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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
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☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2022
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☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from _____ to ____ .
Commission File Number: 001-39614
TARSUS PHARMACEUTICALS, INC.
(Exact name of Registrant as specified in its charter)
| | | | | | | | |
Delaware | | 81-4717861 |
(State or other jurisdiction of incorporation or organization) | | (I.R.S. Employer Identification Number) |
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15440 Laguna Canyon Road, Suite 160 | | |
Irvine, California | | 92618 |
(Address of principal executive offices) | | (Zip Code) |
(949) 409-9820
(Registrant's telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class | Trading Symbol | Name of each exchange on which registered |
Common Stock, $0.0001 par value per share | TARS | The Nasdaq Global Market LLC (Nasdaq Global Select Market) |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Large accelerated filer | ☐ | | Accelerated filer | ☐ |
Non-accelerated filer | ☒ | | Smaller reporting company | ☒ |
| | | Emerging growth company | ☒ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
26,658,468 shares of common stock, $0.0001 par value, outstanding as of August 5, 2022.
TABLE OF CONTENTS
PART I—FINANCIAL INFORMATION
Item I. Financial Statements (Unaudited)
TARSUS PHARMACEUTICALS, INC.
INDEX TO THE FINANCIAL STATEMENTS
TARSUS PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS
(In thousands, except share and par value amounts)
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| June 30, 2022 | | December 31, 2021 |
| (unaudited) | | |
ASSETS | | | |
Current assets: | | | |
Cash and cash equivalents | $ | 245,363 | | | $ | 171,332 | |
| | | |
Marketable securities | — | | | 483 | |
Accounts receivable | 17 | | | — | |
Other receivables | 603 | | | 92 | |
Prepaid expenses and other current assets | 4,300 | | | 4,045 | |
Total current assets | 250,283 | | | 175,952 | |
Property and equipment, net | 963 | | | 755 | |
Operating lease right-of-use assets | 813 | | | 1,074 | |
Long-term investments | 169 | | | — | |
Other assets | 600 | | | 1,126 | |
Total assets | $ | 252,828 | | | $ | 178,907 | |
LIABILITIES AND STOCKHOLDERS' EQUITY | | | |
Current liabilities: | | | |
Accounts payable and other accrued liabilities | $ | 8,938 | | | $ | 8,680 | |
Accrued payroll and benefits | 2,780 | | | 2,798 | |
Total current liabilities | 11,718 | | | 11,478 | |
Term loan, net | 19,262 | | | — | |
Other long-term liabilities | 343 | | | 699 | |
Total liabilities | 31,323 | | | 12,177 | |
Commitments and contingencies (Note 8) | | | |
Stockholders’ equity: | | | |
Preferred stock, $0.0001 par value; 10,000,000 authorized; no shares issued and outstanding | — | | | — | |
Common stock, $0.0001 par value; 200,000,000 shares authorized; 26,650,078 shares issued and 26,644,252 outstanding, which excludes 5,826 shares subject to repurchase at June 30, 2022 (unaudited); 20,726,580 shares issued and 20,698,737 outstanding, which excludes 27,840 shares subject to repurchase at December 31, 2021 | 5 | | | 4 | |
Additional paid-in capital | 294,153 | | | 213,398 | |
Accumulated deficit | (72,653) | | | (46,672) | |
Total stockholders’ equity | 221,505 | | | 166,730 | |
Total liabilities and stockholders’ equity | $ | 252,828 | | | $ | 178,907 | |
See accompanying notes to these unaudited condensed financial statements.
TARSUS PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE (LOSS) INCOME
(Unaudited)
(In thousands, except share and per share amounts)
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | Six Months Ended June 30, |
| 2022 | | 2021 | | 2022 | | 2021 |
Revenues: | | | | | | | |
License fees | $ | 13,893 | | | $ | 19,048 | | | $ | 13,893 | | | $ | 52,359 | |
Collaboration revenue | 1,384 | | | 2,969 | | | 1,923 | | | 3,090 | |
Total revenues | 15,277 | | | 22,017 | | | 15,816 | | | 55,449 | |
Operating expenses: | | | | | | | |
Cost of license fees and collaboration revenue | 522 | | | 737 | | | 555 | | | 2,034 | |
Research and development | 9,603 | | | 7,204 | | | 21,684 | | | 23,465 | |
General and administrative | 10,376 | | | 6,794 | | | 18,322 | | | 11,954 | |
Total operating expenses | 20,501 | | | 14,735 | | | 40,561 | | | 37,453 | |
(Loss) income from operations before other (expense) income and income taxes | (5,224) | | | 7,282 | | | (24,745) | | | 17,996 | |
Other (expense) income: | | | | | | | |
Interest (expense) income, net | (247) | | | 7 | | | (563) | | | 16 | |
Other income (expense), net | 106 | | | (39) | | | 143 | | | (73) | |
Unrealized loss on equity investments | (121) | | | — | | | (313) | | | — | |
Change in fair value of equity warrants issued by licensee | (257) | | | (876) | | | (502) | | | (876) | |
Total other expense, net | (519) | | | (908) | | | (1,235) | | | (933) | |
Provision for income taxes | — | | | (29) | | | (1) | | | (342) | |
Net (loss) income and comprehensive (loss) income | $ | (5,743) | | | $ | 6,345 | | | $ | (25,981) | | | $ | 16,721 | |
| | | | | | | |
Net (loss) income per share, basic | $ | (0.24) | | | $ | 0.31 | | | $ | (1.15) | | | $ | 0.81 | |
Net (loss) income per share, diluted | $ | (0.24) | | | $ | 0.29 | | | $ | (1.15) | | | $ | 0.76 | |
| | | | | | | |
Weighted-average shares outstanding, basic | 24,332,531 | | | 20,555,258 | | | 22,531,384 | | | 20,446,246 | |
Weighted-average shares outstanding, diluted | 24,332,531 | | | 21,966,599 | | | 22,531,384 | | | 21,895,304 | |
See accompanying notes to these unaudited condensed financial statements.
TARSUS PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF PREFERRED STOCK AND STOCKHOLDERS’ EQUITY
(Unaudited)
(In thousands, except share data)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Preferred Stock | | Common Stock | | Additional Paid-In Capital | | Accumulated Deficit | | Total Stockholders’ Equity |
| Shares | | Amount | | Shares | | Amount | | |
Balance as of December 31, 2021 | — | | | $ | — | | | 20,698,737 | | | $ | 4 | | | $ | 213,398 | | | $ | (46,672) | | | $ | 166,730 | |
Net loss | — | | | — | | | — | | | — | | | — | | | (20,238) | | | (20,238) | |
Recognition of stock-based compensation expense | — | | | — | | | — | | | — | | | 2,674 | | | — | | | 2,674 | |
Exercise of vested stock options | — | | | — | | | 225 | | | — | | | — | | | — | | | — | |
Issuance of common stock upon the vesting of restricted stock units | — | | | — | | | 4,257 | | | — | | | — | | | — | | | — | |
Lapse of repurchase obligation for stock option exercises, prior to vesting | — | | | — | | | 15,309 | | | — | | | 31 | | | — | | | 31 | |
Balance as of March 31, 2022 | — | | | $ | — | | | 20,718,528 | | | $ | 4 | | | $ | 216,103 | | | $ | (66,910) | | | $ | 149,197 | |
Net loss | — | | | — | | | — | | | — | | | — | | | (5,743) | | | (5,743) | |
Recognition of stock-based compensation expense | — | | | — | | | — | | | — | | | 3,532 | | | — | | | 3,532 | |
Issuance of common stock upon follow-on public offering, net of issuance costs of $5,246 | — | | | — | | | 5,889,832 | | | 1 | | | 74,266 | | | — | | | 74,267 | |
Shares issued in connection with the employee stock purchase plan | — | | | — | | | 17,874 | | | — | | | 222 | | | | | 222 | |
Exercise of vested stock options | — | | | — | | | 7,056 | | | — | | | 17 | | | — | | | 17 | |
Issuance of common stock upon the vesting of restricted stock units | — | | | — | | | 4,257 | | | — | | | — | | | — | | | — | |
Lapse of repurchase obligation for stock option exercises, prior to vesting | — | | | — | | | 6,705 | | | — | | | 13 | | | — | | | 13 | |
Balance as of June 30, 2022 | — | | | $ | — | | | 26,644,252 | | | $ | 5 | | | $ | 294,153 | | | $ | (72,653) | | | $ | 221,505 | |
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| Preferred Stock | | Common Stock | | Additional Paid-In Capital | | Accumulated Deficit | | Total Stockholders’ Equity |
| Shares | | Amount | | Shares | | Amount | | |
Balance as of December 31, 2020 | — | | | $ | — | | | 20,323,201 | | | $ | 4 | | | $ | 198,821 | | | $ | (32,845) | | | $ | 165,980 | |
Net income | — | | | — | | | — | | | — | | | — | | | 10,376 | | | 10,376 | |
Recognition of stock-based compensation expense | — | | | — | | | — | | | — | | | 1,363 | | | — | | | 1,363 | |
Exercise of vested stock options | — | | | — | | | 13,773 | | | — | | | 19 | | | — | | | 19 | |
Shares issued as consideration for in-license rights | — | | | — | | | 187,500 | | | — | | | 5,494 | | | — | | | 5,494 | |
Balance as of March 31, 2021 | — | | | $ | — | | | 20,524,474 | | | $ | 4 | | | $ | 205,697 | | | (22,469) | | | $ | 183,232 | |
Net income | — | | | — | | | — | | | — | | | — | | | 6,345 | | | 6,345 | |
Recognition of stock-based compensation expense | — | | | — | | | — | | | — | | | 2,794 | | | — | | | 2,794 | |
Lapse of repurchase obligation for stock option exercises, prior to vesting | — | | | — | | | 49,222 | | | — | | | 99 | | | — | | | 99 | |
Exercise of vested stock options | — | | | — | | | 255 | | | — | | | 1 | | | — | | | 1 | |
Balance as of June 30, 2021 | — | | | $ | — | | | 20,573,951 | | | $ | 4 | | | $ | 208,591 | | | (16,124) | | | $ | 192,471 | |
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See accompanying notes to these unaudited condensed financial statements.
TARSUS PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)
(In thousands)
| | | | | | | | | | | |
| Six Months Ended June 30, |
| 2022 | | 2021 |
Cash Flows From Operating Activities: | | | |
Net (loss) income | $ | (25,981) | | | $ | 16,721 | |
Adjustments to reconcile net (loss) income to net cash used in operating activities: | | | |
Depreciation and amortization | 133 | | | 189 | |
Amortization and accretion of term loan-related costs | 137 | | | — | |
Stock-based compensation | 6,206 | | | 4,157 | |
Non-cash lease expense | 226 | | | 87 | |
Loss on disposal of property and equipment | — | | | 70 | |
Loss on lease termination | — | | | 2 | |
Unrealized loss on equity investments | 313 | | | — | |
Change in fair value of equity warrants issued by licensee | 502 | | | 876 | |
| | | |
Unrealized gain from transactions denominated in a foreign currency | (1) | | | (8) | |
Issuance of common stock upon in-license agreement milestone achievement | — | | | 5,494 | |
Changes in operating assets and liabilities: | | | |
Accounts receivable | (17) | | | (20,000) | |
| | | |
Other receivables | (510) | | | (137) | |
Prepaid expenses and other current assets | (254) | | | (1,527) | |
Other non-current assets | (75) | | | (2,326) | |
Accounts payable and other accrued liabilities | (135) | | | 4,622 | |
Accrued payroll and benefits | (18) | | | 430 | |
Other long-term liabilities | (71) | | | 107 | |
Net cash used in operating activities | (19,545) | | | 8,757 | |
Cash Flows From Investing Activities: | | | |
Purchases of property and equipment | (283) | | | (191) | |
Cash used in investing activities | (283) | | | (191) | |
Cash Flows From Financing Activities: | | | |
Proceeds from issuance of common stock upon follow-on public offering, net of paid issuance costs | 74,570 | | | — | |
Proceeds from sale of common stock under employee stock purchase plan | 222 | | | — | |
Proceeds from exercise of vested stock options | 17 | | | 20 | |
Payment of deferred offering costs | (75) | | | — | |
| | | |
| | | |
Proceeds from term loan | 20,000 | | | — | |
Payment of term loan issuance costs | (875) | | | — | |
| | | |
Net cash provided by financing activities | 93,859 | | | 20 | |
Net increase in cash and cash equivalents | 74,031 | | | 8,586 | |
Cash and cash equivalents — beginning of period | 171,332 | | | 168,149 | |
Cash and cash equivalents — end of period | $ | 245,363 | | | $ | 176,735 | |
| | | |
| | | |
| | | |
| | | |
Supplemental Disclosures Noncash Investing and Financing Activities: | | | |
| | | |
"Interest expense" paid in cash | $ | 127 | | | $ | — | |
Additions of "property and equipment, net" included within "accounts payable and other accrued liabilities" | $ | 59 | | | $ | — | |
Expensing of "operating lease right-of-use assets" upon lease termination | $ | — | | | $ | (38) | |
Stock issued for in-license agreements included within "research and development" expense | $ | — | | | $ | 5,494 | |
| | | |
Deferred offering costs included within "additional-paid in capital" | $ | 184 | | | $ | — | |
Deferred offering costs included within "accounts payable and accrued liabilities" | $ | — | | | $ | 281 | |
See accompanying notes to these unaudited condensed financial statements.
