Eagle Pharmaceuticals Reports Third Quarter 2021 Results

09 Nov 2021
www.biospace.com
CollaborateFinancial StatementFirst in ClassPriority Review
Nov. 9, 2021 11:50 UTC Q3 2021 net loss was $0.43 per basic and diluted share and adjusted non-GAAP net income was $0.57 per basic and $0.56 per diluted share 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 in Europe and Japan WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)-- Eagle Pharmaceuticals. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced financial results for the three and nine months ended September 30, 2021. 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: Three Months Ended September 30, 2021 2020 (unaudited) (unaudited) Revenue (in thousands): Product sales, net $ 12,124 $ 17,317 Royalty revenue 27,729 27,611 License and other revenue — 5,000 Total revenue $ 39,853 $ 49,928 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: Date Tuesday, November 9, 2021 Time 8:30 A.M. EDT Toll free (U.S.) 866-342-8591 International 203-518-9822 Webcast (live and replay) , 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 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 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 . 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 the United States, if approved; the ability of the Company’s product candidates, including landiolol, vasopressin and PEMFEXY, to deliver value to stockholders; ; the success of the Company's collaborations with its strategic partners and the timing and results of these partners’ preclinical studies and clinical trials; the Company’s timing and ability to enroll patients in ongoing and upcoming clinical trials; the ability of the Company to obtain and maintain coverage and adequate reimbursement for its products; the implementation of certain healthcare reform measures; the Company's timing and ability to repurchase additional shares of the Company's common stock, if any, under its Share Repurchase Program; the Company's ability to deliver value in 2021 and over the long term; 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. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the Company's control, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. Such risks and uncertainties include, but are not limited to: the impacts of the COVID-19 pandemic, 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 on the Company's business, financial condition and results of operations; risks that the Company's business, financial condition and results of operations will be impacted by the spread of COVID-19 in the geographies where the Company's third-party partners operate; 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 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 our 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, 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 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, 2020 filed with the Securities and Exchange Commission (the “SEC”) on March 5, 2021, as updated by the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, which the Company expects to the SEC on November 9, 2021, and its other subsequent filings with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and the Company does not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events, except as required by law. 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 and adjusted non-GAAP earnings per share attributable to Eagle. 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 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 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 measures used by the Company may differ from similar measures used by other companies, even when similar terms are used to identify such measures. -- Financial tables follow -- EAGLE PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) (In thousands, except share amounts) September 30, 2021 December 31, 2020 ASSETS Current assets: Cash and cash equivalents $ 99,741 $ 103,155 Accounts receivable, net 45,335 50,678 Inventories 9,315 8,075 Prepaid expenses and other current assets 17,303 4,157 Total current assets 171,694 166,065 Property and equipment, net 1,775 2,077 Intangible assets, net 10,799 12,917 Goodwill 39,743 39,743 Deferred tax asset, net 17,713 15,180 Other assets 14,537 17,208 Total assets $ 256,261 $ 253,190 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 12,717 $ 6,268 Accrued expenses and other liabilities 27,714 23,817 Current portion of long-term debt 8,000 8,000 Total current liabilities 48,431 38,085 Other long-term liabilities 3,048 3,959 Long-term debt, less current portion 19,489 25,135 Total liabilities 70,968 67,179 Commitments and Contingencies Stockholders' equity: Preferred stock, 1,500,000 shares authorized and no shares issued or outstanding as of September 30, 2021 and December 31, 2020 — — Common stock, $0.001 par value; 50,000,000 shares authorized; 16,886,123 and 16,739,203 shares issued as of September 30, 2021 and December 31, 2020, respectively 17 17 Additional paid in capital 320,566 305,403 Accumulated other comprehensive loss (882 ) — Retained earnings 82,058 84,489 Treasury stock, at cost, 3,941,541 and 3,682,176 shares as of September 30, 2021 and December 31, 2020, respectively (216,466 ) (203,898 ) Total stockholders' equity 185,293 186,011 Total liabilities and stockholders' equity $ 256,261 $ 253,190 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, 2021 2020 2021 2020 Revenue: Product sales, net $ 12,124 $ 17,317 $ 48,865 $ 49,387 Royalty revenue 27,729 27,611 80,361 83,499 License and other revenue — 5,000 — 5,000 Total revenue 39,853 49,928 129,226 137,886 Operating expenses: Cost of product sales 5,486 8,726 21,835 23,804 Cost of royalty revenue 2,773 3,260 8,036 9,120 Research and development 23,289 4,828 47,488 21,390 Selling, general and administrative 18,482 17,697 54,997 60,411 Total operating expenses 50,030 34,511 132,356 114,725 (Loss) income from operations (10,177 ) 15,417 (3,130 ) 23,161 Interest income 197 46 395 542 Interest expense (396 ) (489 ) (1,240 ) (2,164 ) Other expense (2,284 ) (6,049 ) (1,797 ) (10,249 ) Total other expense, net (2,483 ) (6,492 ) (2,642 ) (11,871 ) (Loss) income before income tax benefit (provision) (12,660 ) 8,925 (5,772 ) 11,290 Income tax benefit (provision) 7,038 (1,866 ) 3,341 (7,358 ) Net (loss) income $ (5,622 ) $ 7,059 $ (2,431 ) $ 3,932 (Loss) earnings per share attributable to common stockholders: Basic $ (0.43 ) $ 0.52 $ (0.19 ) $ 0.29 Diluted $ (0.43 ) $ 0.51 $ (0.19 ) $ 0.28 Weighted average number of common shares outstanding: Basic 13,077,298 13,531,372 13,103,203 13,620,981 Diluted 13,077,298 13,786,803 13,103,203 13,917,800 EAGLE PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) (In thousands) Nine Months Ended September 30, 2021 2020 Cash flows from operating activities: Net (loss) income $ (2,431 ) $ 3,932 Adjustments to reconcile net (loss) income to net cash provided by operating activities: Deferred income taxes (2,533 ) (1,671 ) Depreciation expense 575 656 Noncash operating lease expense related to right-of-use assets 768 980 Amortization expense of intangible assets 2,118 1,999 Fair value adjustments on equity investment 1,900 7,700 Stock-based compensation expense 14,873 18,435 Convertible promissory note related credit losses 150 — Amortization of debt issuance costs 354 301 Fair value adjustments related to derivative instrument (254 ) 2,549 Accretion of discount on convertible promissory note (102 ) — Changes in operating assets and liabilities which provided (used) cash: Accounts receivable 5,343 (4,195 ) Inventories (1,240 ) (20 ) 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 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, 2021 2020 2021 2020 Net (loss) income - GAAP $ (5,622 ) $ 7,059 $ (2,431 ) $ 3,932 Adjustments: Cost of product revenues: Amortization expense 301 261 903 784 Research and development: Stock-based compensation expense 641 (514 ) 2,177 2,070 Depreciation expense 57 72 164 206 Expense of acquired in-process research & development 15,000 - 15,000 - Severance - - 274 - Selling, general and administrative: Stock-based compensation expense 3,443 5,236 12,696 16,365 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 Fair value adjustments on equity investment 2,300 3,500 1,900 7,700 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 ) Adjusted non-GAAP net income $ 7,516 $ 16,147 $ 23,183 $ 35,904 Adjusted non-GAAP earnings per share: Basic $ 0.57 $ 1.19 $ 1.77 $ 2.64 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 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, 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
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