The following discussion analyzes the Company's historical financial condition and results of operations. As you read this discussion and analysis, refer to the Company's financial statements and the notes thereto included elsewhere in this Quarterly Report on Form 10-Q, which represents the results of operations for the three and nine months endedSeptember 30, 2022 and 2021. Also refer to the Company's Annual Report on Form 10-K for the year endedDecember 31, 2021 , which includes detailed discussions of various items impacting the Company's business, results of operations and financial condition. The discussion and analysis below has been organized as follows: •Executive summary, including a description of the Company's pending merger with Viatris Inc. and the business and recent events that are important to understanding the results of operations and financial condition; •Results of operations, including an explanation of significant differences between the periods in the specific line items of the condensed statements of operations; •Financial condition addressing the Company's sources of liquidity, future funding requirements, cash flows, sources and uses of cash, updates to contractual obligations and commitments, and off-balance sheet arrangements; and •Critical accounting policies, significant judgements and estimates, which are most important to both the portrayal of the Company's results of operations and financial condition. Some of the information contained in the following discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to Company's expectations in connection with the pending merger with Viatris Inc., the Company's plans and strategy for its business, includes forward-looking statements within the meaning of Section 27A of the Act and Section 21E of the Exchange Act that involve risks and uncertainties. As a result of many factors, including those factors set forth in the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year endedDecember 31, 2021 and in this Quarterly Report on Form 10-Q, the Company's actual results could differ materially from the results described in or implied by these forward-looking statements. Please also see the section of this Quarterly Report on Form 10-Q titled "Special Note Regarding Forward-Looking Statements." The forward-looking statements in this Quarterly Report on Form 10-Q, other than the statements regarding the pending merger with Viatris Inc., do not assume the consummation of the proposed merger unless specifically stated otherwise. 22 --------------------------------------------------------------------------------
Executive Summary Introduction and OverviewOyster Point Pharma, Inc. (the Company) is a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ophthalmic diseases. OnOctober 15, 2021 , TYRVAYA® (varenicline solution) Nasal Spray (TYRVAYA Nasal Spray), formerly referred to as OC-01 (varenicline solution) nasal spray, a highly selective nicotinic acetylcholine receptor (nAChR) agonist, was approved by theU.S. Food and Drug Administration (FDA) for the treatment of the signs and symptoms of dry eye disease. TYRVAYA Nasal Spray's highly differentiated mechanism of action is designed to increase basal tear production with a goal to re-establish tear film homeostasis. The Company began selling TYRVAYA Nasal Spray inNovember 2021 and generated net product revenues of$13.0 million for the nine months endedSeptember 30, 2022 . The Company expects its product revenue to increase if it gains market share and TYRVAYA Nasal Spray obtains insurance coverage from additional third-party payors. The Company generated net losses of$134.6 million and$58.6 million for the nine months endedSeptember 30, 2022 , and 2021, respectively, and had an accumulated deficit of$390.0 million as ofSeptember 30, 2022 . The Company has financed its operations primarily through the sale and issuance of its securities. InAugust 2021 , the Company secured debt capital in the form of a long-term credit facility of up to$125.0 million (the Credit Agreement) withOrbiMed Royalty & Credit Opportunities III, LP (OrbiMed) to help finance its operations. Recent Events
Pending Transaction with Viatris Inc.
OnNovember 7, 2022 , the Company entered into an Agreement and Plan of Merger (Merger Agreement) by and among the Company, Viatris Inc. andIris Purchaser Inc. (Purchaser), a wholly owned subsidiary of Viatris Inc. The Merger Agreement provides that, subject to satisfaction of customary closing conditions, including the completion of the Offer (as defined below), Purchaser will merge with and into the Company, with the Company continuing as the surviving corporation as a wholly owned subsidiary of Viatris Inc. (the Merger). Pursuant to the terms and subject to the conditions of the Merger Agreement, Viatris Inc. has agreed to cause Purchaser to commence a tender offer (Offer) to acquire all of the outstanding shares of common stock of the Company for (i)$11.00 per share in cash plus (ii) the right to receive one contingent value right payment (CVR) per share, which represents the right to receive a Milestone Payment, defined as$1.00 per share in cash if Milestone One (as defined below) is achieved or$2.00 per share in cash if Milestone Two (as defined below) is achieved, net of applicable withholding taxes and without interest. Milestone One will be met if the Company both (i) recognizes at least$21.6 million net revenue from sales of