KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company
focused on the discovery and development of proprietary prodrugs,
today reported its financial results for the third quarter ended
September 30, 2021. In addition, the Company announced that Richard
W. Pascoe, lead independent director on the Board of Directors, has
been named Executive Chairman to support execution of the Company’s
strategic growth objectives to expand its pipeline and
commercialization capabilities. Travis C. Mickle, Ph.D., remains
the Company’s President and Chief Executive Officer, and as a
member of the Board of Directors.
“I am delighted to partner with Rich in his new
role as Executive Chairman as we build upon our successful track
record of clinical development and U.S. regulatory approvals to
create an innovative biopharmaceutical company with an expanded
pipeline and commercial capabilities,” stated Dr. Mickle. “Rich and
I have built a strong working relationship since he joined our
Board in 2014, and I am proud of our many accomplishments at
KemPharm to date. Working together to expand the Company’s growth
opportunities will be exciting as together we pursue our shared
goal to increase shareholder value.”
“I am excited for the opportunity to continue my
service to KemPharm as its Executive Chairman and to partner with
Travis and the executive team as we seek to grow into a profitable,
fully integrated, biopharmaceutical company,” said Mr. Pascoe.
“Travis, the Board of Directors, and I are committed to this
objective which we will seek to accomplish by successfully
building, developing, and commercializing a pipeline of innovative
product candidates focused on the treatment of
neurodegenerative/central nervous system indications.”
Mr. Pascoe has a strong track record building
and leading life sciences organizations. He has served in key
leadership roles in companies that successfully raised over $300
million in equity capital, taken private companies public, closed
more than $2 billion of value in business development transactions,
obtained regulatory approvals for two products in both the U.S. and
Europe, and led commercial launches of prescription drugs in the
U.S. across multiple therapeutic categories.
Most recently, Mr. Pascoe served as Chief
Executive Officer of Histogen Inc., and his prior experiences
include serving as Chief Executive Officer at Apricus Biosciences
Inc. and Somaxon Pharmaceuticals, Inc. Mr. Pascoe’s career is also
highlighted by several senior management roles, including Chief
Operating Officer at ARIAD Pharmaceuticals, Inc., and Senior Vice
President of the Neuroscience Division at King Pharmaceuticals,
Inc. In addition to serving as Executive Chairman of KemPharm,
Inc., Mr. Pascoe is currently a member of the board of directors of
Seelos Therapeutics, Inc., and the board of directors of the Johnny
Mac Soldiers Fund, a charity for military veterans. Mr. Pascoe is a
graduate of the Unites States Military Academy at West Point.
Q3 2021 Corporate and Financial
Results:
“The third quarter of 2021 was highlighted by
the U.S. commercial launch of AZSTARYS®, a seminal event in
KemPharm’s history, which occurred during a year with numerous
transformative milestones for the company,” said Dr. Mickle.
“Corium’s commercialization of AZSTARYS continues to proceed as
planned, and their team has recently reported to us their estimate
that more than 50 million commercial and Medicaid lives now have
access to AZSTARYS with more progress expected in the coming
months. Additionally, research involving AZSTARYS and
serdexmethylphenidate (SDX) was presented at three recent ADHD
medical conferences, including data from the pivotal study of
AZSTARYS demonstrating the drug’s 30-minute onset-of-action and
13-hour duration-of-effect. At only 100 days post-launch, we are
encouraged by the early progress, and we believe that Corium’s
commercialization efforts will continue to gain traction with
payors, providers, prescribers and patients.”
Dr. Mickle continued, “In addition to Rich’s
appointment as Executive Chairman, we also announced several other
corporate advancements, including the appointment of Tamara Seymour
to our Board of Directors and the uplisting of our common stock to
The Nasdaq Global Select Market. These developments continue a
period of transformation for KemPharm as we position ourselves to
capitalize on pipeline development opportunities that, we believe,
will ultimately translate to enhanced shareholder value. The
advancement of our SDX program is also moving ahead, with data from
the ongoing SDX clinical trial expected to be announced prior to
year-end. This information will provide valuable insights into the
potential path forward for developing SDX-based product candidates
designed for therapeutic indications with underserved patient
populations.”
Financial results for Q3 2021 included revenue
of $2.0 million, as compared to Q3 2020 revenue of $1.9 million,
which was derived primarily from service fee revenue. The service
fee revenue is being earned under consulting arrangements which
contractually continue through March 2022.
KemPharm’s net loss for Q3 2021 was $1.8
million, or $0.05 per basic share, compared to a net loss of $3.0
million, or a loss of $0.68 per basic and diluted share for the
same period in 2020. Net loss for Q3 2021 was driven primarily by
operating loss of $2.2 million, partially offset by non-cash fair
value adjustment income of $0.3 million related to derivative and
warrant liability and net interest income and other items of $0.1
million. The net operating loss of $2.2 million for Q3 2021 was a
change of $1.0 million compared to net operating loss of $1.2
million in the same period in 2020, which was primarily due to
increases in operating expenses period over period. The net
increase in operating expenses was primarily due to increases in
research and development expense of $0.5 million and general and
administrative expenses of $0.5 million.
