Conference Call and Live Audio Webcast with Slide Presentation Scheduled for Today at 4:30 p.m. ET
Development Highlights:
Corporate Highlights
Financial Highlights:
CELEBRATION, Fla., Nov. 08, 2018 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today reported its corporate and financial results for the third quarter ended September 30, 2018, including an update on clinical development events related to its prodrug development pipeline.
“This has been one of the most important periods in KemPharm’s history,” said Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “In the span of just four months, we completed the KP415 efficacy and human abuse potential (HAP) programs, announced a definitive collaboration and license agreement with KVK for the U.S. commercial rights for APADAZ, entered into a technology collaboration with twoXAR to develop novel prodrugs, and solidified our balance sheet. As a result of these efforts, we believe we are now well-positioned to file a New Drug Application (NDA) as soon as the first quarter of 2019 for what we believe is a differentiated methylphenidate product for the high-demand ADHD treatment market, commercialize APADAZ with KVK, and create new opportunities to apply our prodrug expertise to under-served therapeutic areas.”
“Much has been accomplished recently; however, we have only just begun to unlock KemPharm’s value potential,” Mickle continued. “With partnering discussions for KP415 and KP484 advancing towards a potential year-end event, and launch preparation for APADAZ soon to commence in anticipation of a commercial launch in the second half of 2019, we believe the remainder of 2018 and all of 2019 will be a time of substantial growth and opportunity for our company.”
Q3 2018 Financial Results:
For Q3 2018, KemPharm’s reported net loss was $15.1 million, or $0.94 per basic and diluted share, compared to a net loss of $10.0 million, or $0.68 per basic and diluted share for the same period in 2017. Net loss for Q3 2018 was driven primarily by a loss from operations of $18.0 million and net interest expense and other items of $1.6 million, partially offset by non-cash fair value adjustment income of $4.5 million. Loss from operations increased from $9.6 million in Q3 2017 to $18.0 million in Q3 2018, which was primarily due to an increase of $7.0 million in research and development expenses and severance expense of $1.6 million, partially offset by a decrease of $0.3 million in general and administrative expenses.
As of September 30, 2018, total cash and investments, which is comprised of cash, cash equivalents, restricted cash and marketable securities, was $14.1 million, which was a decrease of $15.2 million compared to June 30, 2018.
On October 10, 2018, the Company closed an underwritten public offering of 8,333,334 shares of its common stock at $3.00 per share, receiving net proceeds of approximately $23.2 million. Pro forma total cash and investments following the offering were approximately $37.3 million.
Conference Call Information:
KemPharm will host a conference call and live audio webcast with slide presentation on Thursday, November 8, 2018, at 4:30 p.m. ET, to discuss its corporate and financial results for the third quarter of 2018. Interested participants and investors may access the conference call by dialing either:
An audio webcast with slide presentation 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 later today, November 8, 2018, at approximately 5:30 p.m. ET.
Recent and Q3 2018 Activities:
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 LATTM (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 product pipeline is focused on the high need areas of ADHD, pain and other central nervous system disorders, and its co-lead clinical development candidates are KP415 and KP484, both based on a prodrug of d-methylphenidate, but with differing extended-release/effect profiles, are intended for the treatment of ADHD. In addition, KemPharm has received FDA approval 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 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 Annual Report on Form 10-K for the year ended December 31, 2017, 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.
| Investor/Media Contacts: |
| Jason Rando / Joshua Drumm, Ph.D. Tiberend Strategic Advisors, Inc. 212-375-2665 / 2664 jrando@tiberend.com jdrumm@tiberend.com |
KEMPHARM, INC.
