Conference Call and Live Audio Webcast with Slide Presentation Scheduled for Today at 4:30 p.m. ET
Clinical Development & Regulatory Highlights:
Corporate & Financial Highlights:
CORALVILLE, Iowa, Aug. 10, 2017 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today reported its corporate and financial results for the second quarter ended June 30, 2017, including an update on clinical and regulatory events involving its prodrug development pipeline.
“The second quarter was highlighted by key advances to our ADHD prodrug portfolio, including the completion of the KP415 End-of-Phase 1 meeting with the FDA and the requisite Phase 1 pharmacokinetics trial, the data of which was announced today and has provided us additional support of the potential early onset and extended duration of therapy that may be provided by KP415,” said Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “We believe these two events keep us on schedule for the initiation of the pivotal efficacy study and human abuse liability program prior to year-end.”
“Importantly, we also were able to announce the development of a new ADHD prodrug product candidate, KP484, a super-extended release d-threo-methylphenidate. We now expect to file the Investigational New Drug (IND) application for KP484 as early as the third quarter of 2017, after which we anticipate initiating an expedited clinical development program in 2018,” Dr. Mickle continued. “Should we continue to advance our ADHD prodrug portfolio as expected, KemPharm foresees submitting New Drug Applications (NDAs) for KP415 and KP484 in 2018 and 2019, respectively, enabling the Company to potentially introduce two highly differentiated products to the ADHD market in close succession. Altogether, these completed and anticipated milestones have strengthened our conviction that our ADHD prodrug portfolio is not only KemPharm’s most valuable asset, but also has the potential to address important treatment needs across the ADHD patient spectrum.”
“In addition to the significant activity with our ADHD portfolio, we anticipate the completion of the Formal Dispute Resolution Request (FDRR) process for Apadaz™, our product candidate combining KP201with APAP, with the FDA in the near future as well,” Dr. Mickle concluded. “Collectively, we believe these internal opportunities may add significant value to KemPharm in 2017 and 2018, while serving to highlight the potential of our Ligand Activated Therapy (LAT) prodrug platform. We will continue to leverage this drug discovery engine, which is designed to enhance the performance of an active pharmaceutical ingredient and increase the marketability of the parent drug.”
Q2 2017 Financial Results:
KemPharm’s reported net loss of $6.5 million, or $0.44 per basic and diluted share for Q2 2017, compared to net income of $9.8 million, or net income per basic share of $0.59 and net loss per diluted share of $0.58, for the same period in 2016. Net loss for the Q2 2017 was driven primarily by a loss from operations of $8.2 million, and net interest expense and other items of $1.8 million; these expenses were partially offset by fair value adjustment income of $3.5 million. Loss from operations was $9.3 million for the same period in 2016. The decrease in loss from operations for Q2 2017 compared to the same quarter in 2016 was primarily due to a decrease in general and administrative costs related to overhead and personnel spending.
As of June 30, 2017, total cash, cash equivalents, restricted cash, marketable securities, and long-term investments was $65.8 million, which reflected a decrease of $6.6 million compared to March 31, 2017. Based on the Company’s current forecast, existing resources are expected to fund operating expenses and capital expenditure requirements through Q2 2019.
Conference Call Information:
The company will host a conference call and live audio webcast with slide presentation on Thursday, August 10, 2017, at 4:30 p.m. ET, to discuss its corporate and financial results for the second quarter 2017. Interested participants and investors may access the conference call by dialing either:
The live webcast with accompanying slides will be accessible via the Investor Relations section of the KemPharm website http://investors.kempharm.com/. An archive of the webcast and presentation will remain available for 90 days beginning at approximately 5:00 p.m. ET, on August 10, 2017.
Second Quarter 2017 Activities:
About KemPharm
KemPharm is a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs to treat serious medical conditions through its LATTM (Ligand Activated Therapy) platform technology. KemPharm utilizes its LATTM platform technology to generate improved prodrug versions of FDA-approved drugs in the high need areas of pain, ADHD and other central nervous system disorders. KemPharm’s co-lead clinical development candidates are KP415 and KP484, both based on a prodrug of methylphenidate, but with differing extended-release profiles for the treatment of ADHD, and KP201/IR, an acetaminophen-free formulation of the company’s immediate release abuse deterrent hydrocodone product candidate, KP201. For more information on KemPharm and its pipeline of prodrug product candidates visit www.kempharm.com.