As of September 30, 2021, total cash and cash
equivalents was $131.5 million, which was a decrease of $0.8
million compared to $132.3 million as of June 30, 2021.
As of September 30, 2021, total shares of common
stock outstanding was 35,317,313 shares, and fully diluted common
shares outstanding was 46,553,727 shares, which included 4,252,600
shares issuable upon exercise of warrants. In addition, no
preferred stock is outstanding as of September 30, 2021.
Conference Call
Information:
KemPharm will host a conference call and live
audio webcast with slide presentation on Wednesday, November 10,
2021, at 4:30 p.m. ET, to discuss its corporate and financial
results for the third quarter 2021.
Telephone Access: |
To access the conference call telephonically, interested
participants and investors will be required to register via the
following online form:
http://www.directeventreg.com/registration/event/6718737 Once
registered, all individuals will be provided with participant
dial-in numbers, a passcode and a registrant ID, which can then be
used to access the conference call. Participants may register at
any time. It is recommended that the registration process be
completed at least 15 minutes prior to the start of the call. |
|
Webcast Access: |
The live audio webcast with slide presentation will be accessible
via the Investor Relations section of KemPharm’s
website, http://investors.kempharm.com/. An archive of the
webcast and presentation will be available for 90 days beginning at
approximately 5:30 p.m. ET, on November 10, 2021. |
|
|
|
About
AZSTARYS®:
AZSTARYS is an FDA-approved, once-daily product
for the treatment of attention deficit hyperactivity disorder
(ADHD) in patients age six years or older. AZSTARYS consists of
SDX, KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated
with immediate release d-MPH.
The complete approved prescribing information
for AZSTARYS may be downloaded in PDF format
here:https://kempharm.com/wp-content/uploads/2021/03/AZSTARYS-Master-Label-Final_20210302.pdf
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 LAT®
(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 prodrug product candidate pipeline is
focused on the high need areas of attention deficit hyperactivity
disorder, or ADHD, stimulant use disorder (SUD) and CNS rare
diseases, including idiopathic hypersomnia (IH). In addition,
KemPharm has received FDA approval for AZSTARYS®, a new once-daily
treatment for ADHD in patents age six years and older, and 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,
including the continued commercialization of AZSTARYS and the
further development of KemPharm’s pipeline of product candidates,
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 Quarterly Report on Form 10-Q for the quarter ended
September 30, 2021, and KemPharm’s other filings 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 Contacts:
Tiberend Strategic Advisors, Inc.Jason
Rando/Maureen McEnroe, CFA(212) 375-2665 /
2664jrando@tiberend.commmcenroe@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, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
|
Revenue |
$ |
1,965 |
|
|
$ |
1,925 |
|
|
$ |
26,068 |
|
|
$ |
10,922 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Royalty and direct contract acquisition costs |
|
— |
|
|
|
— |
|
|
|
2,000 |
|
|
|
1,305 |
|
|
Research and development |
|
2,239 |
|
|
|
1,709 |
|
|
|
7,352 |
|
|
|
5,789 |
|
|
General and administrative |
|
1,948 |
|
|
|
1,429 |
|
|
|
6,145 |
|
|
|
5,393 |
|
|
Severance expense |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
830 |
|
|
Total operating expenses |
|
4,187 |
|
|
|
3,138 |
|
|
|
15,497 |
|
|
|
13,317 |
|
|
(Loss) income from
operations |
|
(2,222 |
) |
|
|
(1,213 |
) |
|
|
10,571 |
|
|
|
(2,395 |
) |
|
Other income (expense): |
|
|
|
|
|
|
|
|
Loss on extinguishment of debt |
|
— |
|
|
|
— |
|
|
|
(16,096 |
) |
|
|
— |
|
|
Interest expense related to amortization of debt issuance costs and
discount |
|
— |
|
|
|
(578 |
) |
|
|
(150 |