TYRVAYA Nasal Spray for the twelve months endedDecember 31, 2022 ; and (ii) achieves at least 131,822 total TYRVAYA Nasal Spray prescriptions inthe United States for the twelve months endedDecember 31, 2022 . Milestone Two will be met if the Company both (i) recognizes at least$24.0 million net revenue from sales of TYRVAYA Nasal Spray for the twelve months endedDecember 31, 2022 ; and (ii) achieves at least 146,469 total TYRVAYA Nasal Spray prescriptions inthe United States for the twelve months endedDecember 31, 2022 . If Milestone One is achieved and Milestone Two is not achieved, the stockholders who had shares of the Company's common stock acquired by Viatris Inc. in connection with the Offer shall receive a Milestone Payment of$1.00 per share in cash. If Milestones One and Two are achieved, the stockholders who had shares of the Company's common stock acquired by Viatris Inc. in connection with the Offer shall receive a Milestone Payment of$2.00 per share in cash. If Milestone One is not achieved, no Milestone Payment will become payable and stockholders who had shares of the Company's common stock acquired by Viatris Inc. in connection with the Offer shall not receive additional consideration. Pursuant to the terms and and subject to the conditions of the Merger Agreement, the Merger will be affected pursuant to Section 251(h) of the Delaware General Corporation Law, which permits completion of the Merger without a vote of the holders of common stock upon the acquisition by Purchaser of a majority of the aggregate voting power of common stock. As a result of the Merger, the Company will cease to be a publicly traded company. The Merger Agreement contains customary representations and warranties. The Merger is anticipated to close in the first quarter of 2023, subject to the satisfaction of customary closing conditions, including completion of the Offer. However, there can be no assurance that the conditions to the completion of the Offer and the Merger will be satisfied or waived, that the Offer and the Merger will be completed on the expected timeframe or at all, or that the Offer and the Merger will be consummated as contemplated by the Merger Agreement. If the Merger Agreement is 23 -------------------------------------------------------------------------------- terminated under specified circumstances provided in the Merger Agreement, the Company will be required to pay Viatris Inc. a termination fee of approximately$11.9 million . The foregoing description of the Merger Agreement and the Transactions does not purport to be complete and is qualified in its entirety by reference to the Merger Agreement, which is attached hereto as Exhibit 2.1 to this Quarterly Report on Form 10-Q and incorporated by reference herein. Please also see "Item 1A. Risk Factors-Risks related to the pending merger with Viatris Inc.".
Operating Expense Streamlining Plan
In the second quarter of 2022, the Company announced a plan to streamline operating expenses. The plan, which has since been implemented, included a reduction in force and certain other cost-cutting measures. These measures, which were approved by the Company's Board of Directors, served to better align the Company's workforce with the anticipated current needs of its business, maximize the commercial potential of TYRVAYA Nasal Spray, and create value for the Company's stakeholders. The Company reduced its operating expenses, primarily driven by lower non-employee-related general and administrative and research and development expenses, and to a lesser extent, by the reduction of approximately 40 positions across the organization.
Ji Xing Pharmaceuticals Enrolls Patients in a Phase 3 Clinical Trial of OC-01 in
The Company grantedJi Xing an exclusive license to develop and commercialize OC-01 (varenicline solution) nasal spray and OC-02 (simpinicline) nasal spray pharmaceutical products, for all prophylactic uses for, and treatment of, ophthalmology diseases or disorders in the greaterChina region inAugust 2021 . InJuly 2022 ,Ji Xing announced that the first patients have been enrolled in its Phase 3 clinical study of OC-01 (varenicline solution) nasal spray inChina . The study is being carried out in over 20 leading clinical centers acrossChina and is designed to evaluate the efficacy and safety of OC-01 nasal spray for the treatment of the signs and symptoms of dry eye disease to support a new drug application inChina .
Expansion of Commercial Coverage for TYRVAYA Nasal Spray
InJuly 2022 , the Company introduced expanded patient access programs to include more eligible patients. As of the third quarter of 2022, TYRVAYA Nasal Spray is covered by commercial prescription drug plans managed by the nation's top three Pharmacy Benefit Manager Group Purchasing Organizations. The Company expects to expand market access to TYRVAYA Nasal Spray with additional coverage for Medicare Part D patients in 2023 and beyond.
Continued Enrollment of Subjects in the
During the nine months endedSeptember 30, 2022 , the Company continued enrollment of subjects in theOLYMPIA Phase 2 clinical trial of OC-01 for the treatment of Stage 1 Neurotrophic Keratopathy (NK). NK is a degenerative disease resulting from a loss on corneal sensation, which causes progressive damage to the top layer of the cornea and can negatively impact visual acuity. Enrollment was completed inOctober 2022 and study results are expected in the first quarter of 2023.
