ARATANATHERAPEUTICS,INC. (NASDAQ:PETX) Files An 8-K Entry into a Material Definitive Agreement
Item 1.01
Entry into a Material Definitive Agreement. |
Amendment to Agreement with Elanco
On April 28, 2017 (the Effective Date), Aratana Therapeutics,
Inc. (the Company, we, and our) and Eli Lilly and Company, on
behalf of its Elanco Animal Health division (Elanco), entered
into an amendment (the Amendment) to the Collaboration, License,
Development and Commercialization Agreement (the Collaboration
Agreement), dated April 22, 2016, which was filed with the
Securities and Exchange Commission as Exhibit 10.3 to the
Companys Form 10-Q on August 5, 2016. The Amendment modifies
certain provisions of the Supply Term Sheet attached as Exhibit
8.1.2(A) to the Collaboration Agreement.
Under the Amendment, Elanco has agreed to submit binding purchase
orders to the Company, within 15 days of the Effective Date of
the Amendment, for certain finished grapiprant products to be
produced from certain batches of active pharmaceutical ingredient
(API) the Company has agreed to purchase from its third-party
manufacturer (the API Batches). In addition, Elanco has agreed to
pay the Company for the API Batches within 30 days after the
Company provides Elanco with proof of payment to the manufacturer
for such API Batches.
The Amendment provides that, in the event Elanco provides notice
of its intent to assume responsibility for manufacturing to
Section 8.2.2 of the Collaboration Agreement, Elanco would assume
all responsibilities of the Company with respect to any
undelivered API, including paying the third-party manufacturer
for such undelivered API.
Placement Agency Agreement and Securities Purchase Agreement
On May 3, 2017, the Company entered into a Securities Purchase
Agreement (the Securities Purchase Agreement) with certain
investors for the sale by the Company of 5,000,000 shares of the
Companys common stock, par value $0.001 per share (the Shares),
at a purchase price of $5.25 per share (the Offering). The Shares
are being offered and sold to an effective registration statement
on Form S-3 (File No. 333-197414) and a related prospectus
supplement. Subject to certain closing conditions, the Offering
is expected to close on or around May 9, 2017.
The Company expects to receive net proceeds from the Offering of
approximately $24.4 million, after deducting placement agent fees
and estimated offering expenses. The Company intends to use the
net proceeds of the offering for general corporate purposes,
including commercialization activities relating to ENTYCE and
inventory related to GALLIPRANT.
In connection with the Offering, on May 3, 2017, the Company
entered into aPlacement Agency Agreement (the Placement Agency
Agreement) with Barclays Capital Inc. (Barclays), to which
Barclays agreed to serve as placement agent for the Offering. The
Company agreed to pay Barclays an aggregate fee equal to 6.0% of
the gross proceeds received by the Company from the Offering. The
Placement Agency Agreement contains, among other things,
customary representations, warranties and agreements by the
Company, customary conditions to closing, indemnification
obligations of the Company and Barclays, including for
liabilities under the Securities Act of 1933, as amended (the
Securities Act), other obligations of the parties and termination
provisions.
The Securities Purchase Agreement and Placement Agency Agreement
are filed as Exhibits 10.1 and 10.2, respectively, to this
Current Report on Form 8-K. The foregoing summaries of these
documents are qualified in their entirety by such exhibits, which
are incorporated herein by reference.
Latham Watkins LLP, counsel to the Company, has issued an opinion
to the Company, dated May4, 2017, relating to the legality of the
issuance and sale of the Shares. A copy of the opinion is filed
as Exhibit 5.1 to this Current Report on Form 8-K.
Item 1.02 |
Termination of a Material Definitive Agreement |
On April 28, 2017, the Company terminated its Sales Agreement,
dated October 16, 2015, with Barclays (the Sales Agreement), to
which the Company could from time to time sell up to an aggregate
of $52.0 million of shares of its common stock through Barclays
as sales agent (the ATM Program). Prior to termination, the
Company sold approximately $18.0 of the $52.0 million available
to be sold under the Sales Agreement. The Company terminated the
Sales Agreement because it does not intend to raise additional
capital through the ATM Program, and no additional shares of the
Companys common stock will be sold to the Sales Agreement. The
Company will not incur any termination penalties as a result of
its termination of the Sales Agreement.