TARSUS PHARMACEUTICALS, INC.
NOTES TO THE FINANCIAL STATEMENTS
(all tabular amounts presented in thousands, except share, per share, per unit, and number of years)
(Unaudited)
1. DESCRIPTION OF BUSINESS AND PRESENTATION OF FINANCIAL STATEMENTS
(a) Description of Business
Tarsus Pharmaceuticals, Inc. (“Tarsus” or the “Company”) is a biopharmaceutical company focused on the development and commercialization of therapeutics, starting with eye care.
(b) Liquidity Overview
The Company has no product sales and has accumulated losses and negative cash flows from operations since inception (other than consideration received from an out-licensing agreement, as discussed in Note 9), resulting in an accumulated deficit of $72.7 million as of June 30, 2022 and $46.7 million as of December 31, 2021. The Company’s cash and cash equivalents were $245.4 million and $171.3 million as of June 30, 2022 and December 31, 2021, respectively. The Company expects to continue to incur operating losses and negative cash flows.
The Company has funded its inception-to-date operations primarily through equity capital raises, proceeds from its out-license agreement, and draw downs on its credit facility. The Company estimates its existing capital resources will be sufficient to meet projected operating expense requirements for at least 12 months from the filing date of the accompanying Condensed Financial Statements in this Form 10-Q; accordingly, these financial statements have been prepared on a "going-concern" basis.
The Company’s operations currently consist of its corporate organization build-out, intellectual property licensing activities, and preclinical and clinical study progression. The Company faces the clinical, business, and liquidity risks that are typically associated with biopharma companies; it must significantly invest in and conduct research and development activities, achieve research and development outcomes that are inherently uncertain, recruit and retain skilled personnel (including executive management), and expand and defend its intellectual property rights.
Management expects the Company to continue to incur losses in the foreseeable future as a result of research and development activities and other operating expenses. The Company may be required to raise additional capital to fund its future operations. However, no assurance can be given as to whether financing will be available on terms acceptable to the Company, if at all. If the Company raises additional funds by issuing equity securities, its stockholders may experience dilution. The Company's Credit Facility imposes additional covenants that restrict operations, including limitations on its ability to incur liens or additional debt, pay dividends, repurchase common stock, make certain investments, or engage in certain merger or asset sale transactions. Any debt financing or additional equity raise may contain terms that are not favorable to the Company or its stockholders. The Company’s potential inability to raise capital when needed could have a negative impact on its financial condition and ability to pursue planned business strategies. If the Company is unable to raise additional funds as required, it may need to delay, reduce, or terminate some or all of its development programs and clinical trials. The Company may also be required to sell or license its rights to product candidates in certain territories or indications that it would otherwise prefer to develop and commercialize on its own. If the Company is required to enter into collaborations and other arrangements to address its liquidity needs, it may have to give up certain rights that limit its ability to develop and commercialize product candidates or may have other terms that are not favorable to the Company or its stockholders, which could materially and adversely affect its business and financial prospects. These factors may adversely impact the Company's ability to achieve its business objectives and would likely have an adverse effect on its future business prospects, or even its ability to remain a going concern.
(c) Operating Segment
To date, the Company has operated and managed its business and financial information on an aggregate basis based on its organizational structure, for the purposes of evaluating financial performance and the allocation of capital and personnel resources, consistent with the way operations and investments are centrally managed and evaluated. Accordingly, the Company’s management determined that it operates one reportable operating segment. This single segment is focused exclusively on developing pharmaceutical products for eventual commercialization.
(d) Emerging Growth Company Status
TARSUS PHARMACEUTICALS, INC.
NOTES TO THE FINANCIAL STATEMENTS
(all tabular amounts presented in thousands, except share, per share, per unit, and number of years)
(Unaudited)
The Company is an "emerging growth company," as defined in the Jumpstart Our Business Startups Act of 2012 (the "JOBS Act"). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. The Company has irrevocably elected to not take this exemption. As a result, it will adopt new or revised accounting standards on the relevant effective dates on which adoption of such standards is required for other public companies that are not emerging growth companies.
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND USE OF ESTIMATES
(i) Basis of Presentation
The Company’s Condensed Financial Statements have been prepared in conformity with generally accepted accounting principles ("GAAP") in the United States ("U.S.") for interim financial information and pursuant to Form 10-Q and with the rules and regulations of the Securities and Exchange Commission ("SEC"). Accordingly, the accompanying Condensed Financial Statements do not include all of the information and footnotes required by GAAP for complete financial statements.
The interim Condensed Balance Sheet as of June 30, 2022, the interim Condensed Statements of Operations and Comprehensive (Loss) Income, and Stockholders’ Equity for the three and six months ended June 30, 2022 and 2021, and the interim Condensed Cash Flows for the six months ended June 30, 2022 and 2021 are unaudited. These unaudited interim financial statements have been prepared on the same basis as the Company’s annual financial statements and, in the opinion of management, reflect all adjustments, which consist of only normal and recurring adjustments for the fair presentation of its financial information.
The financial data and other information disclosed in these notes related to the three and six-month periods are also unaudited. The Condensed Balance Sheet as of December 31, 2021 has been derived from the audited financial statements at that date but does not include all information and footnotes required by GAAP for annual financial statements. The condensed interim operating results for three and six months ended June 30, 2022 are not necessarily indicative of results to be expected for the year ending December 31, 2022 or any other interim or annual period.
The accompanying interim unaudited Condensed Financial Statements should be read in conjunction with the audited financial statements and the related notes thereto in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the SEC on March 14, 2022.
The preparation of financial statements in conformity with GAAP and with the rules and regulations of the SEC requires management to make informed estimates and assumptions that affect the amounts reported in these financial statements and accompanying notes. These estimates and assumptions involve judgments with respect to numerous factors that are difficult to forecast and may materially differ from the amounts ultimately realized and reported due to the inherent uncertainty of any estimate or assumption.
There have been no significant changes in the Company’s significant accounting policies during the three and six months ended June 30, 2022, as compared with those disclosed in its Annual Report on Form 10-K for the year ended December 31, 2021, filed with the SEC on March 14, 2022. The accounting policies and estimates that most significantly impact the presented amounts within the accompanying Condensed Financial Statements are further described below.
(ii) Cash and Cash Equivalents
Cash and cash equivalents consist of bank deposits and highly liquid investments, including money market fund accounts, that are readily convertible into cash without penalty, with original maturities of three months or less from the purchase date.
(iii) Marketable Securities and Long-Term Investments
As of December 31, 2021, "marketable securities" represents LianBio common stock (see Note 7). These shares are reported within "long-term investments" on the Condensed Balance Sheet as of June 30, 2022, reflecting the intent to hold these shares for at least one year from the balance sheet date. These securities are designated as "available-for-sale" with associated
TARSUS PHARMACEUTICALS, INC.
NOTES TO THE FINANCIAL STATEMENTS
(all tabular amounts presented in thousands, except share, per share, per unit, and number of years)
(Unaudited)
gains or losses reported in "other expense, net" within the Condensed Statements of Operations and Comprehensive (Loss) Income for each reported period.
(iv) Concentration of Credit Risk and Other Risks and Uncertainties
Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents in deposits at financial institutions that exceed federally insured limits.
In March 2020, the World Health Organization declared a pandemic related to the global novel coronavirus disease 2019 (“COVID-19”) outbreak. The COVID-19 pandemic continues to evolve and its impact on the Company’s business will depend on several factors that are highly uncertain and unpredictable, including the efficacy and adoption of vaccines, future resurgences of the virus and its variants, and the speed at which government restrictions are lifted. To date, the Company’s operations have not been significantly impacted by the COVID-19 pandemic, though the Company continues to monitor the potential impact COVID-19 may have on its ongoing and planned clinical trials. However, the Company cannot at this time predict the specific extent, duration, or full impact that the COVID-19 outbreak may have on these activities or its financial condition.
The Company’s results of operations involve numerous risks and uncertainties. Factors that could adversely impact the Company’s operating results and business objectives include, but are not limited to, (1) uncertainty of results of clinical trials, (2) uncertainty of regulatory approval of the Company’s potential product candidates, (3) uncertainty of market acceptance of its product candidates, (4) competition from substitute products and other companies, (5) securing and protecting proprietary technology and strategic relationships, and (6) dependence on key individuals and sole source suppliers.
The Company’s product candidates require approvals from the U.S. Food and Drug Administration (“FDA”) and comparable foreign regulatory agencies prior to commercial sales in their respective jurisdictions. There can be no assurance that any product candidates will receive the necessary approvals. If the Company is denied approval, approval is delayed, or the Company is unable to maintain approval for any product candidate, it could have a materially adverse impact on its business.
(v) Revenue Recognition for Out-License Arrangements
Overview
The Company currently has one out-license arrangement that allows the third-party licensee to market the TP-03 product candidate (representing "functional intellectual property") in certain territories for a certain field of use and for a stated term - see Note 9. The accounting and reporting of revenue for out-license arrangements requires significant judgment for: (a) identification of the number of performance obligations within the contract, (b) the contract’s transaction price for allocation (including variable consideration), (c) the stand-alone selling price for each identified performance obligation, and (d) the timing and amount of revenue recognition in each period.
The Company's out-license arrangement, as described in Note 9, was analyzed under GAAP to determine whether the promised goods or services (which include the license, and know-how, data, and information necessary or reasonably useful for the research, development, manufacture, or commercialization of any licensed product, and governance committee services) are distinct or must be accounted for as part of a combined performance obligation. In making these assessments, the Company considers factors such as the stage of development of the underlying intellectual property and the capabilities of the customer to develop the intellectual property on their own, and/or whether the required expertise is readily available. If the license is considered to not be distinct, the license is combined with other promised goods or services as a combined performance obligation for revenue recognition.
The Company's out-license arrangement includes the following forms of consideration: (i) non-refundable upfront license payments, (ii) equity-based consideration, (iii) sales-based royalties, (iv) sales threshold milestones, (v) development milestone payments, and (vi) regulatory milestone payments. Revenue is recognized in proportion to the allocated transaction price when (or as) the respective performance obligation is satisfied. The Company evaluates the progress related to each milestone at each reporting period and, if necessary, also adjusts the probability of achievement and related revenue recognition. The measure of progress, and thereby periods over which revenue is recognized, is subject to estimates by management and may change over the course of the respective agreement.
TARSUS PHARMACEUTICALS, INC.
NOTES TO THE FINANCIAL STATEMENTS
(all tabular amounts presented in thousands, except share, per share, per unit, and number of years)
(Unaudited)
Contractual Terms for Receipt of Payments
The contractual terms that establish the Company’s right to collect specified amounts from its customers and that require contemporaneous evaluation and documentation under GAAP for the corresponding timing and amount of revenue recognition, are as follows:
(1) Upfront License Fees: The Company determines whether non-refundable license fee consideration is recognized at the time of contract execution (i.e., when the license is transferred to the customer and the customer is able to use and benefit from the license) or over the actual (or implied) contractual period of the out-license. The Company also evaluates whether it has any other requirements to provide substantive services that are inseparable from the performance obligation of the license transfer to determine whether any combined performance obligation is satisfied over time or at a point in time. Upfront payments may require deferral of revenue recognition to a future period until the Company performs obligations under these arrangements.
(2) Development Milestones: The Company utilizes the “most likely amount” method to estimate the amount of consideration to which it will be entitled for achievement of development milestones as these represent variable consideration. For those payments based on development milestones (e.g., patient dosing in a clinical study or the achievement of statistically significant clinical results), the Company assesses the probability that the milestone will be achieved, including its ability to control the timing or likelihood of achievement, and any associated revenue constraint. Given the high degree of uncertainty around the occurrence of these events, the Company determines the milestone and other contingent amounts to be "constrained" until the uncertainty associated with these payments is resolved. At each reporting period, the Company re-evaluates this associated revenue recognition constraint. Any resulting adjustments are recorded to revenue on a cumulative catch-up basis, and reflected in the financial statements in the period of adjustment.
