PUMA BIOTECHNOLOGY, INC.
- INDEX -
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| PART I – FINANCIAL INFORMATION: | 1 | |
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| Item 1. | Financial Statements (Unaudited): | 1 |
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| Condensed Consolidated Balance Sheets as of June 30, 2024 and December 31, 2023 | 1 |
| Condensed Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2024 and 2023 | 2 |
| Condensed Consolidated Statements of Comprehensive Income for the Three and Six Months Ended June 30, 2024 and 2023 | 3 |
| Condensed Consolidated Statements of Stockholders’ Equity for the Three and Six Months Ended June 30, 2024 and 2023 | 4 |
| Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2024 and 2023 | 6 |
| Notes to the Unaudited Condensed Consolidated Financial Statements | 7 |
| Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 25 |
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| Item 3. | Quantitative and Qualitative Disclosures About Market Risk | 33 |
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| Item 4. | Controls and Procedures | 33 |
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| PART II – OTHER INFORMATION: | 34 | |
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| Item 1. | Legal Proceedings | 34 |
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| Item 1A. | Risk Factors | 36 |
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| Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | 36 |
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| Item 3. | Defaults Upon Senior Securities | 36 |
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| Item 4. | Mine Safety Disclosures | 36 |
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| Item 5. | Other Information | 36 |
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| Item 6. | Exhibits | 37 |
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| Signatures | 38 | |
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CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q, (this “Quarterly Report”), contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, (the “Exchange Act”). Any statements about our expectations, beliefs, plans, objectives, assumptions, future events or performance are not historical facts and may be forward looking. These forward-looking statements include, but are not limited to, statements about:
| • | the commercialization of NERLYNX® (neratinib) tablets (“NERLYNX”); |
| • | the development of our drug candidates, including when we expect to undertake, initiate and complete clinical trials of our drug candidates; |
| • | the anticipated timing of regulatory filings; |
| • | the regulatory approval of our drug candidates; |
| • | our use of clinical research organizations and other contractors; |
| • | our ability to find collaborative partners for research, development and commercialization of potential products; |
| • | efforts of our sub-licensees to obtain regulatory approval and commercialize NERLYNX in areas outside the United States; |
| • | our ability to market any of our products; |
| • | our expectations regarding our costs and expenses; |
| • | our anticipated capital requirements and estimates regarding our needs for additional financing; |
| • | our ability to compete against other companies and research institutions; |
| • | our ability to secure adequate protection for our intellectual property; |
| • | our intention and ability to vigorously defend against any litigation to which we are or may become party; |
| • | our ability to in-license additional drugs; |
| • | our ability to attract and retain key personnel; and |
| • | our ability to obtain adequate financing on favorable terms or at all. |
These statements are often, but not always, made through the use of words or phrases such as “anticipate,” “estimate,” “plan,” “project,” “continuing,” “ongoing,” “expect,” “believe,” “intend” and similar words or phrases. Accordingly, these statements involve estimates, assumptions and uncertainties that could cause actual results to differ materially from those expressed in them. Discussions containing these forward-looking statements may be found throughout this Quarterly Report, including, in Part I, the section entitled “Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.” These forward-looking statements involve risks and uncertainties, including the risks discussed in Part I, Item 1A. “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2023, and this Quarterly Report on Form 10-Q, that could cause our actual results to differ materially from those in the forward-looking statements. Such risks should be considered in evaluating our prospects and future financial performance. We undertake no obligation to update the forward-looking statements or to reflect events or circumstances after the date of this document.
Part I – FINANCIAL INFORMATION
| Item 1. | FINANCIAL STATEMENTS |
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PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
(unaudited)** **
| June 30, 2024 | December 31, 2023 |
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| ASSETS |
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| Current assets: |
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| Cash and cash equivalents | $67,149 | $84,585 |
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| Marketable securities | 29,683 | 11,354 |
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| Accounts receivable, net of allowance for credit loss of $808 and $881 | 28,105 | 47,837 |
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| Inventory | 9,049 | 7,080 |
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| Prepaid expenses, current | 3,493 | 4,417 |
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| Other assets, current | 241 | 912 |
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| Total current assets | 137,720 | 156,185 |
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| Lease right-of-use assets, net | 6,231 | 7,792 |
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| Property and equipment, net | 680 | 855 |
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| Intangible assets, net | 56,001 | 60,871 |
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| Restricted cash, long-term | 2,091 | 2,091 |
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| Prepaid expenses and other, long-term | 2,279 | 2,734 |
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| Total assets | $205,002 | $230,528 |
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| LIABILITIES AND STOCKHOLDERS’ EQUITY |
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| Current liabilities: |
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| Accounts payable | $13,500 | $6,889 |
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| Accrued expenses, current | 39,005 | 52,721 |
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| Post-marketing commitment liability | 1,303 | 975 |
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| Lease liabilities, current | 5,159 | 4,800 |
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| Current portion of long-term debt | 45,329 | 33,997 |
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| Total current liabilities | 104,296 | 99,382 |
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| Other liabilities, long-term | 121 | 121 |
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| Lease liabilities, long-term | 4,364 | 7,034 |
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| Post-marketing commitment liability, long-term | 3,977 | 4,890 |
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| Long-term debt, net | 43,735 | 65,659 |
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| Total liabilities | 156,493 | 177,086 |
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| Commitments and contingencies (Note 12) |
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| Stockholders’ equity: |
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| Common stock - $.0001 par value per share; 100,000,000 shares authorized; 48,460,120 shares issued and outstanding at June 30, 2024 and 47,646,787 issued and outstanding at December 31, 2023 | 5 | 5 |
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| Additional paid-in capital | 1,403,044 | 1,398,605 |
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| Accumulated other comprehensive loss | (32) | (4) |
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| Accumulated deficit | (1,354,508) | (1,345,164) |
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| Total stockholders’ equity | 48,509 | 53,442 |
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| Total liabilities and stockholders’ equity | $205,002 | $230,528 |
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