Additional Pre-Clinical Studies for Enriched Tear Film (ETF™) Gene Therapy to Target Neurotrophic Keratopathy and Vernal and Atopic Keratoconjunctivitis patients
During the nine months endedSeptember 30, 2022 , the Company progressed in its multiple pre-clinical studies for the proprietary ETF™ gene therapy with OC-101 (AAV-NGF). OC-101 (AAV-NGF) is administered as a single, intralacrimal gland injection of an adeno-associated virus (AAV) vector containing the human nerve growth factor (NGF) gene for Stages 2 and 3 NK patients. The Company submitted a Pre-IND meeting request and briefing document to theU.S. FDA for the OC-101 (AAV-NGF) program and received a response from FDA on the briefing document questions. The Company expects to begin the final IND enabling study for this platform in 2023. The Company also announced the development of OC-103 (AAV-DAO). OC-103 (AAV-DAO) is administered as a single, intralacrimal gland injection of an adeno-associated virus (AAV) vector containing the enzyme diamine oxidase (DAO) in vernal and atopic keratoconjunctivitis patients. OC-103 (AAV-DAO) is planned to begin preclinical animal studies in 2023. 24 --------------------------------------------------------------------------------
The Impact of the SARS-CoV-2 Virus Pandemic
The Company does not believe its financial results were materially affected by the SARS-CoV-2 virus pandemic during the three and nine months endedSeptember 30, 2022 . The Company will continue to make practical decisions in compliance withCenters for Disease Control and Prevention , federal, state and local guidelines. The extent to which the SARS-CoV-2 virus pandemic may affect the Company's future financial results and operations will depend on future developments which are highly uncertain and cannot be predicted. For further discussion of the risks that the Company faces as a result of the SARS-CoV-2 virus pandemic refer to the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year endedDecember 31, 2021 .
Results of Operations
Comparison of the Results of Operations for the Three Months Ended
The following table summarizes the Company's results of operations for the periods indicated (in thousands, except percentages):
Three Months Ended September 30, 2022 2021 $ Change % Change Revenue: Product revenue, net$ 5,591 $ -$ 5,591 100 % License revenue - related party - 17,943 (17,943) 100 % Total revenue 5,591 17,943 (12,352) (69) % Cost of product revenue 1,348 - 1,348 100 % Operating expenses: Sales and marketing 22,094 18,170 3,924 22 % General and administrative 12,149 10,327 1,822 18 % Research and development 3,913 6,214 (2,301) (37) % Total operating expenses 38,156 34,711 3,445 10 % Loss from operations (33,913) (16,768) (17,145) 102 % Other (expense) income: Interest expense (3,495) (1,124) (2,371) 211 % Other income, net 661 222 439 198 % Total other (expense) income, net (2,834) (902) (1,932) 214 % Net loss and comprehensive loss$ (36,747) $ (17,670) $ (19,077) 108 % Product Revenue, Net Product revenue, net was$5.6 million for the three months endedSeptember 30, 2022 , and was related to sales of TYRVAYA Nasal Spray, which was launched in theU.S. inNovember 2021 . Approximately 34,000 TYRVAYA Nasal Spray prescriptions, written by approximately 6,100 unique eye care professionals, were filled during the three months endedSeptember 30, 2022 . The Company did not generate any revenues from product sales during the three months endedSeptember 30, 2021 .
License Revenue -
The Company did not recognize any license revenue during the three months endedSeptember 30, 2022 . The Company recognized$17.9 million in license revenue during the three months endedSeptember 30, 2021 in connection with the License Agreement entered into withJi Xing . The license revenue was recognized upon the transfer of control of the licenses toJi Xing 25 --------------------------------------------------------------------------------
and was comprised of
Cost of Product Revenue
Cost of product revenue for the three months endedSeptember 30, 2022 was$1.3 million , which consisted of material costs, third-party manufacturing costs, and royalty expense. Sales and Marketing Sales and marketing expenses increased by$3.9 million during the three months endedSeptember 30, 2022 compared to the three months endedSeptember 30, 2021 . The increase was primarily due to higher payroll-related expenses of$3.1 million , which was driven by the growth of the Company's sales force since 2021. Other sales and marketing expenses increased by$0.8 million during the three months endedSeptember 30, 2022 compared to the three months endedSeptember 30, 2021 , in connection with samples, trade shows, educational programs, patient services, payor access and other marketing efforts related to the commercialization of TYRVAYA Nasal Spray.
General and Administrative Expenses
General and administrative expenses increased by$1.8 million during the three months endedSeptember 30, 2022 compared to the three months endedSeptember 30, 2021 . The increase was primarily driven by additional payroll-related expenses of$2.7 million due to an increase in headcount to support the Company's business operations, including an increase in stock compensation expense of$0.8 million . Other general and administrative expenses decreased by$0.9 million during the three months endedSeptember 30, 2022 compared to the three months endedSeptember 30, 2021 primarily related to a decrease in sponsorships, public relations and recruiting activities.
