KemPharm Reports Fourth Quarter and Fiscal Year 2021 Financial Results and Corporate Updates
KemPharm Reports Fourth Quarter and Fiscal Year 2021 Financial Results and Corporate Updates
March 30, 2022 at 4:05 PM EDT
Conference Call and Live Audio Webcast with Slide Presentation Scheduled for Today,
Corporate and Regulatory Highlights
- Announced strategic focus on developing and commercializing therapeutics targeting rare central nervous system (CNS) and neurodegenerative conditions;
- Advancing development of KP1077, a serdexmethylphenidate (SDX) based product candidate for idiopathic hypersomnia (IH), as KemPharm’s lead candidate:
- Pre-Investigational New Drug (IND) process with the
U.S. Food and Drug Administration (FDA) successfully completed inFebruary 2022 ; - IND filing expected as early as the second quarter of 2022; Phase 2 trial initiation expected in the second half of 2022; and
- Reported data from the Phase 1 clinical trial exploring the safety and pharmacokinetics (PK) of “higher-dose” SDX which validates selection of KP1077 as lead product candidate.
- Pre-Investigational New Drug (IND) process with the
- AZSTARYS® national launch accelerating; full national sales team in place as of
January 31, 2022 , growing payor access; KemPharm named 2021David J. Gury Company of the Year by BioFlorida; and- Earned
$1.975 million fee in first quarter of 2022 following FDA approval of Corium, Inc.’s product, ADLARITY®.
Financial Highlights
- Reported quarter ended
December 31, 2021 (Q4 2021) revenue of$2.6 million and FY 2021 revenue of$28.7 million ; and - Total cash, cash equivalents and long-term investments was
$127.8 million as ofDecember 31, 2021 .
“KemPharm advanced on multiple fronts during the fourth quarter of 2021 and into early 2022, cementing the past twelve months as the most substantial in KemPharm’s history,” stated
“As KemPharm focuses on advancing KP1077 and expanding our development pipeline, we remain bullish on the potential for the commercial success of AZSTARYS®, which is now being commercialized nationally by Corium. There have been significant gains in payor access, and prescription volume is beginning to grow. If this growth continues along the same trajectory observed since the beginning of 2022, the potential to achieve the initial sales milestones provided in the licensing agreement with an affiliate of
“Supporting these strategic and product development efforts is our strong financial position. With
Q4 and Full-Year 2021 Financial Results:
KemPharm’s revenue for Q4 2021 was
KemPharm’s net loss for Q4 2021 was
For FY 2021,
KemPharm’s net loss attributable to common stockholders for FY 2021 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/8038872. 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 benefits of KP1077, SDX or any other product candidates for any specific disease indication, 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
STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
| Year Ended |
||||||||
| 2021 (unaudited) |
2020 |
|||||||
| Revenue | $ | 28,650 | $ | 13,288 | ||||
| Operating expenses: | ||||||||
| Royalty and direct contract acquisition costs | 2,059 | 1,305 | ||||||
| Research and development | 10,161 | 8,843 | ||||||
| General and administrative | 8,701 | 7,921 | ||||||
| Severance expense | - | 828 | ||||||
| Total operating expenses | 20,921 | 18,897 | ||||||
| Income (loss) from operations | 7,729 | (5,609 | ) | |||||
| Other (expense) income: | ||||||||
| Loss on extinguishment of debt | (16,096 | ) | - | |||||
| Interest expense related to amortization of debt issuance costs and discount | (150 | ) | (2,305 | ) | ||||
| Interest expense on principal | (226 | ) | (4,785 | ) | ||||
| Fair value adjustment related to derivative and warrant liability | (26 | ) | (184 | ) | ||||
| Interest and other income, net | 248 | 89 | ||||||
| Total other expense | (16,250 | ) | (7,185 | ) | ||||
| Loss before income taxes | (8,521 | ) | (12,794 | ) | ||||
| Income tax (expense) benefit | (34 | ) | 34 | |||||
| Net loss | (8,555 | ) | (12,760 | ) | ||||
| Deemed dividend | (54,342 | ) | - | |||||
| Net loss attributable to common stockholders | $ | (62,897 | ) | $ | (12,760 | ) | ||
| Basic net loss per share of common stock: | ||||||||
| Net loss attributable to common stockholders | $ | (2.11 | ) | $ | (3.21 | ) | ||
| Diluted net loss per share of common stock: | ||||||||
| Net loss attributable to common stockholders | $ | (2.11 | ) | $ | (3.21 | ) | ||
| Weighted average number of shares of common stock outstanding: | ||||||||
| Basic | 29,766,347 | 3,980,975 | ||||||
| Diluted | 29,766,347 | 3,980,975 | ||||||
BALANCE SHEETS
(in thousands, except share and par value amounts)
| 2021 (unaudited) |
2020 |
|||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 112,346 | $ | 4,213 | ||||
| Accounts and other receivables | 1,528 | 2,579 | ||||||
| Prepaid expenses and other current assets | 1,182 | 1,481 | ||||||
| Restricted cash | - | 109 | ||||||
| Total current assets | 115,056 | 8,382 | ||||||
| Property and equipment, net | 884 | 1,039 | ||||||
| Operating lease right-of-use assets | 1,141 | 1,350 | ||||||
| Long-term investments | 15,422 | - | ||||||
| Other long-term assets | 438 | 438 | ||||||
| Total assets | $ | 132,941 | $ | 11,209 | ||||
| Liabilities and stockholders’ equity (deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 3,038 | $ | 6,647 | ||||
| Current portion of operating lease liabilities | 356 | 327 | ||||||
| Current portion of loans payable | - | 390 | ||||||
| Other current liabilities | 836 | 172 | ||||||
| Total current liabilities | 4,230 | 7,536 | ||||||
| Convertible notes, less current portion, net | - | 67,658 | ||||||
| Derivative and warrant liability | 330 | 304 | ||||||
| Operating lease liabilities, less current portion | 1,232 | 1,587 | ||||||
| Loans payable, less current portion | - | 391 | ||||||
| Other long-term liabilities | 31 | 145 | ||||||
| Total liabilities | 5,823 | 77,621 | ||||||
| Stockholders' equity (deficit): | ||||||||
| Preferred stock: | ||||||||
| Series A convertible preferred stock, |
- | - | ||||||
| Series B-1 convertible preferred stock, |
- | - | ||||||
| Series B-2 convertible preferred stock, |
- | - | ||||||
| Undesignated preferred stock, |
- | - | ||||||
| Common stock, |
4 | 0 | ||||||
| Additional paid-in capital | 396,957 | 192,062 | ||||||
| (2,814 | ) | - | ||||||
| Accumulated deficit | (267,029 | ) | (258,474 | ) | ||||
| Total stockholders' equity (deficit) | 127,118 | (66,412 | ) | |||||
| Total liabilities and stockholders' equity (deficit) | $ | 132,941 | $ | 11,209 | ||||
Source: KemPharm