KemPharm Reports Second Quarter 2021 Financial Results
KemPharm, Inc. (NASDAQ: KMPH) reported its Q2 2021 results, highlighting a revenue of $12.0 million, up from $6.9 million in Q2 2020. The revenue increase was driven by a $10 million milestone payment for DEA scheduling of serdexmethylphenidate (SDX). The company experienced a net income of $6.2 million, or $0.18 per share, but faced a net loss of $10.7 million attributable to common stockholders due to a non-cash deemed dividend. Cash and equivalents stood at $132.3 million as of June 30, 2021.
- Revenue increased by 73% year-over-year to $12 million.
- Successfully launched AZSTARYS in the U.S. market.
- Received a $10 million milestone payment from the DEA for SDX scheduling.
- Net loss attributable to common stockholders of $10.7 million due to non-cash deemed dividend.
- Operating expenses rose by $1.8 million, impacting overall profitability.
Corporate and Regulatory Highlights
- U.S. Commercial Launch of AZSTARYS™ Initiated on July 21, 2021
- Serdexmethylphenidate (SDX) Classified as a Schedule IV Controlled Substance by the DEA
- Announced Orange Book Listing for Six Patents Covering SDX and Confirmation of NCE Status
- KemPharm Added to Russell 2000® and Russell 3000® Indexes
Financial Highlights
- Q2 2021 net income of
$0.18 per basic share - Reported Q2 2021 revenue of
$12.0 million - Confirmed receipt of
$10 million milestone payment for DEA scheduling of SDX - Total cash and cash equivalents was
$132.3 million at June 30, 2021
CELEBRATION, Fla., Aug. 12, 2021 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today reported its financial results for the second quarter ended June 30, 2021.
“The second quarter of 2021 and recent weeks continued what has been a period of unprecedented growth and opportunity for KemPharm, highlighted by the U.S. commercial launch of AZSTARYS,” said Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “AZSTARYS, previously KP415, was conceived based on the vision that our LAT® technology was well-suited to developing a prodrug of d-methylphenidate (d-MPH) that could address key patient and prescriber demands that were underserved by ADHD products on the market at the time. Today that vision is a reality, and as the commercial rollout of AZSTARYS by Corium continues, ADHD patients and their caregivers will have the opportunity to benefit from the unique attributes inherent only to AZSTARYS. It is a truly exciting time for KemPharm and, we believe, for the millions of patients seeking a better treatment option for their ADHD symptoms.”
Dr. Mickle continued, “In addition to the commercial launch of AZSTARYS, the second quarter was highlighted by the classification of serdexmethylphenidate (SDX) as a Schedule IV controlled substance by the Drug Enforcement Administration (DEA). SDX comprises
Q2 2021 Financial Results:
For Q2 2021, KemPharm reported revenue of
KemPharm’s net income for Q2 2021 was
As of June 30, 2021, total cash and cash equivalents was
As of June 30, 2021, total shares of common stock outstanding was 34,977,923 shares, and fully diluted common shares outstanding was 46,546,998 shares, which included 4,584,889 shares issuable upon exercise of warrants. In addition, no preferred stock is outstanding as of June 30, 2021.
Conference Call Information:
KemPharm will host a conference call and live audio webcast on Thursday, August 12, 2021, at 4:30 p.m. ET, to discuss its corporate and financial results for Q2 2021.
| Telephone Access: | To access the conference call telephonically, interested participants and investors are required to register via the following online form: http://www.directeventreg.com/registration/event/2069253 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 5:30 p.m. ET, on August 12, 2021. |
About AZSTARYS™:
AZSTARYS is an FDA-approved, once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in patients age six years or older. AZSTARYS consists of SDX, KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate release d-MPH.
