KemPharm, Inc. (NasdaqGS: KMPH) (KemPharm, or the Company), a
specialty pharmaceutical company focused on the discovery,
development and commercialization of novel treatments for rare
central nervous system (CNS) and neurodegenerative diseases, today
reported its financial results for the first quarter ended March
31, 2022.
“KemPharm continued to make significant progress
during the first quarter of 2022 and recent weeks, in particular
taking several important steps to further the clinical development
of our SDX-based drug candidates led by KP1077,” stated Travis
Mickle, Ph.D., President and Chief Executive Officer of KemPharm.
“In keeping with our strategic focus on developing and
commercializing therapeutics for rare CNS and neurodegenerative
conditions, we filed an IND with the FDA seeking permission to
commence a clinical program to evaluate KP1077 for IH, a rare sleep
disorder with limited treatment options. Upon clearance of the IND,
we plan to initiate a Phase 2 clinical trial of KP1077 for IH
(KP1077.D01) as early as the second half of 2022, with a second
trial in narcolepsy targeted to begin the quarter following the
start of KP1077.D01.”
Dr. Mickle continued, “We believe there is great
potential for KP1077 and other SDX-based treatments in IH and the
broader rare sleep disorder market. Stimulant-based
drugs currently in use come with significant limitations, including
cardiovascular side effects, such as elevated blood pressure which
results in many of these treatments being contraindicated for many
IH patients. Understanding this, we initiated a Phase 1 trial last
month comparing the cardiovascular safety of SDX to
immediate-release and long-acting formulations of Ritalin, a
commonly prescribed CNS stimulant. We believe that demonstrating an
improved cardiovascular safety profile compared to current
stimulants is a key potential differentiator for KP1077. This
benefit could allow SDX to be dosed at higher levels than current
treatments which should provide improved efficacy when compared to
other off-label stimulant-based medications.”
Dr. Mickle continued, “We are also excited by
the growing momentum behind the national commercialization of
AZSTARYS® by Corium. Payor access continues to expand with 110
million commercial lives now covered and prescription volumes
continue to grow as well. More than 2,600 pharmacies have dispensed
AZSTARYS, and it is listed on formularies by two of the three
largest PBMs in the U.S. We look forward to watching the progress
of AZSTARYS as our partners at Corium continue the U.S.
launch.”
Dr. Mickle concluded, “On the business
development front, we continue to pursue our goal of acquiring or
licensing complimentary clinical-stage assets in rare CNS and
neurodegenerative diseases where we can leverage our existing
clinical development and regulatory expertise. Internally, we are
advancing several early-stage candidates and hope to announce a
potential addition to our development pipeline as soon as this
quarter. Supporting our strategic and pipeline development efforts
is a strong financial foundation, bolstered by $119.1 million in
cash, cash equivalents, marketable securities and long-term
investments as of March 31, 2022.”
Q1 2022 Financial Results:
KemPharm’s revenue for Q1 2022 was $4.0 million,
as compared to Q1 2021 revenue of $12.1 million.
Research and development expenses were $3.1
million for Q1 2022, as compared to $2.3 million in Q1 2021, driven
primarily by the initiation of the KP1077 clinical development
program.
General and administrative expenses were $2.7
million for Q1 2022, as compared to $1.9 million in Q1 2021. The
period-over-period increase was primarily driven by increased
compensation costs, including non-cash stock-based compensation,
and an increase in professional fees associated with commercial and
strategic planning.
Net loss attributable to common stockholders for
Q1 2022 was ($1.9) million, or ($0.05) per basic and diluted share,
compared to a net loss attributable to common stockholders of
($47.7) million, or ($2.49) per basic and diluted share for the
same period in 2021. Net loss for Q1 2022 was driven
primarily by a loss from operations of ($1.9) million and net
interest and other loss of ($0.2) million, partially offset by
non-cash fair value adjustment income related to derivative and
warrant liability of $0.2 million.
As of March 31, 2022, total cash, cash
equivalents, marketable securities and long-term investments was
$119.1 million, which was a decrease of $8.7 million compared to
$127.8 million as of December 31, 2021, driven in part by $4.7
million of repurchases of common stock during the period and
increased spending on third-party research and development costs
related to the KP1077 clinical trial program. Based on
the Company’s current operating forecast, existing cash, cash
equivalents, marketable securities and long-term investments are
expected to be sufficient to continue operations through and beyond
2025.
