KemPharm, Inc. Reports Fourth Quarter and Year End 2016 Results
Conference Call and Live Audio Webcast with Slide Presentation Scheduled for Today at
- Reported Positive Data from Phase 1 Proof-of-Concept Clinical Trial of KP415
- Received Clearance from
FDA toInitiate Clinical Program for KP201/IR - Granted “Fast Track” Designation from
FDA for KP201/IR - Reported Positive Data from Proof-of-Concept Phase 1 Intranasal Pharmacokinetic Study of KP511
Recent Corporate and Financial Highlights:
- Net loss of
$0.68 per basic and diluted share for the quarter endedDecember 31, 2016 ; net loss of$1.13 per basic and diluted share for the year endedDecember 31, 2016 - Total cash and security-related amounts were
$82.1 million atDecember 31, 2016 , which includes cash, cash equivalents, restricted cash, marketable securities, trade date receivables and long-term investments balance
“The fourth quarter of 2016 and early 2017 were highlighted by substantive progress across our clinical-stage programs, demonstrating the strength and potential of our Ligand Activated Therapy prodrug discovery platform and our product candidate pipeline,” said
“Looking ahead to the coming year, we anticipate several clinical and developmental milestones that could serve to greatly enhance the value of the LAT prodrug platform and our product candidate portfolio,” Dr. Mickle continued. “As a prodrug discovery company, KemPharm’s mission is to develop prodrugs that are an improvement on currently approved drugs and address unmet medical needs in large, established markets. We believe our current product candidate portfolio, led by KP415, which has demonstrated the potential to address critical patient needs in the multi-billion dollar ADHD market, exemplifies this strategy. Our scientific discovery is intended to showcase opportunities that could be extended to other drug products in large markets where improving one or more attributes, such as bioavailability, safety or efficacy, could potentially enable the capture of significant market share.”
Q4 and Year-End 2016 Financial Results:
KemPharm’s reported net loss of
For the year ended
As of
Conference Call Information:
The company will host a conference call and live audio webcast with slide presentation on
- (866) 395-2480 (U.S.)
- (678) 509-7538 (international)
- Conference ID: 80582549
The live webcast with accompanying slides will be accessible via the Investor Relations section of the
Fourth Quarter and Recent Activities:
- Reported Positive Data from Phase 1 Proof-of-Concept Clinical Trial of KP415
OnDecember 14, 2016 ,KemPharm announced the results of its Phase 1 proof-of-concept clinical trial of KP415, the Company’s extended-release prodrug of d-threo-methylphenidate (d-MPH) for the treatment of ADHD. Data from the study indicated that KP415 demonstrated PK properties that produced earlier d-MPH exposure followed by a slower extended release of d-MPH relative to the comparator, Concerta®.KemPharm expects to initiate pivotal efficacy trials during 2017 and submit an NDA in 2018.
- Received Clearance from
FDA toInitiate Clinical Program for KP201/IR
OnNovember 29, 2016 ,KemPharm announced that its Investigational New Drug (IND) application for KP201/IR was accepted by theU.S. Food and Drug Administration (FDA ). KP201/IR is KemPharm’s single-entity benzhydrocodone HCl immediate release abuse-deterrent prodrug for the treatment of acute pain.KemPharm expects to initiate human clinical trials of KP201/IR in the first half of 2017 and remains on target for a potential submission in 2018 of the KP201/IR NDA.
- Granted “Fast Track” Designation from
FDA for KP201/IR
OnDecember 20, 2016 ,KemPharm announced that its IND application for KP201/IR was granted “Fast Track” designation by the FDA. Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.
- Reported Positive Data from Phase 1 Intranasal Pharmacokinetic Study of KP511
OnJanuary 9, 2017 ,KemPharm announced the results of its exploratory Phase 1, double-blind, single-dose, 2-treatment, 2-period, randomized, crossover study (KP511.A01) intended to assess the PK, safety and intranasal abuse potential of KP511 Active Pharmaceutical Ingredient (API) compared to equivalent doses of hydromorphone hydrochloride (HM API). KP511 is KemPharm’s investigational prodrug of hydromorphone for the treatment of pain. The results of the study indicated that KP511 demonstrated statistically significant reduction in peak and overall hydromorphone exposure with KP511 API versus HM API. The improved PK of KP511 resulted in meaningful, statistically lower scores in the exploratory PD measures of “Drug Liking,” “Feeling High,” “Overall Drug Liking” and “Take Drug Again” when compared to HM API.