Research and Development Expenses
Research and development expenses decreased by$2.3 million during the three months endedSeptember 30, 2022 , compared to the three months endedSeptember 30, 2021 . The decrease was primarily due to decreased research and development activity relating to OC-01 following its approval by the FDA onOctober 15, 2021 , and lower payroll-related expenses of$0.7 million .
Interest Expense
The Company incurred$3.5 million and$1.1 million of interest expense during the three months endedSeptember 30, 2022 and 2021, respectively, related to the Credit Agreement, which the Company entered into with OrbiMed inAugust 2021 . Interest expense for both periods included contractual interest, as well as the amortization of loan commitment fees and accretion of other long-term debt related costs. Interest expense for the three months endedSeptember 30, 2022 relates to$95.0 million of outstanding borrowings under the Credit Agreement for the entire three-month period. For the three months endedSeptember 30, 2021 , the Company had outstanding borrowings under the Credit Agreement of$45.0 million fromAugust 5, 2021 toSeptember 30, 2021 . In addition, the variable rates of interest for a portion of the three months endedSeptember 30, 2022 were higher than the variable rates of interest in the prior year period.
Other Income, net
Other income for the three months endedSeptember 30, 2022 of$0.7 million consisted of a$0.4 million change in the fair value of the net embedded derivative liability related to the Credit Agreement, in addition to interest earned on money market funds. Other income for the three months endedSeptember 30, 2021 primarily consisted of$0.2 million of income associated with the change in the fair value of the net embedded derivative liability, as well as interest income earned on money market funds. 26 --------------------------------------------------------------------------------
Comparison of the Results of Operations for the Nine Months Ended
The following table summarizes the Company's results of operations for the periods indicated (in thousands, except percentages):
Nine Months Ended September 30, 2022 2021 $ Change % Change Revenue: Product revenue, net$ 12,988 $ -$ 12,988 100 % License revenue - related party - 17,943 (17,943) 100 % Total revenue 12,988 17,943 (4,955) (28) % Cost of product revenue 2,994 - 2,994 100 % Operating expenses: Sales and marketing 77,169 28,947 48,222 167 % General and administrative 39,079 27,938 11,141 40 % Research and development 13,258 18,772 (5,514) (29) % Total operating expenses 129,506 75,657 53,849 71 % Loss from operations (119,512) (57,714) (61,798) 107 % Other (expense) income: Interest expense (9,717) (1,124) (8,593) 765 % Other (expense) income, net (5,352) 243 (5,595) (2302) % Total other (expense) income, net (15,069) (881) (14,188) 1610 % Net loss and comprehensive loss$ (134,581) $ (58,595) $ (75,986) 130 % Product Revenue, Net Product revenue, net was$13.0 million for the nine months endedSeptember 30, 2022 , and was related to sales of TYRVAYA Nasal Spray, which was launched in theU.S. inNovember 2021 . Approximately 83,000 TYRVAYA Nasal Spray prescriptions, written by over 8,600 unique eye care professionals, were filled during the nine months endedSeptember 30, 2022 . The Company did not generate any revenues from product sales during the nine months endedSeptember 30, 2021 .
License Revenue -
The Company did not recognize any license revenue during the nine months endedSeptember 30, 2022 . The Company recognized$17.9 million in license revenue during the nine months endedSeptember 30, 2021 in connection with the License Agreement entered into withJi Xing . The license revenue was recognized upon the transfer of control of the licenses toJi Xing and was comprised of$17.5 million cash consideration, and non-cash consideration of 397,562 senior common shares ofJi Xing valued at$0.4 million .
Cost of Product Revenue
Cost of product revenue for the nine months ended
Sales and Marketing
Sales and marketing expenses increased by$48.2 million during the nine months endedSeptember 30, 2022 compared to the nine months endedSeptember 30, 2021 . The increase was primarily due to higher payroll-related expenses of$25.8 million , which was primarily driven by the growth of the Company's sales force since 2021. The increase in payroll-related expenses included an increase in commission expense of$5.1 million , in addition to an increase in severance expense of$1.5 million due to the operating expenses streamlining plan announced onJune 28, 2022 . Other sales and marketing expenses increased by 27 --------------------------------------------------------------------------------$22.4 million during the nine months endedSeptember 30, 2022 compared to the nine months endedSeptember 30, 2021 , in connection with advertising, samples, trade shows, educational programs, patient services, payor access and other marketing efforts related to the commercialization of TYRVAYA Nasal Spray.