The foregoing description of the Sales Agreement is not complete
and is qualified in its entirety by reference to the full text of
the Sales Agreement, a copy of which was filed as Exhibit 10.1 to
the Companys Current Report on Form 8-K filed with the Securities
and Exchange Commission on October 16, 2015 and incorporated
herein by reference.
Item 2.02 |
Results of Operation and Financial Condition. |
Preliminary First Quarter Financial Information
We are currently finalizing our financial results for the three
months ended March 31, 2017. While complete financial information
and operating data for this period are not yet available, based
on the information and data currently available, we preliminarily
estimate that for the three months ended March 31, 2017, our
total net revenues were approximately $3.8 million, our operating
(research and development and selling, general and
administrative) expenses were approximately $12.1 million and our
net loss was approximately $12.6 million or $0.34 diluted loss
per share. Of total revenues in the first quarter of 2017, we
believe that approximately $3.5 million was related to
GALLIPRANT, consisting of approximately $2.5 million in product
sales as finished goods under our supply arrangement with Elanco,
and approximately $903,000 in licensing and collaboration
revenue. We estimate that total revenues also included NOCITAnet
product sales of approximately $327,000 in the first quarter of
2017, which represents a sequential increase from approximately
$147,000 in the fourth quarter of 2016. We believe that the
growth in NOCITA product sales is primarily a result of continued
growth of new accounts and strong re-order rates, including
re-orders from the large majority of the top fifty customers in
the last month. We estimate that the remaining total revenues in
the first quarter of 2017 were related to net product sales of
BLONTRESS and TACTRESS.
As of March 31, 2017, we estimate that we had approximately $68.4
million in cash, cash equivalents, restricted cash and short-term
investments. We estimate that utilization of cash in the first
quarter included approximately $5.0 million of payments for
inventory purchases and a $3.0 million milestone payment for the
first product sale of GALLIPRANT.
During March and April 2017, we received net proceeds of
approximately $2.8 million from the sale of shares of common
stock under our ATM Program. As described in Item 1.02 of this
Current Report on Form 8-K, we terminated the ATM Program on
April 28, 2017.
Thepreliminary financial data above and elsewhere in this Current
Report on Form 8-K is preliminary and may change, and is based on
information available to management as of the date of this
Current Report on Form 8-K. It is subject to completion by
management of our financial statements as our financial closing
procedures for the quarter ended March 31, 2017 are not yet
complete. There can be no assurance that our final revenues,
expenses or cash position for this period will not differ from
these estimates, including completion of quarter-end closing and
review procedures that may result in adjustments that could be
material. The preliminary financial data has been prepared by,
and is the responsibility of, our
management.PricewaterhouseCoopers LLP has not audited, reviewed,
compiled, or performed any procedures with respect to the
preliminary financial data. Accordingly, PricewaterhouseCoopers
LLP does not express an opinion or any other form of assurance
with respect thereto and these estimates should not be viewed as
a substitute for full interim financial statements prepared in
accordance with accounting principles generally accepted in the
United States. Accordingly, you should not draw any conclusions
based on the foregoing estimates and should not place undue
reliance on these preliminary estimates. The preliminary results
of operations for the quarter ended March 31, 2017 are not
necessarily indicative of the results to be achieved for any
future period. Complete quarterly results will be announced
during our published first quarter financial results and included
in our Quarterly Report on Form 10-Q for the quarter ended March
31, 2017. We assume no duty to update these preliminary estimates
except as required by law.
