NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND SIX MONTHS ENDED JUNE 30, 2019
(Unaudited)
Note
1 – Nature of Operations, Basis of Presentation and Significant Accounting Policies
Business
Overview
Adhera
Therapeutics, Inc. (formerly known as Marina Biotech, Inc.) and its wholly-owned subsidiaries, MDRNA Research, Inc. (“MDRNA”),
Cequent Pharmaceuticals, Inc. (“Cequent”), Atossa Healthcare, Inc. (“Atossa”), and IThenaPharma, Inc.
(“IThena”) (collectively “Adhera,” the “Company,) is an emerging specialty pharmaceutical company
that leverages innovative distribution models and technologies to improve the quality of care for patients in the United States
suffering from chronic diseases. The Company is focused on fixed dose combination (“FDC”) therapies in hypertension,
with plans to expand the portfolio of drugs we commercialize to include other therapeutic areas.
The
Company’s mission is to provide effective and patient centric treatment for hypertension while actively seeking additional
assets that can be commercialized through our proprietary Total Care System (“TCS”). At the core of our TCS system
is DyrctAxess, our patented technology platform. DyrctAxess is designed to offer enhanced efficiency, control and access to the
information necessary to empower patients, physicians and manufacturers to achieve optimal care.
The Company is focused
on demonstrating the therapeutic and commercial value of TCS through the commercialization of Prestalia
®
,
a single-pill FDC of perindopril arginine (“perindopril”) and amlodipine besylate (“amlodipine”) which
is used as a first-line treatment for hypertension. Prestalia was developed in coordination with Les Laboratories, Servier, a
French pharmaceutical conglomerate, that sells the formulation outside the United States under the brand names Coveram
®
and/or Viacoram
®
. Prestalia
®
was approved by the U.S. Food and Drug Administration (“FDA”)
in January 2015 and was licensed by the Company from Symplmed in June 2017. By combining Prestalia
®
, DyrctAxess
and an independent pharmacy network, the Company has created a proprietary system for drug adherence including patient counseling
and prescription reminder services, as well as improving the distribution of blood pressure monitors for therapeutic drug monitoring
(“TDM”).
In 2018, the Company discontinued
all significant clinical development activities and is evaluating disposition options for its development assets, including but
not limited to: (i) a next generation celecoxib program of drug candidates for the treatment of acute and chronic pain;
(ii) an FDC used to suppress polyps in the precancerous syndrome and orphan indication Familial Adenomatous Polyposis; (iii) an
FDC to treat Colorectal Cancer; and (iv) an FDC for irritable bowel disease (IBD). The Company plans to license or divest these
development assets since they no longer align with the Company’s focus on the commercialization of Prestalia.
Basis
of Presentation
The
accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally
accepted in the United States of America for interim financial information and in accordance with the instructions pursuant to
the rules and regulations of the Securities and Exchange Commission. Accordingly, they do not include all of the information and
note disclosures required by U.S. generally accepted accounting principles (“U.S. GAAP”) for complete audited financial
statements. This quarterly report should be read in conjunction with the consolidated financial statements in the Company’s
Annual Report on Form 10-K for the year ended December 31, 2018. The information furnished in this report reflects all adjustments
(consisting of normal recurring adjustments), which are, in the opinion of management, necessary for a fair presentation of our
financial position, results of operations and cash flows for each period presented. The results of operations for the three or
six months ended June 30, 2019 are not necessarily indicative of the results for the year ending December 31, 2019 or for any
future period.
Principles
of Consolidation
The
condensed consolidated financial statements include the accounts of Adhera Therapeutics, Inc. and the wholly-owned subsidiaries,
Ithena, Cequent, MDRNA, and Atossa, and eliminate any inter-company balances and transactions.
Going
Concern and Management’s Liquidity Plans
The
accompanying condensed consolidated financial statements have been prepared on the basis that the Company will continue as a going
concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business. As of
June 30, 2019, the Company had cash and cash equivalents of $1.6 million and has negative working capital of approximately $3.0
million.
The
Company has incurred recurring losses and negative cash flows from operations since inception and has funded its operating losses
through the sale of common stock, preferred stock, warrants to purchase common stock, convertible notes and promissory notes.
The Company incurred a net operating loss of approximately $2.8 million and $5.3 million for the three and six months
ended June 30, 2019, respectively. The Company had an accumulated deficit of approximately $31.9 million as of June 30,
2019.
The
Company expects to continue to incur operating losses as it executes the commercialization plans for Prestalia
®
,
as well as other strategic and business development initiatives. If the Company is unable to obtain additional financing in the
future, there may be a negative impact on the financial viability of the Company. The Company plans to increase working capital
by managing its cash flows and expenses, divesting development assets and raising additional capital through private or public
equity or debt financing. There can be no assurance that such financing or partnerships will be available or on terms which are
favorable to the Company. While management of the Company believes that it has a plan to fund ongoing operations, there is no
assurance that its plan will be successfully implemented. Failure to raise additional capital through one or more financings,
divesting development assets or reducing discretionary spending could have a material adverse effect on the Company’s ability
to achieve its intended business objectives. These factors raise substantial doubt about the Company’s ability to continue
as a going concern. The condensed consolidated financial statements do not contain any adjustments that might result from the
resolution of any of the above uncertainties.