(3) Regulatory Milestones: The Company utilizes the “most likely amount” method to estimate the consideration to which it will be entitled and recognizes revenue in the period regulatory approval occurs (the performance obligation is satisfied) as these represent variable consideration. Amounts constrained as variable consideration are included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The Company evaluates whether the milestones are considered probable of being reached and not otherwise "constrained." Accordingly, due to the inherent uncertainty of achieving regulatory approval, associated milestones are deemed constrained for revenue recognition until achievement.
(4) Royalties: Under the "sales-or-usage-based royalty exception" the Company recognizes revenue based on the contractual percentage of the licensee’s sale of products to its customers at the later of (i) the occurrence of the related product sales or (ii) the date upon which the performance obligation to which some or all of the royalty has been allocated has been satisfied or partially satisfied. To date, the Company has not recognized any royalty revenue from its out-licensing arrangements.
(5) Sales Threshold Milestones: Similar to royalties, applying the "sales-or-usage-based royalty exception", the Company recognizes revenue from sales threshold milestones at the later of (i) the period the licensee achieves the one-time annual product sales levels in their territories for which the Company is contractually entitled to a specified lump-sum receipt, or (ii) the date upon which the performance obligation to which some or all of the milestone has been allocated has been satisfied or partially satisfied. To date, the Company has not recognized any sales threshold milestone revenue from out-licensing arrangements.
The Company re-evaluates the measure of progress to each performance obligation in each reporting period as uncertain events are resolved and other changes in circumstances occur. A "performance obligation" is a promise in a contract to transfer a distinct good or service and is the unit of accounting. A contract’s "transaction price" is allocated among each distinct performance obligation based on relative standalone selling price and recognized when, or as, the applicable performance obligation is satisfied.
(vi) Research and Development Costs
TARSUS PHARMACEUTICALS, INC.
NOTES TO THE FINANCIAL STATEMENTS
(all tabular amounts presented in thousands, except share, per share, per unit, and number of years)
(Unaudited)
Research and development costs are expensed as incurred or as certain upfront or milestone payments become contractually due to licensors upon the achievement of clinical or regulatory events. These expenses also include internal costs directly attributable to in-development programs, including cost of certain salaries, payroll taxes, employee benefits, and stock-based compensation expense, as well as laboratory and clinical supplies, pre-clinical and clinical trial related expenses, clinical manufacturing costs, and the cost of services provided by outside contractors. The Company recognizes expense for pre-clinical studies and clinical trial activities performed by these third parties. This is typically based upon estimates of the proportion of work completed over the term of the individual study or trial, as well as patient enrollment and dosing events in accordance with agreements established with clinical research organizations (CROs) and clinical trial or pre-clinical study sites.
The Company has entered, and may continue to enter into, license agreements to access and utilize intellectual property for drug development. In each case, the Company evaluates if the assets acquired in a transaction represent the acquisition of an asset or a business, as defined under applicable GAAP. The Company’s executed in-license agreements (see Note 8(b)) were evaluated and determined to represent asset acquisitions. Because these assets have not yet received regulatory approval and have no alternative future use, the purchase price for each was immediately recognized as research and development expense. In addition, any future milestone payments (whether in the form of cash or stock) made before product regulatory approval (that do not meet the definition of a derivative) will also be immediately recognized as research and development expense when paid or becomes payable, provided there is no alternative future use of the rights in other research and development projects.
(vii) Stock-Based Compensation
The Company recognizes stock-based compensation expense for equity awards granted to employees, consultants, and members of its Board of Directors. The Black-Scholes pricing model is used to estimate the fair value of stock option awards as of the date of grant. The fair value of restricted stock units is representative of the closing share price preceding the date of grant.
For stock-based awards that vest subject to the satisfaction of a service requirement, the related expense is recognized on a straight-line basis over each award’s actual or implied vesting period. For stock-based awards that vest subject to a performance condition, the Company recognizes related expense on an accelerated attribution method, if and when it concludes that it is highly probable that the performance condition will be achieved. As applicable, the Company reverses previously recognized expense for unvested awards in the same period of forfeiture.
The measurement of the fair value of stock option awards and recognition of stock-based compensation expense requires assumptions to be estimated by management that involve inherent uncertainties and the application of management’s judgment, including (a) the fair value of the Company’s common stock on the date of the option grant for all awards granted prior to its October 2020 Initial Public Offering ("IPO"), (b) the expected term of the stock option until its exercise by the recipient, (c) stock price volatility over the expected term, (d) the prevailing risk-free interest rate over the expected term, and (e) expected dividend payments over the expected term.
Management estimates the expected term of awarded stock options utilizing the “simplified method” for awards as the Company does not yet have sufficient exercise history since its November 2016 corporate formation. Additionally, the Company lacks company-specific historical and implied volatility information of its stock since its IPO. Accordingly, management estimated this expected volatility based on a designated peer-group of publicly-traded companies for a look-back period, as of the date of grant, that corresponded with the expected term of the awarded stock option. The Company estimates the risk-free interest rate based upon the U.S. Department of the Treasury yield curve in effect at award grant for time periods that correspond with the expected term of the awarded stock option. The Company’s expected dividend yield is zero because it has never paid cash dividends and does not expect to for the foreseeable future.
The fair value of the Company’s common stock is based on the closing quoted market price of its common stock as reported by the Nasdaq Global Select Market on the date of grant.
All stock-based compensation expense is reported in the Statements of Operations and Comprehensive (Loss) Income within "research and development" expense or "general and administrative" expense, based upon the assigned department of the award recipient.
TARSUS PHARMACEUTICALS, INC.
NOTES TO THE FINANCIAL STATEMENTS
(all tabular amounts presented in thousands, except share, per share, per unit, and number of years)
(Unaudited)
(viii) Net (Loss) Income per Share
Basic net (loss) income per share is calculated by dividing the net (loss) income by the weighted-average number of shares of common stock outstanding for the period, without consideration for potential dilutive shares of common stock. Diluted net (loss) income per share is computed by dividing the net (loss) income by the weighted-average number of common stock equivalents outstanding for the period determined using the "treasury-stock method" and "if-converted method" as applicable.
The Company’s "participating securities" include unvested common stock awards issued upon early exercise of certain stock options, as early exercised unvested common stock awards have a non-forfeitable right to dividends. The Company’s participating securities do not have a contractual obligation to share in the Company’s losses, so in periods of net losses, the "two-class method" of calculating basic and diluted earnings per share is not required. In periods of net income, basic and diluted net loss per share attributable to common stockholders is presented in conformity with the two-class method required for participating securities. Also, net income is attributed to both common stockholders and participating security holders, and therefore, net income is allocated to shares of common stock and participating securities, as if all of the earnings for the period had been distributed. Diluted earnings per share under the two-class method is calculated using the more dilutive of the treasury stock or the two-class method.
Due to a net loss for the three and six months ended June 30, 2022, all otherwise potentially dilutive securities are antidilutive, and accordingly, the reported basic net loss per share equals the reported diluted net loss per share in this period.
(ix) Fair Value Measurements
Assets and liabilities recorded at fair value on a recurring basis in the balance sheets are categorized based upon the level of judgment associated with the inputs used to measure their fair values. Fair value is defined as the exchange price that would be received for an asset or an exit price that would be paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The authoritative guidance on fair value measurements establishes a three-tier fair value hierarchy for disclosure of fair value measurements as follows:
•Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities that are publicly accessible at the measurement date.
•Level 2: Observable prices that are based on inputs not quoted on active markets, but that are corroborated by market data. These inputs may include quoted prices for similar assets or liabilities or quoted market prices in markets that are not active to the general public.
•Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
The carrying amounts for financial instruments consisting of cash and cash equivalents, accounts payable and accrued liabilities approximate fair value due to the short maturities for each. The Company's equity warrant holdings are carried at fair value based on unobservable market inputs (see Note 7).
Assets and liabilities are classified based on the lowest level of input that is significant to the fair value measurements. The Company reviews the fair value hierarchy classification on a quarterly basis. Changes in the ability to observe valuation inputs may result in a reclassification of levels for certain assets or liabilities within the fair value hierarchy. The Company did not have any transfers of assets and liabilities between the levels of the fair value measurement hierarchy during the years presented.
(x) Comprehensive (Loss) Income
TARSUS PHARMACEUTICALS, INC.
NOTES TO THE FINANCIAL STATEMENTS
(all tabular amounts presented in thousands, except share, per share, per unit, and number of years)
(Unaudited)
Comprehensive (loss) income represents all changes in stockholders’ equity, except those resulting from distributions to stockholders. For all periods presented in the accompanying Condensed Financial Statements, comprehensive (loss) income was the same as reported net (loss) income.
(xi) Recently Issued or Effective Accounting Standards
Recently issued or effective accounting pronouncements that impact, or may have an impact, on the Company’s financial statements have been discussed within the footnote to which each relates. Other recent accounting pronouncements not disclosed in these Condensed Financial Statements have been determined by the Company’s management to have no impact, or an immaterial impact, on its current and expected future financial position, results of operations, or cash flows.
3. BALANCE SHEET ACCOUNT DETAIL
The composition of selected captions within the accompanying Condensed Balance Sheets are summarized below:
(a) Property and Equipment, Net
“Property and equipment, net” consists of the following:
| | | | | | | | | | | |
| June 30, 2022 | | December 31, 2021 |
Furniture and fixtures | $ | 596 | | | $ | 596 | |
Office equipment | 197 | | | 84 | |
Laboratory equipment | 167 | | | 167 | |
Leasehold improvements | 357 | | | 129 | |
Property and equipment, at cost | 1,317 | | | 976 | |
(Less): Accumulated depreciation and amortization | 354 | | | 221 | |
Property and equipment, net | $ | 963 | | | $ | 755 | |
Depreciation expense (included within “total operating expenses” in the accompanying Condensed Statements of Operations and Comprehensive (Loss) Income) for the three months ended June 30, 2022 and 2021 was $92 thousand and $125 thousand, respectively, and for the six months ended June 30, 2022 and 2021 was $133 thousand and $189 thousand, respectively.
(b) Other Assets
"Other assets" consists of the following:
| | | | | | | | | | | |
| June 30, 2022 | | December 31, 2021 |
Deposits | $ | 71 | | | $ | 71 | |
Equity warrants issued by licensee (Note 7) | 264 | | | 663 | |
Other long-term assets | 265 | | | 392 | |
Other assets | $ | 600 | | | $ | 1,126 | |
(c) Accounts Payable and Other Accrued Liabilities
“Accounts payable and other accrued liabilities” consists of the following:
TARSUS PHARMACEUTICALS, INC.
NOTES TO THE FINANCIAL STATEMENTS
(all tabular amounts presented in thousands, except share, per share, per unit, and number of years)
(Unaudited)
| | | | | | | | | | | |
| June 30, 2022 | | December 31, 2021 |
Trade accounts payable and other | $ | 4,093 | | | $ | 2,856 | |
| | | |
Operating lease liability, current | 605 | | | 609 | |
Accrued clinical studies | 4,068 | | | 4,407 | |
Contract liability | — | | | 697 | |
Accrued interest, current | 160 | | | — | |
Income taxes payable | — | | | 55 | |
Employee stock option pre-vesting exercise liability | 12 | | | 56 | |
Accounts payable and other accrued liabilities | $ | 8,938 | | | $ | 8,680 | |
(d) Other Long-Term Liabilities
“Other long-term liabilities” consists of the following:
| | | | | | | | | | | |
| June 30, 2022 | | December 31, 2021 |
Operating lease liability, non-current | $ | 300 | | | $ | 585 | |
Lotilaner licensor liability | 43 | | | 114 | |
| | | |
Other long-term liabilities | $ | 343 | | | $ | 699 | |
4. STOCKHOLDERS’ EQUITY AND EQUITY INCENTIVE PLANS
Common Stock Outstanding and Reserves for Future Issuance
As of June 30, 2022, the Company had 26.7 million and 26.6 million common shares issued and outstanding, respectively. As of December 31, 2021, the Company had 20.7 million common shares issued and outstanding, respectively. Each share of common stock is entitled to one vote.
The Company's outstanding equity awards and shares reserved for future issuance under its 2020 and 2016 Equity Incentive Plans and 2020 Employee Stock Purchase Plan is summarized below:
| | | | | | | | | | | |
| June 30, 2022 | | December 31, 2021 |
Common stock awards reserved for future issuance under 2020 and 2016 Equity Incentive Plans | 8,678,128 | | | 9,266,200 | |
Common stock awards reserved for future issuance under the 2020 Employee Stock Purchase Plan | 2,682,601 | | | 2,493,488 | |
Stock options issued and outstanding under 2020 and 2016 Equity Incentive Plans | 3,739,078 | | | 2,759,830 | |
Restricted stock units outstanding under 2020 Equity Incentive Plan | 440,737 | | | 17,251 | |
Total shares of common stock reserved | 15,540,544 | | | 14,536,769 | |
Follow-On Public Offering
On May 5, 2022, the Company completed a follow-on public offering under its Shelf Registration Statement for an initial underwritten sale of 5,600,000 shares of its common stock at a price of $13.50 per share. This resulted in gross proceeds of $75.6 million, before underwriting discounts, commissions and other estimated offering expenses, for net proceeds of $70.6 million.
