Item 8.01. Other Events.
Business Update
The Company
is filing information for the purpose of supplementing and updating certain aspects of the description of its business from that described
under the heading, “Item 1. Business” in the Company’s Annual Report on Form 10-K for the year ended
December 31, 2020, filed with the U.S. Securities and Exchange Commission (the “SEC”) on February 23, 2021. The
updated disclosure is set forth below:
On October 18,
2021, the Company announced its plan to align operational and expense structure to better enable future growth for its two first-in-class
oral medicines, NEXLETOL and NEXLIZET, and prioritize its investment in the CLEAR Outcomes trial. The Company will be reducing operational
expense across its organization through a 40% corporate workforce reduction and through targeted program savings. The Company will focus
its commercialization efforts on an optimized blend of focused outreach including a streamlined sales force, directed to targeted cardiologists
and primary care physicians, and a suite of digital initiatives designed to increase awareness and utilization of our medicines in appropriate
patients.
The Company also pre-announced preliminary,
unaudited U.S. net product revenue of $10.5 million to $11.0 million for the quarter ended September 30, 2021. The
Company revised its 2021 operating expense guidance and expects at least $20 million of savings from prior issued mid-point expense
guidance. The Company now estimates Research and Development expenses for fiscal year 2021 to be $110 to $115 million (from $120 to
$130 million previously) and Selling, General and Administrative expenses for fiscal year 2021 to be $195 to $200 million (from $200
to $210 million previously), inclusive of $25 million of non-cash, stock-based compensation expense. These reductions reflect
optimization activities already implemented, as well as additional savings the Company expects to realize during the third and
fourth quarter of 2021.
The Company
anticipates Research and Development expenses for fiscal year 2022 to be $100 to $110 million and Selling, General and Administrative
expenses for fiscal year 2022 to be $120 to $130 million. The Company expects fiscal year 2022 operating expenses to be $220 to $240 million,
inclusive of $25 million of non-cash, stock-based compensation expense.
As of
September 30, 2021, total cash, cash equivalents, and restricted cash totaled approximately $153.7 million, assuming $50.0
million will become restricted cash subject to a block account control agreement pursuant to the Amendment to the Security Agreement
and Waiver (the “Amendment and Waiver”) by and among the Company, Eiger Partners II LP and Eiger III SA LLC
(“Oberland”) after Specified Net Revenue (as defined in the Amendment and Waiver) for the quarter ended
September 30, 2021 did not exceed $15.0 million, unless we are able to negotiate a waiver with Oberland on terms that are acceptable to both parties. There were approximately 26.8 million shares of common stock outstanding,
excluding the 2.0 million treasury shares to be purchased in the prepaid forward transaction as part of the convertible debt
financing with another 4.6 million issuable upon exercise of stock options and vesting of restricted stock units.
The preliminary
unaudited results described in this Form 8-K are estimates only and are subject to revision until the Company reports full financial
results for the quarter ended September 30, 2021.
Risk Factors
The Company
is supplementing the risk factors previously included in Item 1A of its Annual Report on Form 10-K for the year ended December 31,
2020, filed with the SEC on February 23, 2021, update the following new risk factors:
Risks Related to Our Capital Needs
Our payment obligations under the Revenue Interest Purchase Agreement
with Oberland may adversely affect our financial position or results of operations and our ability to raise additional capital which in
turn may increase our vulnerability to adverse regulatory developments or economic or business downturns.
On June 26,
2019, we entered into the RIPA with Oberland and the Purchasers named therein. Pursuant to the RIPA, Oberland paid us $125.0 million on
closing, less certain transaction expenses, and, Oberland paid us an additional $25.0 million in March 2020 upon receiving regulatory
approval of NEXLETOL. Pursuant to the RIPA Amendment, we received the final $50.0 million. As consideration for the payments, Oberland
has the right to receive certain revenue interests from us based on the net sales of certain products, once approved, which will be tiered
payments initially ranging from 3.33% to 10% of our net sales in the covered territory. See Note 8 "Liability Related to the Revenue
Interest Purchase Agreement" in our condensed financial statements included in our Form 10-Q for the quarter ended June 30,
2021.
The
RIPA and the revenue interest stream payable to Oberland could have important negative consequences to the holders of our
securities. For example, a portion of our cash flow from operations will be needed to pay certain revenue interests to Oberland and
will not be available to fund future operations. Further, if we fail to achieve the Specified Net Revenue thresholds, we will be obligated to deposit $50 million into the Blocked Account, which would reduce our unrestricted cash and could have a material adverse effect, unless we are able to negotiate a waiver with Oberland on terms that are acceptable to both parties.