Summary
of Significant Accounting Policies
Use
of Estimates
The
preparation of the accompanying condensed consolidated financial statements in conformity with GAAP requires management to make
estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities
at the date of the financial statements and the reported amounts of revenue and expenses during the reported period. Significant
areas requiring the use of management estimates include revenue and related discounts and allowances and accruals related to our
operating activity including legal and other consulting expenses. Actual results could differ materially from such estimates
under different assumptions or circumstances.
Fair
Value of Financial Instruments
The
Company considers the fair value of cash, accounts payable, accounts receivable and accrued expenses not to be materially different
from their carrying value. These financial instruments have short-term maturities. We follow authoritative guidance with respect
to fair value reporting issued by the Financial Accounting Standards Board (“FASB”) for financial assets and liabilities,
which defines fair value, provides guidance for measuring fair value and requires certain disclosures. The guidance does not apply
to measurements related to share-based payments. The guidance discusses valuation techniques, such as the market approach (comparable
market prices), the income approach (present value of future income or cash flow), and the cost approach (cost to replace the
service capacity of an asset or replacement cost). The guidance establishes a fair value hierarchy that prioritizes the inputs
to valuation techniques used to measure fair value into three broad levels. The following is a brief description of those three
levels:
Level
1:
|
Observable
inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities.
|
Level
2:
|
Inputs
other than quoted prices that are observable for the asset or liability, either directly or indirectly. These include quoted
prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities
in markets that are not active.
|
|
|
Level
3:
|
Unobservable
inputs in which little or no market data exists, therefore developed using estimates and assumptions developed by us, which
reflect those that a market participant would use.
|
There were no liabilities measured at fair value
as of June 30, 2019 or December 31, 2018.
Accounts Receivable, net
Accounts receivable consists of amounts due from
wholesale distributors and specialty pharmacy providers. The Company records an allowance for doubtful accounts at the time
potential collection risk is identified. The Company estimates its allowance based on historical experience, assessment of
specific risks and discussions with individual customers. The Company believes the reserve is adequate to mitigate
current collection risks. During the three and six months ended June 30, 2019 and 2018, the Company recorded an additional
allowance of approximately $41,000 and $0, respectively.
Goodwill
and Intangible Assets
The
Company periodically reviews the carrying value of intangible assets, including goodwill, to determine whether impairment may
exist. Goodwill and certain intangible assets are assessed annually, or when certain triggering events occur, for impairment using
fair value measurement techniques. These events could include a significant change in the business climate, legal factors, a decline
in operating performance, competition, sale or disposition of a significant portion of the business, or other factors. Specifically,
goodwill impairment is determined using a two-step process. The first step of the goodwill impairment test is used to identify
potential impairment by comparing the fair value of a reporting unit with its carrying amount, including goodwill. The Company
uses level 3 inputs and a discounted cash flow methodology to estimate the fair value of a reporting unit. A discounted cash flow
analysis requires one to make various judgmental assumptions including assumptions about future cash flows, growth rates, and
discount rates. The assumptions about future cash flows and growth rates are based on the Company’s budget and long-term
plans. Discount rate assumptions are based on an assessment of the risk inherent in the respective reporting units. If the fair
value of a reporting unit exceeds its carrying amount, goodwill of the reporting unit is considered not impaired and the second
step of the impairment test is unnecessary. If the carrying amount of a reporting unit exceeds its fair value, the second step
of the goodwill impairment test is performed to measure the amount of impairment loss, if any. The second step of the goodwill
impairment test compares the implied fair value of the reporting unit’s goodwill with the carrying amount of that goodwill.
If the carrying amount of the reporting unit’s goodwill exceeds the implied fair value of that goodwill, an impairment loss
is recognized in an amount equal to that excess. The implied fair value of goodwill is determined in the same manner as the amount
of goodwill recognized in a business combination. That is, the fair value of the reporting unit is allocated to all of the assets
and liabilities of that unit (including any unrecognized intangible assets) as if the reporting unit had been acquired in a business
combination and the fair value of the reporting unit was the purchase price paid to acquire the reporting unit.
During
the year ended December 31, 2018, the Company determined that goodwill was impaired and recognized a loss on impairment of approximately
$3.5 million. The impairment determination was primarily a result of the decision to divest assets that no longer aligned with
the Company’s strategic objectives. No impairment charges were recognized for the three and six-month period ended June
30, 2019 or 2018.
