SAN FRANCISCO, March 16, 2021 /PRNewswire/ -- Kindred
Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company
focused on saving and improving the lives of pets, today
announced financial results for the fourth quarter and full year
ended December 31, 2020 and provided
updates on its programs. For the fourth quarter of 2020, KindredBio
reported net revenues of $1.0 million
and a net loss of $10.9 million, or
$0.28 per share. For the full year
2020, net product revenues were $42.2
million and the net loss was $21.8
million, or $0.55 per
share.
"We had a strong finish to 2020, reporting positive results from
our pilot study for canine inflammatory bowel disease and
initiating the tirnovetmab (IL-31 antibody) pivotal study for
canine atopic dermatitis. Together with the recent award of a
manufacturing contract by the National Cancer Institute, this
positive momentum positions KindredBio strongly for the year ahead.
We look forward to a number of important developments across our
late-stage pipeline in 2021, including potential approval of our
monoclonal antibody for canine parvovirus, updates on the
tirnovetmab pivotal efficacy study, and pilot study results for our
IL-4R program for canine atopic dermatitis," said KindredBio's
Chief Executive Officer, Richard
Chin, M.D.
Development and Corporate Updates
Biologics Candidates
- On December 22, 2020, KindredBio
initiated the pivotal efficacy study for tirnovetmab
(KIND-016), a fully caninized, high-affinity monoclonal antibody
targeting interleukin (IL)-31 for the treatment of atopic
dermatitis in dogs.
Atopic dermatitis is the most common reason owners take their dog
to the veterinarian, and is estimated to affect 10 - 15% of dogs
worldwide. The current market size exceeds $900 million annually and is growing.
- In September 2020, KindredBio
reported positive results from its pivotal efficacy study of
KIND-030 for the prophylactic indication. KIND-030 is a monoclonal
antibody targeting canine parvovirus. Completion of the upcoming
pivotal efficacy study for the treatment indication is expected in
the second quarter of 2021, with possible approval anticipated by
year-end 2021. Approval of KIND-030 is subject to regulatory risk
and timelines, and there is no set review timeline at the United
States Department of Agriculture Center for Veterinary
Biologics.
KIND-030 is being pursued for two indications in dogs: prophylactic
therapy to prevent clinical signs of canine parvovirus
infection and treatment of established parvovirus infection.
On December 11, 2020, KindredBio
announced an agreement granting Elanco Animal Health
Incorporated exclusive global rights to KIND-030, with total
milestone payments exceeding $100
million.
- A second pilot study to further assess dosing for KIND-032, a
fully caninized monoclonal antibody targeting IL-4R for the
treatment of atopic dermatitis in dogs, commenced in the third
quarter of 2020. In December 2019,
KindredBio unveiled positive results from a randomized,
placebo-controlled laboratory pilot study of KIND-032.
- On December 21, 2020, KindredBio
announced positive results from the pilot field effectiveness
study of its monoclonal antibody against tumor necrosis factor
alpha (anti-TNFα antibody) for canine inflammatory bowel disease.
Complete remission, defined as ≥ 75% reduction in average post-dose
Canine Inflammatory Bowel Disease Activity Index (CIBDAI) score
from baseline, was achieved in 75% of the anti-TNFα group compared
to 17% in the placebo group. The treatment effect was early-onset
and durable. At Day 7, the first post-dose visit, 75% of the
anti-TNFα treated dogs showed ≥ 75% reduction of CIBDAI score from
baseline, compared to 17% in the placebo group. Furthermore, 50% of
the anti-TNFα treated dogs achieved and maintained 100% reduction
of CIBDAI score from baseline throughout all post-dose visits,
whereas none in the placebo group achieved the same result.
Mirataz
- Dechra has realized strong growth in US Mirataz sales since
their launch of the product in April
2020, achieving a near 50% increase in monthly sales to US
clinics. While fourth quarter sales of Mirataz to distributors were
lower quarter-over-quarter amid seasonal fluctuations in
distributor ordering pattern, sales of Mirataz from distributors to
veterinary clinics increased versus the third quarter. Dechra has
launched Mirataz in the UK and European Union and is planning
registration in several other territories. The sale of Mirataz to
Dechra comprised an upfront payment of $43
million and royalties on worldwide sales.