Under our current operating plan, which contemplates the launch
of ENTYCE by the fall of 2017, we believe that our cash, cash
equivalents, restricted cash and short-term investments, together
with the net proceeds from the Offering, will be sufficient to
fund operations and debt obligations through 2018. Our current
operating plan also contemplates continued growth in sales of
GALLIPRANT, which we believe will result in the achievement of
certain milestones under the Collaboration Agreement described
below under the heading GALLIPRANTin Item 8.01 of this Current
Report on Form 8-K. However, our operating plan may change as a
result of many factors currently unknown to us, and we may seek
additional funds sooner than planned, through public or private
equity or debt financings or other sources, such as strategic
collaborations. Such financing may result in dilution to
stockholders, imposition of debt covenants and repayment
obligations, or other restrictions that may affect our business.
In addition, we may seek additional capital due to favorable
market conditions or strategic considerations even if we believe
we have sufficient funds for our current or future operating
plans.Our forecast of the period of
time through which our financial resources will be adequate to
support our operations is a forward-looking statement and
involves risks and uncertainties, and actual results could vary
as a result of a number of factors, including the factors
discussed in the section of our Annual Report on Form 10-K titled
Risk Factors.
Our future capital requirements depend on many factors,
including, but not limited to:
the results of our target animal studies for our current |
the amount and timing of any milestone payments or |
the timing of, and the costs involved in, obtaining |
the upfront and other payments, and associated costs, |
the number and characteristics of the therapeutic |
the scope, progress, results and costs of researching and |
whether we acquire any other companies, assets, |
our ability to partner with companies with an established |
the cost of commercialization activities, if any of our |
cost of manufacturing our current and future therapeutic |
our ability to establish and maintain strategic |
whether we are required to repay amounts that we received |
whether we are able to service our debt and satisfy debt |
the expenses needed to attract and retain skilled |
the costs associated with being a public company; |
the costs associated with any securities class action |
the costs involved in preparing, filing, prosecuting, |
For the full year 2017, we estimate operating expenses of
approximately $45 million, which includes approximately $10
million of non-cash expenses. These non-cash expenses are
expected to be further off-set by contractual milestones and
working capital expenditures, net of modest positive gross
margins, totaling approximately $10 million, which we believe
will result in approximately $45 million of cash used in
operations and investing activities during 2017.
The information in Item 2.02 of this Current Report on Form 8-K
shall not be deemed filed for purposes of Section 18 of the
Securities Exchange Act of 1934, as amended (the Exchange Act),
or otherwise subject to the liabilities of that section, nor
shall it be deemed incorporated by reference in any filing under
the Securities Act or the Exchange Act, except as expressly set
forth by specific reference in such a filing.
Item 8.01 Other Events
Recent Developments
GALLIPRANT
We continue to supply GALLIPRANT to Elanco at a modest
manufacturing margin under the Collaboration Agreement. During
the first quarter of 2017, we estimate that we made additional
GALLIPRANT API manufacturing commitments of $15.3 million, which
we believe will supply API throughout 2017 and into 2018.
GALLIPRANT API is manufactured by our contract manufacturers into
finished goods as 20 mg, 60 mg, and 100 mg tablets in a variety
of packaging configurations. Given the initial strong demand for
GALLIPRANT and the continued need for process improvements to
resolve isolated reports of 100 mg tablets breaking in the
bottle, we are currently focused on supplying the 20 mg and 60 mg
tablets. We believe these two tablet sizes address the dosing
needs of the large majority of dogs, and that the minority of
dogs above 75 pounds who would typically receive the 100 mg
tablet could potentially use a mix of smaller tablets to achieve
the labeled dose. We anticipate being able to supply all SKUs in
the second half of 2017.
We intend to complete transfer of manufacturing of GALLIPRANT to
Elanco before the end of 2018, which under certain circumstances
would allow us to achieve a $4.0 million milestone payment. We
are eligible to achieve an additional $4.0 million milestone
payment if GALLIPRANT is approved for pain and inflammation for
dogs in the EU, which we believe could happen as early as the
second half of 2017. When and if GALLIPRANT achieves certain
levels of net sales, we would be eligible to earn up to $75.0
million in commercial milestones; the first of these milestones
would be a $15.0 million payment which we believe we could
achieve as early as 2018.