UNAUDITED CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Revenue | $ | — | $ | — | $ | — | $ | — | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 13,330 | 6,293 | 35,455 | 15,057 | ||||||||||||
| General and administrative | 2,992 | 3,319 | 9,544 | 10,159 | ||||||||||||
| Severance expense | 1,636 | — | 1,636 | — | ||||||||||||
| Total operating expenses | 17,958 | 9,612 | 46,635 | 25,216 | ||||||||||||
| Loss from operations | (17,958 | ) | (9,612 | ) | (46,635 | ) | (25,216 | ) | ||||||||
| Other (expense) income: | ||||||||||||||||
| Interest expense related to amortization of debt issuance costs and discount | (326 | ) | (391 | ) | (1,106 | ) | (1,171 | ) | ||||||||
| Interest expense on principal | (1,367 | ) | (1,448 | ) | (4,228 | ) | (4,332 | ) | ||||||||
| Fair value adjustment related to derivative and warrant liability | 4,468 | 1,312 | 289 | (2,381 | ) | |||||||||||
| Interest and other income, net | 52 | 154 | 290 | 268 | ||||||||||||
| Total other (expense) income | 2,827 | (373 | ) | (4,755 | ) | (7,616 | ) | |||||||||
| Loss before income taxes | (15,131 | ) | (9,985 | ) | (51,390 | ) | (32,832 | ) | ||||||||
| Income tax benefit | 60 | 4 | 107 | 12 | ||||||||||||
| Net loss | $ | (15,071 | ) | $ | (9,981 | ) | $ | (51,283 | ) | $ | (32,820 | ) | ||||
| Net loss per share: | ||||||||||||||||
| Basic and diluted | $ | (0.94 | ) | $ | (0.68 | ) | $ | (3.33 | ) | $ | (2.24 | ) | ||||
| Weighted average number of shares of common stock outstanding: | ||||||||||||||||
| Basic and diluted | 16,033,923 | 14,657,430 | 15,385,663 | 14,651,371 | ||||||||||||
KEMPHARM, INC.
CONDENSED BALANCE SHEETS
(in thousands, except share and par value amounts)
| September 30, 2018 | December 31, 2017 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 1,788 | $ | 10,871 | ||||
| Restricted cash | 1,100 | 1,100 | ||||||
| Marketable securities | 11,239 | 31,358 | ||||||
| Trade date receivables | — | 2,005 | ||||||
| Prepaid expenses and other current assets | 2,610 | 1,662 | ||||||
| Total current assets | 16,737 | 46,996 | ||||||
| Property and equipment, net | 1,817 | 2,004 | ||||||
| Long-term investments | — | 3,250 | ||||||
| Other long-term assets | 183 | 206 | ||||||
| Total assets | $ | 18,737 | $ | 52,456 | ||||
| Liabilities and stockholders' deficit | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 14,677 | $ | 7,875 | ||||
| Current portion of convertible notes | 3,333 | 3,333 | ||||||
| Current portion of capital lease obligation | 210 | 189 | ||||||
| Other current liabilities | 103 | 112 | ||||||
| Total current liabilities | 18,323 | 11,509 | ||||||
| Convertible notes, less current portion, net | 87,171 | 89,398 | ||||||
| Derivative and warrant liability | 7,420 | 7,709 | ||||||
| Capital lease obligation, less current portion | 451 | 562 | ||||||
| Other long-term liabilities | 717 | 794 | ||||||
| Total liabilities | 114,082 | 109,972 | ||||||
| Stockholders' deficit: | ||||||||
| Common stock, $0.0001 par value, 250,000,000 shares authorized, 16,042,018 shares issued and outstanding as of September 30, 2018 (unaudited); 14,657,430 shares issued and outstanding as of December 31, 2017 | 2 | 1 | ||||||
| Additional paid-in capital | 120,662 | 107,209 | ||||||
| Preferred stock, $0.0001 par value, 10,000,000 shares authorized, no shares issued or outstanding as of September 30, 2018 (unaudited) or December 31, 2017 | — | — | ||||||
| Accumulated deficit | (216,009 | ) | (164,726 | ) | ||||
| Total stockholders' deficit | (95,345 | ) | (57,516 | ) | ||||
| Total liabilities and stockholders' deficit | $ | 18,737 | $ | 52,456 | ||||