Contract Manufacturing
- On October 7, 2020, KindredBio
announced an expansion of the original agreement for the
manufacture of Vaxart's COVID-19 vaccine, among other vaccine
candidates. Total revenue from the partnership is expected to be
approximately $20.5 million.
Subsequent to quarter end, KindredBio was selected by the National
Cancer Institute, part of the National Institutes of Health, to
produce an experimental human papillomavirus (HPV) vaccine for
clinical testing under the PREVENT Cancer Preclinical Drug
Development Program (PREVENT) Indefinite Delivery Indefinite
Quantity (IDIQ) contract. KindredBio was previously
selected by the NCI as one of the three IDIQ contractors
eligible for task order awards under the PREVENT Program.
Fourth Quarter and Full Year 2020 Financial
Results
For the quarter ended December 31,
2020, KindredBio reported a net loss of $10.9 million, or $0.28 per share, compared to a net loss of
$15.7 million, or $0.40 per share, for the same period in 2019. For
the year ended December 31, 2020, the
net loss was $21.8 million, or
$0.55 per share, as compared to a net
loss of $61.4 million, or
$1.59 per share, in 2019.
The company recorded $1.0 million
of net product revenues for the fourth quarter of 2020, versus
$1.4 million in the year-ago period.
Full year 2020 net product revenues were $42.2 million, compared with $4.3 million for the year ended December 31, 2019. The year-over-year increase in
revenue was primarily due to $38.7
million from the sale of Mirataz to Dechra Pharmaceuticals,
which was completed in April 2020.
The company recorded royalty revenue of $122,000 in the fourth quarter and $535,000 for the year.
Substantially all of the $878,000
in product revenues for the year 2020 were for Mirataz. Product
revenues for ZimetaTM (dipyrone injection) were
$8,000 in the fourth quarter and
$27,000 for the year, reflecting
decreased equine events and transportation due to COVID-19. Dechra
has been granted exclusive marketing, sales & distribution
rights to Zimeta in the US and Canada in return for a royalty on sales and
milestone payment upon achievement
of a certain sales milestone. In conjunction with Mirataz
and Zimeta, the company also recorded $12,000 and $29,000
in revenue derived from the co-marketing of products for partners,
namely Butterfly Networks and Astaria Global, in 2020.
The company's agreement with Vaxart, Inc. for the manufacture of
Vaxart's oral vaccine candidate for COVID-19 resulted in contract
manufacturing revenue of $233,000 and
$1.6 million, based on the percentage
completion of specific milestones, for the three and twelve months
ended December 30, 2020,
respectively.
Elanco's non-refundable upfront payment of $500,000 for the parvovirus partnership was
recorded as partner licensing revenue.
The cost of product revenue totaled $336,000 in the fourth quarter and $3.9 million for the twelve-month period in 2020,
compared to $187,000 and $587,000 for the same periods in 2019. Cost of
product sales in 2020 included a $3.5
million inventory write-off on Mirataz due to the transition
to Dechra brand labelling. Cost of contract manufacturing revenues,
which consisted primarily of the cost of direct materials, direct
labor and overhead costs, were $45,000 and $681,000 for the three and twelve months ended
December 30, 2020.
Research and development expenses totaled $7.6 million for the fourth quarter ended
December 31, 2020 versus $7.1 million for the same period in 2019. For the
full year 2020, research and development expenses were $31.3 million, compared to $28.3 million in 2019. Stock-based compensation
expense related to research and development was $1.9 million, versus $1.8
million in 2019. The $3.0
million year-over-year increase in research and development
expenses was primarily due to the inclusion of expenses from the
Kansas facility as it began to
manufacture clinical trial material, partially offset by lower
costs consistent with the decision to discontinue small molecule
development in favor of biologics programs. Prior to 2020,
construction and commissioning expenditures associated with the
Kansas facility had been
categorized as general and administrative expenses.
Selling, general and administrative expenses totaled
$3.3 million for the fourth quarter
ended December 31, 2020, versus
$9.6 million for the same period in
2019. For the full year 2020, selling, general and administrative
expenses were $22.0 million, compared
to $37.9 million for 2019. The
$15.9 million year-over-year decrease
is the result of the re-categorization of Kansas plant expenditures as research and
development expenses, and lower payroll and related expenses as a
result of the elimination of KindredBio's companion animal sales
force. Stock based compensation expense was $5.7 million in 2020, versus $5.5 million in the prior year.
