAP adjustments |
|
(9,205 |
) |
|
(2,663 |
) |
|
(9,608 |
) |
|
(2,466 |
) |
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Adjusted non-GAAP net income | $ |
7,516 |
|
$ |
16,147 |
|
$ |
23,183 |
|
$ |
35,904 |
|
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Adjusted non-GAAP earnings per share: | ||||||||||||||||
Basic | $ |
0.57 |
|
$ |
1.19 |
|
$ |
1.77 |
|
$ |
2.64 |
|
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Diluted | $ |
0.56 |
|
$ |
1.17 |
|
$ |
1.74 |
|
$ |
2.58 |
|
||||
Weighted average number of common shares outstanding: | ||||||||||||||||
Basic |
|
13,077,298 |
|
|
13,531,372 |
|
|
13,103,203 |
|
|
13,620,981 |
|
||||
Diluted |
|
13,307,559 |
|
|
13,786,803 |
|
|
13,290,677 |
|
|
13,917,800 |
|
||||
RECONCILIATION OF GAAP TO ADJUSTED NON-GAAP EBITDA (UNAUDITED) | |||||||||||||||||||||
(In thousands) | |||||||||||||||||||||
Three Months Ended |
Nine Months Ended |
Twelve Months Ended |
Twelve Months Ended |
||||||||||||||||||
|
2021 |
|
|
|
2020 |
|
|
2021 |
|
|
|
2020 |
|
2021 |
|
2020 |
|||||
Net (loss) income - GAAP | $ |
(5,622 |
) |
$ |
7,059 |
$ |
(2,431 |
) |
$ |
3,932 |
$ |
5,626 |
|
$ |
11,989 |
||||||
Add back: | |||||||||||||||||||||
Interest expense, net of interest income |
|
199 |
|
|
443 |
|
845 |
|
|
1,622 |
|
1,238 |
|
|
2,015 |
||||||
Income tax (benefit) provision |
|
(7,038 |
) |
|
1,866 |
|
(3,341 |
) |
|
7,358 |
|
(11 |
) |
|
10,688 |
||||||
Depreciation and amortization expense |
|
903 |
|
|
862 |
|
2,693 |
|
|
2,655 |
|
3,576 |
|
|
3,538 |
||||||
Add back: | |||||||||||||||||||||
Stock-based compensation expense |
|
4,084 |
|
|
4,722 |
|
14,873 |
|
|
18,435 |
|
21,194 |
|
|
24,756 |
||||||
Fair value adjustments on equity investment |
|
2,300 |
|
|
3,500 |
|
1,900 |
|
|
7,700 |
|
(500 |
) |
|
5,300 |
||||||
Expense of acquired in-process research & development |
|
15,000 |
|
|
- |
|
15,000 |
|
|
- |
|
15,000 |
|
|
- |
||||||
Convertible promissory note related credit losses |
|
50 |
|
|
- |
|
150 |
|
|
- |
|
150 |
|
|
- |
||||||
Fair value adjustments related to derivative instrument |
|
(66 |
) |
|
2,549 |
|
(254 |
) |
|
2,549 |
|
159 |
|
|
2,962 |
||||||
Expense related to collaboration with Tyme |
|
- |
|
|
- |
|
- |
|
|
2,500 |
|
- |
|
|
2,500 |
||||||
Severance |
|
- |
|
|
- |
|
608 |
|
|
245 |
|
1,287 |
|
|
924 |
||||||
Adjusted Non-GAAP EBITDA | $ |
9,810 |
|
$ |
21,001 |
$ |
30,043 |
|
$ |
46,996 |
$ |
47,719 |
|
$ |
64,672 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20211109005935/en/
Investor Relations for
T: 212-452-2793
E: lwilson@insitecony.com
Source:
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