General and Administrative Expenses
General and administrative expenses increased by$11.1 million during the nine months endedSeptember 30, 2022 compared to the nine months endedSeptember 30, 2021 . The increase was primarily driven by additional payroll-related expenses of$8.4 million due to an increase in headcount to support the Company's business operations. The increase in payroll-related expenses included an increase in stock compensation expense of$2.0 million . Other general and administrative expenses increased by$2.7 million during the nine months endedSeptember 30, 2022 compared to the nine months endedSeptember 30, 2021 , related to accounting, consulting, public relations, legal, insurance and other professional services, partially offset by decreases in sponsorships, recruiting activities and software services. The increase in other general and administrative expenses was primarily driven by the Company's transition from a clinical-stage to a commercial stage company. Research and Development Expenses Research and development expenses decreased by$5.5 million during the nine months endedSeptember 30, 2022 compared to the nine months endedSeptember 30, 2021 . The decrease was primarily due to decreased research and development activity relating to OC-01 following its approval by the FDA onOctober 15, 2021 . This was partially offset by an increase in stock compensation expense of$0.5 million , in addition to an increase in severance expense of$0.6 million due to the reduction in force announced onJune 28, 2022 .
Interest Expense
The Company incurred$9.7 million and$1.1 million of interest expense during the nine months endedSeptember 30, 2022 and 2021, respectively, related to the Credit Agreement. Interest expense for the nine months endedSeptember 30, 2022 included contractual interest, as well as the amortization of loan commitment fees and accretion of other long-term debt related costs. Interest expense for the nine months endedSeptember 30, 2022 relates to$95.0 million of outstanding borrowings under the Credit Agreement for the entire nine-month period. For the nine months endedSeptember 30, 2021 , the Company had outstanding borrowings under the Credit Agreement of$45.0 million fromAugust 5, 2021 toSeptember 30, 2021 . In addition, the variable rates of interest for a portion of the nine months endedSeptember 30, 2022 were higher than the variable rates of interest in the prior year period. Other (Expense) Income, net Other expense for the nine months endedSeptember 30, 2022 of$5.4 million consisted of a$5.8 million change in the fair value of the net embedded derivative liability related to the Credit Agreement, partially offset by interest earned on money market funds. Other income for the nine months endedSeptember 30, 2021 primarily consisted$0.2 million of income associated with the change in the fair value of the net embedded derivative liability, as well as interest income earned on money market funds. 28 --------------------------------------------------------------------------------
Liquidity and Capital Resources
Sources of Liquidity
The Company's principal sources of liquidity include cash on hand and borrowings under the Credit Agreement, as further described in Note 8, Long-term Debt, to the Company's condensed financial statements. The Company has$30.0 million remaining to be drawn under the Credit Agreement, which may be funded, at the option of the Company, on or prior toJune 30, 2023 , upon the Company having received at least$40.0 million in TYRVAYA Nasal Spray net recurring revenue, as defined in the Credit Agreement, in any twelve-month period prior toMarch 31, 2023 , among other conditions. There can be no assurance that the Company will meet the net recurring revenue minimum threshold to enable the Company to draw on the third tranche.
As of
The Company is party to an at-the-market sales agreement withCowen and Company, LLC (Agent), pursuant to which the Company may offer and sell shares of its common stock having an aggregate offering price of up to$100.0 million from time to time through the Agent. As ofSeptember 30, 2022 , the Company had not sold any shares of common stock pursuant to the sales agreement and$100.0 million in shares remained available to be sold under the at-the-market program. There can be no assurance the Company will be able to raise such additional equity capital, or that any equity capital that may be raised will be at market conditions that are favorable to the Company. Additionally, while the Merger Agreement is in effect, the Company is subject to restrictions on its business activities, generally requiring the Company to conduct our business in the ordinary course, consistent with past practice, and subjecting the Company to a variety of specified limitations absent Viatris Inc.'s prior consent. These limitations include, among other things, restrictions on the Company's ability to acquire other businesses and assets, sell, transfer or license the Company's assets, make investments, repurchase or issue securities, pay dividends, make capital expenditures, amend the Company's organizational documents, issue securities and incur indebtedness.