The Company also granted the underwriters a 30-day option to purchase up to 840,000 additional shares of its common stock at the public offering price, less underwriting discounts and commissions. On June 1, 2022, the underwriters partially exercised this option by purchasing an additional 289,832 shares of the Company's common stock at the public offering price of $13.50 per share for additional gross proceeds of $3.9 million, before underwriting discounts and commissions for net proceeds of $3.7 million.
TARSUS PHARMACEUTICALS, INC.
NOTES TO THE FINANCIAL STATEMENTS
(all tabular amounts presented in thousands, except share, per share, per unit, and number of years)
(Unaudited)
After giving effect to the exercise of the underwriters’ option, the Company sold 5,889,832 shares for total gross proceeds of $79.5 million, before underwriting discounts, commissions and other estimated offering expenses. Total net proceeds during the second quarter of 2022 from this offering were $74.3 million.
5. STOCK-BASED COMPENSATION
Stock-Based Compensation Summary
Stock-based compensation expense is recorded to "research and development" or "general and administrative" expenses in the accompanying Condensed Statements of Operations and Comprehensive (Loss) Income, based on the functional role of each recipient. Stock-based compensation expense for the three and six months ended June 30, 2022 and 2021 was reported as follows:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | Six Months Ended June 30, |
| 2022 | | 2021 | | 2022 | | 2021 |
Research and development | $ | 984 | | | $ | 427 | | | $ | 1,662 | | | $ | 771 | |
General and administrative | 2,548 | | | 2,367 | | | 4,544 | | | 3,386 | |
Total stock-based compensation | $ | 3,532 | | | $ | 2,794 | | | $ | 6,206 | | | $ | 4,157 | |
6. NET (LOSS) INCOME PER SHARE
The following table sets forth the computation of basic and diluted net (loss) income per share:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | Six Months Ended June 30, |
| 2022 | | 2021 | | 2022 | | 2021 |
Basic EPS | | | | | | | |
Net (loss) income | $ | (5,743) | | | $ | 6,345 | | | $ | (25,981) | | | $ | 16,721 | |
Less: undistributed income allocated to participating securities | — | | | 46 | | | — | | | 133 | |
Net (loss) income available to common shareholders | $ | (5,743) | | | $ | 6,299 | | | $ | (25,981) | | | $ | 16,588 | |
| | | | | | | |
Basic weighted average shares outstanding | 24,332,531 | | | 20,555,258 | | | 22,531,384 | | | 20,446,246 | |
Net (loss) income per share—basic | $ | (0.24) | | | $ | 0.31 | | | $ | (1.15) | | | $ | 0.81 | |
| | | | | | | |
Diluted EPS | | | | | | | |
Net (loss) income | $ | (5,743) | | | $ | 6,345 | | | $ | (25,981) | | | $ | 16,721 | |
Less: undistributed income reallocated to participating securities | — | | | 43 | | | — | | | 124 | |
Net (loss) income available to common shareholders | $ | (5,743) | | | $ | 6,302 | | | $ | (25,981) | | | $ | 16,597 | |
| | | | | | | |
Basic weighted average shares outstanding | 24,332,531 | | | 20,555,258 | | | 22,531,384 | | | 20,446,246 | |
Effect of dilutive securities: | | | | | | | |
Common stock options | — | | | 1,411,341 | | | — | | | 1,449,058 | |
Diluted weighted average shares outstanding | 24,332,531 | | | 21,966,599 | | | 22,531,384 | | | 21,895,304 | |
Net (loss) income per share—diluted | $ | (0.24) | | | $ | 0.29 | | | $ | (1.15) | | | $ | 0.76 | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
The following outstanding potentially dilutive securities were excluded from the calculation of diluted net loss per
share because their impact under the “treasury stock method” and “if-converted method” would have been anti-dilutive for the
periods presented:
TARSUS PHARMACEUTICALS, INC.
NOTES TO THE FINANCIAL STATEMENTS
(all tabular amounts presented in thousands, except share, per share, per unit, and number of years)
(Unaudited)
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | Six Months Ended June 30, 2022 |
| 2022 | | 2021 | | 2022 | | 2021 |
Stock options, unexercised—vested and unvested | 3,739,078 | | | 803,238 | | | 3,739,078 | | | 803,238 | |
Stock options exercised prior to vesting— remaining unvested | 5,826 | | | 130,153 | | | 5,826 | | | 130,153 | |
Restricted stock units—unvested | 440,737 | | | 4,257 | | | 440,737 | | | 4,257 | |
Total | 4,185,641 | | | 937,648 | | | 4,185,641 | | | 937,648 | |
7. FAIR VALUE MEASUREMENTS
The table below summarizes certain financial instruments measured at fair value that are included within the accompanying balance sheets, and their designation among the three fair value measurement categories (see Note 2(ix)):
| | | | | | | | | | | | | | | | | | | | | | | |
| June 30, 2022 Fair Value Measurements |
| Level 1 | | Level 2 | | Level 3 | | Total |
Assets: | | | | | | | |
Money market funds | $ | 245,363 | | | $ | — | | | $ | — | | | $ | 245,363 | |
Common stock in LianBio (included in "long-term investments") | 169 | | | — | | | — | | | 169 | |
Equity warrants in LianBio (included in "other assets") | — | | | — | | | 264 | | | 264 | |
Total assets measured at fair value | $ | 245,532 | | | $ | — | | | $ | 264 | | | $ | 245,796 | |
| | | | | | | |
| December 31, 2021 Fair Value Measurements |
| Level 1 | | Level 2 | | Level 3 | | Total |
Assets: | | | | | | | |
Money market funds | $ | 171,332 | | | — | | — | | $ | 171,332 | |
Common stock in LianBio (included in "marketable securities") | 483 | | | — | | | — | | | $ | 483 | |
Equity warrants in LianBio (included in "other assets") | — | | | — | | | 663 | | | $ | 663 | |
Total assets measured at fair value | $ | 171,815 | | | $ | — | | | $ | 663 | | | $ | 172,478 | |
Money Market Funds
Money market fund holdings are included in "cash and cash equivalents" on the accompanying Condensed Balance Sheets and are classified within Level 1 of the fair value hierarchy because they have readily-available market prices in active markets that are publicly observable at the measurement date. These money market funds are invested in U.S. Treasury bills and notes and other securities issued or guaranteed as to principal and interest by the U.S. Government or its agencies.
Equity Warrants
In March 2021, contemporaneous with the China Out-License transaction (see Note 9), the Company and LianBio, executed a warrant agreement for the Company to purchase, in three tranches, a stated number of common shares in LianBio, a pharmaceutical company focused on the Greater China and other Asian markets (NASDAQ: LIAN). These warrants vest or have vested upon the achievement of certain clinical and regulatory events and have an exercise price at common stock par value.
In June 2021, one of these three warrant tranches vested and converted to 78,373 shares of LianBio common stock, reported within "marketable securities" as of December 31, 2021, and within "long-term investments" as of June 30, 2022. LianBio common stock is classified within Level 1 of the fair value hierarchy, given its publicly reported price on the NASDAQ Global Market.
TARSUS PHARMACEUTICALS, INC.
NOTES TO THE FINANCIAL STATEMENTS
(all tabular amounts presented in thousands, except share, per share, per unit, and number of years)
(Unaudited)
In May 2022, the second warrant tranche vested, but has not yet been exercised, leaving one remaining unvested tranche. The second and third warrant tranche remain classified as Level 3 in the fair value measurement hierarchy as of June 30, 2022 and December 31, 2021 and is presented within "other assets" in the accompanying Condensed Balance Sheets (see Note 3(b)). The most significant assumptions used in the option pricing valuation model as of each balance sheet date to determine its fair value included: LianBio common stock volatility (based on the historical volatility of similar companies), the probability of regulatory milestone achievement for vesting, and the application of an assumed discount rate.
The estimated fair value of these equity warrants will be remeasured each reporting period with adjustments reported within "other expense, net" on the accompanying Statements of Operations and Comprehensive (Loss) Income, until exercised or expired, and is presented in these accompanying financial statements as follows:
| | | | | |
| Value of equity warrants (see Note 3(b)) |
Fair value as of December 31, 2021 | $ | 663 | |
| |
Revaluation of equity warrant value in "other expense, net" within the Condensed Statement of Operations | (245) | |
Fair value as of March 31, 2022 | $ | 418 | |
Recognition of equity warrant value in "total revenues" within the Condensed Statement of Operations for the three months ended June 30, 2022 | 103 | |
Revaluation of equity warrant value in "other expense, net" within the Condensed Statement of Operations for the three months ended June 30, 2022 | (257) | |
Fair value as of June 30, 2022 | $ | 264 | |
| | | | | |
| Value of equity warrants (see Note 3(b)) |
Fair value as of December 31, 2020 | $ | — | |
Initial fair value estimate of equity warrant value in "total revenues" | 1,233 | |
Fair value as of March 31, 2021 | $ | 1,233 | |
Recognition of equity warrant value in "total revenues" within the Condensed Statement of Operations for the three months ended June 30, 2021 | 719 | |
Revaluation of equity warrant value in "other expense, net" within the Condensed Statement of Operations for the three months ended June 30, 2021 | (876) | |
Fair value as of June 30, 2021 | $ | 1,076 | |
8. COMMITMENTS & CONTINGENCIES
(a) Facility Leases
Overview
In the ordinary course of business, the Company enters lease agreements with unaffiliated third parties for facilities and office equipment. As of June 30, 2022 and December 31, 2021, the Company had four active leases in Irvine, California for adjacent office and laboratory suites that each expire on January 31, 2024.
The Company's operating leases have annual rent that is payable monthly and carry fixed annual increases. Under these arrangements the Company is responsible for real estate taxes, certain operating expenses, and common area maintenance. Since these costs are variable in nature, they are expensed as incurred and excluded from the reported amounts on the accompanying Condensed Balance Sheets, summarized below. During the year ended December 31, 2021, and the six months ended June 30, 2022, the Company had no sublease arrangements with it as lessor.
Financial Reporting Captions
TARSUS PHARMACEUTICALS, INC.
NOTES TO THE FINANCIAL STATEMENTS
(all tabular amounts presented in thousands, except share, per share, per unit, and number of years)
(Unaudited)
The below table summarizes the lease asset and liability accounts presented on the accompanying Condensed Balance Sheets:
| | | | | | | | | | | | | | | | | | | | |
Operating Leases | | Condensed Balance Sheet Caption | | June 30, 2022 | | December 31, 2021 |
Operating lease right-of-use assets— non-current | | Operating lease right-of-use assets | | $ | 813 | | | $ | 1,074 | |
| | | | | | |
Operating lease liability— current | | Accounts payable and other accrued liabilities | | $ | 605 | | | $ | 609 | |
Operating lease liability— non-current | | Other long-term liabilities | | 300 | | | 585 | |
Total lease liabilities | | | | $ | 905 | | | $ | 1,194 | |
Components of Lease Expense
The liability associated with each lease is amortized over the respective lease term using the “effective interest rate method.” The Company’s "operating lease right-of-use assets" are amortized over each lease term on a straight-line basis to lease expense and is allocated to "research and development" and "general and administrative" expenses in the accompanying Condensed Statements of Operations and Comprehensive (Loss) Income. The Company combines lease and non-lease components in the recognition of lease expense. The components of total lease cost were as follows:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | Six Months Ended June 30, |
| 2022 | | 2021 | | 2022 | | 2021 |
Operating lease cost | $ | 142 | | | $ | 60 | | | $ | 285 | | | $ | 120 | |
Variable lease cost | 62 | | | 11 | | | 101 | | | 71 | |
Short-term lease cost | — | | | 63 | | | — | | | 95 | |
Total lease cost | $ | 204 | | | $ | 134 | | | $ | 386 | | | $ | 286 | |
Weighted-Average Remaining Lease Term and Applied Discount Rate
As of June 30, 2022, the Company's facility leases had a weighted average remaining lease term of 1 year, 7 months. The weighted-average estimated incremental borrowing rate of 10% was utilized to present value future minimum lease payments since an implicit interest rate in each at-market lease agreement was not determinable.