As of December 31, 2019,
KindredBio had $59.9 million in cash,
cash equivalents and investments, compared to $73.5 million at December
31, 2019. Net cash used in operating activities in 2020 was
approximately $9.9 million,
reflecting payment received for the Mirataz asset sale. The company
also invested approximately $3.6
million in capital expenditures for the purchase of lab and
manufacturing equipment for the Kansas facility.
With respect to spending in 2021, the Company remains focused on
advancing its core biologics programs. KindredBio anticipates
operating expenses to range between $41 to $43 million,
excluding the impact of stock-based compensation expense and the
impact of acquisitions, if any. KindredBio also plans to invest
approximately $3.0 million in capital
expenditures on lab and manufacturing equipment for its biologics
programs in 2021. KindredBio believes its existing cash, cash
equivalents and investments, remaining proceeds from the Mirataz
sale, revenue from contract manufacturing and revenues in the form
of royalties and partner licensing, will be sufficient to fund the
current operating plan through early 2023, excluding the drawdown
of $30 million from its debt
facility.
Webcast and Conference Call
KindredBio will host a conference call and webcast today
at 4:30 p.m. Eastern time/1:30 p.m.
Pacific time. Interested parties may access the call by
dialing toll-free (855) 433-0927 from the U.S. or (484) 756-4262
internationally, and using conference ID 3989605. The call will be
webcast live here, with a replay available at that
link for 30 days.
About Kindred Biosciences
Kindred Biosciences is a biopharmaceutical company developing
innovative biologics focused on saving and improving the lives of
pets. Its mission is to bring to pets the same kinds of safe and
effective medicines that human family members enjoy. The Company's
strategy is to identify targets that have already demonstrated
safety and efficacy in humans and to develop therapeutics based on
these validated targets for dogs and cats. KindredBio has a deep
pipeline of novel biologics in development across many therapeutic
classes, alongside state-of-the-art biologics manufacturing
capabilities and a broad intellectual property portfolio.
For more information, visit: www.kindredbio.com
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the U.S. Private Securities Litigation Reform Act of
1995. All statements contained in this press release that do not
relate to matters of historical fact should be considered
forward-looking statements, including, but not limited to,
statements regarding our expectations about the trials, regulatory
approval, manufacturing, distribution and commercialization of our
current and future product candidates, and statements regarding our
anticipated revenues, expenses, margins, profits and use of
cash.
These forward-looking statements are based on our current
expectations. These statements are not promises or guarantees, but
involve known and unknown risks, uncertainties and other important
factors that may cause our actual results to be materially
different from any future results expressed or implied by the
forward-looking statements. These risks include, but are not
limited to, the following: our limited operating history and
expectations of losses for the foreseeable future; the absence of
significant revenue from our products and our product candidates
for the foreseeable future; the likelihood that our revenue will
vary from quarter to quarter; our potential inability to obtain any
necessary additional financing; our substantial dependence on the
success of our products and our lead product candidates which may
not be successfully commercialized even if they are approved for
marketing; the effect of competition; our potential inability to
obtain regulatory approval for our existing or future product
candidates; our dependence on third parties to conduct some of our
development activities; our dependence upon third-party
manufacturers for supplies related to our products and our
product candidates and the potential inability of these
manufacturers to deliver a sufficient amount of supplies on a
timely basis; the uncertain effect of the COVID-19 pandemic on our
business, results of operations and financial condition;
uncertainties regarding the outcomes of trials regarding our
product candidates; our potential failure to attract and retain
senior management and key scientific personnel; uncertainty about
our ability to enter into satisfactory agreements with third-party
licensees of our biologic products and uncertainty about the amount
of revenue that we will receive from such agreements; our
significant costs of operating as a public company; potential
cyber-attacks on our information technology systems or on our
third-party providers' information technology systems, which could
disrupt our operations; our potential inability to repay the
secured indebtedness that we have incurred from third-party
lenders, and the restrictions on our business activities that are
contained in our loan agreement with these lenders; the risk that
our 2020 strategic realignment and restructuring plans will result
in unanticipated costs or revenue shortfalls; uncertainty about the
amount of royalties that we will receive from the sale of Mirataz®
to Dechra Pharmaceuticals PLC; the risk that the revenue from our
delivery of services or products under any contract may be less
than we anticipate if the other party to the contract exercises its
right to terminate the contract prior to the completion of the
contract or if such party is unable or unwilling to satisfy its
payment obligations under the contract; our potential inability to
obtain and maintain patent protection and other intellectual
property protection for our products and our product candidates;
potential claims by third parties alleging our infringement of
their patents and other intellectual property rights; our potential
failure to comply with regulatory requirements, which are subject
to change on an ongoing basis; the potential volatility of our
stock price; and the significant control over our business by our
principal stockholders and management.