Going Concern
Since inception, the Company has incurred recurring losses and negative cash flows from operations. The Company generated net losses of$134.6 million and$58.6 million for the nine months endedSeptember 30, 2022 and 2021, respectively, and had an accumulated deficit of$390.0 million as ofSeptember 30, 2022 . The Company has cash and cash equivalents of$68.8 million as ofSeptember 30, 2022 . The Company has historically financed its operations primarily through the sale and issuance of its securities. InAugust 2021 , the Company entered into the Credit Agreement with OrbiMed to help finance its operations. The Company is also a party to a license agreement withJi Xing , according to which it is eligible to receive additional development and sales-based milestone payments and royalties in future periods. OnOctober 15, 2021 , the Company's first product, TYRVAYA Nasal Spray, was approved by the FDA for treatment of signs and symptoms of dry eye disease. The Company commenced commercial shipments of TYRVAYA Nasal Spray inNovember 2021 and generated net product revenues of$13.0 million in the nine months endedSeptember 30, 2022 . The current global macro-economic environment is volatile, which has resulted in global supply chain constraints and elevated rates of inflation, which may continue to impact the Company to varying degrees. In addition, the Company is subject to risks and uncertainties common to companies in the biopharmaceutical industry, including, but not limited to, the ability to secure sufficient capital to fund operations, competition from other companies' products, the availability and sufficiency of third-party payor coverage and reimbursement, compliance with law and government regulations, the ability to develop and bring to market new products, protection of proprietary technology, and dependence on third parties and key personnel. Successfully commercializing TYRVAYA Nasal Spray requires significant sales and marketing efforts, and the Company's pipeline programs may require significant additional research and development efforts, including extensive preclinical and clinical testing. These activities will in turn require significant amounts of capital, qualified personnel and adequate infrastructure. There can be no assurance when, if ever, the Company will realize significant revenue from the sales of TYRVAYA Nasal Spray or if the development efforts supporting the Company's pipeline, including future clinical trials, will be successful. Based on the Company's current business plan, management believes that the Company's available cash and cash equivalents will not be sufficient to fund its operations for the next twelve months from the date these financial statements are issued without generating positive cash flows through product sales and by raising additional capital from outside sources. The future viability of the Company is dependent on its ability to fund its operations through the sales and licensing of TYRVAYA 29 -------------------------------------------------------------------------------- Nasal Spray, and raise additional capital through equity offerings, including through the Company's at-the-market sales program, or other collaborative or strategic arrangements. In addition, the Company may have the ability to draw up to$30.0 million on the third tranche of the Credit Agreement, as further described in Note 8, Long-term Debt. This is contingent upon achieving at least$40.0 million in TYRVAYA Nasal Spray net recurring revenue, as defined in the Credit Agreement, in any twelve-month period on or beforeMarch 31, 2023 , and without an improper promotional event having occurred, among other conditions. There can be no assurance that the Company will meet the net recurring revenue minimum threshold to enable the Company to draw on the third tranche. The Credit Agreement also requires the Company to maintain a minimum level of cash and permitted cash equivalent investments, as defined, of at least$5.0 million at all times in a deposit account subject to control by the lender. If the Company is in violation of this covenant and as long as an event of default resulting from such violation is continuing, the lender could exercise remedies, which include but are not limited to, the acceleration of all outstanding debt under the Credit Agreement. In addition, the Company has generated limited revenue from initial sales of TYRVAYA Nasal Spray, and given its limited commercial history, cannot guarantee that its commercialization efforts will result in product revenues that meet its sales expectations or those of analysts and investors. Although the Company believes that it will continue to raise capital to fund its operations as it has in the past, the Company's ability to raise equity capital may depend on the stability ofU.S. capital markets and the demand from investors. There can be no assurance that the Company will be successful in raising this additional capital or that such capital, if available, will be on terms that are acceptable to the Company. These conditions raise substantial doubt about the Company's ability to continue as a going concern within the next twelve months from the filing date of this Quarterly Report on Form 10-Q. The ability to continue as a going concern is dependent upon profitable future operations, positive cash flows from operations, and obtaining additional financing from outside sources. If adequate funds are unavailable on a timely basis from operations and additional sources of financing, the Company may have to delay or reduce the scope of its marketing and commercialization efforts or make other changes to its operating plan, which could materially and adversely affect the Company's business, financial condition and operations.