Impairment
of Long-Lived Assets
The
Company reviews long-lived assets for impairment indicators throughout the year and performs detailed testing whenever impairment
indicators are present. In addition, we perform detailed impairment testing for indefinite-lived intangible assets, at least annually,
at December 31. When necessary, the Company records charges for impairments. Specifically:
●
|
For
finite-lived intangible assets, such as developed technology rights, and for other long-lived assets, we compare the undiscounted
amount of the projected cash flows associated with the asset, or asset group, to the carrying amount. If the carrying amount
is found to be greater, we record an impairment loss for the excess of book value over fair value. In addition, in all cases
of an impairment review, we re-evaluate the remaining useful lives of the assets and modify them, as appropriate; and
|
|
|
●
|
For
indefinite-lived intangible assets, such as acquired in-process R&D assets, each year and whenever impairment indicators
are present, we determine the fair value of the asset and record an impairment loss for the excess of book value over fair
value, if any.
|
The
Company did not recognize any loss on impairment for the three or six-month periods ended June 30, 2019 or 2018.
Revenue
Recognition
Customers
Concentration
The Company sells its
prescription drug (Prestalia
®
) directly to specialty contracted retail pharmacies and indirectly through wholesalers.
For the three months ended June 30, 2019, the Company’s three largest customers accounted for 46%, 31% and 23% of the Company’s
total gross sales. For the six months ended June 30, 2019, the Company’s three largest customers accounted for
39%, 37%, and 24% of the Company’s total gross sales. The Company works with a third-party pharmacy network manager
to attract, retain, and manage the Company’s pharmacy customers and distribution channels. The Company had no sales for
the three or six-month periods ending June 30, 2018.
Revenue,
Net
The
Company adopted the new revenue recognition guidelines in accordance with ASC 606,
Revenue from Contracts with Customers
(ASC
606), effective with the quarter ended March 31, 2018.
The
Company sells its medicines primarily to wholesale distributors and specialty pharmacy providers under agreements with payment
terms typically less than 90 days. These customers subsequently resell the Company’s medicines to health care patients. Revenue is recognized when performance
obligations under the terms of a contract with a customer are satisfied. The majority of the Company’s contracts have a
single performance obligation to transfer medicines. Accordingly, revenues from medicine sales are recognized when the customer
obtains control of the Company’s medicines, which occurs at a point in time, typically upon delivery to the customer. Revenue
is measured as the amount of consideration the Company expects to receive in exchange for transferring medicines and is generally
based upon a list or fixed price less allowances for medicine returns, rebates and discounts. Company records an estimate of unrealized
revenue reductions, and the related liability, for bottles sold to pharmacies but not yet prescribed.
Medicine
Sales Discounts and Allowances
The
nature of the Company’s contracts gives rise to variable consideration because of allowances for medicine returns, rebates
and discounts. Allowances for medicine returns, rebates and discounts are recorded at the time of sale to wholesale pharmaceutical
distributors and pharmacies. The Company applies significant judgments and estimates in determining some of these allowances.
If actual results differ from its estimates, the Company will be required to make adjustments to these allowances in the future.
The Company’s adjustments to gross sales are discussed further below.
Patient
Access Programs
The
Company offers discounts to patients under which the patient receives a discount on his or her prescription. In circumstances
when a patient’s prescription is rejected by a third-party payer, the Company will pay for the full cost of the prescription.
The Company reimburses pharmacies for this discount directly or through third-party vendors. The Company reduces gross sales by
the amount of actual co-pay and other patient assistance in the period based on the invoices received. The Company also records
an accrual to reduce gross sales for estimated co-pay and other patient assistance on units sold to distributors or pharmacies
that have not yet been prescribed/dispensed to a patient. The Company calculates accrued co-pay and other patient assistance fee
estimates using the expected value method. The estimate is based on contract prices, estimated percentages of medicine that will
be prescribed to qualified patients, average assistance paid based on reporting from the third-party vendors and estimated levels
of inventory in the distribution channel. Accrued co-pay and other patient assistance fees are included in “accrued expenses”
on the condensed consolidated balance sheet. Patient assistance programs include both co-pay assistance and fully bought down
prescriptions.
Sales
Returns
Consistent
with industry practice, the Company maintains a return policy that allows customers to return medicines within a specified period
prior to and subsequent to the medicine expiration date. Generally, medicines may be returned for a period beginning six months
prior to its expiration date and up to one year after its expiration date. The right of return expires on the earlier of one year
after the medicine expiration date or the time that the medicine is dispensed to the patient. The majority of medicine returns
result from medicine dating, which falls within the range set by the Company’s policy and are settled through the issuance
of a credit to the customer. The Company calculates sales returns using the expected value method. The estimate of the provision
for returns is based upon industry experience. This period is known to the Company based on the shelf life of medicines at the
time of shipment. The Company records sales returns in “accrued expenses” and as a reduction of revenue.
Cost
of Goods Sold
Distribution
Service Fees
The
Company includes distribution service fees paid for inventory management services as cost of goods sold. The Company calculates
accrued distribution service fee estimates using the most likely amount method. The Company accrues estimated distribution fees
based on contractually determined amounts. Accrued distribution service fees are included in “accrued expenses” on
the condensed consolidated balance sheet.
