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 quarter
ended March 31, 2019.
“The first quarter of 2019 and early April were
highlighted by advancements in our KP415 and APADAZ® programs,
serving to propel each towards what we believe will be significant
value building events in the coming months,” said Travis C. Mickle,
Ph.D., President and Chief Executive Officer of KemPharm.
“For KP415, our prodrug product candidate being developed for the
treatment of attention-deficit/hyperactivity disorder (ADHD), we
announced the completion of the pre-New Drug Application (NDA)
meeting with the U.S. Food and Drug Administration (FDA). We
have recently received the minutes from that meeting which confirm
the previously reported results. In summary, we believe the
review of the KP415 pre-NDA briefing package, which included
clinical, non-clinical and human abuse potential study results, as
well as regulatory elements, was consistent with our interpretation
and previous interactions with the FDA, and, as a result, we
believe that we are positioned to submit the KP415 NDA in late
second quarter or early third quarter 2019.”
“In parallel with the regulatory activities for
KP415, we have entered into what we believe are the final stages of
the partnering process for our ADHD franchise, which includes KP415
and KP484,” continued Dr. Mickle. “Since the initiation of
the partnering process, our goal has been focused on securing an
agreement with a partner fully dedicated to maximizing the
commercial value of KP415 and KP484. While still engaged with
multiple parties, we believe that the process should be complete
sometime later this quarter or early third quarter.”
“With regard to APADAZ, we continue to work with
our partner, KVK Tech, to advance several initiatives that we
believe will contribute to a successful market introduction of the
product. The commercial launch remains on track for the
second half of 2019,” said Dr. Mickle. “The first quarter was
highlighted by three important events. In January, we
received FDA approval of two additional dosage strengths of
APADAZ. Following that, in February, APADAZ was added to
compendia with authorized generic pricing similar to current
generics. And most recently, beginning in March, we learned
that the ongoing process of formulary adoption of APADAZ and its
authorized generic had advanced more rapidly than we
anticipated. Notably, according to Managed Markets Insights
and Technology estimates, APADAZ, both the brand and authorized
generic, is currently being reviewed and added to formularies in
various markets including both commercial and Medicaid. Based
on this progress and other indicators, we continue to believe that
the replacement of current hydrocodone/acetaminophen (APAP)
products with APADAZ and its authorized generic has the potential
to be a meaningful market opportunity.”
Q1 2019 Financial Results:For
the quarter ended March 31, 2019, KemPharm’s reported net loss was
$12.3 million, or $0.46 per basic and diluted share, compared to a
net loss of $26.2 million, or $1.77 per basic and diluted share for
the same period in 2018. Net loss for Q1 2019 was driven primarily
by an operating loss of $11.4 million and net interest expense and
other items of $1.4 million, partially offset by non-cash fair
value adjustment income of $0.5 million. The operating loss
of $11.4 million for Q1 2019 was a decrease of $3.4 million
compared to $14.8 million in Q1 2018, which was primarily due to
decreases of $3.1 million in research and development expenses and
$0.3 million in general and administrative expenses,
respectively.
As of March 31, 2019, total cash, which is
comprised of cash, cash equivalents and restricted cash, was $14.0
million, which was a decrease of $8.4 million as compared to
December 31 2018. The decrease in total cash during Q1 2019
was due to a use of cash of $11.1 million, offset by proceeds of
$2.7 million on the sale of approximately 1.4 million shares under
the equity line of credit with Lincoln Park Capital.
“As we seek to finalize the partnering process
for KP415 and KP484, we have utilized a portion of our equity line
of credit with Lincoln Park Capital. This additional capital,
combined with cost reductions, extends the cash runway further into
Q3 2019,” said Dr. Mickle. “In addition, we expect that our
cash burn rate will reduce substantially following the NDA filing
for KP415.”
Presentation and Webcast at RBC Capital
Markets Global Healthcare Conference:
KemPharm also announced today that Dr. Mickle
will present at the RBC Capital Markets 2019 Global Healthcare
Conference being held May 21-22, 2019, at the InterContinental New
York Barclay.