Future Contractual Lease Payments
The below table summarizes the (i) minimum lease payments over the next five years and thereafter, (ii) lease arrangement imputed interest, and (iii) present value of future lease payments:
| | | | | | | | |
Operating Leases - Future Payments | | June 30, 2022 |
2022 (remaining six months) | | $ | 164 | |
2023 | | 761 | |
2024 | | 66 | |
2025 | | — | |
2026 | | — | |
Total future lease payments, undiscounted | | $ | 991 | |
(Less): Imputed interest | | (86) | |
Present value of operating lease payments | | $ | 905 | |
(b) In-License Agreements for Lotilaner
January 2019 Agreement for Skin and Eye Disease or Conditions in Humans
TARSUS PHARMACEUTICALS, INC.
NOTES TO THE FINANCIAL STATEMENTS
(all tabular amounts presented in thousands, except share, per share, per unit, and number of years)
(Unaudited)
In January 2019, the Company entered into a license agreement with Elanco Tiergesundheit AG (“Elanco”) for exclusive worldwide rights to certain intellectual property for the development and commercialization of lotilaner in the treatment or cure of any eye or skin disease or condition in humans, as amended in June 2022 (the "Eye and Derm Elanco Agreement"). The Company has sole financial responsibility for related development, regulatory, and commercialization activities.
The Company made a $1.0 million upfront payment at execution of the Eye and Derm Elanco Agreement in January 2019, and also made a required $1.0 million clinical milestone payment in September 2020, associated with the first two U.S. pivotal trials for the treatment of Demodex blepharitis. The Company paid an additional $2.0 million for its second pivotal trial milestone in April 2021, which was recorded in “research and development” expense in the accompanying Statements of Operations and Comprehensive Loss for the three months ended June 30, 2021. As part of the China Out-License discussed in Note 9, the Company made a contractual payment in the amount of $2.5 million to Elanco following the receipt of $25 million of initial proceeds from LianBio during the second quarter of 2021. In June 2022, the Company made a contractual prepayment of $1.5 million that can be applied towards any milestones that become due under the Eye and Derm Elanco Agreement and/or the All Human Uses Elanco Agreement. This prepayment is included within "prepaid expenses and other current assets" on the accompanying Condensed Balance Sheet as of June 30, 2022.
The Company may make further cash payments to Elanco under the Eye and Derm Elanco Agreement upon achievement of certain clinical milestones in the treatment of human skin diseases using lotilaner for an aggregate maximum of $3.0 million and various commercial and sales threshold milestones for an aggregate maximum of $79.0 million. In addition, the Company will be obligated to pay tiered contractual royalties to Elanco in the mid to high single digits of its net sales. If the Company receives certain types of payments from its sublicensees, it will be obligated to pay Elanco a variable percentage in the low to mid double-digits of such proceeds, except for territories in which it achieved applicable regulatory approval prior to sublicense execution.
September 2020 Agreement for All Other Diseases or Conditions in Humans
In September 2020, the Company executed an expanded in-license agreement with Elanco, granting it a worldwide license to certain intellectual property for the development and commercialization of lotilaner for the treatment, palliation, prevention, or cure of "all other" diseases and conditions in humans (i.e., beyond that of the eye or skin), as amended in June 2022 (the “All Human Uses Elanco Agreement”). In September 2020, the Company issued Elanco 222,460 shares of its common stock at the execution of the All Human Uses Elanco Agreement with an estimated fair value of $3.1 million ($14.0003 per share, approximating the issuance price of the Company's Series C preferred stock in September 2020).
The Company is required to make cash payments to Elanco under the All Human Uses Elanco Agreement upon the achievement of various clinical milestones for an aggregate maximum of $4.5 million and various commercial and sales threshold milestones for an aggregate maximum of $77.0 million. In addition, the Company will be obligated to pay contractual royalties to Elanco in the single digits of its net product sales. If the Company receives certain types of payments from its sublicensees, it will also be obligated to pay Elanco a variable percentage in the low to mid double-digits of such proceeds, except for territories in which it achieved applicable regulatory approval prior to sublicense execution.
In March 2021, the Company entered into the China Out-License agreement with LianBio (see Note 9) that required it to grant Elanco an additional fixed 187,500 shares of its common stock that otherwise would have been issuable no later than the 18-month anniversary of the All Human Uses Elanco Agreement for its continued license exclusivity. These issued shares were valued at $5.5 million, based on the Company's stock closing price of $29.30 per share on the date this issuance became contractually required and is reported within "research and development" expense within the accompanying Condensed Statements of Operations and Comprehensive (Loss) Income for the six months ended June 30, 2021.
(c) Employment Agreements
The Company has entered into employment agreements with eight of its executive officers. These agreements provide for the payment of certain benefits upon separation of employment under specified circumstances, such as termination without cause, or termination in connection with a change in control event.
TARSUS PHARMACEUTICALS, INC.
NOTES TO THE FINANCIAL STATEMENTS
(all tabular amounts presented in thousands, except share, per share, per unit, and number of years)
(Unaudited)
(d) Litigation Contingencies
From time to time, the Company may be subject to various litigation and related matters arising in the ordinary course of business. The Company is currently not aware of any such matters where there is at least a reasonable probability that a material loss, if any, has been or will be incurred for financial statement recognition.
(e) Indemnities and Guarantees
The Company has certain indemnity commitments, under which it may be required to make payments to its officers and directors in relation to certain transactions to the maximum extent permitted under applicable laws. The duration of these indemnities vary, and in certain cases, are indefinite and do not provide for any limitation of maximum payments. The Company has not been obligated to make any such payments to date and no liabilities have been recorded for this contingency in the accompanying Condensed Balance Sheets.
9. OUT-LICENSE AGREEMENT
Out-License of TP-03 Commercial Rights in Greater China in March 2021
On March 26, 2021, the Company entered into an out-license agreement with LianBio for its exclusive development and commercialization rights of TP-03 (lotilaner ophthalmic solution, 0.25%) in the People’s Republic of China, Hong Kong, Macau, and Taiwan (the “China Territory”) for the treatment of Demodex blepharitis and Meibomian Gland Disease (the “China Out-License”). LianBio is contractually responsible for all clinical development and commercialization activities and costs within the China Territory.
Through June 30, 2022, the Company received payments from LianBio totaling $70.0 million that is comprised of initial consideration of $25.0 million and $45.0 million for the achievement of three clinical development milestones, including $15.0 million received in June 2022.
The Company is eligible to receive further consideration from LianBio upon the achievement of additional milestones, including: (i) TP-03 clinical development and regulatory milestones of up to $30.0 million, (ii) expected drug supply agreement milestone of $5.0 million, (iii) TP-03 sales-based milestones for the China Territory of up to $100 million, (iv) tiered mid-to-high-teen royalties for China Territory TP-03 product sales, and (v) LianBio equity, subject to regulatory milestone achievement for vesting.
For the three and six months ended June 30, 2022 and 2021, the Company reported "license fees" and "collaboration revenue" in the accompanying Condensed Statements of Operations and Comprehensive (Loss) Income, in accordance with the revenue recognition accounting policy described in Note 2(vii). Reported revenue in each presented period relates to the satisfaction performance obligations relating to (i) the transfer of TP-03 license rights in the China Territory to LianBio and (ii) the completion of clinical activities and providing LianBio with the related data for its pivotal trials of TP-03 in the treatment of Demodex blepharitis.
10. CREDIT FACILITY AGREEMENT
On February 2, 2022, the Company executed the Credit Facility with Hercules and SVB that expires on February 2, 2027. The Credit Facility provides an aggregate principal amount of up to $175.0 million with tranched availability as follows: $40.0 million at its execution (to-date, $20.0 million drawn February 2022), $25.0 million upon submission of a New Drug Application ("NDA") with the FDA for TP-03, $35.0 million upon FDA approval of TP-03, $50.0 million upon achievement of product net revenue thresholds, and $25.0 million upon lender approval.
Each of these tranches may be drawn down in $5.0 million increments at the Company's election. The Credit Facility requires interest-only payments through February 1, 2026, followed by 12 months of principal amortization, unless extended for one year to its maturity, upon meeting certain contractual conditions. All unpaid amounts under the Credit Facility become due on its February 2, 2027 expiry.
TARSUS PHARMACEUTICALS, INC.
NOTES TO THE FINANCIAL STATEMENTS
(all tabular amounts presented in thousands, except share, per share, per unit, and number of years)
(Unaudited)
Principal draws accrue interest on the outstanding principal balance at a floating interest rate per annum equal to the greater of either (i) The Wall Street Journal ("WSJ") prime rate plus 5.20% or (ii) 8.45%. At the execution date of the Credit Facility, the WSJ prime rate was 3.25% and further increased during 2022 to 4.75% as of June 30, 2022.
The Company is required to pay a fee upon the earlier of (i) February 2, 2027 or (ii) the date the Company prepays, in full or in part, the outstanding principal balance of the Credit Facility ("End of Term Charge"). The current End of Term Charge of $1.0 million was derived at the execution of the Credit Facility by multiplying 4.75% by the $20.0 million drawn at closing and is accreted to "interest expense" through maturity.
As of June 30, 2022, the carrying value of the Credit Facility (reported as "term loan, net" on the accompanying Condensed Balance Sheets) consisted of $20.0 million principal outstanding less legal and administrative issuance costs of approximately $0.9 million that were recorded as a contra-liability to the "term loan, net" and accreted to "interest expense" using the effective interest method during its term.
The calculated effective interest rate (i.e., coupon rate and other applicable fees) during the term of the credit facility was 10.90% for the six months ended June 30, 2022. As of December 31, 2021 the Company had no outstanding debt.
During the three and six months ended June 30, 2022, the Company recognized "interest expense" on its Condensed Statement of Operations and Comprehensive (Loss) Income in connection with the Credit Facility as follows:
| | | | | | | | | | | |
| Three Months Ended June 30, 2022 | | Six Months Ended June 30, 2022 |
Interest expense for term loan | $ | 462 | | | $ | 736 | |
Accretion of end of term charge | 48 | | | 79 | |
Amortization of debt issuance costs | 35 | | | 59 | |
Total interest expense related to term loan | $ | 545 | | | $ | 874 | |
The principal balance of this term loan and related accretion and amortization as of June 30, 2022, were as follows:
| | | | | |
| June 30, 2022 |
Term loan, gross (amount drawn) | $ | 20,000 | |
Debt issuance costs (legal and other administrative fees) | (875) | |
Accretion of end of term charge | 79 | |
Accumulated amortization of debt issuance costs | 58 | |
Term loan, net | $ | 19,262 | |
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
Note Regarding Forward-Looking Statements
This Quarterly Report on Form 10-Q contains certain forward-looking statements. All statements other than statements of historical facts contained in this report, including statements regarding our future results of operations and financial position, future revenue, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that are in some cases beyond our control and may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.
The words “anticipate,” “believe,” contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would,” or the negative of these terms or other similar expressions are intended to identify forward-looking statements. Factors that may cause actual results to differ from expected results, include, among others:
•the likelihood of our clinical trials demonstrating safety and efficacy of our product candidates, and other positive results;
•the timing and progress of our current clinical trials and timing of initiation of our future clinical trials, and the reporting of data from our current and future trials;
•our plans relating to the clinical development of our current and future product candidates, including the size, number and disease areas to be evaluated;
•the prevalence of Demodex blepharitis and the size of the market opportunity for our product candidates;
•the rate and degree of market acceptance and clinical utility of our product candidates;
•our plans relating to commercializing our product candidates, if approved, including sales strategy;
•the impact of COVID-19 on our business and operations;
•the success of competing therapies that are or may become available;
•our estimates of the number of patients in the United States ("U.S.") or globally, as applicable, who suffer from Demodex blepharitis, Meibomian Gland Disease ("MGD"), rosacea, Lyme disease and malaria and the number of patients that will enroll in our clinical trials;
•the beneficial characteristics, safety, efficacy, therapeutic effects and potential advantages of our product candidates;
•the timing or likelihood of regulatory filings and approval for our product candidates;
•our ability to obtain and maintain regulatory approval of our product candidates and our product candidates to meet existing or future regulatory standards;
•our plans relating to the further development and manufacturing of our product candidates, including additional indications for which we may pursue;
•our ability to identify additional products, product candidates or technologies with significant commercial potential that are consistent with our commercial objectives;
•the expected potential benefits of strategic collaborations with third parties (including, for example, the receipt of payments, achievement and timing of milestones under license agreements, and the ability of our third party collaborators to commercialize our product candidates in the territories under license) and our ability to attract collaborators with development, regulatory and commercialization expertise;
•existing regulations and regulatory developments in the U.S. and other jurisdictions;
•our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available;
•our continued reliance on third parties to conduct additional clinical trials of our product candidates, and for the manufacture of our product candidates for preclinical studies and clinical trials;
•the need to hire additional personnel, in particular sales personnel, and our ability to attract and retain such personnel;
•the accuracy of our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;
•our financial performance;
•the sufficiency of our existing capital resources to fund our future operating expenses and capital expenditure requirements;
•our competitive position;
•our expectations regarding the period during which we will qualify as an emerging growth company under the JOBS Act; and
•our anticipated use of our existing resources and the proceeds from our Initial Public Offering ("IPO") and Follow-on Public Offering (defined below).
