-- Multiple Clinical Data Readouts Expected
Throughout 2017 --
Kadmon Holdings, Inc. (NYSE:KDMN) (“Kadmon” or the “Company”)
today provided an update on upcoming milestones and recent
achievements, and reported financial and operational results for
the fourth quarter and full year ended December 31, 2016.
“Kadmon continues to advance our robust clinical pipeline
programs, setting the stage for multiple near-term inflection
points,” said Harlan W. Waksal, M.D., President and Chief Executive
Officer at Kadmon. “In 2017, we expect to report data from our
three ongoing Phase 2 clinical studies of KD025, our selective
ROCK2 inhibitor, in autoimmune and fibrotic diseases, as well as
initiate three new clinical trials of tesevatinib in oncology and
in polycystic kidney disease (PKD). We look forward to executing on
these upcoming milestones.”
2017 Anticipated Key Milestones:
KD025
The Company expects to report data from three ongoing Phase 2
clinical trials as follows:
- Randomized, placebo-controlled clinical
trial in moderate to severe psoriasis – Q4 2017
- Randomized, open-label clinical trial
in idiopathic pulmonary fibrosis – no later than Q4 2017
- Open-label, dose-escalating clinical
trial in chronic graft-versus-host disease (cGVHD) – no later than
Q4 2017
Tesevatinib
- Initiate first-line, randomized,
controlled Phase 2 clinical trial in non-small cell lung cancer
(NSCLC) with activating epidermal growth factor receptor (EGFR)
mutations with brain metastases – Q2 2017
- Initiate dose-finding Phase 1 clinical
trial in autosomal recessive PKD (ARPKD) – Q2 2017
- Initiate randomized, double-blind,
placebo-controlled Phase 2 clinical trial in autosomal dominant PKD
(ADPKD) – mid-2017
KD034
- Submit second Abbreviated New Drug
Application (ANDA) to the U.S. Food and Drug Administration
(FDA) for generic trientine hydrochloride capsule formulation in
room-temperature stable packaging for the treatment of Wilson’s
disease – end of Q1 2017
Fourth Quarter 2016 and Recent Highlights
KD025
- Enrollment is on target in the
Company’s trial in moderate to severe psoriasis, with full
enrollment expected in mid-2017.
- Kadmon’s trial in idiopathic pulmonary
fibrosis continues to enroll rapidly. Assuming the current rate of
enrollment continues, Kadmon expects enrollment will be complete by
mid-2017.
- Enrollment is ahead of schedule in the
Company’s cGVHD trial, which consists of three cohorts: KD025 200
mg QD, 200 mg BID and 400 mg QD, enrolled in a sequential,
dose-escalating manner. Enrollment in the 200 mg QD cohort is
complete and its safety assessment supports initiating enrollment
in the 200 mg BID cohort.
Tesevatinib
- In December 2016, Kadmon presented
encouraging data from its ongoing Phase 2 clinical trial of
tesevatinib, the Company’s blood-brain barrier penetrant oral
tyrosine kinase inhibitor, for the treatment of EGFR
mutation-positive NSCLC that has metastasized to the brain and/or
the leptomeninges (membranes lining the brain and spinal cord), in
which eleven of the first thirteen enrolled patients showed no CNS
disease progression. The data were presented at the International
Association for the Study of Lung Cancer 17th World Conference on
Lung Cancer.
- In November 2016, Kadmon presented data
from its ongoing Phase 2a clinical trial further demonstrating the
safety of tesevatinib for the treatment of ADPKD at the American
Society of Nephrology Kidney Week 2016.
- Kadmon continues to enroll patients in
its ongoing exploratory Phase 2 clinical trial in glioblastoma,
which initiated in August 2016.
KD034
- In December 2016, Kadmon submitted an
ANDA for KD034, the Company’s generic trientine hydrochloride
formulation, to the FDA for the treatment of Wilson’s disease,
a genetic liver disease.