We have also entered into the Amendment with Elanco as described
under Item 1.01 of this Current Report on Form 8-K.
ENTYCE
With respect to ENTYCE (capromorelin oral solution), we announced
that we recently met with the U.S. Food and Drug Administration
Center for Veterinary Medicine (CVM) regarding the proposed
manufacturing transfer. We believe that we have an agreement with
the CVM on how to proceed. We intend to resubmit the required
prior approval submission in the coming weeks. If the submission
is approved, we believe we would be able to make ENTYCE
commercially available by the fall of 2017.
Other Therapeutics in Development
With respect to other therapeutics in development, we have
completed the pivotal target safety study for AT-003 in cats and
we expect results from our pivotal field effectiveness study by
mid-2017. Our pivotal field effectiveness study and pivotal
target animal safety study of AT-002 in cats continue. Our
development collaborator, VetStem, continues the pivotal field
effectiveness study of AT-016 for dogs and has initiated the
pivotal target animal safety study; results from both studies are
anticipated in 2017. We continue to anticipate USDA conditional
licensure for AT-014 in the second half of 2017.
Item9.01 |
Financial Statements and Exhibits. |
(d) |
Exhibits. |
Exhibit No. |
Description |
|
10.1 |
Securities Purchase Agreement, dated May 3, 2017, by and |
|
10.2 |
Placement Agency Agreement, dated May 3, 2017, by and |
|
5.1 |
Opinion of Latham Watkins LLP. |
|
23.1 |
Consent of Latham Watkins LLP (included in Exhibit 5.1). |
Forward-Looking Statements
This report contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
All statements contained in this report that do not relate to
matters of historical fact should be considered forward-looking
statements, including, without limitation, statements with
respect to:the Offering and the anticipated closing of the
Offering; the expected net proceeds from the Offering; the
intended use of proceeds from the Offering;our estimated revenue
and expenses for the three months ended March 31, 2017, including
the sources of our revenue; our estimated cash, cash equivalents,
restricted cash and short-term investments and cash utilization
for the same period; our forecast of the period of time through
which our financial resources will be adequate to support our
operations; the amount of GALLIPRANT manufacturing commitments
and the time period through which those commitments will be
sufficient to provide GALLIPRANT API; the sufficiency of 20 mg
and 60 mg tablets of GALLIPRANT to treat dogs that were treated
with the 100 mg tablet; our ability to supply all SKUs of
GALLIPRANT; the timing of the manufacturing transfer to Elanco;
the timing and amount of milestone payments under the
Collaboration Agreement, as amended; our understanding of CVMs
requirements for ENTYCE and expected timing for resubmission of
the prior approval submission; expectations regarding when ENTYCE
will be commercially available; timing of results for studies of
AT-003, AT-002, and AT-016; timing for the USDA conditional
licensure for AT-014; and our estimated operating expenses,
non-cash expenses, contractual milestones and working capital
expenditures, gross margins, cash used in operations and
investing activities.
