SAN FRANCISCO, May 11, 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 first quarter ended
March 31, 2021 and provided updates
on its programs. For the first quarter 2021, KindredBio reported
net revenues of $2.4 million and a
net loss of $9.7 million, or
$0.24 per share.
"We had a strong start to the year, announcing positive results
in a new long-acting interleukin-31 antibody program that has the
potential to become a best-in-class therapeutic, alongside the
acceptance of efficacy data for our parvovirus monoclonal antibody
program. With cash runway now through the end of 2023, we are
well-positioned to realize the value of our promising late-stage
pipeline," said KindredBio's Chief Executive Officer, Richard Chin, M.D.
Development and Corporate Updates
Biologics Candidates
- On April 20, 2021, KindredBio
unveiled positive results in a new long-acting interleukin
(IL)-31 antibody program (KIND-039) that integrates the Company's
novel half-life extension technology. Results from the
pharmacokinetic study of the molecule demonstrated that the fully
caninized, high-affinity antibody has up to a three-fold longer
half-life compared to tirnovetmab. This extended half-life is
expected to allow for up to three-fold longer interval between
dosing.
KindredBio's half-life extension technology is intended to
reduce dosing frequency, lower doses, and/or reduce cost of goods
sold, while increasing pet owner convenience and compliance.
- On December 22, 2020, KindredBio
initiated the pivotal efficacy study for tirnovetmab
(KIND-016), a fully caninized, high-affinity monoclonal antibody
targeting 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 is close to $1 billion annually and growing.
- On April 28, 2021 KindredBio
announced acceptance of the parvovirus antibody prophylaxis
study data and approval of the efficacy indication by the United
States Department of Agriculture (USDA) Center for Veterinary
Biologics. The USDA approved the claim that KIND-030 is effective
for the passive immunization of healthy dogs 13 weeks of age or
older against canine parvovirus (CPV) disease. The pivotal efficacy
data demonstrated that 0% of the KIND-030 treated dogs developed
parvovirus infection while 100% of the placebo-control dogs
developed the disease, and also showed 100% survival rate in
KIND-030. KIND-030 is a monoclonal antibody targeting CPV, and is
partnered with Elanco Animal Health.
The program is being pursued for two indications in dogs:
prophylactic therapy to prevent clinical signs of canine parvovirus
infection and treatment of established parvovirus infection.
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 USDA Center for Veterinary Biologics.
- The KIND-032 program is proceeding as expected with
preparations underway for a pivotal study. 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 for
canine inflammatory bowel disease.
First Quarter 2021 Financial Results
For the quarter ended March 31,
2021, KindredBio reported a net loss of $9.7 million or $0.24 per share, as compared to a net loss of
$22.8 million or $0.58 per share, for the same period in 2020.
The Company recorded $227,000 in
net product revenues for ZimetaTM (dipyrone injection)
for the first quarter of 2021, versus $603,000 in net product revenues for Mirataz for
the same period in 2020. 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. Zimeta product revenue in the first quarter of 2021
relates to excess inventory sold to Dechra.
With the sale of Mirataz to Dechra Pharmaceuticals completed in
April 2020, KindredBio recorded
royalty revenue of $326,000 for the
quarter ended March 31, 2021. This
compares with royalty revenue of $122,000 in the fourth quarter of 2020. The
sequential increase reflects continued strong growth in US Mirataz
sales to veterinary customers, alongside the initial contribution
of European sales, which now span over 25 countries following the
EU launch on February 4, 2021. The
move-outs, or sales from distributors to veterinarians, were 60%
higher in the U.S. in March 2021
compared to April 2020 when Dechra
US assumed responsibility for commercialization of the
drug. In addition, the manufacture of Vaxart's oral vaccine
candidate for COVID-19 resulted in contract manufacturing revenue
of $1.8 million for the first quarter
period.
The cost of product revenue totaled $207,000 in the first quarter of 2021, compared
to $3.6 million in the same period in
2020. The cost of contract manufacturing revenue, which consisted
primarily of the cost of direct materials, direct labor and
overhead costs, was $383,000.
Research and development expenses for the quarter ended
March 31, 2021 were $6.3 million, compared to $8.9 million for the same period in 2020. The
$2.6 million decrease was primarily
due to lower costs across the board consistent with the Company's
decision to discontinue small molecule development in favor of
biologics programs. Stock based compensation expense for the first
quarter of 2021 was $0.4 million, as
compared to $0.6 million for the same
period in 2020.
Selling, general and administrative expenses for the 2021 and
2020 first quarters were $4.7 million
and $8.9 million, respectively. The
$4.2 million year-over-year decrease
was mainly the result of the elimination of KindredBio's companion
animal sales force. Stock based compensation expense was
$2.1 million for the 2021 first
quarter, versus $1.5 million in the
year-ago period.
As of March 31, 2021, KindredBio
had $63.3 million in cash, cash
equivalents and investments, compared with $59.9 million as of December 31, 2020. Net cash used in operating
activities for the first quarter of 2021 was approximately
$9.4 million, reflecting a smaller
organizational structure and to a lesser degree the contribution of
contract manufacturing revenue. The Company invested approximately
$260,000 in capital expenditures
mainly for the Kansas facility.
Cash used was offset by $13.7 million
of net cash proceeds from the sale of securities in conjunction
with an At Market Issuance Sales Agreement. In April 2021, the Company sold an additional
$13.1 million (net) of
securities through the ATM, which will be reflected in the second
quarter financial results. KindredBio does not expect to use the
remaining portion of the At Market Issuance Sales Agreement in the
foreseeable future.
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 $2.9 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 the end of 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 7573679. 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
Condensed
Consolidated Statements of Operations
|
(In thousands,
except per share amounts)
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
|
|
March 31,
|
|
|
|
2021
|
|
2020
|
Revenues
|
|
|
|
|
Net product
revenues
|
$
227
|
|
$
603
|
|
Royalty
revenue
|
326
|
|
-
|
|
Contract
manufacturing
|
1,842
|
|
-
|
|
|
Total
revenues
|
2,395
|
|
603
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
Cost of product
revenues
|
207
|
|
3,577
|
|
Contract
manufacturing costs
|
383
|
|
-
|
|
Research and
development
|
6,287
|
|
8,867
|
|
Selling, general and
administrative
|
4,684
|
|
8,873
|
|
Restructuring
costs
|
-
|
|
1,676
|
|
|
Total operating costs
and expenses
|
11,561
|
|
22,993
|
|
|
|
|
|
|
Loss from
operations
|
(9,166)
|
|
(22,390)
|
|
|
|
|
|
|
Interest and other
income, net
|
(574)
|
|
(371)
|
Net loss
|
$
(9,740)
|
|
$
(22,761)
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
$
(0.24)
|
|
$
(0.58)
|
|
|
|
|
|
|
Weighted average
shares used to calculate basic
|
|
|
|
|
and diluted net loss
per share
|
41,089
|
|
39,186
|
Selected Balance
Sheet Data
|
(In
thousands)
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
December
31,
|
|
|
|
2021
|
|
2020
|
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
Cash, cash
equivalents and investments
|
$
63,309
|
|
$
59,878
|
|
|
|
|
|
|
Total
assets
|
109,979
|
|
95,814
|
|
|
|
|
|
|
Stockholders'
equity
|
83,785
|
|
67,482
|
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SOURCE Kindred Biosciences, Inc.