On November 9, 2021 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported financial results for the three and nine months ended September 30, 2021 (Press release, Eagle Pharmaceuticals, NOV 9, 2021, View Source [SID1234594847]).
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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 the U.S. District Court for the District of Delaware that Eagle’s proposed vasopressin product does not infringe any of the patents Par Pharmaceutical, Inc. asserted against Eagle.
U.S. Food and Drug Administration ("FDA") maintained Priority Review for the Company’s ANDA with December 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.
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 in Europe and Japan. Landiolol is currently approved in Europe 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 $39.9 million, compared to $49.9 million in Q3 2020, primarily reflecting lower product sales of BELRAPZO and BENDEKA, partially offset by higher product sales of TREAKISYM.
Q3 2021 net loss was $5.6 million, or $0.43 per basic and diluted share, compared to net income of $7.1 million, or $0.52 per basic and $0.51 diluted share in Q3 2020.
Q3 2021 adjusted non-GAAP net income was $7.5 million, or $0.57 per basic and $0.56 per diluted share, compared to adjusted non-GAAP net income of $16.1 million, or $1.19 per basic and $1.17 per diluted share, in Q3 2020.
Cash and cash equivalents were $99.7 million, net accounts receivable was $45.3 million, and debt was $28.0 million as of 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 Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.
Third Quarter 2021 Financial Results
Total revenue for the three months ended September 30, 2021 was $39.9 million, as compared to $49.9 million for the three months ended September 30, 2020.
Q3 2021 BELRAPZO product sales were $4.9 million, compared to $8.7 million in Q3 2020.
Q3 2021 RYANODEX product sales were $4.5 million, compared to $4.2 million in Q3 2020.
Royalty revenue was $27.7 million in the third quarter of 2021, compared to $27.6 million in the third quarter of 2020. BENDEKA royalties were $26.5 million in the third quarter of 2021, compared to $27.6 million in the third quarter of 2020. A summary of total revenue is outlined below:
Gross Margin was 79% during the third quarter of 2021, as compared to 76% in the third quarter of 2020. The increase in gross margin for the third quarter of 2021 was driven by revenue mix.
R&D expense was $23.3 million for the third quarter of 2021, compared to $4.8 million in the third quarter of 2020. The increase includes a $10.0 million upfront payment related to our license agreement with Combioxin for CAL02, a $5.0 million upfront expense related to our licensing agreement with AOP Orphan for landiolol, a $0.8 million increase in development and pre-launch inventory costs for vasopressin and a $1.1 million increase related to PEMFEXY. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense during the third quarter of 2021 was $7.6 million.
SG&A expenses in the third quarter of 2021 totaled $18.5 million compared to $17.7 million in the third quarter of 2020. This increase is primarily related to higher external legal costs partially offset by a decrease in stock-based compensation expense. Excluding stock-based compensation and other non-cash and non-recurring items, third quarter 2021 SG&A expense was $14.5 million.
Net loss for the third quarter of 2021 was $5.6 million, or $0.43 per basic and diluted share, compared to net income of $7.1 million, or $0.52 per basic and $0.51 per diluted share, in the third quarter of 2020, due to the factors discussed above.
Adjusted non-GAAP net income for the third quarter of 2021 was $7.5 million, or $0.57 per basic and $0.56 per diluted share, compared to adjusted non-GAAP net income of $16.1 million or $1.19 per basic and $1.17 per diluted share in the third quarter of 2020. For a full reconciliation of adjusted non-GAAP net income to the most comparable GAAP financial measures, please see the tables at the end of this press release.
2021 Expense Guidance
R&D spend in 2021, on a non-GAAP basis, is expected to be $34-$38 million, as compared to $27.8 million in 2020.
SG&A spend in 2021, on a non-GAAP basis, is expected to be $52-$56 million, as compared to $50.9 million in 2020.
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 September 30, 2021, the Company had $99.7 million in cash and cash equivalents plus $45.3 million in net accounts receivable. The Company had $28.0 million in outstanding debt. Therefore, as of September 30, 2021, the Company had net cash plus receivables of $117.0 million.
In the third quarter of 2021, the Company purchased $8.3 million of its common stock as part of its $160.0 million Share Repurchase Program. From August 2016 through September 30, 2021, the Company has repurchased $219.4 million of its common stock.
Conference Call
As previously announced, Eagle management will host its third quarter 2021 conference call as follows:
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.