You should read the following discussion and analysis of our financial condition and results of operations together with our condensed consolidated financial statements and the related notes and other financial information included elsewhere in this Quarterly Report on Form 10-Q and our audited financial statements and the related notes and other financial information included in our Annual Report on Form 10-K for the year endedDecember 31, 2021 filed with theU.S. Securities and Exchange Commission (the "SEC") onMarch 9, 2022 (the "Form 10-K"). Forward-looking Statements This Quarterly Report on Form 10-Q contains "forward-looking statements" within the meaning of the federal securities laws, and such statements may involve substantial risks and uncertainties. All statements, other than statements of historical facts included in this Quarterly Report on Form 10-Q, including statements concerning our plans, objectives, goals, strategies, future events, future revenues or performance, future expenses, financing needs, plans or intentions relating to acquisitions, business trends and other information referred to under this section titled "Management's Discussion and Analysis of Financial Condition and Results of Operations" are forward-looking statements. Forward-looking statements generally relate to future events or our future financial or operating performance. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "plan," "anticipate," "target," "forecast" or the negative of these terms and similar expressions intended to identify forward-looking statements. Forward-looking statements are not historical facts and reflect our current views with respect to future events. Forward-looking statements are also based on assumptions and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. There are a number of risks, uncertainties and other important factors that could cause our actual results to differ materially from the forward-looking statements contained in this Quarterly Report on Form 10-Q. Such risks, uncertainties and other factors are described under "Risk Factors" in Part I, Item 1A of our Form 10-K and Part II, Item 1A of this Quarterly Report on Form 10-Q. We caution you that these risks, uncertainties and other factors may not contain all of the risks, uncertainties and other factors that are important to you. In addition, we cannot assure you that we will realize the results, benefits or developments that we expect or anticipate or, even if substantially realized, that they will affect us or our business in the way expected. All forward-looking statements in this Quarterly Report on Form 10-Q apply only as of the date made and are expressly qualified in their entirety by the cautionary statements included in this Quarterly Report on Form 10-Q. We undertake no obligation to publicly update or revise any forward-looking statements to reflect subsequent events or circumstances.
Business Overview
La Jolla Pharmaceutical Company is dedicated to the commercialization of innovative therapies that improve outcomes in patients suffering from life-threatening diseases. GIAPREZA® (angiotensin II) injection is approved by theU.S. Food and Drug Administration ("FDA") as a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock. XERAVA® (eravacycline) for injection is approved by the FDA as a tetracycline class antibacterial indicated for the treatment of complicated intra-abdominal infections ("cIAI") in patients 18 years of age and older. OnJuly 10, 2022 , the Company entered into an Agreement and Plan of Merger (the "Merger Agreement") with Innoviva, Inc., aDelaware corporation (the "Parent") andInnoviva Acquisition Sub, Inc. , aDelaware corporation and a wholly owned subsidiary of the Parent (the "Purchaser"). The Merger Agreement provides for the acquisition of the Company by the Parent through a cash tender offer (the "Offer") by the Purchaser for all of the Company's outstanding shares of common stock, for$6.23 per share of common stock (the "Offer Price"). Purchaser commenced the Offer onJuly 25, 2022 and the Offer will expire one minute after11:59 p.m. New York City Time, onAugust 19, 2022 , unless the Offer is extended or terminated. Following the completion of the Offer, the satisfaction or waiver of certain conditions set forth in the Merger Agreement and in accordance with the General Corporation Law of theState of Delaware , the Purchaser will merge with and into the Company, with the Company surviving as a wholly owned subsidiary of the Parent. 18 --------------------------------------------------------------------------------
Product Portfolio [[Image Removed]] (1) ForU.S. and European approval (2)U.S. : GIAPREZA is a vasoconstrictor to increase blood pressure in adults with septic or other distributive shockEuropean Union : GIAPREZA is indicated for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies (3)U.S. : XERAVA is a tetracycline class antibacterial indicated for the treatment of cIAIs in patients 18 years of age and olderEuropean Union : XERAVA is indicated for the treatment of cIAI in adults GIAPREZA® (angiotensin II) GIAPREZA® (angiotensin II) injection is approved by the FDA as a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock. GIAPREZA is approved by theEuropean Commission ("EC") for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies. GIAPREZA mimics the body's endogenous angiotensin II peptide, which is central to the renin-angiotensin-aldosterone system ("RAAS"), which in turn regulates blood pressure. GIAPREZA is marketed in theU.S. byLa Jolla Pharmaceutical Company on behalf ofLa Jolla Pharma, LLC , its wholly owned subsidiary, and is marketed inEurope byPAION Deutschland GmbH on behalf ofLa Jolla Pharma, LLC .