Details of KemPharm’s presentation are as
follows:
Event: |
|
RBC Capital Markets 2019
Global Healthcare Conference |
Date: |
|
Wednesday, May 22, 2019 |
Time: |
|
1:35 PM (EST) |
Room: |
|
Morgan Suite |
Location: |
|
InterContinental New York
Barclay, 111 East 48th Street, New York, NY |
The presentation will be webcast and available
one hour following the live event at
http://www.veracast.com/webcasts/rbc/healthcare2019/82314394157.cfm.
The replay will be available for 90 days.
In addition, the presentation will be available
on the Investor Relations section of the Company's website at
http://investors.kempharm.com/.
Recent and Q1 2019
Activities:
- Announced Completion of KP415 Pre-NDA Meeting with
FDAOn April 11, 2019, KemPharm announced that it concluded
a pre- NDA meeting with the FDA for KP415, KemPharm’s
investigational attention-deficit/hyperactivity disorder (ADHD)
product candidate that contains serdexmethylphenidate (SDX, a
prodrug of d-methylphenidate) and d-methylphenidate. At the pre-NDA
meeting, representatives from the FDA reviewed KemPharm’s summary
of the data package being prepared for the KP415 NDA submission,
including clinical, non-clinical and human abuse potential studies,
as well as regulatory elements. Based on the feedback from the FDA,
the Company believes its regulatory data package will be sufficient
for submission, with acceptance of the filing subject to the FDA's
review of the complete package.
- Provided Update on APADAZ Formulary AdoptionOn
March 13, 2019, KemPharm provided an update on formulary adoption
of APADAZ, an immediate release combination of KemPharm’s prodrug,
benzhydrocodone, and APAP. APADAZ and its authorized generic
are currently being reviewed and added to formularies in various
markets including Medicaid. KemPharm believes the continued
adoption of APADAZ by formularies is another stepping stone in the
efforts to prepare APADAZ for commercial launch as soon as the
second half of this year.
- Announced Enhancements to U.S. and Global Intellectual
Property Estate, Including IP Protection for KP415 in Canada, Japan
and KoreaOn January 29, 2019, KemPharm announced
enhancements to its U.S. and global intellectual property estate
governing its portfolio of prodrug product candidates. The
United States Patent and Trademark Office issued seven (7) new
patents to KemPharm during 2018 related to several of its compound
families, including KP201, KP303, KP511, KP606 and KP746. In
addition, KemPharm has augmented and strengthened the global patent
estate for KP415 with the addition of issued patents last year in
Canada, Japan and Korea.
- Presented Scientific Posters at APSARD's 2019 Annual
MeetingOn January 18, 2019, KemPharm announced that
research assessing the oral and intranasal human abuse potential of
SDX, KemPharm’s prodrug of d-methylphenidate (d-MPH), as well as
new pharmacokinetic data for KP415, were presented in four posters
and one oral “data blitz session” at the 2019 Annual Meeting of the
American Professional Society for ADHD and Related Disorders
(APSARD).
- Announced FDA Approval of sNDA for Two Additional
Strengths of APADAZ (4.08 mg benzhydrocodone/325 mg APAP and 8.16
mg benzhydrocodone/325 mg APAPOn January 7, 2019, KemPharm
announced that the FDA approved a Supplemental New Drug Application
(sNDA) for two additional strengths of APADAZ. The approval
of these new dosage strengths, 4.08 mg benzhydrocodone/325 mg
APAP and 8.16 mg benzhydrocodone/325 mg APAP, follows the NDA
approval on February 23, 2018 of the 6.12 mg benzhydrocodone/325 mg
APAP dosage strength of APADAZ.