We have based these forward-looking statements largely on our current expectations and projections about our business, the industry in which we operate and financial trends that we believe may affect our business, financial condition, results of operations and growth prospects, and these forward-looking statements are not guarantees of future performance or development. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in the section titled “Risk Factors” elsewhere in this report. Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.
You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, advancements, discoveries, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, except as required by law, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements. We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this report to conform these statements to actual results or to changes in our expectations.
You should read this report and the documents that we reference in this report and have filed with the SEC as exhibits to this report with the understanding that our actual future results, levels of activity, performance and events and circumstances may be materially different from what we expect.
Overview of our Business
We are a biopharmaceutical company focused on the development and commercialization of therapeutics, starting with eye care. Our lead product candidate, TP-03 (lotilaner ophthalmic solution, 0.25%), is a novel investigational eye drop to treat blepharitis caused by the infestation of Demodex mites, which is referred to as Demodex blepharitis. Blepharitis ("Blephar" is a reference to eyelid and “itis” is a reference to inflammation) is an ophthalmic lid margin disease characterized by inflammation of the eyelid margin, redness and ocular irritation, including a specific type of eyelash dandruff called collarettes, which are pathognomonic for Demodex blepharitis. Poorly controlled and progressive blepharitis can lead to corneal damage over time and, in extreme cases, blindness. There are an estimated 25 million people in the U.S. who suffer from Demodex blepharitis.
We designed TP-03 to target and eradicate the root cause of Demodex blepharitis — Demodex mite infestation. The active pharmaceutical ingredient ("API") of TP-03, lotilaner, paralyzes and eradicates mites and other parasites through the inhibition of parasite-specific gamma-aminobutyric acid-gated chloride ("GABA-Cl") channels.
To date, we have completed four Phase 2 trials, the Phase 2b/3 Saturn-1 trial, and the Phase 3 Saturn-2 trial for TP-03 in Demodex blepharitis. Each of these trials for TP-03 met their primary, secondary and/or exploratory endpoints, with the drug well tolerated. In May 2022, we announced positive topline results of the Saturn-2 trial and will use the data from the Saturn-1 and Saturn-2 trials to support our submission of a new drug application ("NDA") in the second half of 2022. We believe that TP-03 has the potential to be the first therapeutic approved by the U.S. Food and Drug Administration ("FDA") and become the definitive standard of care for the treatment of Demodex blepharitis.
We intend to further advance our pipeline with the lotilaner API to address several diseases across therapeutic categories in human medicine, including eye care, dermatology, and other diseases. We are developing product candidates to address targeted diseases with high unmet medical needs, which currently include TP-03 for the potential treatment of MGD, TP-04 for the potential treatment of rosacea, and TP-05 for potential Lyme disease prophylaxis and community malaria reduction.
Recent Business and Clinical Highlights
TP-03 Demodex Blepharitis Pivotal Trials, Saturn-1 & Saturn-2: In May 2022, we announced positive topline results of Saturn-2, our second and final pivotal trial. Saturn-2 enrolled 412 adults having, among other things, more than 10 collarettes per lid and at least mild lid erythema. All pre-specified primary and secondary endpoints were met, TP-03 was well tolerated and complete resolution of Demodex blepharitis was demonstrated in patients treated with TP-03 (lotilaner ophthalmic solution, 0.25%).
Primary Endpoint:
•56% of patients on TP-03 achieved complete collarette cure, defined as 0-2 collarettes per lid at day 43, compared to 13% on vehicle (p<0.0001).
◦89% of patients on TP-03 achieved a clinically meaningful collarette cure, defined as 0-10 collarettes per lid at day 43 compared to 33% of those on vehicle (p<0.0001).
Secondary Endpoints:
•52% of patients on TP-03 achieved mite eradication defined as zero mites per lash at day 43, compared to 14% on vehicle (p<0.0001).
•31% of patients on TP-03 compared to 9% of patients on vehicle (p<0.0001) achieved complete lid erythema cure at day 43.
•19% of patients on TP-03 achieved a complete composite cure, based on achieving both complete collarette cure and complete lid erythema cure, compared to 4% on vehicle (p<0.0001) at day 43.
Safety Profile:
•Consistent with Saturn-1, Saturn-2 demonstrated that TP-03 was well tolerated with a safety profile similar to the vehicle group.
◦91% of TP-03 patients reported that the drop comfort was neutral to very comfortable.
◦There were no serious treatment-related adverse events nor any treatment-related adverse events leading to treatment discontinuation.
TP-03 Meibomian Gland Disease, Phase 2a Trial, Ersa: On August 5, 2022, we announced the enrollment of our first patient in the Phase 2a Ersa clinical trial studying TP-03 for the treatment of MGD.
TP-05 Lyme disease Phase 1 Trial, Callisto: We advanced our Phase 1 Callisto trial, evaluating TP-05, a novel, oral, non-vaccine therapeutic for the prevention of Lyme disease, with data expected in the second half of 2022. The Callisto trial is a single ascending dose and multiple ascending dose trial to evaluate the safety, tolerability and pharmacokinetics ("PK") of TP-05 in healthy volunteers. There are currently no FDA-approved pharmacological prophylactic options for Lyme disease, which is the most common vector-borne disease in the U.S., transmitted to humans via Borrelia burgdorferi bacterium infection following the bite of a tick.
We believe TP-05 is currently the only non-vaccine, drug-based, preventive therapeutic in development that targets the ticks, and potentially prevents Lyme disease transmission. It is designed to rapidly provide systemic blood levels of lotilaner potentially sufficient to kill infected ticks attached to the human body before they can transmit the Borrelia bacteria that causes Lyme disease.
TP-03 China Territory Out-License: In March 2021, we executed an out-license agreement (the "China Out-License") with LianBio Ophthalmology Limited ("LianBio"), granting exclusive commercial rights to TP-03 for the treatment of Demodex blepharitis and MGD within The People’s Republic of China, Macau, Hong Kong, and Taiwan (the "China Territory"). In May 2022, LianBio announced that they are on track to initiate a TP-03 Phase 3 pivotal trial in Chinese patients for the treatment of Demodex blepharitis in the second half of 2022 to support regulatory approval in China.
To date, we have received contractual cash proceeds from LianBio of $70.0 million, representing initial consideration of $25.0 million and $45.0 million for the achievement of three clinical development milestones (including the Saturn-2 topline primary endpoint achievement milestone of $15.0 million received in June 2022). We also received equity warrant rights in LianBio as part of this license, a portion of which remains subject to a regulatory vesting provision.
We are further eligible to receive:
•drug supply agreement execution milestone of $5.0 million (expected by December 2022)
•China-based clinical and regulatory milestones totaling $30.0 million ($10.0 million of which we expect by December 2022 for LianBio's initiation of a Phase 3 pivotal trial in China)
•sales threshold milestones in the China Territory totaling $100.0 million; and
•tiered mid-to-high teen royalties on the net product sales of TP-03 within the China Territory
Credit Facility with Hercules Capital and Silicon Valley Bank: On February 2, 2022, we executed a loan and security agreement with Hercules Capital and Silicon Valley Bank (the "Credit Facility). This $175.0 million Credit Facility has tranched availability as follows:
•$40.0 million at closing ($20 million drawn in February 2022 and $20 million remaining available)
•$25.0 million upon NDA submission of TP-03
•$35.0 million upon FDA approval of TP-03
•$50.0 million upon achievement of certain quarterly revenue thresholds
•$25.0 million available with lender approval
Capital draws are at our election and are in $5.0 million increments. This Credit Facility includes a four-year interest only period and is extendable to five years upon meeting certain conditions that we expect to achieve.
Follow-On Public Offering: On May 5, 2022, we completed a follow-on public offering under our effective Form S-3 shelf registration statement through an initial underwritten sale of 5.6 million shares of common stock at a price of $13.50 per share (the “Follow-On Public Offering”). This resulted in gross proceeds of $75.6 million before underwriting discounts, commissions, and other estimated offering expenses, for net proceeds of $70.6 million.
We also granted the underwriters a 30-day option to purchase up to 840,000 additional shares of common stock at the public offering price, less discounts and commissions. On June 1, 2022, the underwriters partially exercised this option by purchasing an additional 289,832 shares of common stock at $13.50 per share, for additional gross proceeds of $3.9 million before underwriting discounts and commissions, for net proceeds of $3.7 million.
After giving effect to the exercise of the underwriters’ option, the total number of shares of our common stock sold in the Follow-On Public Offering was 5,889,832 shares which resulted in total gross proceeds of $79.5 million before underwriting discounts, commissions and other estimated offering expenses for total net proceeds in the second quarter of 2022 of $74.3 million.
Corporate and Financial Overview
We were incorporated as a Delaware corporation in November 2016, and our headquarters is located in Irvine, California. Since our inception, we have devoted substantially all of our resources to organizing and staffing our company, acquiring intellectual property, clinical development of our product candidates, building our research and development capabilities, raising capital, and enhancing our corporate infrastructure.
To date we have financed our operations through private placements of preferred stock, convertible promissory notes, the net proceeds from issuance of common stock in our IPO and Follow-on Public Offering, cash proceeds from our out-licensing arrangements, and draw downs on our Credit Facility.
We have incurred significant net operating losses in every year since our inception and expect to continue to incur significant operating expenses and, other than the effect of license fee revenue from the China Out-License Agreement, increasing operating losses for the foreseeable future. Our net (loss) income was $(5.7) million and $6.3 million for the three months ended June 30, 2022 and 2021, respectively. Our net losses and any net income we may generate may fluctuate significantly from quarter to quarter and year to year and could be substantial. As of June 30, 2022 and December 31, 2021, we had an accumulated deficit of $72.7 million and $46.7 million, respectively, from our research and development and general and administrative activities since our inception. We anticipate that our operating expenses will increase significantly as we:
•conduct and complete clinical activities for our lead product candidate, TP-03, for the treatment of Demodex blepharitis;
•advance the clinical development of TP-03 for the potential treatment of MGD, TP-04 for the potential treatment of rosacea and TP-05 for potential Lyme prophylaxis and community malaria reduction;
•seek regulatory and marketing approvals for product candidates that successfully complete clinical development, if any;
•establish our own sales force in the U.S. to commercialize our products for which we obtain regulatory approval;
•engage with contract manufacturers to ensure a sufficient supply chain capacity to provide commercial quantities of any products for which we may obtain marketing approval;
•maintain, expand and protect our intellectual property portfolio;
•hire additional staff, including clinical, scientific, technical, regulatory, marketing, operations, financial, and other support personnel, to execute our business plan; and
•add information systems and personnel to support our product development and potential future commercialization efforts, and to enable us to operate as a public company.
We do not expect to generate revenues from product sales unless and until we successfully complete clinical development and obtain regulatory approval for a product candidate and commercially launch such product. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through private or public equity or debt financings, or collaborations, strategic alliances, or licensing arrangements with third parties. Adequate funding may not be available to us when needed on acceptable terms, or at all. If we raise additional funds through collaborations, strategic alliances, or licensing arrangements with third parties, we may have to relinquish valuable rights to our intellectual property, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional capital or enter into such agreements as and when needed, we could be forced to significantly delay, scale back, or discontinue our product development and/or commercialization plans, which would negatively and adversely affect our financial condition.
Because of the numerous risks and uncertainties associated with drug product development, we are unable to accurately forecast the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability. Even if we are able to generate revenue from product sales, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels.
Though we do not have revenue from product sales, we have recognized "license fees" and "collaboration revenue" from our China Out-License for the three and six months ended June 30, 2022 and 2021. We expect to recognize additional revenue under these captions in future periods (see Note 9).
As of June 30, 2022, our aggregate cash and cash equivalents was $245.4 million – see the section below titled “Management's Discussion and Analysis of Financial Condition and Results of Operations — Liquidity and Capital Resources” for additional liquidity discussion.
Impact of the COVID-19 Pandemic on our Operations
Efforts to contain the spread of COVID-19 in the U.S. (including in California where our corporate headquarters and laboratory facility are located) and other countries have included quarantines, shelter-in-place orders, and various other government restrictions in order to control the spread of this virus.
We have been monitoring the COVID-19 pandemic as it continues to progress and its potential impact on our business. We have taken important steps to ensure the workplace safety of our employees when working within our laboratory and administrative offices, or when traveling. We have also implemented a vaccination policy and we may take further actions as may be required by federal, state or local authorities.