Shipping
Fees
The
Company includes fees incurred by pharmacies for shipping medicines to patients as cost of goods sold. The Company calculates
accrued shipping fee estimates using the expected value method. The Company records accrued shipping fees in “accrued expenses”
on the condensed consolidated balance sheet.
Non-Commercial
Product
The
Company records the cost of non-commercial product distributed to patients as a cost of goods sold.
Royalties
on Product Sales
The
Company records royalty fees on the sale of commercial product as a cost of goods sold.
Recently
Issued Accounting Pronouncements
In February 2016, the
FASB issued ASU No. 2016-02, Leases (Topic 842) (“ASU No. 2016-02”). Under ASU No. 2016-02, an entity is required
to recognize right-of-use assets and lease liabilities on its balance sheet and disclose key information about leasing arrangements.
For leases with a term of twelve months or less, the lessee is permitted to make an accounting policy election not to recognize
lease assets and lease liabilities by class of underlying assets. ASU No. 2016-02 became effective for the Company beginning
in the first quarter of 2019. The Company adopted this standard on January 1, 2019, using a modified retrospective approach at
the adoption date through a cumulative-effect adjustment to retained earnings. The adoption did not have a material impact on
its condensed consolidated statement of operations. The Company elected to not recognize lease assets and liabilities for leases
with an initial term of twelve months or less.
Net
Income (Loss) per Common Share
Basic
net loss per share is calculated by dividing the net loss by the weighted average number of common shares outstanding during the
period. Diluted net loss per share is computed by dividing the net loss by the weighted average number of common shares and common
stock equivalents outstanding for the period. Common stock equivalents are only included when their effect is dilutive. Potentially
dilutive securities which include outstanding warrants, stock options and preferred stock have been excluded from the computation
of diluted net loss per share as their effect would be anti-dilutive. For all periods presented, basic and diluted net loss were
the same.
The
following table presents the computation of net loss per share (in thousands, except share and per share data):
|
|
Three Months ended June 30,
|
|
|
Six Months ended June 30,
|
|
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
|
Numerator
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(2,780
|
)
|
|
$
|
(4,648
|
)
|
|
$
|
(5,338
|
)
|
|
$
|
(6,009
|
)
|
Preferred stock dividends
|
|
$
|
(357
|
)
|
|
$
|
(271
|
)
|
|
$
|
(739
|
)
|
|
$
|
(271
|
)
|
Net Loss allocable to common stock holders
|
|
$
|
(3,137
|
)
|
|
$
|
(4,919
|
)
|
|
$
|
(6,077
|
)
|
|
$
|
(6,280
|
)
|
Denominator
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding used to compute net loss per share, basic and diluted
|
|
|
10,860,049
|
|
|
|
10,821,230
|
|
|
|
10,811,138
|
|
|
|
10,672,082
|
|
Net loss per share of common stock, basic and diluted
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
|
|
$
|
(0.29
|
)
|
|
$
|
(0.45
|
)
|
|
$
|
(0.56
|
)
|
|
$
|
(0.59
|
)
|
Potentially
dilutive securities not included in the calculation of diluted net loss per common share because to do so would be anti-dilutive
are as follows:
|
|
Three and Six Months
Ended June 30,
|
|
|
|
2019
|
|
|
2018
|
|
|
|
|
|
|
|
|
Stock options outstanding
|
|
|
4,992,807
|
|
|
|
1,122,457
|
|
Warrants
|
|
|
36,267,329
|
|
|
|
33,028,829
|
|
Series C Preferred Stock
|
|
|
68,000
|
|
|
|
68,000
|
|
Series D Preferred Stock
|
|
|
3,000
|
|
|
|
3,000
|
|
Series E Preferred Stock
|
|
|
34,780,000
|
|
|
|
34,990,000
|
|
Series F Preferred Stock
|
|
|
3,810,000
|
|
|
|
-
|
|
Total
|
|
|
79,921,136
|
|
|
|
69,212,286
|
|
NOTE
2 – Inventory
Inventory
consists of raw material and finished goods stated at the lower of cost or net realizable value with cost determined on a first-in,
first-out basis. The Company reviews the composition of inventory at each reporting period in order to identify obsolete, slow-moving,
quantities in excess of expected demand, or otherwise non-saleable items.
Inventory
as of the following as of June 30, 2019 and December 31, 2018 are as follows:
|
|
June 30, 2019
|
|
|
December 31, 2018
|
|
|
|
(in thousands)
|
|
Raw Materials
|
|
$
|
173
|
|
|
$
|
147
|
|
Finished Goods
|
|
|
59
|
|
|
|
95
|
|
Inventory, Net
|
|
$
|
232
|
|
|
$
|
242
|
|
Note
3 - Intangible Assets
Intangible
Asset Summary
Intangible
assets as of June 30, 2019 are as follows:
|
|
Net Book Value
June 30, 2019
|
|
|
Remaining
Estimated
Useful Life
(Years)
|
|
|
Annual
Amortization
Expense
|
|
|
|
(in thousands)
|
|
|
|
|
|
|
|
Intangible asset - Prestalia
|
|
$
|
292
|
|
|
|
4.50
|
|
|
$
|
65
|
|
Intangible asset - DyrctAxess
|
|
|
65
|
|
|
|
12.09
|
|
|
|
5
|
|
Total
|
|
$
|
357
|
|
|
|
|
|
|
$
|
70
|
|
Amortization
expense for the three months ended June 30, 2019 and June 30, 2018 was approximately $17,000 and $123,000, respectively.