Conference Call
Information:
KemPharm will host a conference call and live
audio webcast with a slide presentation today at 5:00 p.m. ET, to
discuss its corporate and financial results for the first quarter
of 2022.
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/1133056. |
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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. |
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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. |
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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 6:00 p.m. ET, on Wednesday, May 12, 2022. |
About KemPharm:
KemPharm is a specialty pharmaceutical company
focused on the discovery and development of novel treatments for
rare central nervous system (CNS) diseases through its proprietary
LAT® (Ligand Activated Therapy) platform technology. KemPharm
utilizes its proprietary LAT® platform 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
idiopathic hypersomnia (IH) and other CNS/rare diseases. In
addition, the U.S. Food and Drug Administration (FDA) has approved
AZSTARYS®, a once-daily treatment for ADHD in patients age six
years and older containing KemPharm’s prodrug,
serdexmethylphenidate (SDX), which is being commercialized by
Corium, Inc. in the U.S., and APADAZ®, an immediate-release
combination product containing benzhydrocodone, KemPharm’s prodrug
of hydrocodone, and acetaminophen, which is being commercialized by
KVK-Tech, Inc. in the U.S. 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 within the meaning of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements include all
statements that do not relate solely to historical or current
facts, including without limitation and which can be identified by
the use of words such as “may,” “will,” “expect,” “project,”
“estimate,” “anticipate,” “plan,” “believe,” “potential,” “should,”
“continue,” “could,” “intend,” “target,” “predict,” or the negative
versions of those words or other comparable words or expressions,
although not all forward-looking statements contain these
identifying words or expressions. Forward-looking statements are
not guarantees of future actions or performance. These
forward-looking statements include statements regarding the promise
and potential impact of our preclinical or clinical trial data,
including without limitation the timing and results of any clinical
trials or readouts, the timing or results of any IND applications,
the potential uses or benefits of KP1077, SDX or any other product
candidates for any specific disease indication or at any dosage,
the potential benefits of any of KemPharm’s product candidates, the
success or timing of the launch or commercialization of AZSTARYS or
any other products or related sales milestones, the sufficiency of
cash to fund operations, our plans or ability to seek funding, our
plans with respect to our share repurchase program, and our
strategic and product development objectives. 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 known and unknown uncertainties, risks and other important
factors that may cause our actual results, performance or
achievements to be materially different from any future results,
performance or achievements expressed or implied by the
forward-looking statements. These and other important factors are
described in detail in the “Risk Factors” section of KemPharm’s
Annual Report on Form 10-K for the year ended December 31, 2021, as
updated by the Quarterly Report on Form 10-Q for the three months
ended March 31, 2022, and KemPharm’s other filings with the
Securities and Exchange Commission.
While we may elect to update such
forward-looking statements at some point in the future, except as
required by law, we disclaim any obligation to do so, even if
subsequent events cause our views to change. Although we believe
the expectations reflected in such forward-looking statements are
reasonable, we can give no assurance that such expectations will
prove to be correct. These forward-looking statements should not be
relied upon as representing our views as of any date subsequent to
the date of this press release.
This press release also may contain estimates
and other statistical data made by independent parties and by us
relating to market size and other data about our industry. This
data involves a number of assumptions and limitations, and you are
cautioned not to give undue weight to such estimates. In addition,
projections, assumptions and estimates of our future performance
and the future performance of the markets in which we operate are
necessarily subject to a high degree of uncertainty and risk.
KemPharm Contacts:
Tiberend Strategic Advisors, Inc.Jason
Rando/Daniel Kontoh-Boateng
jrando@tiberend.comdboateng@tiberend.com
KEMPHARM, INC.