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. KemPharm’s co-lead clinical development candidates
for the treatment of ADHD, KP415 and KP484, are both based on a
prodrug of d-methylphenidate, but have differing duration/effect
profiles. 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, 2018, 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 RandoTiberend Strategic Advisors,
Inc.212-375-2665jrando@tiberend.com |
KEMPHARM, INC.UNAUDITED
CONDENSED STATEMENTS OF OPERATIONS(in thousands,
except share and per share amounts)
|
|
|
Three months ended March 31, |
|
|
|
2019 |
|
2018 |
Revenue |
|
|
$ |
— |
|
|
$ |
— |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
|
|
8,531 |
|
|
|
11,637 |
|
General and administrative |
|
|
|
2,838 |
|
|
|
3,132 |
|
Total operating expenses |
|
|
|
11,369 |
|
|
|
14,769 |
|
Loss from operations |
|
|
|
(11,369 |
) |
|
|
(14,769 |
) |
Other (expense) income: |
|
|
|
|
|
|
|
|
|
Interest expense related to amortization of debt issuance costs and
discount |
|
|
|
(305 |
) |
|
|
(390 |
) |
Interest expense on principal |
|
|
|
(1,229 |
) |
|
|
(1,442 |
) |
Fair value adjustment related to derivative and warrant
liability |
|
|
|
453 |
|
|
|
(9,741 |
) |
Interest and other income, net |
|
|
|
151 |
|
|
|
115 |
|
Total other (expense) income |
|
|
|
(930 |
) |
|
|
(11,458 |
) |
Loss before income taxes |
|
|
|
(12,299 |
) |
|
|
(26,227 |
) |
Income tax benefit |
|
|
|
8 |
|
|
|
8 |
|
Net loss |
|
|
$ |
(12,291 |
) |
|
$ |
(26,219 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss per share: |
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
$ |
(0.46 |
) |
|
$ |
(1.77 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of shares of common stock
outstanding: |
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
|
26,701,891 |
|
|
|
14,791,882 |
|
KEMPHARM, INC. BALANCE
SHEETS (in thousands, except share and par value
amounts)
|
|
March
31,2019 |
|
December 31,2018 |
|
|
|
(unaudited) |
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
13,438 |
|
|
$ |
18,409 |
|
Marketable securities |
|
|
— |
|
|
|
3,260 |
|
Prepaid expenses and other current assets |
|
|
1,873 |
|
|
|
2,052 |
|
Total current assets |
|
|
15,311 |
|
|
|
23,721 |
|
Property and equipment, net |
|
|
1,688 |
|
|
|
1,753 |
|
Operating lease right-of-use assets |
|
|
1,785 |
|
|
|
— |
|
Restricted cash |
|
|
528 |
|
|
|
710 |
|
Other long-term assets |
|
|
555 |
|
|
|
562 |
|
Total assets |
|
$ |
19,867 |
|
|
$ |
26,746 |
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders'
deficit |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
8,178 |
|
|
$ |
8,342 |
|
Current portion of convertible notes |
|
|
6,370 |
|
|
|
3,333 |
|
Current portion of capital lease obligation |
|
|
— |
|
|
|
214 |
|
Current portion of operating lease liabilities |
|
|
395 |
|
|
|
— |
|
Other current liabilities |
|
|
229 |
|
|
|
115 |
|
Total current liabilities |
|
|
15,172 |
|
|
|
12,004 |
|
Convertible notes, less current portion, net |
|
|
75,373 |
|
|
|
78,105 |
|
Derivative and warrant liability |
|
|
1,665 |
|
|
|
2,118 |
|
Capital lease obligation, less current portion |
|
|
— |
|
|
|
396 |
|
Operating lease liabilities, less current portion |
|
|
2,142 |
|
|
|
— |
|
Other long-term liabilities |
|
|
351 |
|
|
|
689 |
|
Total liabilities |
|
|
94,703 |
|
|
|
93,312 |
|
|
|
|
|
|
|
|
|
|
Stockholders' deficit: |
|
|
|
|
|
|
|
|
Preferred stock: |
|
|
|
|
|
|
|
|
Series A convertible preferred stock, $0.0001 par value, 9,578
shares authorized, 9,577 shares issued and 3,337 shares outstanding
as of March 31, 2019 (unaudited) and December 31, 2018 |
|
|
— |
|
|
|
— |
|
Undesignated preferred stock, $0.0001 par value, 9,990,422 shares
authorized, no shares issued or outstanding as of March 31, 2019
(unaudited) and December 31, 2018 |
|
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value, 250,000,000 shares authorized,
27,976,823 shares issued and outstanding as of March 31, 2019
(unaudited); 26,455,352 shares issued and outstanding as of
December 31, 2018 |
|
|
3 |
|
|
|
3 |
|
Additional paid-in capital |
|
|
158,644 |
|
|
|
154,623 |
|
Accumulated deficit |
|
|
(233,483 |
) |
|
|
(221,192 |
) |
Total stockholders' deficit |
|
|
(74,836 |
) |
|
|
(66,566 |
) |
Total liabilities and
stockholders' deficit |
|
$ |
19,867 |
|
|
$ |
26,746 |
|
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