The complete approved prescribing information for AZSTARYS may be downloaded in PDF format here:
https://kempharm.com/wp-content/uploads/2021/03/AZSTARYS-Master-Label-Final_20210302.pdf
About KemPharm:
KemPharm is a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs to treat serious medical conditions through its proprietary LAT® (Ligand Activated Therapy) technology. KemPharm utilizes its proprietary LAT® technology to generate improved prodrug versions of FDA-approved drugs as well as to generate prodrug versions of existing compounds that may have applications for new disease indications. KemPharm’s prodrug product candidate pipeline is focused on the high need areas of attention deficit hyperactivity disorder, or ADHD, stimulant use disorder (SUD) and CNS rare diseases, including idiopathic hypersomnia (IH). KemPharm’s lead clinical development candidate for the treatment of SUD, KP879, is based on its prodrug of d-methylphenidate, known as serdexmethylphenidate (SDX). In addition, KemPharm has received FDA approval for AZSTARYSTM, a new once-daily treatment for ADHD in patents age six years and older, and for APADAZ®, an immediate-release combination product containing benzhydrocodone, a prodrug of hydrocodone, and acetaminophen. For more information on KemPharm and its pipeline of prodrug product candidates visit www.kempharm.com or connect with us on Twitter, LinkedIn, Facebook and YouTube.
Caution Concerning Forward Looking Statements:
This press release may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include all statements that do not relate solely to historical or current facts and can be identified by the use of words such as “may,” “will,” “expect,” “project,” “estimate,” “anticipate,” “plan,” “believe,” “potential,” “should,” “continue” or the negative versions of those words or other comparable words. Forward-looking statements are not guarantees of future actions or performance. These forward-looking statements, including the potential benefits of AZSTARYS, and the potential commercial success of AZSTARYS, are based on information currently available to KemPharm and its current plans or expectations and are subject to a number of uncertainties and risks that could significantly affect current plans. Risks concerning KemPharm’s business are described in detail in KemPharm’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, and KemPharm’s other filings with the Securities and Exchange Commission. KemPharm is under no obligation to, and expressly disclaims any such obligation to, update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.
KemPharm Contacts:
Jason Rando / Maureen McEnroe
Tiberend Strategic Advisors, Inc.
(212) 375-2665 / 2664
jrando@tiberend.com
mmcenroe@tiberend.com
KEMPHARM, INC.
UNAUDITED CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenue | $ | 11,986 | $ | 6,908 | $ | 24,103 | $ | 8,997 | ||||||||
| Operating expenses: | ||||||||||||||||
| Royalty and direct contract acquisition costs | 1,000 | 642 | 2,000 | 1,305 | ||||||||||||
| Research and development | 2,848 | 1,954 | 5,113 | 4,080 | ||||||||||||
| General and administrative | 2,305 | 1,719 | 4,197 | 3,964 | ||||||||||||
| Severance expense | — | — | — | 830 | ||||||||||||
| Total operating expenses | 6,153 | 4,315 | 11,310 | 10,179 | ||||||||||||
| Income (loss) from operations | 5,833 | 2,593 | 12,793 | (1,182 | ) | |||||||||||
| Other income (expense): | ||||||||||||||||
| Gain (loss) on extinguishment of debt | 789 | — | (16,096 | ) | — | |||||||||||
| Interest expense related to amortization of debt issuance costs and discount | — | (574 | ) | (150 | ) | (1,145 | ) | |||||||||
| Interest expense on principal | (16 | ) | (1,197 | ) | (215 | ) | (2,457 | ) | ||||||||