Future Funding Requirements
The Company's primary uses of capital have been, and the Company expects will continue to be, developing and commercializing TYRVAYA Nasal Spray, including the costs and timing associated with marketing activities, patient services, obtaining third-party payor coverage and reimbursement and maintaining regulatory compliance. The Company also expects that it will continue to use capital to advance its clinical and preclinical development programs. The Company anticipates that it will need to raise substantial additional capital, the requirements for which will depend on many factors, including: •the completion of the Company's pending merger with Viatris Inc.; •the cost and timing associated with commercializing TYRVAYA Nasal Spray, including the costs and timing associated with marketing activities, patient services, obtaining third-party payor coverage and reimbursement and maintaining regulatory compliance; •the scope, timing, rate of progress and costs of the Company's drug discovery efforts, preclinical development activities, laboratory testing, clinical trials and regulatory review for the Company's product candidates, and the cost and timing associated with commercializing such product candidates, if they receive regulatory approval; •the scope and costs of development and commercial manufacturing activities; •the extent to which the Company acquires or in-licenses other product candidates and technologies; •the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing the Company's intellectual property rights and defending intellectual property-related claims; •the Company's ability to establish and maintain collaborations on favorable terms, if at all; •its efforts to enhance operational systems and the Company's ability to attract, hire and retain qualified personnel, including personnel to support the commercialization of TYRVAYA Nasal Spray and the development and the sale of additional products, following FDA approval; •the Company's ability to manufacture products, the reliability of its supply chain, labor shortages, backlog and any increase in costs as a result of inflation; •the Company's implementation of operational, financial and management systems; •any current or future potential effects of the SARS-CoV-2 virus pandemic on the Company's business, operations, preclinical and clinical development and commercialization timelines and plans; •the impact and effectiveness of the Company's operating expenses streamlining plan, including the reduction in force, announcedJune 28, 2022 ; and •the costs associated with being a public company. 30 -------------------------------------------------------------------------------- A change in the outcome of any of these or other variables with respect to the commercialization of TYRVAYA Nasal Spray or development of any of the Company's product candidates could significantly change the costs and timing associated with the development of that product candidate. Furthermore, the Company's operating plans may change in the future, and it will continue to require additional capital to meet operational needs and capital requirements associated with such operating plans. If additional funds are raised by issuing equity securities, the Company's stockholders may experience dilution. Any future debt financing into which the Company might enter may impose upon it additional covenants that restrict the Company's operations, including limitations on its ability to incur liens or additional debt, pay dividends, repurchase its common stock, make certain investments or engage in certain merger, consolidation or asset sale transactions. Any debt financing or additional equity that it raises may contain terms that are not favorable to the Company or its stockholders. The SARS-CoV-2 virus pandemic has impacted global economies, the rate of inflation, supply chains, distribution networks and consumer behavior around the world. Adequate funding may not be available to the Company on acceptable terms or at all, and any uncertainty and volatility in capital markets caused by the SARS-CoV-2 virus pandemic, or other events may negatively impact the availability and cost of capital. The Company's failure to raise capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies. If the Company is unable to raise additional funds when needed, it may be required to delay, reduce, or eliminate certain commercial expenses, including in selling, general and administrative expenses, as well as delay, reduce, or eliminate one or more of its research or development programs. The Company may also be required to sell or license to others, rights to its product candidates in certain territories or indications that it would prefer to develop and commercialize itself. The Company may seek to raise capital through private or public equity or debt offerings, or collaborative and other arrangements. If the Company chooses to enter into collaborations and other arrangements to supplement its funds, it may have to give up certain rights, thereby limiting its ability to develop and commercialize the product candidates or may have other terms that are not favorable to the Company, which could materially affect its business, results of operation and financial condition.
See those factors set forth in the "Risk Factors" section of the Company's
Annual Report on Form 10-K for the year ended
31 --------------------------------------------------------------------------------
Cash Flow Discussion
The following table sets forth the primary sources and uses of cash, cash equivalents and restricted cash for each of the periods presented below (in thousands): Nine Months Ended September 30, 2022 2021 $ Change Net cash (used in) provided by: Operating activities$ (124,506) $ (47,881) $ (76,625) Investing activities (203) (1,250) 1,047 Financing activities 76 40,712 (40,636) Net decrease in cash and cash equivalents, and restricted cash$ (124,633) $ (8,419) $ (116,214)
Cash Flows Used in Operating Activities
Net cash used in operating activities during the nine months endedSeptember 30, 2022 , was$124.5 million , which was primarily attributable to the Company's net loss, adjusted for non-cash items, in the amount of$112.5 million , and working capital needs in the amount of$12.0 million . Working capital needs were primarily driven by the Company's commercialization of TYRVAYA Nasal Spray, which resulted in increases in accounts receivable of$6.5 million and inventory of$5.6 million . There was also a decrease in accounts payable of$3.6 million , primarily due to the timing of payments to vendors. Net cash used in operating activities during the nine months endedSeptember 30, 2021 , was$47.9 million , which was primarily attributable to the Company's net loss, adjusted for non-cash items, in the amount of$49.4 million and working capital needs in the amount of$1.7 million .
Cash Flows Used in Investing Activities
Net cash used in investing activities decreased by$1.0 million for the nine months endedSeptember 30, 2022 compared to the nine months endedSeptember 30, 2021 , primarily related to payments for equipment used in the manufacturing of TYRVAYA Nasal Spray purchased during 2021.
Cash Flows Provided by Financing Activities
Net cash provided by financing activities for the nine months endedSeptember 30, 2022 decreased by$40.6 million compared to the nine months endedSeptember 30, 2021 . Financing activities for the current period included a$0.4 million revenue sharing fee paid to OrbiMed, payment of withholding taxes related to stock-based compensation to the Company's employees and lower proceeds from the exercise of employee stock options, partially offset by$0.5 million in proceeds received under the Company's Employee Stock Purchase Plan.