To date, we have been able to continue our key business activities and advance our clinical programs. However, in the future, it is possible that our clinical development timelines and business plans could be adversely affected. We maintain regular communication with our vendors and clinical sites to appropriately plan for, and mitigate, the impact of the COVID-19 pandemic on our operations. The ultimate effect from this pandemic on our development timelines for TP-03 and our other product candidates is inherently uncertain.
See the section titled Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2021, filed with the SEC on March 14, 2022 and in this Quarterly Report, for a further discussion of the potential adverse impact of COVID-19 on our business, results of operations and financial condition.
Results of Operations
Comparison of the Three Months Ended June 30, 2022 and 2021
The following table summarizes our results of operations for the periods indicated:
| | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | Change |
| 2022 | | 2021 | |
| (in thousands) |
Revenues: | | | | | |
License fees | $ | 13,893 | | | 19,048 | | | $ | (5,155) | |
Collaboration revenue | 1,384 | | | 2,969 | | | (1,585) | |
Total revenues | 15,277 | | | 22,017 | | | (6,740) | |
Operating expenses: | | | | | |
Cost of license fees and collaboration revenue | 522 | | | 737 | | | (215) | |
Research and development | 9,603 | | | 7,204 | | | 2,399 | |
General and administrative | 10,376 | | | 6,794 | | | 3,582 | |
Total operating expenses | 20,501 | | | 14,735 | | | 5,766 | |
(Loss) income from operations before other (expense) income and income taxes | (5,224) | | | 7,282 | | | (12,506) | |
Other (expense) income: | | | | | |
Interest (expense) income, net | (247) | | | 7 | | | (254) | |
Other income (expense), net | 106 | | | (39) | | | 145 | |
Unrealized loss on equity investments | (121) | | | — | | | (121) | |
Change in fair value of equity warrants issued by licensee | (257) | | | (876) | | | 619 | |
Total other expense, net | (519) | | | (908) | | | 389 | |
Provision for income taxes | — | | | (29) | | | 29 | |
Net (loss) income and comprehensive (loss) income | $ | (5,743) | | | $ | 6,345 | | | $ | (12,088) | |
License Fees and Collaboration Revenue
License fees and collaboration revenue was $15.3 million for the three months ended June 30, 2022. This amount was attributable to the contractual milestones under the China Out-License (see Note 9) to the extent completed by June 30, 2022. These amounts represent the satisfaction of the transfer of TP-03 license rights to LianBio and the partial completion of clinical-related "performance obligations".
We will recognize additional "license fee and collaboration revenue" to the extent the contractual performance obligations are further satisfied or other events occur, specifically related to (i) the achievement of a drug supply agreement execution milestone, (ii) milestone payments upon TP-03 pivotal trial completion and the delivery of associated clinical data and reports to our licensee, (iii) achievement of regulatory events in the China Territory that trigger milestone payments, and (iv) our licensee's product sales of TP-03 in the China Territory.
Cost of License Fees and Collaboration Revenue
Cost of license fees and collaboration revenue decreased by $0.2 million for the three months ended June 30, 2022, as compared to the prior year period. These amounts relate to our contractual payment obligations to our licensor that are attached to our China Out-License proceeds.
Research and Development Expenses
Research and development expenses increased by $2.4 million for the three months ended June 30, 2022, as compared to the prior year period. The increase was primarily due to (i) $1.5 million of increased payroll and personnel-related costs (which includes stock-based compensation) for 11 employee additions period over period to drive our product development initiatives, (ii) $0.5 million of increased regulatory and consulting costs in preparation for our NDA filing, and (iii) $0.3 million of increased clinical and preclinical study costs.
General and Administrative Expenses
General and administrative expenses increased by $3.6 million for the three months ended June 30, 2022, as compared to the prior year period. The increase was primarily due to (i) $2.0 million of increased payroll and personnel-related costs (which includes stock-based compensation) for 19 employee additions period over period to support our business growth, and (ii) $1.5 million of increased market research costs.
Other Expense, Net
Other expense, net decreased by $0.4 million primarily due to a $0.6 million change in fair value of the LianBio equity warrants we received as part of our China Out-License in March 2021, partially offset by (i) interest expense of $0.2 million related to the Credit Facility executed in February 2022, and (ii) mark-to-market adjustments of $0.1 million for revaluation of LianBio common stock held (after our exercise of the first warrant tranche).
Provision for Income Taxes
We maintain a valuation allowance against our net deferred tax assets as of June 30, 2022 and 2021 due to the uncertainty that such assets will be realized. We evaluate the recoverability of our deferred tax assets on at least an annual basis. For the three months ended June 30, 2022, we did not record any income tax benefit due to the losses we incurred in that period.
Comparison of the Six Months Ended June 30, 2022 and 2021
The following table summarizes our results of operations for the periods indicated:
| | | | | | | | | | | | | | | | | |
| Six Months Ended June 30, | | Change |
| 2022 | | 2021 | |
| (in thousands) |
Revenues: | | | | | |
License fees | $ | 13,893 | | | 52,359 | | | $ | (38,466) | |
Collaboration revenue | 1,923 | | | 3,090 | | | (1,167) | |
Total revenues | 15,816 | | | 55,449 | | | (39,633) | |
Operating expenses: | | | | | |
Cost of license fees and collaboration revenue | 555 | | | 2,034 | | | (1,479) | |
Research and development | 21,684 | | | 23,465 | | | (1,781) | |
General and administrative | 18,322 | | | 11,954 | | | 6,368 | |
Total operating expenses | 40,561 | | | 37,453 | | | 3,108 | |
(Loss) income from operations before other (expense) income and income taxes | (24,745) | | | 17,996 | | | (42,741) | |
Other (expense) income: | | | | | |
Interest (expense) income, net | (563) | | | 16 | | | (579) | |
Other income (expense), net | 143 | | | (73) | | | 216 | |
Unrealized loss on equity investments | (313) | | | — | | | (313) | |
Change in fair value of equity warrants issued by licensee | (502) | | | (876) | | | 374 | |
Total other expense, net | (1,235) | | | (933) | | | (302) | |
Provision for income taxes | (1) | | | (342) | | | 341 | |
Net (loss) income and comprehensive (loss) income | $ | (25,981) | | | $ | 16,721 | | | $ | (42,702) | |
License Fees and Collaboration Revenue
License fees and collaboration revenue was $15.8 million for the six months ended June 30, 2022. This amount was attributable to the contractual milestones under the China Out-License (see Note 9) to the extent completed by June 30, 2022. These amounts represent the satisfaction of the transfer of TP-03 license rights to LianBio and the partial completion of clinical-related "performance obligations".
We will recognize additional "license fee and collaboration revenue" to the extent the contractual performance obligations are further satisfied or other events occur, specifically related to (i) the achievement of a drug supply agreement execution milestone, (ii) milestone payments upon TP-03 pivotal trial completion and the delivery of associated clinical data and reports to our licensee, (iii) achievement of regulatory events that trigger milestone payments, and (iv) our licensee's product sales of TP-03 in the China Territory.
Cost of License Fees and Collaboration Revenue
Cost of license fees and collaboration revenue decreased by $1.5 million for the six months ended June 30, 2022, as compared to the prior year period. These amounts relate to our contractual payment obligations to our licensor that are attached to our China Out-License proceeds.
Research and Development Expenses
Research and development expenses decreased by $1.8 million for the six months ended June 30, 2022, as compared to the prior year period. The decrease was primarily due to non-recurring costs in the prior year period including (i) a contractual payment in March 2021 in the form of 187,500 shares of our common stock then valued at $5.5 million to extend the period of our September 2020 in-license agreement, and (ii) contractual payment of $2 million under our January 2019 in-license for the commencement of our Saturn-2 trial. These decreases were partially offset by (i) $2.6 million of increased payroll and personnel-related costs (which includes stock-based compensation), for 11 employee additions period over period to drive our product development initiatives, (ii) $2.0 million of increased clinical and preclinical study costs, (iii) $0.7 million of increased regulatory and consulting costs in preparation of our NDA filing, and (iv) $0.3 million of increased manufacturing and formulation costs.
General and Administrative Expenses
General and administrative expenses increased by $6.4 million for the six months ended June 30, 2022, as compared to the prior year period. The increase was primarily due to (i) $4.2 million of increased payroll and personnel-related costs (which includes stock-based compensation) for 19 employee additions period over period to support our business growth, and (ii) $2.1 million of increased market research costs.
Other Expense, Net
Other expense, net increased by $0.3 million which substantially consists of $0.6 million of increased interest expense related to the Credit Facility executed in February 2022, partially offset by $0.2 million of miscellaneous items.
Provision for Income Taxes
We maintain a valuation allowance against our net deferred tax assets as of June 30, 2022 and 2021 due to the uncertainty that such assets will be realized. We evaluate the recoverability of our deferred tax assets on at least an annual basis. For the six months ended June 30, 2022, we recorded nominal income tax expense.
Liquidity and Capital Resources
Sources of Liquidity
Overview
As of June 30, 2022, we had cash and cash equivalents of $245.4 million. Since our inception, our operations have been substantially financed by cash proceeds of private placements of preferred stock, IPO proceeds, China Out-License consideration, Credit Facility draw, and the Follow-On Public Offering.
IPO - October 2020
In connection with our October 2020 IPO, we sold 6,325,000 shares of our common stock (inclusive of the full exercise of the underwriters’ option to purchase 825,000 shares of common stock). After deducting underwriting discounts, commissions and other related expenses, our IPO proceeds were $91.7 million.
Follow-On Public Offering - completed May 2022
In May 2022, we completed the Follow-On Public Offering. This resulted in gross proceeds of $75.6 million before underwriting discounts, commissions and other estimated offering expenses for net proceeds of $70.6 million. We also granted the underwriters a 30-day option to purchase up to 840,000 additional shares of common stock at the public offering price, less underwriting discounts and commissions. In June 2022, the underwriters partially exercised their option to purchase an additional 289,832 shares of common stock at the offering price of $13.50 per share for additional gross proceeds of $3.9
million, before underwriting discounts and commissions, for net proceeds of $3.7 million. After giving effect to the exercise of the underwriters’ option, we sold 5,889,832 shares for total gross proceeds of $79.5 million, before underwriting discounts, commissions and other estimated offering expenses, for total net proceeds received in the second quarter of 2022 of $74.3 million.
China Out-License - executed March 2021
As of June 30, 2022, we have received $70.0 million of total proceeds in connection with our China Out-License, inclusive of 2022 milestone receipts of $15.0 million in June for the achievement of the Saturn-2 topline primary endpoint (see Note 9). We expect to receive an additional $15.0 million during the second half of 2022 for the achievement of a China-based clinical development milestone and a supply agreement milestone, resulting in aggregate milestone receipts through December 2022 of $85.0 million. The remaining $120.0 million of available milestones under this arrangement will potentially be received upon future regulatory and sales achievements all within the China Territory.
Credit Facility - executed February 2022
In February 2022, we drew $20.0 million from our credit facility with Hercules Capital and Silicon Valley Bank. This $175.0 million facility has tranched availability as follows:
• $40.0 million at closing ($20 million drawn and $20.0 million available);
• $25.0 million upon NDA submission of TP-03;
• $35.0 million upon FDA approval of TP-03;
• $50.0 million upon achievement of certain quarterly revenue thresholds; and
• $25.0 million with lender approval.
Capital draws are at our election and are in $5.0 million increments. The Credit Facility includes four-year period of interest-only payments and is extendable for a fifth year to February 2027 maturity, upon our expected achievement of required conditions. We currently have no other financing commitments, such as lines of credit or guarantees.
Funding Requirements
Cash Runway
Our operating expenditures currently consist of research and development costs (including activities within our preclinical, clinical, regulatory, and drug manufacturing initiatives) and general and administrative costs. Our use of cash is impacted by the timing and extent of payments for each of these activities and other business requirements.
We believe that our cash and cash equivalents of $245.4 million as of June 30, 2022 is sufficient to fund our current and planned operations for at least the next twelve months from the date of this filing on Form 10-Q. These funds in combination with additional expected milestone proceeds from our China Out-License of $30.0 million through 2024 ($15.0 million of which is expected in the second half of 2022), should provide sufficient capital resources to fund our planned pipeline development, operating expenses, and capital expenditure requirements at least into 2026.
We base this latest cash runway estimate on revenue and expense assumptions that may require future adjustments, as part of our ongoing business decisions within pipeline development and our other corporate initiatives. Accordingly, we may require additional capital resources earlier than we currently expect. We also anticipate having at least $80.0 million of standby capital availability from our Credit Facility through December 2023 (excluding our $20.0 million draw in February 2022) and an additional $75.0 million of availability through maturity in February 2027.