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. These forward-looking statements include statements regarding the expected features and characteristics of KP415, KP484, KP201/IR and KP511, the expected timing of the initiation and completion of any clinical trials for the Company’s product candidates and the expected timing for any submission of an New Drug Application with the FDA for any of the Company’s 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 and its current plans or expectations, and are subject to a number of uncertainties and risks that could significantly affect current plans. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: KemPharm's financial resources and whether they will be sufficient to meet KemPharm's business objectives and operational requirements; results of earlier studies and trials may not be predictive of future clinical trial results; the protection and market exclusivity provided by KemPharm's intellectual property; risks related to the drug discovery and the regulatory approval process; the impact of competitive products and technological changes; and the FDA approval process under the Section 505(b)(2) regulatory pathway, including without limitation any timelines for related approval. KemPharm's forward-looking statements also involve assumptions that, if they prove incorrect, would cause its results to differ materially from those expressed or implied by such forward-looking statements. These and other risks concerning KemPharm’s business are described in additional detail in KemPharm's Annual Report on Form 10-K for the year ended December 31, 2016, and KemPharm’s other Periodic and Current Reports filed 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, INC. | ||||||||||||||||
UNAUDITED CONDENSED STATEMENTS OF OPERATIONS | ||||||||||||||||
(in thousands, except share and per share amounts) | ||||||||||||||||
Three months ended June 30, | Six months ended June 30, | |||||||||||||||
2017 | 2016 | 2017 | 2016 | |||||||||||||
Revenue | $ | — | $ | — | $ | — | $ | — | ||||||||
Operating expenses: | ||||||||||||||||
Research and development | 4,650 | 4,988 | 8,764 | 8,222 | ||||||||||||
General and administrative | 3,574 | 4,287 | 6,840 | 8,023 | ||||||||||||
Total operating expenses | 8,224 | 9,275 | 15,604 | 16,245 | ||||||||||||
Loss from operations | (8,224 | ) | (9,275 | ) | (15,604 | ) | (16,245 | ) | ||||||||
Other (expense) income: | ||||||||||||||||
Loss on extinguishment of debt | — | — | — | (4,740 | ) | |||||||||||
Interest expense related to amortization of debt issuance costs and discount | (390 | ) | (393 | ) | (780 | ) | (835 | ) | ||||||||
Interest expense on principal | (1,443 | ) | (1,475 | ) | (2,884 | ) | (2,625 | ) | ||||||||
Fair value adjustment | 3,523 | 20,763 | (3,693 | ) | 31,041 | |||||||||||
Interest and other income, net | 13 | 144 | 114 | 246 | ||||||||||||
Total other (expense) income | 1,703 | 19,039 | (7,243 | ) | 23,087 | |||||||||||
(Loss) income before income taxes | (6,521 | ) | 9,764 | (22,847 | ) | 6,842 | ||||||||||
Income tax benefit (expense) | 4 | 4 | 8 | (8 | ) | |||||||||||
Net (loss) income | $ | (6,517 | ) | $ | 9,768 | $ | (22,839 | ) | $ | 6,834 | ||||||
Net (loss) income per share: | ||||||||||||||||
Basic | $ | (0.44 | ) | $ | 0.59 | $ | (1.56 | ) | $ | 0.41 | ||||||
Diluted | $ | (0.44 | ) | $ | (0.58 | ) | $ | (1.56 | ) | $ | (1.36 | ) | ||||
Weighted average number of shares of common stock outstanding: | ||||||||||||||||
Basic | 14,649,586 | 14,597,449 | 14,648,291 | 14,546,576 | ||||||||||||
Diluted | 14,649,586 | 15,435,322 | 14,648,291 | 15,583,390 |
KEMPHARM, INC. | ||||||||
CONDENSED BALANCE SHEETS | ||||||||
(in thousands, except share and par value amounts) | ||||||||
As of June 30, | As of December 31, | |||||||
2017 | 2016 | |||||||
(unaudited) | ||||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 12,386 | $ | 16,762 | ||||
Restricted cash | 1,100 | 1,100 | ||||||
Marketable securities | 41,107 | 51,003 | ||||||
Trade date receivables | — | 5,003 | ||||||
Prepaid expenses and other current assets | 771 | 489 | ||||||
Total current assets | 55,364 | 74,357 | ||||||
Property and equipment, net | 2,148 | 1,970 | ||||||
Long-term investments | 11,215 | 8,200 | ||||||
Other long-term assets | 321 | 360 | ||||||
Total assets | $ | 69,048 | $ | 84,887 | ||||
Liabilities and stockholders' deficit | ||||||||
Current liabilities: | ||||||||
Accounts payable and accrued expenses | $ | 6,303 | $ | 6,444 | ||||
Current portion of capital lease obligation | 177 | 157 | ||||||
Other current liabilities | 112 | 41 | ||||||
Total current liabilities | 6,592 | 6,642 | ||||||
Convertible notes, net | 91,950 | 91,170 | ||||||
Derivative and warrant liability | 8,311 | 4,618 | ||||||
Other long-term liabilities | 1,472 | 1,153 | ||||||
Total liabilities | 108,325 | 103,583 | ||||||
Commitments and contingencies (Note D) | ||||||||
Stockholders’ deficit: | ||||||||
Common stock, $0.0001 par value, 250,000,000 shares authorized, 14,657,430 shares issued and outstanding as of June 30, 2017 (unaudited); 14,646,982 shares issued and outstanding as of December 31, 2016 | 1 | 1 | ||||||
Additional paid-in capital | 104,901 | 102,643 | ||||||
Preferred stock, $0.0001 par value, 10,000,000 shares authorized, no shares issued or outstanding as of June 30, 2017 (unaudited) and December 31, 2016 | — | — | ||||||
Accumulated deficit | (144,179 | ) | (121,340 | ) | ||||
Total stockholders' deficit | (39,277 | ) | (18,696 | ) | ||||
Total liabilities and stockholders' deficit | $ | 69,048 | $ | 84,887 |