XERAVA® (eravacycline)
XERAVA® (eravacycline) for injection is approved by the FDA as a tetracycline class antibacterial indicated for the treatment of complicated intra-abdominal infections ("cIAI") in patients 18 years of age and older. XERAVA is approved by the EC for the treatment of cIAI in adults. XERAVA is marketed in theU.S. by Tetraphase Pharmaceuticals, Inc., a wholly owned subsidiary of La Jolla, and is marketed inEurope byPAION Deutschland GmbH on behalf of Tetraphase. Everest, the Company's licensee for mainlandChina ,Taiwan ,Hong Kong ,Macau ,South Korea ,Singapore , theMalaysian Federation , the Kingdom ofThailand , theRepublic of Indonesia , theSocialist Republic of Vietnam and theRepublic of the Philippines , submitted an NDA inChina , which was accepted by theChina National Medical Products Administration ("NMPA") inMarch 2021 . XERAVA was approved inSingapore by theHealth Science Authority inApril 2020 .
Product Candidates
In connection with the acquisition of Tetraphase, we acquired the following product candidates that are in early stage clinical or preclinical development: (i) TP-6076, an IV formulation of a fully synthetic fluorocycline derivative for the treatment of certain multidrug-resistant gram-negative bacteria; (ii) TP-271, an IV and oral formulation of a fully synthetic fluorocycline for the treatment of respiratory disease caused by bacterial biothreat and antibiotic-resistant public health pathogens, as well as bacterial pathogens associated with community-acquired bacterial pneumonia; and (iii) TP-2846, an IV formulation of a tetracycline for the treatment of acute myeloid leukemia. At this time, there are no active studies nor anticipated future studies for any of these product candidates. We intend to seek out-license opportunities for these product candidates; however, we are unable to predict the likelihood of successfully out-licensing any of these product candidates. 19 --------------------------------------------------------------------------------
Results of Operations
The following table summarizes our results of operations for each of the periods below (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2022 2021 Change 2022 2021 Change Net product sales$ 10,511 $ 11,059 $ (548 ) $ 20,920 $ 19,696 $ 1,224 License and other revenue 32 5,000 (4,968 ) 48 30,500 (30,452 ) Cost of product sales 1,691 2,156 (465 ) 3,856 4,887 (1,031 ) Cost of license and other revenue 6 - 6 11 3,600 (3,589 ) Selling, general and administrative expense 9,762 8,996 766 20,035 17,751 2,284 Research and development expense 154 1,114 (960 ) 181 2,672 (2,491 ) Other income (expense), net 3,545 (60 ) 3,605 5,593 (3,117 ) 8,710 Provision for income taxes 17 - 17 18 18 - Net income$ 2,458 $ 3,733 $ (1,275 ) $ 2,460 $ 18,151 $ (15,691 ) Net Product Sales Net product sales consist of revenue recognized from sales of GIAPREZA and XERAVA to hospitals and other healthcare organizations in theU.S. , generally through a network of specialty distributors. These specialty distributors are considered our customers for accounting purposes. For the three and six months endedJune 30, 2022 , La Jolla's net product sales were$10.5 million and$20.9 million , respectively, compared to$11.1 million and$19.7 million , respectively, for the same periods in 2021. For the three and six months endedJune 30, 2022 , GIAPREZAU.S. net product sales were$7.3 million and$15.0 million , respectively, compared to$8.6 million and$15.4 million , respectively, for the same periods in 2021. For the three and six months endedJune 30, 2022 , XERAVAU.S. net product sales were$3.2 million and$5.9 million , respectively, compared to$2.5 million and$4.3 million , respectively, for the same periods in 2021. The decrease in GIAPREZAU.S. net product sales is primarily due to a decrease in the number of vials sold to our customers. The increase in XERAVAU.S. net product sales is primarily due to an increase in the number of vials sold to our customers.