Shelf Registration Statement
On November 1, 2021, we filed a shelf registration statement on Form S-3 that was declared effective by the SEC on November 5, 2021 (the “Shelf Registration Statement”). This permits us to offer up to $300.0 million of common stock, preferred stock, debt securities and warrants in one or more offerings and in any combination, including in units from time to time. Our Shelf Registration Statement is intended to provide us with additional flexibility to access capital markets for general corporate purposes, which may include working capital, capital expenditures, other corporate expenses and acquisitions of complementary products, technologies, or businesses. We completed our recent Follow-on Public Offering under this Shelf Registration Statement.
Also, as part of this Shelf Registration Statement, we concurrently filed a sales agreement prospectus covering the sale of up to $100.0 million of our common stock pursuant to an Open Market Sale AgreementTM (the “ATM Agreement”) with Jefferies LLC. Through the date of this Form 10-Q filing, we have not sold any shares of our common stock under the ATM Agreement.
Other Liquidity Risks
To date, we have not generated any product sales, though have recognized revenue and cash receipts from our China Out-License. We do not expect to report any product revenue unless and until we (1) complete development of any of our product candidates; (2) obtain applicable regulatory approvals; and then (3) successfully commercialize or enter into other collaborative agreements for our product candidates with third parties. We do not know with certainty when, or if, any of these items will ultimately occur.
We expect to incur significant operating losses for the foreseeable future, and expect these losses to further increase, as we ramp up our clinical development programs and begin activities for commercial launch readiness. We may also encounter unforeseen expenses, difficulties, complications, delays and other currently unknown factors that could adversely affect our business.
We may require additional capital to fully develop our product candidates and to execute our business strategy. Our requirements of a future capital raise will depend on many factors, including:
•the scope, timing, rate of progress and costs of our drug discovery efforts, preclinical development activities, laboratory testing and clinical trials for our product candidates;
•the number and scope of clinical programs we decide to pursue;
•the cost, timing and outcome of preparing for and undergoing regulatory review of our product candidates;
•the scope and costs of development and commercial manufacturing activities;
•the cost and timing associated with commercializing our product candidates, if they receive marketing approval;
•the amount of revenue, if any, received from commercial sales of our product candidates, should any of our product candidates receive marketing approval;
•the achievement of milestones or occurrence of other developments that trigger payments under any collaboration agreements we might have at such time and availability under our Credit Facility;
•the extent to which we acquire or in-license other product candidates and technologies;
•the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;
•our ability to establish and maintain collaborations on favorable terms, if at all;
•our efforts to enhance operational systems and our ability to attract, hire and retain qualified personnel, including personnel to support the development of our product candidates and, ultimately, the sale of our products, following FDA approval;
•our implementation of various computerized information systems;
•impact of COVID-19 on our clinical development or operations; and
•the costs associated with being a public company.
A change in the outcome of any of these or other variables with respect to the development of any of our product candidates could significantly change the costs and timing associated with the development of that product candidate. Furthermore, our operating plans may change in the future, and we will continue to require additional capital to meet operational needs and capital requirements associated with such operating plans. If we raise additional funds by issuing equity
securities, our stockholders may experience dilution. Any future debt financing into which we enter may impose upon us additional covenants that restrict our operations, including limitations on our ability to incur liens or additional debt, pay dividends, repurchase our common stock, make certain investments or engage in certain merger, consolidation or asset sale transactions. Any debt financing or additional equity that we raise may contain terms that are not favorable to us or our stockholders.
Adequate funding may not be available to us on acceptable terms or at all. Our potential inability to raise capital when needed could have a negative impact on our financial condition and our ability to pursue our business strategies. If we are unable to raise additional funds as required, we may need to delay, reduce, or terminate some or all development programs and clinical trials. We may also be required to sell or license our rights to product candidates in certain territories or indications that we would otherwise prefer to develop and commercialize ourselves. If we are required to enter into collaborations and other arrangements to address our liquidity needs, we may have to give up certain rights that limit our ability to develop and commercialize our product candidates or may have other terms that are not favorable to us or our stockholders, which could materially and adversely affect our business and financial prospects. See the section titled “Risk Factors” in this report for additional risks associated with our substantial capital requirements.
Summary Statements of Cash Flows
The following table sets forth the primary sources and uses of cash and cash equivalents for each of the periods presented below:
| | | | | | | | | | | |
| Six Months Ended June 30, |
| 2022 | | 2021 |
| (in thousands) |
Net cash (used in) provided by: | | | |
Operating activities | $ | (19,545) | | | $ | 8,757 | |
Investing activities | (283) | | | (191) | |
Financing activities | 93,859 | | | 20 | |
Net increase in cash and cash equivalents | $ | 74,031 | | | $ | 8,586 | |
Net Cash (Used in) Provided by Operating Activities
Net cash used in operating activities was $19.5 million for the six months ended June 30, 2022. We recognized $15.8 million of license fee and collaboration revenue, and received $15.0 million in June 2022 in connection with our China Out-License. In the current six-month period, our cash payments to vendors for our operating activities totaled $26.0 million and payroll-related cash payments (inclusive of 2021 bonus payouts) totaled $9.1 million.
Net cash provided by operating activities was $8.8 million for the three months ended June 30, 2021. We recognized $55.4 million of license fee and collaboration revenue, though we received $35.0 million in cash from the China Out-License in the prior year period. Our cash payments to vendors for our operating activities totaled $17.4 million and payroll-related cash payments (inclusive of 2020 bonus payouts) totaled $4.6 million. In addition, we made contractual payments of $4.5 million under our in-license agreements for lotilaner.
Net Cash Used in Investing Activities
Net cash used in investing activities was $0.3 million for the six months ended June 30, 2022, which primarily consisted of leasehold improvements for our laboratory and administrative offices and various purchases of office equipment.
Net cash used in investing activities was $0.2 million for the six months ended June 30, 2021, which consisted of leasehold improvements for our laboratory and administrative offices and various purchases of property and equipment.
Net Cash Provided by Financing Activities
Net cash provided by financing activities was $93.9 million for the six months ended June 30, 2022, which primarily consisted of (i) $74.6 million of net proceeds from the issuance of common stock upon the Follow-On Public Offering, (ii) $20.0 million of proceeds from the Credit Facility, partially offset by our $0.9 million payment for its issuance costs, and (iii) $0.2 million of proceeds from our employee stock purchase plan.
Net cash provided by financing activities was $20 thousand for the six months ended June 30, 2021, and relates to proceeds from the exercise of stock options.
Critical Accounting Policies, Significant Judgments and Use of Estimates
The preparation of our Condensed Financial Statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and notes to the financial statements. Some of those judgments can be subjective and complex, and therefore, actual results could differ materially from those estimates are different assumptions and conditions. A summary of our critical accounting policies is presented in our filed Annual Report on Form 10-K for the year ended December 31, 2021.
There were no material changes to our previously reported "Critical Accounting Policies" during the six months ended June 30, 2022.
Recent Accounting Pronouncements
A description of recent accounting pronouncements that may potentially impact our financial position, results of operations or cash flows are disclosed in the footnote to which each relates within these accompanying Condensed Financial Statements.
Off-Balance Sheet Arrangements
Since our inception, we have not engaged in any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.
Indemnification Agreements
As permitted under Delaware law and in accordance with our bylaws, we indemnify our officers and directors for certain events or occurrences while the officer or director is or was serving in such capacity. We are also party to indemnification agreements with our officers and directors. We believe the fair value of the indemnification rights and agreements is minimal. Accordingly, we have not recorded any liabilities for these indemnification rights and agreements as of June 30, 2022.
JOBS Act Accounting Election
The Jumpstart Our Business Startups Act of 2012 (the "JOBS Act") permits an “emerging growth company” such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies. We have irrevocably elected to opt out of this provision and, as a result, we will comply with new or revised accounting standards as required when they are adopted.
We will remain an emerging growth company until the earliest of (1) the last day of our first fiscal year (a) following the fifth anniversary of the completion of our IPO, (b) in which we have total annual gross revenues of at least $1.07 billion or (c) in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by non-affiliates exceeds $700 million of the prior June 30th and (2) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
Interest Rate Risk
The market risk inherent in our financial instruments and in our financial position represents the potential loss arising from adverse changes in interest rates. As of June 30, 2022, we had cash and cash equivalents of $245.4 million, consisting of interest-bearing money market accounts, for which the fair market value would be affected by changes in the general level of United States interest rates. However, due to the short-term maturities and the low-risk profile of our investments, an immediate 100 basis point change in interest rates would not have a material effect on the fair market value of our cash and cash equivalents.
As of June 30, 2022, we had $20.0 million of debt principal outstanding. Our Credit Facility bears interest at an annual rate equal to the greater of (i) the Wall Street Journal prime rate plus 5.20% or (ii) 8.45%; as of June 30, 2022, our resulting interest rate on the Credit Facility is 9.95%. A hypothetical interest rate of 20% would have resulted in reported interest expense of $1.0 million and $2.0 million for the three and six months ended June 30, 2022, respectively.
Inflation, interest rate changes, and foreign currency exchange rate fluctuations did not have a significant impact on our results of operations for any periods presented herein. However, with further inflationary pressures, certain significant increased costs could have an adverse impact on the results of our operations.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act of 1934, as amended ("Exchange Act")) as of the end of the period covered by this report. Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of the end of the period covered by this report, our disclosure controls and procedures were effective to provide reasonable assurance that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms and to provide reasonable assurance that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the period covered by this report that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
Inherent Limitations on Effectiveness of Controls
Our management, including our Chief Executive Officer and Chief Financial Officer, do not expect that our disclosure controls or our internal controls over financial reporting will prevent all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by management override of the controls. The design of any system of controls is also based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions, over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
PART II—OTHER INFORMATION
Item 1. Legal Proceedings
We are not currently a party to any material legal proceedings. From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. Regardless of outcome, litigation can have an adverse impact on us due to defense and settlement costs, diversion of management resources, negative publicity, reputational harm and other factors.
Item 1A. Risk Factors
As of the date of this filing, there have been no material changes to the risk factors included in our Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the SEC on March 14, 2022, as updated by our Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, filed on May 11, 2022.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Use of Proceeds from Initial Public Offering
There has been no material change in the planned use of proceeds from our IPO as described in the Registration Statement on Form S-1 (File No. 333-249076), declared effective by the SEC on October 15, 2020, and the related final prospectus, dated October 15, 2020, filed with the SEC on October 16, 2020, pursuant to Rule 424(b) of the Securities Act.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
None.
Item 5. Other Information.
None.
Item 6. Exhibits
| | | | | | | | | | | | | | | | | | | | | | | |
Exhibit Number | | Description | Form | File Number | Incorporated by Reference Exhibit | Date | Filed Herewith |
| | | | | | | |
10.1† | | | | | | | X |
10.2 †^ | | | | | | | X |
31.1 | | | | | | | X |
31.2 | | | | | | | X |
32.1* | | | | | | | X |
32.2* | | | | | | | X |
101.INS | | Inline XBRL Instance Document - The instance document does not appear in the interactive data file because its XBRL tags are embedded within the inline XBRL document. | | | | | X |
101.SCH | | Inline XBRL Taxonomy Extension Schema Document. | | | | | X |
101.CAL | | Inline XBRL Taxonomy Extension Calculation Linkbase Document. | | | | | X |
101.DEF | | Inline XBRL Taxonomy Extension Definition Linkbase Document. | | | | | X |
101.LAB | | Inline XBRL Taxonomy Extension Label Linkbase Document. | | | | | X |
101.PRE | | Inline XBRL Taxonomy Extension Presentation Linkbase Document. | | | | | X |
104 | | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). | | | | | X |
| | | | | |
* | The certifications attached as Exhibit 32.1 and 32.2 that accompany this Quarterly Report on Form 10-Q are not deemed filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of Tarsus Pharmaceuticals, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Quarterly Report on Form 10-Q, irrespective of any general incorporation language contained in such filing. |
† | Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted by means of marking such portions with asterisks as the identified confidential portions (i) are not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed. |
^ | Pursuant to Item 601(a)(5) of Regulation S-K, certain exhibits and schedules have been omitted. The Company hereby undertakes to furnish supplementally a copy of any omitted exhibit or schedule upon request by the SEC. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| | |
TARSUS PHARMACEUTICALS, INC. |
|
/s/ Bobak Azamian, M.D., Ph.D. |
Bobak Azamian, M.D., Ph.D. |
President and Chief Executive Officer |
(Principal Executive Director) |
| | |
|
|
/s/ Leonard M. Greenstein |
Leonard M. Greenstein |
Chief Financial Officer |
(Principal Financial Officer and Principal Accounting Officer) |