For a further description of these risks and other risks that we
face, please see the risk factors described in our filings with the
U.S. Securities and Exchange Commission (the SEC), including the
risk factors discussed under the caption "Risk Factors" in our
Annual Report on Form 10-K and any subsequent updates that may be
contained in our Quarterly Reports on Form 10-Q filed with the SEC.
As a result of the risks described above and in our filings with
the SEC, actual results may differ materially from those indicated
by the forward-looking statements made in this press release.
Forward-looking statements contained in this press release speak
only as of the date of this press release and we undertake no
obligation to update or revise these statements, except as may be
required by law.
The results stated in this press release have not been reviewed
by the Food and Drug Administration or the United States Department
of Agriculture Center for Veterinary Biologics, as applicable.
Contacts
For investor inquiries:
Katja Buhrer
Katja.buhrer@kindredbio.com
(917) 969-3438
Kindred
Biosciences, Inc.
|
Consolidated
Statements of Operations
|
(In thousands,
except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Years
Ended
|
|
|
|
December
31,
|
|
December
31,
|
|
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
|
|
(Unaudited)
|
|
|
|
|
Revenues
|
|
|
|
|
|
|
|
|
|
Net product
revenues
|
$
96
|
|
$
1,401
|
|
$
878
|
|
$
4,256
|
|
Revenue from asset
sale
|
-
|
|
-
|
|
38,700
|
|
-
|
|
Royalty
revenue
|
122
|
|
-
|
|
535
|
|
-
|
|
Contract
manufacturing
|
233
|
|
-
|
|
1,551
|
|
-
|
|
Partner licensing
revenue
|
500
|
|
-
|
|
500
|
|
-
|
|
Total revenues
|
951
|
|
1,401
|
|
42,164
|
|
4,256
|
|
|
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
|
|
|
Cost of product
revenue
|
336
|
|
187
|
|
3,945
|
|
587
|
|
Contract manufacuring
costs
|
45
|
|
-
|
|
681
|
|
-
|
|
Research and
development
|
7,629
|
|
7,134
|
|
31,281
|
|
28,310
|
|
Selling, general and
administrative
|
3,303
|
|
9,578
|
|
21,979
|
|
37,926
|
|
Restructuring
costs
|
-
|
|
-
|
|
4,246
|
|
-
|
Total operating costs
and expenses
|
11,313
|
|
16,899
|
|
62,132
|
|
66,823
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(10,362)
|
|
(15,498)
|
|
(19,968)
|
|
(62,567)
|
|
|
|
|
|
|
|
|
|
|
Interest and other
income, net
|
(536)
|
|
(236)
|
|
(1,828)
|
|
1,178
|
Net
loss
|
|
$
(10,898)
|
|
$
(15,734)
|
|
$
(21,796)
|
|
$
(61,389)
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
$
(0.28)
|
|
$
(0.40)
|
|
$
(0.55)
|
|
$
(1.59)
|
|
|
|
|
|
|
|
|
|
|
Shares used to
calculate basic and diluted net loss per common share
|
|
|
|
|
|
|
|
39,415
|
|
38,999
|
|
39,289
|
|
38,657
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selected
Consolidated Balance Sheet Data
|
|
|
|
|
(In
thousands)
|
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December
31,
|
|
|
|
|
|
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash
equivalents and investments
|
$
59,878
|
|
$
73,546
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
95,814
|
|
114,024
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity
|
67,482
|
|
81,921
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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SOURCE Kindred Biosciences, Inc.