License and Other Revenue
License and other revenue consists of revenue from out-license agreements with counterparties to develop and/or commercialize our products in territories outside of theU.S. in exchange for: (i) nonrefundable, upfront license fees; (ii) development, regulatory or commercial milestone payments; and/or (iii) sales-based royalties. License and other revenue also consists of revenue from commercial supply agreements with our out-licensees to supply a minimum quantity of our products in territories outside theU.S. in exchange for: (i) nonrefundable, upfront fees; and/or (ii) the reimbursement of manufacturing costs, plus a margin in certain cases. For the three and six months endedJune 30, 2022 , La Jolla's license and other revenue was$32,000 and$48,000 , respectively, compared to$5.0 million and$30.5 million , respectively, for the same periods in 2021. For the three and six months endedJune 30, 2022 , La Jolla's license and other revenue consists of royalties from out-license agreements. The three months endedJune 30, 2021 , consists of$5.0 million for the transfer of certain XERAVA-related manufacturing know-how to Everest in connection with the Everest commercial supply agreement (the "Technology Transfer"). The six months endedJune 30, 2021 , consists of: (i) a$22.5 million upfront payment in connection with the PAION license; (ii) a$3.0 million milestone payment received in connection with the Company's agreements with PAION AG and Everest Medicines Limited covering ex-U.S. rights to GIAPREZA and XERAVA; and (iii)$5.0 million for the Technology Transfer. Cost of Product Sales Cost of product sales consists primarily of expense associated with: (i) manufacturing; (ii) royalties payable toGeorge Washington University ,Harvard University and Paratek Pharmaceuticals, Inc.; (iii) shipping and distribution; and (iv) the inventory fair value step-up adjustment recorded in connection with the acquisition of Tetraphase. La Jolla's cost of product sales were$1.7 million and$3.9 million for the three and six months endedJune 30, 2022 , respectively, compared to$2.2 million and$4.9 million , respectively, for the same periods in 2021. For the three and six months endedJune 30, 2021 , cost of product sales includes zero and$0.9 million , respectively, of the 20 --------------------------------------------------------------------------------
inventory fair value step-up adjustment recorded in connection with the
acquisition of Tetraphase. No such adjustment was included in costs of product
sales for the three and six months ended
Cost of License and Other Revenue
Cost of license and other revenue consists of amounts due under in-license agreements and commercial supply agreements in connection with license and other revenue from commercially approved product. Cost of license and other revenue recognized in connection with product that is not commercially approved is recorded as research and development expense. For the three and six months endedJune 30, 2022 , La Jolla's cost of license and other revenue was$6,000 and$11,000 , respectively, compared to zero and$3.6 million , respectively, for the same periods in 2021. This decrease is due to a decrease in amounts due under theGeorge Washington University andHarvard University license agreements of$2.7 million and$0.9 million , respectively, in connection with the upfront cash payment received pursuant to the PAION AG out-license agreement.