Research
- In February 2017, Kadmon received an
additional $2.0 million milestone payment under its collaboration
and license agreement with Jinghua Pharmaceutical Co. to develop
KD035, the Company’s anti-VEGFR2 antibody, and KD036, its
anti-PD-L1 antibody. Kadmon continues to advance its preclinical
platforms in biologics and small molecules for unmet medical
needs.
Financial Results
Fourth Quarter 2016 Results
Loss from operations for the three months ended
December 31, 2016 was $20.5 million, compared to $25.4 million
for the same period in 2015.
Revenue was $4.3 million for the three months ended
December 31, 2016, compared to $7.9 million for the same
period in 2015.
Research and development expenses for the three months ended
December 31, 2016 were $8.7 million, compared
to $10.2 million for the same period in 2015.
Selling, general and administrative expenses were $15.3 million
for the three months ended December 31, 2016, compared
to $22.3 million for the same period in 2015.
Full Year 2016 Results
Loss from operations for the year ended December 31, 2016,
was $115.4 million, compared to $139.9 million for the same period
in 2015.
Revenue was $26.1 million for the year ended
December 31, 2016, compared to $35.7 million for the same
period in 2015. Sales from the Company’s ribavirin portfolio
continued to decline in 2016 as the treatment landscape for chronic
HCV infection has rapidly evolved, with multiple ribavirin-free
treatment regimens, including novel direct-acting antivirals,
having entered the market and becoming the new standard of care. As
a result, the Company expects sales of its ribavirin portfolio of
products to contribute insignificantly in 2017 and beyond.
Research and development expenses for the year ended
December 31, 2016, were $35.8 million, compared
to $33.6 million for the same period in 2015.
Selling, general and administrative expenses were $105.9 million
for the year ended December 31, 2016, compared
to $104.7 million for the same period in 2015. The
increase in selling, general and administrative expenses is
primarily related to an increase in shared-based compensation of
$36.9 million, of which $22.0 million is related to the LTIP, $3.6
million is related to the repricing of employee options, $9.3
million is related to an option grant to our Chief Executive
Officer, and $3.0 million is related to an increase in severance
expense primarily related to the separation agreement with Dr.
Samuel D. Waksal. These increases were partially offset by a
decrease in salary and salary-related expenses of $3.7 million
related to a reduction in headcount, legal expense of $17.6 million
related to legal settlements entered into during 2015, amortization
of intangible assets of $12.2 million due to a change to
proportional performance method of amortization starting October 1,
2015, royalty expense of $1.5 million and consulting fees of $3.0
million resulting from the expiration of an advisory agreement
entered into in April 2015.
Liquidity and Capital Resources
At December 31, 2016, Kadmon’s cash and cash equivalents
totaled $36.1 million compared to $21.5
million at December 31, 2015. Additionally, in March
2017, Kadmon completed a private placement equity financing
pursuant to which Kadmon received gross proceeds of approximately
$23 million from the issuance of 6,767,855 shares of Kadmon’s
common stock, at a price of $3.36 per share, and warrants to
purchase 2,707,138 million shares of Kadmon’s common stock at an
initial exercise price of $4.50 per share for a term of 13 months
from the date of issuance. If these warrants are exercised, the
Company would receive approximately $12.2 million.
About Kadmon Holdings, Inc.
Kadmon Holdings, Inc. is a fully integrated biopharmaceutical
company developing innovative products for significant unmet
medical needs. We have a diversified product pipeline in autoimmune
and fibrotic diseases, oncology and genetic diseases.