Amortization expense for the six months ended June 30, 2019 and June 30, 2018 was approximately $35,000 and $247,000 respectively.
Note
4 – Term Loan
On
June 28, 2019, the Company entered into term loan subscription agreements with certain accredited investors, pursuant to which
the Company issued secured promissory notes (the “Notes”) in the aggregate principal amount of approximately $1.5
million. The Company paid $236,000 in debt issuance costs which was recorded as a debt discount to be amortized as interest
expense over the term of the loan using the effective interest rate method.
The
Notes shall accrue interest at a rate of 12.0% per annum. Interest will be payable quarterly with the first interest payment to
be made on the six-month anniversary of the date of the closing and each subsequent payment every three months thereafter.
The unpaid principal balance
of the Notes, plus accrued and unpaid interest thereon, will mature on the earliest to occur of: (i) June 28, 2020 (subject to
extension for up to sixty (60) days based upon the mutual agreement of the Company and the holders of a majority of the unpaid
principal balance of all outstanding Notes) or (ii) at any time following an Event of Default. The Notes may not be prepaid
without the prior written consent of the holders of the Notes. The Notes are secured by a first lien and security interest on
all the assets of the Company and certain of its wholly owned subsidiaries.
The Company recognized
approximately $1,000 in interest expense related to Notes for the three and six months ended June 30, 2019.
Note
5 - Related Party Transactions
Due
to Related Party
The
Company and other related entities have had a commonality of ownership and/or management control, and as a result, the reported
operating results and/or financial position of the Company could significantly differ from what would have been obtained if such
entities were autonomous.
The
Company had a Master Services Agreement (“MSA”) with Autotelic Inc., a related party that is partly owned by one of
the Company’s former Board members and executive officers, namely Vuong Trieu, Ph.D., effective November 15, 2016. The MSA
stated that Autotelic Inc. will provide business functions and services to the Company and allowed Autotelic Inc. to charge the
Company for these expenses paid on its behalf. The MSA included personnel costs allocated based on amount of time incurred and
other services such as consultant fees, clinical studies, conferences and other operating expenses incurred on behalf of the Company.
The MSA required a 90-day written termination notice in the event either party requires to terminate such services. We and Autotelic
Inc. agreed to terminate the MSA effective October 31, 2018. Dr. Trieu resigned as a director of our company effective October
1, 2018.
During
the period commencing November 15, 2016 (the “Effective Date”) and ending on the date that the Company had completed
an equity offering of either common or preferred stock in which the gross proceeds therefrom is no less than $10 million (the
“Equity Financing Date”), the Company paid Autotelic the following compensation: cash in an amount equal to the actual
labor cost (paid on a monthly basis), plus 100% markup in warrants for shares of the Company’s common stock with a strike
price equal to the fair market value of the Company’s common stock at the time said warrants were issued. The Company also
paid Autotelic for the services provided by third party contractors plus 20% mark up. The warrant price per share was calculated
based on the Black-Scholes model.
After
the Equity Financing Date, the Company paid Autotelic Inc. a cash amount equal to the actual labor cost plus 100% mark up of provided
services and 20% mark up of provided services by third party contractors or material used in connection with the performance of
the contracts, including but not limited to clinical trial, non-clinical trial, Contract Manufacturing Organizations, FDA regulatory
process, Contract Research Organizations and Chemistry and Manufacturing Controls.
In
accordance with the MSA, Autotelic Inc. billed the Company for personnel and service expenses Autotelic Inc. incurred on behalf
of the Company. For the six months ended June 30, 2019 and 2018, Autotelic Inc. billed a total of $0 and approximately $616,000,
respectively, including personnel costs of $0 and $284,000, respectively. An unpaid balance of approximately $4,000 is included
in due to related party in the accompanying balance sheets for both periods ending June 30, 2019 and December 31, 2018.
In
April 2018, and in connection with the closing of our private placement on that date, we entered into a Compromise and Settlement
Agreement with Autotelic Inc. pursuant to which we agreed to issue to Autotelic Inc. an aggregate of 162.59 shares of Series E
Preferred Stock to settle accounts payable of $813,000 and Warrants to purchase up to 1,345,040 shares of common stock to satisfy
accrued and unpaid fees in the aggregate amount of approximately $740,000, and other liabilities, owed to Autotelic Inc. as of
June 30, 2018 pursuant to the MSA. The warrants have a five-year term, an initial exercise price of $0.55, and have a fair value
of approximately $1.5 million resulting in a loss on settlement of debt of approximately $750,000.
Transactions
with BioMauris, LLC/Erik Emerson
Until
February of 2019, the Company had engaged the services of BioMauris, LLC, of which Erik Emerson, our former Chief Commercial Officer
and a current director of Adhera, is Executive Chairman.