Net cash provided by financing activities for the nine months ended
32 --------------------------------------------------------------------------------
Contractual Obligations and Commitments
Purchase Commitments
As ofSeptember 30, 2022 , the Company has non-cancelable commitments for the purchase of raw materials and materials for research and development, packaging and product manufacturing costs of approximately$5.4 million , consisting of$3.7 million for the remainder of 2022 and$1.7 million for 2023. No purchase commitments have been made beyond year 2023. The Company made purchases of$8.1 million and$2.3 million under its purchase commitments during the nine months endedSeptember 30, 2022 and 2021, respectively.
Manufacturing and Supply Commitments
In 2021, the Company entered into a manufacturing and supply agreement with a CMO to manufacture and supply TYRVAYA Nasal Spray for an initial term of three years. Under this agreement, the Company pays a minimum capacity reservation fee in the amount of$2.5 million for the twelve months endedOctober 2022 , 2023 and 2024. The minimum capacity reservation fee is subject to potential future credit allowances based upon the prior year's manufacturing production, as provided for in the agreement. InOctober 2022 , the Company paid the$1.8 million minimum capacity reservation fee for the twelve months endedOctober 2023 .
As of
Off-Balance Sheet Arrangements
As of
Critical Accounting Estimates
The Company's financial statements have been prepared in accordance withU.S. GAAP. The preparation of these condensed financial statements requires the Company to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed financial statements and the reported revenues and expenses incurred during the reporting periods. The Company bases its estimates on historical experience, terms of existing contracts, commonly accepted industry practices and on other assumptions that it believes are reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis. The future effects of the SARS-CoV-2 virus pandemic on the Company's results of operations, cash flows, and financial position are unclear, however the Company believes it has used reasonable estimates and assumptions in preparing the interim condensed financial statements. Actual results may differ from these estimates under different assumptions or conditions. The Company's critical accounting policies and estimates are included in the Company's Annual Report on Form 10-K for the year endedDecember 31, 2021 . The Company periodically reviews its accounting policies, estimates and assumptions and makes adjustments when facts and circumstances dictate. In addition to the accounting policies that are described in the Company's 2021 Annual Report on Form 10-K, the following critical accounting policies were updated during the nine months endedSeptember 30, 2022 . 33 --------------------------------------------------------------------------------
Stock-Based Compensation - Performance Stock Units
The Company granted PSUs to certain executive officers during the nine months endedSeptember 30, 2022 . The issuance of the PSUs is contingent upon meeting several milestones, as provided for in theJanuary 2022 andJuly 2022 PSU award agreements. For the January PSU 2022 grants, the non-market performance milestones are subject to attaining certain forecasted net product revenues and future prescriptions of TYRVAYA Nasal Spray. The market performance milestone is subject to (i) at least one of the non-market milestones being met and (ii) attaining total shareholder return based on the change in the price of the Company's common stock. The fair value of the market milestone for these PSUs was estimated using a Monte Carlo simulation in a risk-neutral framework and includes an assumption that at least one of the non-market milestones are met, among other assumptions as described in Note 6, Stockholders' Equity and Equity Incentive Plans. The measurement of stock-based compensation expense for these PSUs considers the probability of achievement of the non-market milestones. The forecasted net product revenue and future prescriptions of TYRVAYA Nasal Spray involve management's judgment, which, in and of themselves, could materially affect the measurement of the stock-based compensation cost of the PSUs as reported in the financial statements and related footnote disclosures. For the July PSU 2022 grants, the grant amount is contingent on the executive officers' continued service with the Company and a thirty-day volume-weighted average stock price (VWAP) performance milestone. VWAP performance milestone is based on the achievement of reaching a certain stock price. The fair value of the VWAP-based portion of the award was estimated using a Monte Carlo simulation based on assumptions including the risk free interest rate, expected volatility and derived service period, among others, as described in Note 6, Stockholders' Equity and Equity Incentive Plans.
Recent Accounting Pronouncements
See "Recent Accounting Pronouncements" in Note 1, Nature of Business, Basis of Presentation and Summary of Significant Accounting Policies to the Company's unaudited interim condensed financial statements included in this Quarterly Report.
JOBS Act
The Company is an "emerging growth company," as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. Section 107(b) of the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. Thus, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. The Company has irrevocably elected not to avail itself of this extended transition period, and, as a result, it will adopt new or revised accounting standards on the relevant dates on which adoption of such standards is required for other public companies. The Company intends to rely on other exemptions provided by the JOBS Act, including without limitation, not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act. The Company will remain an emerging growth company until the earliest to occur of: (1) the last day of its first fiscal year in which it has total annual revenues of more than$1.07 billion ; (2) the date it qualifies as a "large accelerated filer," with at least$700.0 million of equity securities held by non-affiliates; (3) the date on which it has issued more than$1.0 billion in non-convertible debt securities during the prior three-year period; and (4) the last day of the fiscal year ending after the fifth anniversary of its initial public offering.
© Edgar Online, source