| Fair value adjustment related to derivative and warrant liability | (394 | ) | (3 | ) | (424 | ) | 72 | |||||||||
| Interest and other (expense) income, net | (9 | ) | 40 | (1 | ) | (183 | ) | |||||||||
| Total other income (expense) | 370 | (1,734 | ) | (16,886 | ) | (3,713 | ) | |||||||||
| Income (loss) before income taxes | 6,203 | 859 | (4,093 | ) | (4,895 | ) | ||||||||||
| Income tax benefit (expense) | — | — | — | — | ||||||||||||
| Net income (loss) | $ | 6,203 | $ | 859 | $ | (4,093 | ) | $ | (4,895 | ) | ||||||
| Deemed dividend | (16,898 | ) | — | (54,342 | ) | — | ||||||||||
| Net (loss) income attributable to common stockholders | $ | (10,695 | ) | $ | 859 | $ | (58,435 | ) | $ | (4,895 | ) | |||||
| Basic net income (loss) per share of common stock: | ||||||||||||||||
| Net income (loss) | $ | 0.18 | $ | 0.21 | $ | (0.17 | ) | $ | (1.41 | ) | ||||||
| Net income (loss) attributable to common stockholders | $ | (0.40 | ) | $ | 0.21 | $ | (2.42 | ) | $ | (1.41 | ) | |||||
| Diluted net income (loss) per share of common stock: | ||||||||||||||||
| Net income (loss) attributable to common stockholders | $ | (0.40 | ) | $ | 0.21 | $ | (2.42 | ) | $ | (1.43 | ) | |||||
| Weighted average number of shares of common stock outstanding: | ||||||||||||||||
| Basic | 29,174,565 | 3,947,656 | 24,187,484 | 3,476,107 | ||||||||||||
| Diluted | 29,174,565 | 3,947,728 | 24,187,484 | 3,476,107 | ||||||||||||
KEMPHARM, INC.
CONDENSED BALANCE SHEETS
(in thousands, except share and par value amounts)
| June 30, | December 31, | |||||||
| 2021 | 2020 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 132,295 | $ | 4,213 | ||||
| Accounts and other receivables | 1,888 | 2,579 | ||||||
| Prepaid expenses and other current assets | 1,998 | 1,481 | ||||||
| Restricted cash | — | 109 | ||||||
| Total current assets | 136,181 | 8,382 | ||||||
| Property and equipment, net | 992 | 1,039 | ||||||
| Operating lease right-of-use assets | 1,187 | 1,350 | ||||||
| Other long-term assets | 437 | 438 | ||||||
| Total assets | $ | 138,797 | $ | 11,209 | ||||
| Liabilities and stockholders' equity (deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 2,973 | $ | 6,647 | ||||
| Current portion of operating lease liabilities | 342 | 327 | ||||||
| Current portion of loans payable | — | 390 | ||||||
| Other current liabilities | 2,644 | 172 | ||||||
| Total current liabilities | 5,959 | 7,536 | ||||||
| Convertible notes, less current portion, net | — | 67,658 | ||||||
| Derivative and warrant liability | 728 | 304 | ||||||
| Operating lease liabilities, less current portion | 1,413 | 1,587 | ||||||
| Loans payable | — | 391 | ||||||
| Other long-term liabilities | 34 | 145 | ||||||
| Total liabilities | 8,134 | 77,621 | ||||||
| Commitments and contingencies (Note D) | ||||||||
| Stockholders’ equity (deficit): | ||||||||
| Undesignated preferred stock, authorized, no shares issued or outstanding as of June 30, 2021 (unaudited); 9,961,846 shares authorized, no shares issued or outstanding as of December 31, 2020 | — | — | ||||||
| Common stock, shares issued and outstanding as of June 30, 2021 (unaudited); 4,537,321 shares issued and outstanding as of December 31, 2020 | 3 | 0 | ||||||
| Additional paid-in capital | 393,227 | 192,062 | ||||||
| Accumulated deficit | (262,567 | ) | (258,474 | ) | ||||
| Total stockholders' equity (deficit) | 130,663 | (66,412 | ) | |||||
| Total liabilities and stockholders' equity (deficit) | $ | 138,797 | $ | 11,209 | ||||
FAQ
What were KemPharm's Q2 2021 revenue results?
What is the significance of the DEA scheduling of SDX for KemPharm?
Did KemPharm incur any net losses in Q2 2021?
What is the cash position of KemPharm as of June 30, 2021?
When is KemPharm's next conference call scheduled?
