KemPharm, Inc. Reports First Quarter 2016 Results
- Introduced Apadaz™ as the proprietary name for KP201/APAP
- FDA Advisory Committees voted 16 to 4 in support of Apadaz approval; voted 18 to 2 against inclusion of abuse deterrent labeling
- Granted “Fast Track” designation for, and received clearance from
FDA to initiate human clinical trials, of KP511, KemPharm’s prodrug of hydromorphone
Recent Corporate and Financial Highlights:
- Expanded senior leadership team with the appointment of
Daniel L. Cohen , Executive Vice President, Government and Public Relations, andRene A. Braeckman , Ph.D., Vice President, Clinical Development - Granted a fee waiver and received the refund of the full user fee amount of
$2.4 million for the Apadaz NDA - Net loss of
$0.20 per basic and diluted share for the quarter ended3/31/2016 - Cash, cash equivalents and marketable securities balance was
$111.0 million at 3/31/2016, an increase of$59.7 million from12/31/2015
“This has been a significant period for
“Earlier this week we received Fast Track designation by the
“Lastly, we anticipate achieving several milestones in 2016 in the development of KP201/IR, our acetaminophen-free hydrocodone prodrug,” Dr. Mickle concluded. “We expect to progress this program into a potential NDA filing during 2017 as we continue to advance our pipeline in a planned effort to submit at least one new NDA each year through 2019.”
Q1 2016 Financial Results:
KemPharm’s net loss for the quarter ended
As of
Conference Call Information:
The Company will host a conference call and live audio webcast on
- (866) 395-2480 (U.S.)
- (678) 509-7538 (international)
- Conference ID: 5096863
An audio webcast will be accessible via the Investor Relations section of the
About
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 21-E 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. These forward-looking statements include statements regarding the timing of completion of the FDA’s review of KemPharm’s NDA for Apadaz, the expected features and characteristics of KP511, the timelines surrounding potential clinical trials for KP511, and the release of any related data and the timing of the submissions of NDAs for KP511/ER, KP201/IR, or any of KemPharm’s other product candidates. These forward-looking statements are not guarantees of future actions or performance. These forward-looking statements are based on information currently available to
| KEMPHARM, INC. | ||||||||||
| UNAUDITED CONDENSED STATEMENTS OF OPERATIONS | ||||||||||
| (In Thousands, Except Share and Per Share Amounts) | ||||||||||
| Three months ended March 31, | ||||||||||
| 2016 | 2015 | |||||||||
| Revenue | $ | — | $ | — | ||||||
| Operating expenses: | ||||||||||
| Research and development | 3,234 | 2,119 | ||||||||
| General and administrative | 3,736 | 977 | ||||||||
| Total operating expenses | 6,970 | 3,096 | ||||||||
| Loss from operations | (6,970 | ) | (3,096 | ) | ||||||
| Other (expense) income: | ||||||||||
| Loss on extinguishment of debt | (4,740 | ) | — | |||||||
| Interest expense related to amortization of debt issuance costs and discount | (442 | ) | (477 | ) | ||||||
| Interest expense on principal | (1,150 | ) | (632 | ) | ||||||
| Fair value adjustment | 10,278 | (1,762 | ) | |||||||
| Interest and other income | 102 | — | ||||||||
| Total other income (expense) | 4,048 | (2,871 | ) | |||||||
| Loss before income taxes | (2,922 | ) | (5,967 | ) | ||||||
| Income tax expense | (12 | ) | (7 | ) | ||||||
| Net loss | $ | (2,934 | ) | $ | (5,974 | ) | ||||
| Net loss per share: | ||||||||||
| Basic and diluted | $ | (0.20 | ) | $ | (2.50 | ) | ||||
| Weighted average common shares outstanding: | ||||||||||
| Basic and diluted | 14,495,703 | 2,387,092 | ||||||||
| KEMPHARM, INC. | ||||||||||
| CONDENSED BALANCE SHEETS | ||||||||||
| (In Thousands, Except Share and Par Value Amounts) | ||||||||||
| As of March 31, |
As of December 31, |
|||||||||
| 2016 | 2015 | |||||||||
| (unaudited) | ||||||||||
| Assets | ||||||||||
| Current assets: | ||||||||||
| Cash and cash equivalents | $ | 77,333 | $ | 32,318 | ||||||
| Marketable securities | 33,668 | 19,002 | ||||||||
| Prepaid expenses and other current assets | 386 | 2,758 | ||||||||
| Total current assets | 111,387 | 54,078 | ||||||||
| Property and equipment, net | 443 | 403 | ||||||||
| Other long-term assets | 109 | 109 | ||||||||
| Total assets | $ | 111,939 | $ | 54,590 | ||||||
| Liabilities and stockholders' deficit | ||||||||||
| Current liabilities: | ||||||||||
| Accounts payable and accrued expenses | $ | 4,178 | $ | 4,906 | ||||||
| Current portion of convertible notes | 1,649 | 1,369 | ||||||||
| Current portion of term notes | — | 2,041 | ||||||||
| Current portion of capital lease obligation | 18 | 26 | ||||||||
| Total current liabilities | 5,845 | 8,342 | ||||||||
| Convertible notes, net | 90,086 | 7,412 | ||||||||
| Term notes, net | — | 11,118 | ||||||||
| Derivative and warrant liability | 27,479 | 37,839 | ||||||||
| Other long-term liabilities | 11 | — | ||||||||
| Total liabilities | 123,421 | 64,711 | ||||||||
| Commitments and contingencies (Note D) | ||||||||||
| Stockholders’ deficit: | ||||||||||
| Common stock, $0.0001 par value, 250,000,000 shares authorized, 14,498,930 shares issued and outstanding as of March 31, 2016 (unaudited); 14,490,954 shares issued and outstanding as of December 31, 2015 |
1 | 1 | ||||||||
| Additional paid-in capital | 96,275 | 94,702 | ||||||||
| Preferred stock, $0.0001 par value, 10,000,000 shares authorized, no shares issued or outstanding as of March 31, 2016 (unaudited) or December 31, 2015 |
— | — | ||||||||
| Accumulated deficit | (107,758 | ) | (104,824 | ) | ||||||
| Total stockholders' deficit | (11,482 | ) | (10,121 | ) | ||||||
| Total liabilities and stockholders' deficit | $ | 111,939 | $ | 54,590 | ||||||
Investor Contacts:Jason Rando /Joshua Drumm , Ph.D. Tiberend Strategic Advisors, Inc. 212-375-2665 / 2664 jrando@tiberend.com jdrumm@tiberend.com Media Contact:Jim Heins Cooney Waters Unlimited 212-886-2221 jheins@cooneywatersunlimited.com