Selling, General and Administrative Expense
Selling, general and administrative expense consists of non-personnel and personnel expenses. Non-personnel-related expense includes expense related to: (i) professional fees for legal, patent, consulting, accounting and audit services; (ii) sales and marketing costs such as speaker programs, advertising and promotion, travel and marketing data; and (iii) facilities and information technology. Personnel-related expense includes expense related to salaries, benefits and share-based compensation for personnel engaged in sales, finance and administrative functions. We expect our selling, general and administrative expense to increase in the third quarter of 2022 due to transaction costs related to the Merger Agreement. The following table summarizes these expenses for each of the periods below (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2022 2021 Change 2022 2021 Change
Non-personnel expense: Professional fees$ 1,618 $ 1,266 $ 352 $ 3,203 $ 2,794 $ 409 Sales and marketing 1,313 1,315 (2 ) 2,670 2,510 159 Amortization of Intangibles 388 388 - 776 776 - Facility 62 105 (43 ) 129 119 10 Other 438 423 15 1,098 826 272 Total non-personnel expense 3,819 3,496 322 7,875 7,025 850 Personnel expense: Salaries, bonuses and benefits 4,609 4,523 86 9,581 8,909 673 Share-based compensation expense 1,334 977 357 2,579 1,817 762 Total personnel expense 5,943 5,500 443 12,160 10,726 1,434 Total selling, general and administrative expense$ 9,762 $ 8,996 $ 765 $
20,035
During the three and six months endedJune 30, 2022 , total selling, general and administrative non-personnel expense increased compared to the same periods in 2021 primarily as a result of: (i) an increase in transaction costs in connection with the Merger Agreement; (ii) an increase in speaker programs, advertising and other promotional activities to support growing net product sales for both GIAPREZA and XERAVA; and (iii) an increase in non-personnel allocations to general and administrative activities. During the three months endedJune 30, 2022 , total selling, general and administrative personnel expense increased compared to the same period in 2021 primarily due to an increase in share-based compensation expense resulting from an increase in the volume and grant date fair value of stock options granted to employees in connection with their annual performance. During the six months endedJune 30, 2022 , total selling, general and administrative personnel expense increased compared to the same period in 2021 primarily as a result of: (i) an increase in the average per cost of employee; (ii) an increase in personnel allocations to general and administrative activities; and (iii) an increase in 21 -------------------------------------------------------------------------------- share-based compensation expense resulting from an increase in the volume and grant date fair value of stock options granted to employees in connection with their annual performance.
Research and Development Expense
Research and development expense consists of non-personnel and personnel expenses. Non-personnel-related expense includes expense related to: (i) manufacturing development; (ii) amounts due under in-license agreements for drug product that is not commercially approved; and (iii) conducting post-marketing pediatric studies. Personnel-related expense includes expense related to salaries, benefits and share-based compensation for personnel engaged in research and development functions. We do not expect our research and development expense to be significant going forward. During the three and six months endedJune 30, 2022 , total research and development expense was$0.2 million and$0.2 million , respectively, compared to$1.1 million and$2.7 million , respectively, for the same period in 2021. These decreases are primarily due to: (i) a decrease in amounts due under in-license agreements for drug product that was not commercially approved; (ii) decreases in manufacturing development and post-marketing pediatric study expenses; and (iii) a decrease in total research and development personnel expense, including share-based compensation expense, due to a decrease in personnel allocations to research and development activities.
Other Income (Expense), Net
Other income (expense), net consists primarily of the following: (i) income from distributions received in connection with the Company's non-core asset, consisting of a non-voting minority interest in a private company (the "Minority Interest"); (ii) interest expense accrued for our deferred royalty obligation; (iii) a gain on the forgiveness of Paycheck Protection Program loan ("PPP Loan"); (iv) unrealized losses on changes in fair value of short term investments; and (vi) gains and/or losses resulting from changes in the fair value of contingent value rights ("CVRs").
During the three months ended
During the six months endedJune 30, 2022 , other income (expense), net was$5.6 million , compared to$(3.1) million for the same period in 2021. This increase is primarily due to: (i) a$5.5 million increase in the receipt of distributions in connection with the Company's Minority Interest; (ii) a$2.3 million increase due to a gain on the forgiveness of the PPP Loan by theU.S. Small Business Administration ; and (iii) a$0.3 million decrease in interest expense accrued for our deferred royalty obligation.