During the six months
ended June 30, 2019 and 2018, the Company recorded approximately $65,000 and $309,000, respectively, for related
party expenses incurred under the agreement. As of December 31, 2018, the Company recorded approximately, $24,000 as a related
party liability on the accompanying balance sheet for amounts due BioMauris, LLC. No related party liability was recorded as of
June 30, 2019.
Beginning in the second quarter of 2019 when components of the financial transaction took place and fully
effective in July 2019, Erik Emerson, a member our Board of Directors and our former Chief Commercial Officer, became the owner
of an equity interest of approximately 22% in Pharma Hub Network, our third-party network manager. During the six months ended
June 30, 2019 and 2018, the Company paid approximately $17,000 and $0, respectively, to Pharma Hub Network. An unpaid balance of
$27,000 and $0 was included in accounts payable and accrued expenses in the accompanying balance sheets as of June 30, 2019 and
December 31, 2018, respectively.
Note
6 - Stockholders’ Equity
Series
E Convertible Preferred Stock Private Placement
In
April and May 2018, the Company entered into Subscription Agreements with certain accredited investors and conducted a closing
pursuant to which we sold 2,812 shares of our Series E Preferred, at a purchase price of $5,000 per share of Series E Preferred.
Each share of Series E Preferred is initially convertible into shares of our common stock at a conversion price of $0.50 per share
of common stock. In addition, each investor received a 5-year warrant to purchase 0.75 shares of common stock for each share of
common stock issuable upon the conversion of the Series E Preferred purchased by such investor at an initial exercise price equal
to $0.55 per share of common stock, subject to adjustment thereunder. The Series E Preferred accrues 8% dividends per annum and
are payable in cash or stock at the Company’s discretion. The Series E Preferred has voting rights, dividend rights, liquidation
preferences, conversion rights and anti-dilution rights as described in the Certificate of Designation of Preferences, Rights
and Limitations of the Preferred Stock, which we filed with the Secretary of State of Delaware in April 2018. The Warrants have
full-ratchet anti-dilution protection, are exercisable for a period of five years and contain customary exercise limitations.
In
April 2019, the Company issued 107,846 unregistered shares of our common stock to a holder of our Series E Convertible Preferred
Stock in connection with the conversion of $53,923 of “Stated Value” of our Series E Convertible Preferred Stock.
As of June 30, 2019, the
Company had recorded accrued dividends of approximately $1.7 million on Series E Preferred Stock.
Series F Convertible Preferred Stock
Private Placement
In
July 2018, the Company entered into Subscription Agreements with certain accredited investors and conducted a closing pursuant
to which we sold 308 shares of our Series F Preferred, at a purchase price of $5,000 per share of Series F Preferred. Each share
of Series F Preferred is initially convertible into shares of our common stock at a conversion price of $0.50 per share of common
stock. In addition, each investor received a 5-year warrant (the “Warrants”, and collectively with the Preferred Stock,
the “Securities”) to purchase 0.75 shares of common stock for each share of common stock issuable upon the conversion
of the Series F Preferred purchased by such investor at an initial exercise price equal to $0.55 per share of common stock, subject
to adjustment thereunder. The Series F Preferred accrues 8% dividends per annum and are payable in cash or stock at the Company’s
discretion. The Series F Preferred has voting rights, dividend rights, liquidation preferences, conversion rights and anti-dilution
rights as described in the Certificate of Designation of Preferences, Rights and Limitations of the Preferred Stock, which we
filed with the Secretary of State of Delaware in July 2018. The Warrants have full-ratchet anti-dilution protection, are exercisable
for a period of five years and contain customary exercise limitations.
The Company received proceeds
of approximately $1.4 million from the sale of the Securities, after deducting placement agent fees and estimated expenses payable
by us of approximately $180,000 associated with such closing. We used the proceeds of the offering for funding our commercial
operations to the sale and promotion of our Prestalia product, working capital needs, capital expenditures, the repayment of certain
liabilities and other general corporate purposes. In connection with the private placement described above, we also issued to
the placement agent for such private placement a Warrant to purchase 308,000 shares of our common stock. The Warrant has a five-year
term and an initial exercise price of $0.55 per share.
On November 9, 2018, the
Company entered into Subscription Agreements with certain accredited investors and conducted a closing pursuant to which we sold
73 shares of our Series F Preferred Stock, at a purchase price of $5,000 per share of Preferred Stock. Each share of Series F
Preferred is initially convertible into shares of our common stock at a conversion price of $0.50 per share of common stock. In
addition, each investor received a 5-year warrant to purchase 0.75 shares of common stock for each share of common stock issuable
upon the conversion of the Series F Preferred purchased by such investor at an initial exercise price equal to $0.55 per share
of common stock, subject to adjustment thereunder. We received total net proceeds of approximately $0.31 million from the issuance
of the securities described above, after deducting placement agent fees and estimated expenses payable by us associated with such
closing. In connection with the private placement described above, we also issued to the placement agent for such private placement
a Warrant to purchase 73,000 shares of our common stock. The Warrant has a five-year term and an initial exercise price
of $0.55 per share.
