KemPharm Reports Third Quarter 2022 Results
KemPharm Reports Third Quarter 2022 Results
November 9, 2022 at 4:05 PM EST
Conference Call and Live Audio Webcast with Slide Presentation Scheduled for Today,
- Significant activities underway for preparation of the arimoclomol NDA resubmission
- Advancing key activities to initiate a Phase 2 clinical trial of KP1077 in IH by year-end 2022
- Total cash (cash, cash equivalents and long-term investments) of
$107.4M as ofSep 30, 2022 ; based on current operating forecast, cash runway extends into 2026
“During Q3, we made substantial progress with our two lead programs, arimoclomol, our NDA-stage product candidate for Niemann-Pick Type C (NPC), an ultra-rare lysosomal disease, and KP1077, our product candidate based on our prodrug of d-methylphenidate, serdexmethylphenidate (SDX), which is intended for the treatment of two rare sleep disorders, idiopathic hypersomnia (IH) and narcolepsy,” stated
Recent Business and Corporate Highlights:
- Continuing activities to bolster the arimoclomol New Drug Application (NDA) for resubmission to the
U.S. Food and Drug Administration (FDA):
- Working to amass and characterize a substantial data repository from a 4-year arimoclomol safety study, and pinpointing key elements to include in the NDA resubmission for arimoclomol based on new data generated since
June 2021 ; - Ongoing collaborative dialogue and periodic meetings with the FDA intended to ensure an optimal NDA data package that demonstrates arimoclomol to be a safe and effective therapy for NPC, if approved; and
- Currently anticipating resubmission of the updated NDA as early as Q3 2023, with plans to provide updated guidance if needed based on ongoing dialogue with the FDA as we seek to compile an optimal data package for resubmission.
- Working to amass and characterize a substantial data repository from a 4-year arimoclomol safety study, and pinpointing key elements to include in the NDA resubmission for arimoclomol based on new data generated since
- Progress in advancing investigational candidate KP1077, an SDX-based product being developed as a treatment for IH and narcolepsy:
- Completed Phase 1 cardiovascular safety clinical trial of SDX which confirmed the initial dosing strengths for the Phase 2 clinical trial of KP1077 in IH;
- Data suggest that SDX can be safely dosed at levels higher than currently available methylphenidate-based products, which is expected to result in improved efficacy while avoiding the potential for greater cardiovascular safety risk; and
- Preparing to initiate a Phase 2 clinical trial of KP1077 in patients with IH prior to year-end 2022 and a second trial in patients with narcolepsy in 2023.
- Completed Phase 1 cardiovascular safety clinical trial of SDX which confirmed the initial dosing strengths for the Phase 2 clinical trial of KP1077 in IH;
- Strong operational and financial foundation, including
$107.4 million in cash, cash equivalents and investments as ofSeptember 30, 2022 :
- Based on current operating forecast, cash runway is expected to continue into 2026; and
- The potential to realize milestone and royalty revenue from AZSTARYS® as Corium executes its commercialization strategy could provide further capital flexibility and extend the operating cash runway.
- Based on current operating forecast, cash runway is expected to continue into 2026; and
Overview of Third Quarter 2022 Financial Results:
Net revenue for Q3 2022 was
Research and development expenses were
General and administrative expenses were
Net loss attributable to common stockholders for Q3 2022 was
As of
As of September 30, 2022, total shares of common stock outstanding was 34,501,144 shares, and fully diluted common shares outstanding was 47,076,872 shares, which included 4,252,600 shares issuable upon exercise of warrants.