Liquidity and Capital Resources
As ofJune 30, 2022 andDecember 31, 2021 , we had cash, cash equivalents and short-term investments of$48.7 million and$46.7 million , respectively. The increase in cash, cash equivalents and short-term investments is primarily due to net cash provided by operating activities, offset by purchases of the Company's common stock under its stock repurchase plan. For the six months endedJune 30, 2022 , La Jolla's net cash provided by operating activities was$9.2 million compared to$24.3 million for the same period in 2021. The 2021 period included a$16.8 million net upfront payment and a$3.0 million milestone payment received in connection with the Company's agreements with PAION AG and Everest Medicines Limited covering ex-U.S. rights to GIAPREZA and XERAVA. We believe that our existing cash, cash equivalents and short-term investments will be sufficient to fund operations for at least one year from the date this Quarterly Report on Form 10-Q is filed with theSEC . The Company expects to fund future operations with existing cash or cash generated from operations. The amount and timing of additional future funding needs, if any, will depend on many factors, including the success of our commercialization efforts for GIAPREZA and XERAVA and our ability to control expenses. If the pending transaction with Innoviva, Inc. does not close, and if necessary, we intend to raise additional capital through equity or debt financings. We can provide no assurance that additional financing will be available to us on favorable terms, or at all. 22 --------------------------------------------------------------------------------
Contractual Obligations
HealthCare Royalty Partners Royalty Agreement
InMay 2018 , we closed a$125.0 million royalty financing agreement (the "Royalty Agreement") withHealthCare Royalty Partners ("HCR"). Under the terms of the Royalty Agreement, we received$125.0 million in exchange for tiered royalty payments on worldwide net sales of GIAPREZA. HCR is entitled to receive quarterly royalties on worldwide net sales of GIAPREZA beginningApril 1, 2018 . Quarterly payments to HCR under the Royalty Agreement start at a maximum royalty rate, with step-downs based on the achievement of annual net product sales thresholds. ThroughDecember 31, 2021 , the maximum royalty rate was 10%. StartingJanuary 1, 2022 , the maximum royalty rate increased by 4%, and, startingJanuary 1, 2024 , the maximum royalty rate may increase by an additional 4% if an agreed-upon, cumulative net product sales threshold has not been met. The Royalty Agreement is subject to maximum aggregate royalty payments to HCR of$225.0 million . The Royalty Agreement expires upon the first to occur ofJanuary 1, 2031 or when the maximum aggregate royalty payments have been made. The Royalty Agreement was entered into by our wholly owned subsidiary,La Jolla Pharma, LLC , and HCR has no recourse under the Royalty Agreement againstLa Jolla Pharmaceutical Company or any assets other than GIAPREZA. See - Recent Developments. In-license Agreements
InDecember 2014 , the Company entered into a patent license agreement withGeorge Washington University ("GW"), which was subsequently amended and restated (the "GW License") and assigned toLa Jolla Pharma, LLC . Pursuant to the GW License, GW exclusively licensed to the Company certain intellectual property rights relating to GIAPREZA, including the exclusive rights to certain issued patents and patent applications covering GIAPREZA. Under the GW License,La Jolla Pharma, LLC is obligated to use commercially reasonable efforts to develop, commercialize, market and sell GIAPREZA. The Company has paid a one-time license initiation fee, annual maintenance fees, an amendment fee, additional payments following the achievement of certain development and regulatory milestones and royalties. The Company is obligated to pay a 6% royalty on net sales of GIAPREZA and 15% on payments received from sublicensees. The obligation to pay royalties under this agreement extends through the last-to-expire patent covering GIAPREZA.
