KemPharm Reports First Quarter 2022 Financial Results and Corporate Updates
KemPharm Reports First Quarter 2022 Financial Results and Corporate Updates
May 12, 2022 at 4:05 PM EDT
Conference Call and Live Audio Webcast with Slide Presentation Scheduled for Today,
- Filed Investigational New Drug (IND) application with
U.S. Food and Drug Administration (FDA) for KP1077, a serdexmethylphenidate (SDX)-based product candidate for idiopathic hypersomnia (IH)- Initiation of a Phase 2 trial (KP1077.D01) expected in the second half of 2022, with a second trial in patients with narcolepsy expected to begin the quarter following start of KP1077.D01
- Dosed first patient in Phase 1 clinical trial evaluating cardiovascular safety of SDX compared to immediate-release and long-acting formulations of Ritalin® (racemic methylphenidate)
- Total cash, cash equivalents, marketable securities and long-term investments was
$119.1 million as ofMarch 31, 2022
“KemPharm continued to make significant progress during the first quarter of 2022 and recent weeks, in particular taking several important steps to further the clinical development of our SDX-based drug candidates led by KP1077,” stated
Q1 2022 Financial Results:
KemPharm’s revenue for Q1 2022 was
Research and development expenses were
General and administrative expenses were
Net loss attributable to common stockholders for Q1 2022 was
As of
Conference Call Information:
| Telephone Access: | To access the conference call telephonically, interested participants and investors will be required to register via the following online form: http://www.directeventreg.com/registration/event/1133056. |
| Once registered, all individuals will be provided with participant dial-in numbers, a passcode, and a registrant ID, which can then be used to access the conference call. | |
| Participants may register at any time. It is recommended that the registration process be completed at least 15 minutes prior to the start of the call. | |
| Webcast Access: |
The live audio webcast with slide presentation will be accessible via the Investor Relations section of KemPharm’s website, http://investors.kempharm.com/. An archive of the webcast and presentation will be available for 90 days beginning at approximately |
About
Caution Concerning Forward Looking Statements:
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts, including without limitation and which can be identified by the use of words such as “may,” “will,” “expect,” “project,” “estimate,” “anticipate,” “plan,” “believe,” “potential,” “should,” “continue,” “could,” “intend,” “target,” “predict,” or the negative versions of those words or other comparable words or expressions, although not all forward-looking statements contain these identifying words or expressions. Forward-looking statements are not guarantees of future actions or performance. These forward-looking statements include statements regarding the promise and potential impact of our preclinical or clinical trial data, including without limitation the timing and results of any clinical trials or readouts, the timing or results of any IND applications, the potential uses or benefits of KP1077, SDX or any other product candidates for any specific disease indication or at any dosage, the potential benefits of any of KemPharm’s product candidates, the success or timing of the launch or commercialization of AZSTARYS or any other products or related sales milestones, the sufficiency of cash to fund operations, our plans or ability to seek funding, our plans with respect to our share repurchase program, and our strategic and product development objectives. These forward-looking statements are based on information currently available to
While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
This press release also may contain estimates and other statistical data made by independent parties and by us relating to market size and other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. In addition, projections, assumptions and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk.
KemPharm Contacts:
jrando@tiberend.com
dboateng@tiberend.com
UNAUDITED CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
| Three months ended |
||||||||
| 2022 | 2021 | |||||||
| Revenue | $ | 3,965 | $ | 12,117 | ||||
| Operating expenses: | ||||||||
| Royalty and direct contract acquisition costs | 8 | 1,000 | ||||||
| Research and development | 3,082 | 2,265 | ||||||
| General and administrative | 2,734 | 1,892 | ||||||
| Total operating expenses | 5,824 | 5,157 | ||||||
| (Loss) income from operations | (1,859 | ) | 6,960 | |||||
| Other (expense) income: | ||||||||
| Loss on extinguishment of debt | — | (16,885 | ) | |||||
| Interest expense related to amortization of debt issuance costs and discount | — | (150 | ) | |||||
| Interest expense on principal | (5 | ) | (199 | ) | ||||
| Fair value adjustment related to derivative and warrant liability | 241 | (30 | ) | |||||
| Interest and other (expense) income, net | (245 | ) | 8 | |||||
| Total other expenses | (9 | ) | (17,256 | ) | ||||
| Loss before income taxes | (1,868 | ) | (10,296 | ) | ||||
| Income tax benefit | 4 | — | ||||||
| Net loss | $ | (1,864 | ) | $ | (10,296 | ) | ||
| Deemed dividend | — | (37,444 | ) | |||||
| Net loss attributable to common stockholders | $ | (1,864 | ) | $ | (47,740 | ) | ||
| Basic and diluted net loss per share of common stock: | ||||||||
| Net loss attributable to common stockholders | $ | (0.05 | ) | $ | (2.49 | ) | ||
| Weighted average number of shares of common stock outstanding: | ||||||||
| Basic and diluted | 34,506,597 | 19,146,270 | ||||||
CONDENSED BALANCE SHEETS
(in thousands, except share and par value amounts)
| 2022 | 2021 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 100,242 | $ | 112,346 | ||||
| Marketable securities | 1,338 | — | ||||||
| Accounts and other receivables | 3,320 | 1,528 | ||||||
| Prepaid expenses and other current assets | 880 | 1,182 | ||||||
| Total current assets | 105,780 | 115,056 | ||||||
| Property and equipment, net | 835 | 884 | ||||||
| Operating lease right-of-use assets | 1,090 | 1,141 | ||||||
| Long-term investments | 17,564 | 15,422 | ||||||
| Other long-term assets | 437 | 438 | ||||||
| Total assets | $ | 125,706 | $ | 132,941 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 2,582 | $ | 3,038 | ||||
| Current portion of operating lease liabilities | 356 | 356 | ||||||
| Other current liabilities | 7 | 836 | ||||||
| Total current liabilities | 2,945 | 4,230 | ||||||
| Derivative and warrant liability | 89 | 330 | ||||||
| Operating lease liabilities, less current portion | 1,144 | 1,232 | ||||||
| Other long-term liabilities | 29 | 31 | ||||||
| Total liabilities | 4,207 | 5,823 | ||||||
| Stockholders’ equity: | ||||||||
| Preferred stock: | ||||||||
| Undesignated preferred stock, |
— | — | ||||||
| Common stock, |
3 | 4 | ||||||
| Additional paid-in capital | 397,925 | 396,957 | ||||||
| (7,536 | ) | (2,814 | ) | |||||
| Accumulated deficit | (268,893 | ) | (267,029 | ) | ||||
| Total stockholders' equity | 121,499 | 127,118 | ||||||
| Total liabilities and stockholders' equity | $ | 125,706 | $ | 132,941 | ||||
Source: KemPharm