Conference Call Information:
The audio webcast with slide presentation will be accessible via the Investor Relations section of the Company’s website, http://investors.kempharm.com/. An archive of the webcast and presentation will be available for 90 days beginning at approximately
Additionally, interested participants and investors may access conference call by dialing either:
- (800) 225-9448 (
U.S. ) - (203) 518-9708 (International)
- Conference ID: KMPHQ322
About
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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 Investigational New Drug applications and NDA submissions, including the resubmission of the NDA for arimoclomol, communications with the FDA, the potential uses or benefits of arimoclomol, 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 sufficiency of cash to fund operations, the potential for and timing of milestone and/or royalty revenues, our plans or ability to seek funding, and our strategic and product development objectives. These forward-looking statements are based on information currently available to
KemPharm Contacts:
jrando@tiberend.com
dboateng@tiberend.com
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
| Three months ended |
Nine months ended |
|||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Revenue, net | $ | 2,874 | $ | 1,965 | $ | 8,139 | $ | 26,068 | ||||||||
| Operating expenses: | ||||||||||||||||
| Cost of revenue | 141 | 0 | 200 | 2,000 | ||||||||||||
| Research and development | 5,385 | 2,239 | 13,262 | 7,352 | ||||||||||||
| General and administrative | 3,974 | 1,948 | 10,266 | 6,145 | ||||||||||||
| Acquired in-process research and development | — | — | 17,663 | — | ||||||||||||
| Total operating expenses | 9,500 | 4,187 | 41,391 | 15,497 | ||||||||||||
| (Loss) income from operations | (6,626 | ) | (2,222 | ) | (33,252 | ) | 10,571 | |||||||||
| Other (expense) income: | ||||||||||||||||
| Loss on extinguishment of debt | — | — | — | (16,096 | ) | |||||||||||
| Interest expense related to amortization of debt issuance costs and discount | — | — | — | (150 | ) | |||||||||||
| Interest expense on principal | (124 | ) | (6 | ) | (165 | ) | (221 | ) | ||||||||
| Fair value adjustment related to derivative and warrant liability | 22 | 332 | 295 | (92 | ) | |||||||||||
| Interest and other (expense) income, net | 79 | 137 | (152 | ) | 136 | |||||||||||
| Total other (expense) income | (23 | ) | 463 | (22 | ) | (16,423 | ) | |||||||||
| Loss before income taxes | (6,649 | ) | (1,759 | ) | (33,274 | ) | (5,852 | ) | ||||||||
| Income tax benefit | 33 | — | 752 | — | ||||||||||||
| Net loss | $ | (6,616 | ) | $ | (1,759 | ) | $ | (32,522 | ) | $ | (5,852 | ) | ||||
| Deemed dividend | — | — | — | (54,342 | ) | |||||||||||
| Net loss attributable to common stockholders | $ | (6,616 | ) | $ | (1,759 | ) | $ | (32,522 | ) | $ | (60,194 | ) | ||||
| Basic and diluted net loss per share of common stock: | ||||||||||||||||
| Net loss attributable to common stockholders | $ | (0.19 | ) | $ | (0.05 | ) | $ | (0.94 | ) | $ | (2.16 | ) | ||||
| Weighted average number of shares of common stock outstanding: | ||||||||||||||||
| Basic and diluted | 34,494,702 | 35,217,953 | 34,482,791 | 27,904,711 | ||||||||||||
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and par value amounts)
| 2022 | 2021 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 70,059 | $ | 112,346 | ||||
| Short-term investments | 5,832 | — | ||||||
| Accounts and other receivables | 6,583 | 1,528 | ||||||
| Prepaid expenses and other current assets | 2,659 | 1,182 | ||||||
| Total current assets | 85,133 | 115,056 | ||||||
| Inventories | 596 | — | ||||||
| Property and equipment, net | 852 | 884 | ||||||
| Operating lease right-of-use assets | 1,068 | 1,141 | ||||||
| Long-term investments | 31,463 | 15,422 | ||||||
| Other long-term assets | 439 | 438 | ||||||
| Total assets | $ | 119,551 | $ | 132,941 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 4,279 | $ | 3,038 | ||||
| Current portion of operating lease liabilities | 474 | 356 | ||||||
| Current portion of discount and rebate liabilities | 2,825 | — | ||||||
| Other current liabilities | 853 | 836 | ||||||
| Total current liabilities | 8,431 | 4,230 | ||||||
| Line of credit payable | 12,800 | — | ||||||
| Derivative and warrant liability | 35 | 330 | ||||||
| Operating lease liabilities, less current portion | 956 | 1,232 | ||||||
| Discount and rebate liabilities, less current portion | 3,509 | — | ||||||
| Other long-term liabilities | 26 | 31 | ||||||
| Total liabilities | 25,757 | 5,823 | ||||||
| Commitments and contingencies (Note D) | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock: | ||||||||
| Undesignated preferred stock, |
— | — | ||||||
| Common stock, |
3 | 4 | ||||||
| Additional paid-in capital | 400,677 | 396,957 | ||||||
| (7,536 | ) | (2,814 | ) | |||||
| Accumulated deficit | (299,551 | ) | (267,029 | ) | ||||
| Accumulated other comprehensive income | 201 | — | ||||||
| Total stockholders' equity | 93,794 | 127,118 | ||||||
| Total liabilities and stockholders' equity | $ | 119,551 | $ | 132,941 | ||||
Source: KemPharm