InAugust 2006 , the Company entered into a license agreement withHarvard University ("Harvard"), which was subsequently amended and restated (the "Harvard License"). Pursuant to the Harvard License, Harvard exclusively licensed to the Company certain intellectual property rights relating to tetracycline-based products, including XERAVA, including the exclusive rights to certain issued patents and patent applications covering such products. Under the Harvard License, the Company is obligated to use commercially reasonable efforts to develop, commercialize, market and sell tetracycline-based products, including XERAVA. For each product covered by the Harvard License, the Company is obligated to make certain payments for the following: (i) up to approximately$15.1 million upon the achievement of certain clinical development and regulatory milestones; (ii) a 5% royalty on directU.S. net sales of XERAVA; (iii) a single-digit tiered royalty on direct ex-U.S. net sales of XERAVA, starting at a minimum royalty rate of 4.5%, with step-ups to a maximum royalty of 7.5% based on the achievement of annual net product sales thresholds; and (iv) 20% on payments received from sublicensees. The obligation to pay royalties under this agreement extends through the last-to-expire patent covering tetracycline-based products, including XERAVA.
Paratek Pharmaceuticals, Inc.
InMarch 2019 , the Company entered into a license agreement with Paratek Pharmaceuticals, Inc. ("Paratek"), which was subsequently amended and restated (the "Paratek License"). Pursuant to the Paratek License, Paratek non-exclusively licensed to the Company certain intellectual property rights relating to XERAVA, including non-exclusive rights to certain issued patents and patent applications covering XERAVA. The Company is obligated to pay Paratek a 2.25% royalty based on directU.S. net sales of XERAVA. The Company's obligation to pay royalties with respect to the licensed product is retroactive to the date of the first commercial sale of XERAVA and shall continue until there are no longer any valid claims of the Paratek patents, which will expire inOctober 2023 . Out-license Agreements PAION AG InJanuary 2021 ,La Jolla Pharmaceutical Company and certain of its wholly owned subsidiaries, includingLa Jolla Pharma, LLC and Tetraphase Pharmaceuticals, Inc., entered into an exclusive license agreement (the "PAION 23 -------------------------------------------------------------------------------- License") with PAION AG and its wholly owned subsidiary (collectively, "PAION"). Pursuant to the PAION License, La Jolla granted PAION an exclusive license to commercialize GIAPREZA and XERAVA in the European Economic Area, theUnited Kingdom andSwitzerland (collectively, the "PAION Territory"). La Jolla has received an upfront cash payment of$22.5 million , less a 15% refundable withholding tax, and is entitled to receive potential commercial milestone payments of up to$109.5 million and double-digit tiered royalty payments. In addition, royalties payable under the PAION License will be subject to reduction on account of generic competition and after patent expiration in a jurisdiction. La Jolla recognized the upfront cash payment of$22.5 million as license and other revenue for the six months endedJune 30, 2021 . As ofJune 30, 2022 andDecember 31, 2021 , the 15% refundable withholding tax of$2.3 million and$3.4 million , respectively, was recorded as an other current asset. OnJuly 7, 2022 , the Company received the remaining refundable withholding tax. Pursuant to the PAION License, PAION will be solely responsible for the future development and commercialization of GIAPREZA and XERAVA in the PAION Territory. PAION is required to use commercially reasonable efforts to commercialize GIAPREZA and XERAVA in the PAION Territory. The Company has not received any payments from PAION related to either royalties or commercial milestones. InJuly 2021 , the Company entered into a commercial supply agreement with PAION whereby the Company will supply PAION a minimum quantity of GIAPREZA and XERAVA throughJuly 13, 2024 . The supply agreement will automatically renew until the earlier ofJuly 13, 2027 , or until a new supply agreement is executed. During the initial 3-year term of the supply agreement, the Company will be reimbursed for direct and certain indirect manufacturing costs at cost.