UNAUDITED CONDENSED STATEMENTS OF
OPERATIONS
(in thousands, except share and per share
amounts)
|
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Three months ended March 31, |
|
|
|
2022 |
|
|
2021 |
|
Revenue |
|
$ |
3,965 |
|
|
$ |
12,117 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Royalty and direct contract acquisition costs |
|
|
8 |
|
|
|
1,000 |
|
Research and development |
|
|
3,082 |
|
|
|
2,265 |
|
General and administrative |
|
|
2,734 |
|
|
|
1,892 |
|
Total operating expenses |
|
|
5,824 |
|
|
|
5,157 |
|
(Loss) income from
operations |
|
|
(1,859 |
) |
|
|
6,960 |
|
Other (expense) income: |
|
|
|
|
|
|
|
|
Loss on extinguishment of debt |
|
|
— |
|
|
|
(16,885 |
) |
Interest expense related to amortization of debt issuance costs and
discount |
|
|
— |
|
|
|
(150 |
) |
Interest expense on principal |
|
|
(5 |
) |
|
|
(199 |
) |
Fair value adjustment related to derivative and warrant
liability |
|
|
241 |
|
|
|
(30 |
) |
Interest and other (expense) income, net |
|
|
(245 |
) |
|
|
8 |
|
Total other expenses |
|
|
(9 |
) |
|
|
(17,256 |
) |
Loss before income taxes |
|
|
(1,868 |
) |
|
|
(10,296 |
) |
Income tax benefit |
|
|
4 |
|
|
|
— |
|
Net loss |
|
$ |
(1,864 |
) |
|
$ |
(10,296 |
) |
Deemed dividend |
|
|
— |
|
|
|
(37,444 |
) |
Net loss attributable to
common stockholders |
|
$ |
(1,864 |
) |
|
$ |
(47,740 |
) |
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per
share of common stock: |
|
|
|
|
|
|
|
|
Net loss attributable to common stockholders |
|
$ |
(0.05 |
) |
|
$ |
(2.49 |
) |
|
|
|
|
|
|
|
|
|
Weighted average number of
shares of common stock outstanding: |
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
34,506,597 |
|
|
|
19,146,270 |
|
|
|
|
|
|
|
|
|
|
KEMPHARM, INC.
CONDENSED BALANCE SHEETS
(in thousands, except share and par value
amounts)
|
|
March 31, |
|
|
December 31, |
|
|
|
2022 |
|
|
2021 |
|
|
|
(unaudited) |
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
100,242 |
|
|
$ |
112,346 |
|
Marketable securities |
|
|
1,338 |
|
|
|
— |
|
Accounts and other receivables |
|
|
3,320 |
|
|
|
1,528 |
|
Prepaid expenses and other current assets |
|
|
880 |
|
|
|
1,182 |
|
Total current assets |
|
|
105,780 |
|
|
|
115,056 |
|
Property and equipment,
net |
|
|
835 |
|
|
|
884 |
|
Operating lease right-of-use
assets |
|
|
1,090 |
|
|
|
1,141 |
|
Long-term investments |
|
|
17,564 |
|
|
|
15,422 |
|
Other long-term assets |
|
|
437 |
|
|
|
438 |
|
Total assets |
|
$ |
125,706 |
|
|
$ |
132,941 |
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
2,582 |
|
|
$ |
3,038 |
|
Current portion of operating lease liabilities |
|
|
356 |
|
|
|
356 |
|
Other current liabilities |
|
|
7 |
|
|
|
836 |
|
Total current liabilities |
|
|
2,945 |
|
|
|
4,230 |
|
Derivative and warrant
liability |
|
|
89 |
|
|
|
330 |
|
Operating lease liabilities,
less current portion |
|
|
1,144 |
|
|
|
1,232 |
|
Other long-term
liabilities |
|
|
29 |
|
|
|
31 |
|
Total liabilities |
|
|
4,207 |
|
|
|
5,823 |
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Preferred stock: |
|
|
|
|
|
|
|
|
Undesignated preferred stock, $0.0001 par value, 10,000,000 shares
authorized, no shares issued or outstanding as of March 31, 2022
(unaudited) or December 31, 2021 |
|
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value, 250,000,000 shares authorized,
35,333,450 shares issued and 34,423,497 shares outstanding as of
March 31, 2022 (unaudited); 35,325,801 shares issued and 35,005,640
shares outstanding as of December 31, 2021 |
|
|
3 |
|
|
|
4 |
|
Additional paid-in capital |
|
|
397,925 |
|
|
|
396,957 |
|
Treasury stock, at cost |
|
|
(7,536 |
) |
|
|
(2,814 |
) |
Accumulated deficit |
|
|
(268,893 |
) |
|
|
(267,029 |
) |
Total stockholders' equity |
|
|
121,499 |
|
|
|
127,118 |
|
Total liabilities and
stockholders' equity |
|
$ |
125,706 |
|
|
$ |
132,941 |
|
|
|
|
|
|
|
|
|
|
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