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended (the “Securities Act”), and Section 21E of the Securities
Exchange Act of 1934, as amended. All statements, other than
statements of historical fact, included or incorporated in this
press release, including statements regarding the Company's
strategy, future operations, collaborations, intellectual property,
cash resources, financial position, future revenues, projected
costs, prospects, clinical trials, plans, and objectives of
management, are forward-looking statements. The words “believes,”
“anticipates,” “estimates,” “plans,” “expects,” “intends,” “may,”
“could,” “should,” “potential,” “likely,” “projects,” “continue,”
“will,” and “would” and similar expressions are intended to
identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Kadmon
cannot guarantee that it will actually achieve the plans,
intentions or expectations disclosed in its forward-looking
statements and you should not place undue reliance on the Company’s
forward-looking statements. There are a number of important factors
that could cause Kadmon’s actual results to differ materially from
those indicated or implied by its 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) our expectations
regarding the period during which we qualify as an emerging growth
company under the JOBS Act; (xxii) statements regarding future
revenue, hiring plans, expenses, capital expenditures, capital
requirements and share performance; (xxiii) litigation, including
costs associated with prosecuting or defending pending or
threatened claims and any adverse outcomes or settlements, whether
or not covered by insurance; (xxiv) our expected use of proceeds
from our initial public offering, March 2017 private placement and
other sources of liquidity; (xxv) the future trading price of the
shares of our common stock and impact of securities analysts’
reports on these prices; and/or (xxvi) 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, without
limitation, the Company’s prospectus filed pursuant to Rule 424(b)
under the Securities Act with the SEC on July 27, 2016 and the
Company’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2016. 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 (in thousands, except per share data)
Three Months Ended December 31, Year Ended December
31, 2016 2015 2016 2015 Revenues
Net sales $ 3,010 $ 5,723 $ 18,514 $ 29,299 License and other
revenue 1,267 2,215 7,541
6,420 Total revenue 4,277 7,938 26,055 35,719 Cost of
sales 640 589 3,485 3,731 Write-down of inventory 119
205 385 2,274 Gross
profit 3,518 7,144 22,185
29,714 Operating expenses: Research and development
8,706 10,214 35,840 33,558 Selling, general and administrative
15,299 22,321 105,880 104,740 Impairment of intangible asset — — —
31,269 Gain on settlement of payable — —
(4,131 ) — Total operating expenses
24,005 32,535 137,589
169,567 Loss from operations (20,487 )
(25,391 ) (115,404 ) (139,853 ) Total other expense
(income) 1,716 9,082 93,009 7,232 Income tax expense 27
(3 ) 342 (3 ) Net loss $ (22,230
) $ (34,470 ) $ (208,755 ) $ (147,082 ) Deemed dividend on
convertible preferred stock 469 —
21,733 — Net loss attributable to
common stockholders $ (22,699 ) $ (34,470 ) $ (230,488 ) $ (147,082
)
Basic and diluted net loss per share
ofcommon stock
$ (0.50 ) $ (4.15 ) $ (9.74 ) $ (18.10 )
Weighted average basic and diluted
sharesof common stock outstanding
45,078,666 8,298,750 23,674,512
8,127,781
Kadmon Holdings, Inc. Condensed Consolidated
Balance Sheets (in thousands) December 31,
2016 2015 Cash and cash equivalents $ 36,093 $
21,498 Other current assets 4,194 11,243 Other noncurrent assets
22,269 51,396 Total assets $ 62,556
$ 84,137 Current liabilities 24,746 49,686
Other long term liabilities 34,325 36,783 Secured term debt – net
of current portion and discount 28,677 26,264 Convertible debt, net
of discount — 183,457 Total liabilities
87,748 296,190 Series E redeemable
convertible units — 58,856 Total stockholders’ deficit
(25,192 ) (270,909 ) Total liabilities, redeemable
convertible units, and stockholders’ deficit $ 62,556 $
84,137
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version on businesswire.com: http://www.businesswire.com/news/home/20170322006216/en/
Kadmon Holdings, Inc.Ellen Tremaine, 646-490-2989Investor
Relationsellen.tremaine@kadmon.comorMaeve Conneighton,
212-600-1902maeve@argotpartners.com
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