Everest Medicines Limited
InFebruary 2018 , the Company entered into a license agreement with Everest, which was subsequently amended and restated (the "Everest License"). Pursuant to the Everest License, the Company granted Everest an exclusive license to develop and commercialize XERAVA for the treatment of cIAI and other indications in mainlandChina ,Taiwan ,Hong Kong ,Macau ,South Korea ,Singapore , theMalaysian Federation , the Kingdom ofThailand , theRepublic of Indonesia , the SocialistRepublic of Vietnam and theRepublic of the Philippines (collectively, the "Everest Territory"). The Company is eligible to receive an additional$8.0 million regulatory milestone payment and up to an aggregate of$20.0 million in sales milestone payments. The Company is also entitled to receive tiered royalties from Everest at percentages in the low double digits on sales, if any, in the Everest Territory of products containing eravacycline. Royalties are payable with respect to each jurisdiction in the Everest Territory until the latest to occur of: (i) the last-to-expire of specified patent rights in such jurisdiction in the Everest Territory; (ii) expiration of marketing or regulatory exclusivity in such jurisdiction in the Everest Territory; or (iii) 10 years after the first commercial sale of a product in such jurisdiction in the Everest Territory. InMarch 2021 , the Company received a$3.0 million milestone payment associated with the submission of an NDA with the China NMPA for XERAVA for the treatment of cIAI in patients inChina . XERAVA was approved inSingapore by theHealth Science Authority inApril 2020 . InMay 2021 , the Company entered into a commercial supply agreement with Everest whereby the Company will supply Everest a minimum quantity of XERAVA throughDecember 31, 2023 and will transfer to Everest certain XERAVA-related manufacturing know-how. Pursuant to the supply agreement: (i) the Company has received$6.8 million of upfront payments comprised of: (1) a$4.0 million upfront technology transfer payment; and (2) a$2.8 million partial prepayment for XERAVA that is expected to be delivered to Everest; (ii) the Company has received an additional$1.0 million technology transfer payment in January, 2022; and (iii) the Company will be reimbursed for direct and certain indirect manufacturing costs at 110% of costs throughDecember 31, 2023 . The Company recognized the$5.0 million of technology transfer-related payments as license and other revenue during the three and six months endedJune 30, 2021 as Everest obtained control of the XERAVA-related manufacturing know-how prior toJune 30, 2021 . The Company recognized the$2.8 million partial prepayment for XERAVA that is expected to be delivered to Everest as deferred revenue as ofJune 30, 2022 , andDecember 31, 2021 , as the performance obligation to deliver XERAVA had not yet been satisfied. Recent Developments OnAugust 5, 2022 , the Company received a notice letter from HCR in which HCR alleges the occurrence, or imminent occurrence, ofLa Jolla Pharma, LLC not meeting certain obligations under the Royalty Agreement and related agreements, including the obligation to use commercially reasonable and diligent efforts to commercialize GIAPREZA and the obligation to not undertake a Change of Control, that would result in HCR's right to terminate the Royalty Agreement. As defined in the Royalty Agreement, a Change of Control means any event or series of events that results in either: (i) the Company no longer directly or indirectly owning 100% ofLa Jolla Pharma, LLC ; or (ii)La Jolla Pharma, LLC no longer directly owning 100% of worldwide net sales of GIAPREZA, except for the granting of ex-U.S. product licenses, neither of which are impacted by the transactions contemplated by the Merger 24 -------------------------------------------------------------------------------- Agreement with Innoviva. IfLa Jolla Pharma, LLC is ultimately determined to not have met these obligations, HCR would have the right to terminate the Royalty Agreement and demand payment fromLa Jolla Pharma, LLC of either$125.0 million or$225.0 million (depending on which obligationLa Jolla Pharma, LLC is held to not have met), minus aggregate royalties already paid to HCR. The Company believes that each of the claims made in the notice letter are wholly without merit and frivolous, disputes them and would vigorously defend against such claims if they were asserted in a legal proceeding. Neither the notice letter nor the meritless and frivolous claims made therein are expected to impede the anticipated closing of the transactions contemplated by the Merger Agreement and the Company expects to complete the transactions as planned.
Critical Accounting Estimates
We believe the estimates, assumptions and judgments involved in the accounting policies described in "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Item 7 of our Form 10-K for the year endedDecember 31, 2021 are most critical to understanding and evaluating our reported financial results. During the six months endedJune 30, 2022 , there have been no material changes to the critical accounting policies and estimates as described in Item 7 of our Form 10-K for the year endedDecember 31, 2021 .
Recent Accounting Pronouncements
See Note 2 to our condensed consolidated financial statements included in Item 1 of this Quarterly Report on Form 10-Q.
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