As of June 30, 2019, the
Company had recorded accrued dividends of approximately $138,000 on Series F Preferred Stock.
Warrants
As
of June 30, 2019, there were 36,267,329 warrants outstanding, with a weighted average exercise price of $0.79 per share, and annual
expirations as follows:
Expiring in 2019
|
|
|
600,000
|
|
Expiring in 2020
|
|
|
1,189,079
|
|
Expiring in 2021
|
|
|
343,750
|
|
Expiring in 2022
|
|
|
66,667
|
|
Expiring in 2023
|
|
|
33,729,180
|
|
Expiring thereafter
|
|
|
338,653
|
|
Total
|
|
|
36,267,329
|
|
The
above includes price adjustable warrants totaling 34,737,030 shares.
No
warrants expired during the six months ended June 30, 2019.
Tender
Offer
On May 28, 2019,
the Company filed a Tender Offer Statement on Schedule TO. The Schedule TO related to the offer (the “Offer”)
by the Company to all holders of the Company’s outstanding warrants that were issued to investors in connection with the
Company’s private placement of its Series E Convertible Preferred Stock and Series F Convertible Preferred Stock during
2018, which warrants are exercisable for shares of the Company’s common stock at an exercise price of $0.50 per share (subject
to adjustment) with respect to the warrants that were issued in connection with the Company’s private placement of its Series
E Convertible Preferred Stock and $0.55 per share with respect to the warrants that were issued in connection with the Company’s
private placement of its Series F Convertible Preferred Stock, to receive two (2) shares of common stock in exchange for
every warrant tendered by the holders thereof.
On
June 6, 2019, the Company amended the Schedule TO to change the conversion terms on the issuance of warrant.
As
of June 30, 2019, no warrants have been accepted for exchange or been exchanged pursuant to the Offer. See Note
11 – Subsequent Events.
Note
7 - Stock Incentive Plans
Stock
Options
The
following table summarizes stock option activity for the six months ended June 30, 2019:
|
|
Options Outstanding
|
|
|
|
Shares
|
|
|
Weighted
Average
Exercise Price
|
|
Outstanding, December 31, 2018
|
|
|
5,613,057
|
|
|
$
|
0.83
|
|
Options granted
|
|
|
1,635,000
|
|
|
|
0.37
|
|
Options expired / forfeited
|
|
|
(2,255,250
|
)
|
|
|
1.03
|
|
Outstanding, June 30, 2019
|
|
|
4,992,807
|
|
|
|
0.77
|
|
Exercisable, June 30, 2019
|
|
|
2,186,414
|
|
|
$
|
0.81
|
|
The
following table summarizes additional information on stock options outstanding at June 30, 2019.
|
|
Options Outstanding
|
|
|
Options Exercisable
|
|
Range of
Exercise
Prices
|
|
Number Outstanding
|
|
|
Weighted-
Average
Remaining Contractual Life (Years)
|
|
|
Weighted Average Exercise Price
|
|
|
Number Exercisable
|
|
|
Weighted Average Exercise Price
|
|
$0.28 - $1.00
|
|
|
4,352,000
|
|
|
|
8.85
|
|
|
$
|
0.57
|
|
|
|
2,024,500
|
|
|
$
|
0.66
|
|
$1.50 - $1.80
|
|
|
493,207
|
|
|
|
8.18
|
|
|
$
|
1.79
|
|
|
|
134,314
|
|
|
$
|
1.78
|
|
$2.60 - $10.70
|
|
|
147,600
|
|
|
|
2.79
|
|
|
$
|
3.43
|
|
|
|
27,600
|
|
|
$
|
7.27
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Totals
|
|
|
4,992,807
|
|
|
|
8.60
|
|
|
$
|
0.77
|
|
|
|
2,186,414
|
|
|
$
|
0.81
|
|
Weighted-Average
Exercisable Remaining Contractual Life (Years) 8.06
During
the six months ended June 30, 2019, the Company granted an aggregate of 1,635,000 stock options to employees.
Total
expense related to stock options was approximately $241,000 and $374,000 for the three months ended June 30, 2019 and 2018,
respectively and approximately $636,000 and $493,000 for the six months ended June 30, 2019 and 2018, respectively.
As
of June 30, 2019, the Company had approximately $474,000 of total unrecognized compensation expense related to unvested
stock options.
As
of June 30, 2019, the intrinsic value of options outstanding was zero.
Note
8 - Intellectual Property and Collaborative Agreements
License
of DiLA
2
Assets
On
March 16, 2018, the Company entered into an exclusive sublicensing agreement for certain intellectual property rights to its DiLA
2
delivery system. The agreement included an upfront payment of $200,000 and future additional consideration for sales and
development milestones. The upfront fee was contingent upon the Company obtaining a third-party consent to the agreement within
ninety days of execution. As of June 30, 2019 and December 31, 2018, the Company had not obtained consent for the sublicense
and has classified the upfront payment as an accrued liability on its balance sheet.