) |
|
|
(1,723 |
) |
|
Interest expense on principal |
|
(6 |
) |
|
|
(1,163 |
) |
|
|
(221 |
) |
|
|
(3,620 |
) |
|
Fair value adjustment related to derivative and warrant
liability |
|
332 |
|
|
|
(137 |
) |
|
|
(92 |
) |
|
|
(65 |
) |
|
Interest and other income (expense), net |
|
137 |
|
|
|
48 |
|
|
|
136 |
|
|
|
(135 |
) |
|
Total other income (expense) |
|
463 |
|
|
|
(1,830 |
) |
|
|
(16,423 |
) |
|
|
(5,543 |
) |
|
Loss before income taxes |
|
(1,759 |
) |
|
|
(3,043 |
) |
|
|
(5,852 |
) |
|
|
(7,938 |
) |
|
Income tax benefit |
|
— |
|
|
|
34 |
|
|
|
— |
|
|
|
34 |
|
|
Net loss |
|
(1,759 |
) |
|
|
(3,009 |
) |
|
|
(5,852 |
) |
|
|
(7,904 |
) |
|
Deemed dividend |
|
— |
|
|
|
— |
|
|
|
(54,342 |
) |
|
|
— |
|
|
Net loss attributable to
common stockholders |
$ |
(1,759 |
) |
|
$ |
(3,009 |
) |
|
$ |
(60,194 |
) |
|
$ |
(7,904 |
) |
|
|
|
|
|
|
|
|
|
|
Basic net loss per share of
common stock: |
|
|
|
|
|
|
|
|
Net loss |
$ |
(0.05 |
) |
|
$ |
(0.68 |
) |
|
$ |
(0.21 |
) |
|
$ |
(2.08 |
) |
|
Net loss attributable to common stockholders |
$ |
(0.05 |
) |
|
$ |
(0.68 |
) |
|
$ |
(2.16 |
) |
|
$ |
(2.08 |
) |
|
|
|
|
|
|
|
|
|
|
Diluted net loss per share of
common stock: |
|
|
|
|
|
|
|
|
Net loss attributable to common stockholders |
$ |
(0.06 |
) |
|
$ |
(0.68 |
) |
|
$ |
(2.16 |
) |
|
$ |
(2.08 |
) |
|
|
|
|
|
|
|
|
|
|
Weighted average number of
shares of common stock outstanding: |
|
|
|
|
|
|
|
|
Basic |
|
35,217,953 |
|
|
|
4,425,474 |
|
|
|
27,904,711 |
|
|
|
3,794,840 |
|
|
Diluted |
|
35,217,953 |
|
|
|
4,425,474 |
|
|
|
27,904,711 |
|
|
|
3,794,840 |
|
|
KEMPHARM, INC.CONDENSED
BALANCE SHEETS(in thousands, except share and par
value amounts)
|
September 30, |
|
December 31, |
|
|
2021 |
|
|
|
2020 |
|
|
(unaudited) |
|
|
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
131,503 |
|
|
$ |
4,213 |
|
Accounts and other receivables |
|
1,619 |
|
|
|
2,579 |
|
Prepaid expenses and other current assets |
|
1,508 |
|
|
|
1,481 |
|
Restricted cash |
|
— |
|
|
|
109 |
|
Total current assets |
|
134,630 |
|
|
|
8,382 |
|
Property and equipment,
net |
|
931 |
|
|
|
1,039 |
|
Operating lease right-of-use
assets |
|
1,186 |
|
|
|
1,350 |
|
Other long-term assets |
|
439 |
|
|
|
438 |
|
Total assets |
$ |
137,186 |
|
|
$ |
11,209 |
|
|
|
|
|
Liabilities and
stockholders' equity (deficit) |
|
|
|
Current liabilities: |
|
|
|
Accounts payable and accrued expenses |
$ |
2,085 |
|
|
$ |
6,647 |
|
Current portion of operating lease liabilities |
|
349 |
|
|
|
327 |
|
Current portion of loans payable |
|
— |
|
|
|
390 |
|
Other current liabilities |
|
1,264 |
|
|
|
172 |
|
Total current liabilities |
|
3,698 |
|
|
|
7,536 |
|
Convertible notes, less
current portion, net |
|
— |
|
|
|
67,658 |
|
Derivative and warrant
liability |
|
396 |
|
|
|
304 |
|
Operating lease liabilities,
less current portion |
|
1,324 |
|
|
|
1,587 |
|
Loans payable |
|
— |
|
|
|
391 |
|
Other long-term
liabilities |
|
31 |
|
|
|
145 |
|
Total liabilities |
|
5,449 |
|
|
|
7,621 |
|
|
|
|
|
Commitments and
contingencies |
|
|
|
|
|
|
|
Stockholders’ equity
(deficit): |
|
|
|
Preferred stock: |
|
|
|
Undesignated preferred stock, $0.0001 par value, 10,000,000 shares
authorized, no shares issued or outstanding as of September 30,
2021; 9,961,846 shares authorized, no shares issued or outstanding
as of December 31, 2020 |
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value, 250,000,000 shares authorized,
35,317,313 shares issued and outstanding as of September 30, 2021;
4,537,321 shares issued and outstanding as of December 31,
2020 |
|
4 |
|
|
|
0 |
|
Additional paid-in capital |
|
396,059 |
|
|
|
192,062 |
|
Accumulated deficit |
|
(264,326 |
) |
|
|
(258,474 |
) |
Total stockholders' equity (deficit) |
|
131,737 |
|
|
|
(66,412 |
) |
Total liabilities and
stockholders' equity (deficit) |
$ |
137,186 |
|
|
$ |
11,209 |
|
KemPharm (NASDAQ:KMPH)
Historical Stock Chart
From Mar 2024 to Apr 2024
KemPharm (NASDAQ:KMPH)
Historical Stock Chart
From Apr 2023 to Apr 2024