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 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, KP201/IR and KP511 the expected timing of potential submissions of NDAs for KP415, KP201/IR and KP511, the expected timing of the initiation and completion of any clinical trials for 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, INC. STATEMENTS OF OPERATIONS (in thousands, except share and per share amounts) |
||||||||||||||||
| Three months ended December 31, | Twelve months ended December 31, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| (unaudited) | (unaudited) | |||||||||||||||
| Revenue | $ | — | $ | — | $ | — | $ | — | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 7,973 | 4,716 | 20,472 | 13,931 | ||||||||||||
| General and administrative | 2,878 | 2,566 | 14,000 | 8,883 | ||||||||||||
| Severance expense | — | — | 3,010 | — | ||||||||||||
| Total operating expenses | 10,851 | 7,282 | 37,482 | 22,814 | ||||||||||||
| Loss from operations | (10,851 | ) | (7,282 | ) | (37,482 | ) | (22,814 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Loss on extinguishment of debt | — | — | (4,740 | ) | — | |||||||||||
| Interest expense related to amortization of debt issuance costs and discount |
(391 | ) | (475 | ) | (1,616 | ) | (1,909 | ) | ||||||||
| Interest expense on principal | (1,445 | ) | (698 | ) | (5,511 | ) | (2,671 | ) | ||||||||
| Fair value adjustment | 2,723 | (764 | ) | 32,465 | (27,276 | ) | ||||||||||
| Interest and other income | 9 | 15 | 353 | 32 | ||||||||||||
| Total other income (expense) | 896 | (1,922 | ) | 20,951 | (31,824 | ) | ||||||||||
| Loss before income taxes | (9,955 | ) | (9,204 | ) | (16,531 | ) | (54,638 | ) | ||||||||
| Income tax benefit (expense) | 4 | 1 | 15 | (26 | ) | |||||||||||
| Net loss | $ | (9,951 | ) | $ | (9,203 | ) | $ | (16,516 | ) | $ | (54,664 | ) | ||||
| Net loss per share: | ||||||||||||||||
| Basic and diluted | $ | (0.68 | ) | $ | (0.64 | ) | $ | (1.13 | ) | $ | (7.42 | ) | ||||
| Weighted average common shares outstanding: |
||||||||||||||||
| Basic and diluted | 14,646,982 | 14,443,421 | 14,597,053 | 7,368,681 | ||||||||||||
| KEMPHARM, INC. BALANCE SHEETS (in thousands, except share and par value amounts) |
||||||||
| As of December 31, 2016 |
As of December 31, 2015 |
|||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 16,762 | $ | 32,318 | ||||
| Restricted cash | 1,100 | — | ||||||
| Marketable securities | 51,003 | 19,002 | ||||||
| Trade date receivables | 5,003 | — | ||||||
| Prepaid expenses and other current assets | 489 | 2,758 | ||||||
| Total current assets | 74,357 | 54,078 | ||||||
| Property and equipment, net | 1,970 | 403 | ||||||
| Long-term investments | 8,200 | — | ||||||
| Other long-term assets | 360 | 109 | ||||||
| Total assets | $ | 84,887 | $ | 54,590 | ||||
| Liabilities and stockholders' deficit | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 6,444 | $ | 4,906 | ||||
| Current portion of convertible notes | — | 1,369 | ||||||
| Current portion of term notes | — | 2,041 | ||||||
| Current portion of capital lease obligation | 157 | 26 | ||||||
| Other current liabilities | 41 | — | ||||||
| Total current liabilities | 6,642 | 8,342 | ||||||
| Convertible notes, net | 91,170 | 7,412 | ||||||
| Term notes, net | — | 11,118 | ||||||
| Derivative and warrant liability | 4,618 | 37,839 | ||||||
| Other long-term liabilities | 1,153 | — | ||||||
| Total liabilities | 103,583 | 64,711 | ||||||
| Stockholders' deficit: | ||||||||
| Common stock, $0.0001 par value, 250,000,000 shares authorized, 14,646,982 shares issued and outstanding as of December 31, 2016; 14,490,954 shares issued and outstanding as of December 31, 2015 |
1 | 1 | ||||||
| Additional paid-in capital | 102,643 | 94,702 | ||||||
| Preferred stock, $0.0001 par value, 10,000,000 shares authorized, no shares issued or outstanding as of December 31, 2016 or December 31, 2015 |
— | — | ||||||
| Accumulated deficit | (121,340 | ) | (104,824 | ) | ||||
| Total stockholders' deficit | (18,696 | ) | (10,121 | ) | ||||
| Total liabilities and stockholders' deficit | $ | 84,887 | $ | 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:Daniel L. Cohen Executive VP,Government and Public Relations KemPharm, Inc. 202-329-1825 dcohen@kempharm.com