Note
9 - Commitments and Contingencies
Litigation
Because
of the nature of the Company’s it is subject to claims and/or threatened legal actions, which arise out of the normal course
of business. Other than the disclosure below, as of the date of this filing, the Company is not aware of any pending lawsuits
against them, its officers or directors.
Paragraph
IV Challenge
The
Company’s Prestalia product was involved in a paragraph IV challenge regarding patents issued to perindopril arginine. This
challenge, which was pending in the United States District Court for the District of Delaware (No. 1:17-cv-00276), was captioned
Apotex Inc. and Apotex Corp. v. Symplmed Pharmaceuticals, LLC and Les Laboratoires Servier
. The challengers (Apotex Inc.
and Apotex Corp. (“Apotex”)) filed an Abbreviated New Drug Application seeking FDA approval to market a generic version
of Prestalia and included a Paragraph (IV) certification. In the litigation, Apotex sought a declaratory judgment that no valid
claims of the two patents Symplmed listed in the FDA Orange Book as having claims covering Prestalia, U.S. Patent No. 6,696,481
and 7,846,961, will be infringed by the Apotex proposed generic version of Prestalia and that the claims of those patents are
invalid. The challenge was designed to provide Apotex with an opportunity to enter the market with a generic version of Prestalia,
ahead of the expiration of the patents with claims covering that product.
Apotex
entered into negotiations with Symplmed Pharmaceuticals, LLC (which entity sold its assets relating to Prestalia to us in June
2017, including its License and Commercialization Agreement with Les Laboratories Servier) and Les Laboratories Servier (which
entity owns or controls intellectual property rights relating to pharmaceutical products containing as an active pharmaceutical
ingredient perindopril in combination with other active pharmaceutical ingredients, which rights have been licensed to Symplmed
Pharmaceuticals) to resolve the challenge in the second quarter of 2017. Such parties, along with us, have reached an agreement
on terms that result in a delay to the challengers’ ability to enter the market with a generic version of Prestalia, while
still providing the challenger with the right to enter the market prior to the expiration of the patent covering such product.
Specifically, the parties have entered into a Confidential Settlement Agreement in connection with the settlement of the matter,
pursuant to which, among other things, the parties entered into a Confidential License Agreement, whereby Symplmed, Servier and
our company agreed to grant to Apotex a non-transferable, non-sublicensable, perpetual, irrevocable, royalty-free, non-exclusive
license to the two patents listed in the FDA Orange Book as having claims covering Prestalia to make, use and market a generic
version of Prestalia, or import a generic version of Prestalia from India into the United States, on or after January 1, 2021.
As
a result of the foregoing, the matter is now settled.
Leases
The
Company entered into a Standard Form Office Lease with ROC III Fairlead Imperial Center, LLC, as landlord, pursuant to which we
lease our corporate headquarters located at 4721 Emperor Boulevard, Suite 350, Durham, North Carolina 27703 for a term of 37 months
starting on October 1, 2018. Our base monthly rent for such space is currently $6,458, which amount will increase to $7,057 for
the final month of the term. Other than the lease for our corporate headquarters, we do not own or lease any real property or
facilities that are material to our current business operations. As we expand our business operations, we may seek to lease additional
facilities of our own in order to support our operational and administrative needs under our current operating plan.
The
Company adopted ASU No. 2016-02 on January 1, 2019, using a modified retrospective approach at the adoption date through a cumulative-effect
adjustment to retained earnings. The adoption did not have a material impact on its condensed consolidated statement of operations.
However, the new standard required the Company to establish approximately $0.2 million of liabilities and corresponding right-of-use
assets of approximately $0.2 million on its condensed consolidated balance sheet for operating leases on rented office properties
that existed as of the January 1, 2019, adoption date. The total right-of-use asset was approximately $178,000 as of June 30,
2019 and is reflected in the operating lease right of use asset on the accompanying condensed consolidated balance sheet. The
total related liability was approximately $185,000 as of June 30, 2019, of which approximately $78,000 is included in current
portion of operating lease liability and approximately $107,000 is reflected in operating lease liability, net of current portion
on the accompanying condensed consolidated balance sheet.
Note
11 - Subsequent Events
Except
for the events discussed below, there were no subsequent events that required recognition or disclosure. The Company evaluated
subsequent events through the date the financial statements were issued and filed with the Securities and Exchange Commission.
On July 2, 2019, the Company
announced the termination of the exchange offer contemplated by that certain Tender Offer Statement on Schedule TO that
was originally filed on May 28, 2019. As a result of the termination of the Offer, no Warrants were accepted for exchange
or exchanged pursuant to the Offer.
On July 3, 2019, July
17, 2019, and August 5, 2019, the Company completed a second, third, and fourth closing of term loan subscription
agreements with certain accredited investors, pursuant to which the Company issued secured promissory notes in the aggregate principal
amount of approximately $4.2 million. The terms of such additional closings of the loan are as described in Note
4 of this filing.