Kadmon Holdings, Inc. (NYSE:KDMN) today provided a business
update and reported financial and operational results for the first
quarter of 2018.
“We have made significant progress this quarter in the
development of KD025 in cGVHD, highlighted by our alignment with
the FDA to commence a registrational trial in this indication,”
said Harlan W. Waksal, M.D., President and CEO at Kadmon. “We
continue to prioritize the development of KD025 in cGVHD and remain
on track to initiate this pivotal trial this year. In parallel, we
remain focused on the advancement of our ROCK inhibitor platform
for the treatment of fibrotic and inflammatory diseases.”
Clinical Update
KD025 – Anticipated 2018 Milestones
- Initiate open-label, pivotal Phase 2
clinical trial in chronic graft-versus-host disease (cGVHD)
- Present updated results from ongoing,
open-label, dose-finding Phase 2 clinical trial in cGVHD at
upcoming medical meetings
- Present additional data from ongoing,
randomized, open-label Phase 2 clinical trial in idiopathic
pulmonary fibrosis (IPF) at the American Thoracic Society (ATS)
International Conference in May 2018
- Initiate Phase 2 clinical trial in
scleroderma
Additional Clinical Updates
Enrollment continues in the Company’s ongoing Phase 2 clinical
trial of tesevatinib in autosomal dominant polycystic kidney
disease and ongoing Phase 1 clinical trial of tesevatinib in
autosomal recessive polycystic kidney disease. Kadmon is also
continuing dialogue with the FDA regarding its review and approval
of KD034, the Company’s generic trientine hydrochloride
formulation, for the treatment of Wilson’s disease.
Financial Results
First Quarter 2018 Results
Loss from operations for the three months ended March 31,
2018 was $17.9 million, compared to $13.9 million for the
respective period in 2017.
Revenue was $0.4 million for the three months ended
March 31, 2018, compared to $5.6 million for the respective
period in 2017. The Company does not rely on the revenue generated
from its commercial operations; however, the Company leverages its
commercial infrastructure to support the development of its
clinical-stage product candidates by providing quality assurance,
compliance, regulatory and pharmacovigilance capabilities, among
others.
Research and development expenses were $9.8 million for the
three months ended March 31, 2018, compared to $8.4 million
for the respective period in 2017. The increase in research and
development expenses is primarily related to development of the
Company’s most advanced product candidates, KD025 and
tesevatinib.
Selling, general and administrative (SG&A) expenses were
$8.3 million for the three months ended March 31, 2018,
compared to $10.1 million for the respective period in 2017.
The decrease in SG&A expenses is primarily related to a
decrease in share-based compensation of $1.6 million.
Liquidity and Capital Resources
As of March 31, 2018, Kadmon’s cash and cash equivalents
totaled $49.2 million, compared to $67.5
million as of December 31, 2017.
About Kadmon Holdings, Inc.
Kadmon Holdings, Inc. is a fully integrated biopharmaceutical
company developing innovative product candidates for significant
unmet medical needs. Our product pipeline is focused on
inflammatory and fibrotic diseases.
Forward Looking Statements
This press release contains forward-looking statements. Such
statements may be preceded by the words “may,” “will,” “should,”
“expects,” “plans,” “anticipates,” “could,” “intends,” “targets,”
“projects,” “contemplates,” “believes,” “estimates,” “predicts,”
“potential” or “continue” or the negative of these terms or other
similar expressions. Forward-looking statements involve known and
unknown risks, uncertainties 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. We believe that these factors include, but are not
limited to, (i) the initiation, timing, progress and results of our
preclinical studies and clinical trials, and our research and
development programs; (ii) our ability to advance product
candidates into, and successfully complete, clinical trials; (iii)
our reliance on the success of our product candidates; (iv) the
timing or likelihood of regulatory filings and approvals; (v) our
ability to expand our sales and marketing capabilities; (vi) the
commercialization of our product candidates, if approved; (vii) the
pricing and reimbursement of our product candidates, if approved;
(viii) the implementation of our business model, strategic plans
for our business, product candidates and technology; (ix) the scope
of protection we are able to establish and maintain for
intellectual property rights covering our product candidates and
technology; (x) our ability to operate our business without
infringing the intellectual property rights and proprietary
technology of third parties; (xi) costs associated with defending
intellectual property infringement, product liability and other
claims; (xii) regulatory developments in the United States, Europe
and other jurisdictions; (xiii) estimates of our expenses, future
revenues, capital requirements and our needs for additional
financing; (xiv) the potential benefits of strategic collaboration
agreements and our ability to enter into strategic arrangements;
(xv) our ability to maintain and establish collaborations or obtain
additional grant funding; (xvi) the rate and degree of market
acceptance of our product candidates; (xvii) developments relating
to our competitors and our industry, including competing therapies;
(xviii) our ability to effectively manage our anticipated growth;
(xix) our ability to attract and retain qualified employees and key
personnel; (xx) our ability to achieve cost savings and other
benefits from our efforts to streamline our operations and to not
harm our business with such efforts; (xxi) the use of proceeds from
our recent public offerings; (xxii) the potential benefits of any
of our product candidates being granted orphan drug designation;
(xxiii) the future trading price of the shares of our common stock
and impact of securities analysts’ reports on these prices; and/or
(xxiv) other risks and uncertainties. More detailed information
about Kadmon and the risk factors that may affect the realization
of forward-looking statements is set forth in the Company’s filings
with the U.S. Securities and Exchange Commission (the “SEC”),
including the Company’s Annual Report on Form 10-K for the fiscal
year ended December 31, 2017. Investors and security holders are
urged to read these documents free of charge on the SEC’s website
at www.sec.gov. The Company assumes no obligation to publicly
update or revise its forward-looking statements as a result of new
information, future events or otherwise.
Kadmon Holdings, Inc.
Consolidated Statements of Operations - Unaudited (in
thousands, except per share data) Three Months
Ended March 31, 2018 2017 Revenues Net
sales $ 274 $ 2,336 License and other revenue 159 3,230
Total revenue 433 5,566 Cost of sales 199 567 Write-down of
inventory 147 370 Gross profit 87 4,629
Operating expenses: Research and development 9,780 8,447 Selling,
general and administrative 8,250 10,118 Total
operating expenses 18,030 18,565 Loss from operations
(17,943) (13,936) Total other expense 2,498 3,315
Income tax expense — 316 Net loss $ (20,441) $
(17,567) Deemed dividend on convertible preferred stock 490
469 Net loss attributable to common stockholders $ (20,931)
$ (18,036) Basic and diluted net loss per share of common
stock $ (0.27) $ (0.39) Weighted average basic and diluted shares
of common stock outstanding 78,650,143 46,507,435
Kadmon Holdings, Inc.
Condensed Consolidated Balance Sheets - Unaudited (in
thousands) March 31, December 31,
2018 2017 Cash and cash equivalents $ 49,167 $
67,517 Other current assets 2,545 2,496 Other noncurrent assets
12,072 13,539 Total assets $ 63,784 $ 83,552
Current liabilities 50,443 56,644 Other long term liabilities
5,409 25,150 Total liabilities 55,852
81,794 Total stockholders’ equity 7,932 1,758 Total
liabilities and stockholders’ equity $ 63,784 $ 83,552
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Kadmon Holdings, Inc.Ellen Tremaine, 646-490-2989Investor
Relationsellen.tremaine@kadmon.com
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