These forward-looking statements are based on management’s
current expectations. These statements are neither promises nor
guarantees, but 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, including, but not limited to,
the following: our history of operating losses and our
expectation that we will continue to incur losses for the
foreseeable future; failure to obtain sufficient capital to fund
our operations; risks relating to the impairment of intangible
assets, including BLONTRESS, TACTRESS, AT-007 and AT-011; risks
pertaining to stockholder class action lawsuits; unstable market
and economic conditions; restrictions on our financial
flexibility due to the terms of our credit facility; our
substantial dependence upon the commercial success of our
therapeutics; development of our biologic therapeutic candidates
is dependent upon relatively novel technologies and uncertain
regulatory pathways, and biologics may not be commercially
viable; denial or delay of regulatory approval for our existing
or future therapeutic candidates; failure of our therapeutic
candidates that receive regulatory approval to obtain market
approval or achieve commercial success; product liability
lawsuits that could cause us to incur substantial liabilities and
limit commercialization of current and future therapeutics;
failure to realize anticipated benefits of our acquisitions and
difficulties associated with integrating the acquired businesses;
development of pet therapeutics is a lengthy and expensive
process with an uncertain outcome; competition in the pet
therapeutics market, including from generic alternatives to our
therapeutic candidates, and failure to compete effectively;
failure to identify, license or acquire, develop and
commercialize additional therapeutic candidates; failure to
attract and retain senior management and key scientific
personnel; our reliance on third-party manufacturers, suppliers
and partners; regulatory restrictions on the marketing of our
therapeutic candidates; our small commercial sales organization,
and any failure to create a sales force or collaborate with
third-parties to commercialize our therapeutic candidates;
difficulties in managing the growth of our company; significant
costs of being a public company; risks related to the restatement
of our financial statements for the year ended December 31, 2013,
and the identification of a material weakness in our internal
control over financial reporting; changes in distribution
channels for pet therapeutics; consolidation of our veterinarian
customers; limitations on our ability to use our net operating
loss carryforwards; impacts of generic products; safety or
efficacy concerns with respect to our therapeutic candidates;
effects of system failures or security breaches; delay or
termination of the development of grapiprant therapeutic
candidates and commercialization of grapiprant products that may
arise from termination of or failure to perform under the
collaboration agreement and/or the co-promotion agreement with
Elanco; failure to obtain ownership of issued patents covering
our therapeutic candidates or failure to prosecute or enforce
licensed patents; failure to comply with our obligations under
our license agreements; effects of patent or other intellectual
property lawsuits; failure to protect our intellectual property;
changing patent laws and regulations; non-compliance with any
legal or regulatory requirements; litigation resulting from the
misuse of our confidential information; the uncertainty of the
regulatory approval process and the costs associated with
government regulation of our therapeutic candidates; failure to
obtain regulatory approvals in foreign jurisdictions; effects of
legislative or regulatory reform with respect to pet
therapeutics; the volatility of the price of our common stock;
our status as an emerging growth company, which could make our
common stock less attractive to investors; dilution of our common
stock as a result of future financings; the influence of certain
significant stockholders over our business; and provisions in our
charter documents and under Delaware law could delay or prevent a
change in control. These and other important factors discussed
under the caption Risk Factors in the Company’s Annual Report on
Form 10-K filed with the Securities and Exchange Commission, or
SEC, on March 14, 2017, along with our other reports filed with
the SEC could cause actual results to differ materially from
those indicated by the forward-looking statements made in this
report. Any such forward-looking statements represent
management’s estimates as of the date of this report. While we
may elect to update such forward-looking statements at some point
in the future, we disclaim any obligation to do so, even if
subsequent events cause our views to change, except as required
under applicable law. These forward-looking statements should not
be relied upon as representing our views as of any date
subsequent to the date of this report.
About ARATANA THERAPEUTICS, INC. (NASDAQ:PETX)
Aratana Therapeutics, Inc. is a pet therapeutics company focused on licensing, developing and commercializing of biopharmaceutical products for companion animals. The Company’s portfolio includes therapeutic candidates in development consisting of small molecule pharmaceuticals and large molecule biologics that target medical conditions in pets. Its lead product candidates in development include small molecules directed at treating osteoarthritis pain and inflammation (AT-001 for dogs, also known as grapiprant for dogs or GALLIPRANT), appetite stimulation (AT-002 for dogs, also known as capromorelin for dogs or ENTYCE) and post-operative pain (AT-003 for dogs, also known as bupivacaine liposome injectable suspension for dogs or NOCITA). AT-001 is a selective antagonist of the prostaglandin E2 (PGE 2) EP4 receptor (EP4 prostaglandin receptor antagonist or EP4 PRA). AT-002 is a potent and selective ghrelin agonist. Its product candidates also include AT-014, AT-016 and AT-018 for dogs. ARATANA THERAPEUTICS, INC. (NASDAQ:PETX) Recent Trading Information
ARATANA THERAPEUTICS, INC. (NASDAQ:PETX) closed its last trading session down -0.13 at 6.22 with 211,561 shares trading hands.