Payment
requirements under the RIPA will increase our cash outflows. Our future operating performance is subject to market conditions and business
factors that are beyond our control. If our cash inflows and capital resources are insufficient to allow us to make required payments,
we may have to reduce or delay capital expenditures, sell assets or seek additional capital. If we raise funds by selling additional equity,
such sale would result in dilution to our stockholders. There is no assurance that if we are required to secure funding we can do so on
terms acceptable to us, or at all. Failure to pay certain amounts to Oberland when due would result in a default under the RIPA and result
in foreclosure on certain of our assets which would have a material adverse effect.
The RIPA
contains customary affirmative and negative non-financial covenants and events of default, including, covenants and restrictions that
among other things, grant a senior security interest in our assets and restrict our ability to incur liens, incur additional indebtedness,
make loans and investments, engage in mergers and acquisitions, and engage in asset sales. Additionally, the Purchasers under the RIPA
have an option (the “Put Option”) to terminate the RIPA and to require the Company to repurchase future Revenue Interests
upon enumerated events such as a bankruptcy event, an uncured material breach, a material adverse effect (which can include adverse developments
related to the regulatory approval of our product candidates) or a change of control. The triggering of the Put Option, including by our
failure to comply with these covenants, could permit the Purchasers to declare certain amounts to be immediately due and payable. If we
default under the terms of the RIPA, including by failure to make such accelerated payments, the Purchasers take control of our pledged
assets. Further, if we are liquidated, the Purchasers’ right to repayment would be senior to the rights of the holders of our common
stock. Any triggering of the Put Option or other declaration by the Purchasers of an event of default under the RIPA could significantly
harm our financial condition, business and prospects and could cause the price of our common stock to decline.
Risks Related to Our
Financial Position
We have incurred significant operating losses since our inception,
and anticipate that we will incur continued losses for the foreseeable future.
Pharmaceutical
product development is a highly speculative undertaking and involves a substantial degree of risk. We were incorporated in January 2008.
Our operations to date have been limited primarily to organizing and staffing our company and conducting research and development activities
for bempedoic acid and the bempedoic acid / ezetimibe combination tablet, as well as preparing for the commercial launch and the initial
commercial launch of these products. Since the launch of our products, we have generated between $40.4 million and $40.9 million
in revenue from product sales in the U.S. We have obtained regulatory approval for both products from the FDA in the U.S., the EC in Europe
and Swissmedic in Switzerland, but have not received approval for bempedoic acid and the bempedoic acid / ezetimibe combination tablet
from any other regulatory agency. As such, we are subject to all the risks incident to the development, regulatory approval and commercialization
of new pharmaceutical products and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors.
Since
our inception, we have focused substantially all of our efforts and financial resources on developing bempedoic acid. We have funded our
operations to date primarily through proceeds from sales of preferred stock, public offerings of common stock, convertible promissory
notes and warrants, the incurrence of indebtedness, milestone payments from collaboration agreements and revenue interest purchase agreements,
and we have incurred losses in each year since our inception. Our net losses were $143.6 million, $97.2 million and $201.8 million for
the years ended December 31, 2020, 2019 and 2018, respectively. As of June 30, 2021, we had an unaudited accumulated deficit
of $971.9 million. Substantially all of our operating losses resulted from costs incurred in connection with our development program
and from selling, general and administrative costs associated with our operations. While we will be reducing operational expense across
our organization through the 40% corporate workforce reduction and through targeted program savings, we will have to attempt to secure
additional cash resources or implement additional cost reduction initiatives as needed to continue to fund the commercialization and further
development of bempedoic acid and the bempedoic acid / ezetimibe combination tablet. After taking into account the 40% corporate workforce
reduction and other targeted program savings, and excluding the $50.0 million of restricted cash (which we assume will become restricted cash, unless we are able to negotiate a waiver with Oberland on terms that are acceptable to both parties, and which, once restricted, could remain restricted until
our secured obligations under the RIPA are satisfied ), we expect that our current cash runway allows us to operate into the second quarter
of 2022.
Our
prior losses, combined with expected future losses, have had and will continue to have an adverse effect on our stockholders’ equity
and working capital. We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future related
to the CLEAR Outcomes trial and to commercialization activities, as well as other related personnel and activities. Our research and development
expenses are expected to continue in the foreseeable future as they relate to our ongoing CLEAR Outcomes trial and any other early-stage
development programs or additional indications we choose to pursue. We also expect to incur significant sales, marketing and outsourced
manufacturing expenses and expect further significant increases in our general and administration expenses in connection with the commercialization
of bempedoic acid and the bempedoic acid / ezetimibe combination tablet, respectively. Even though bempedoic acid and the bempedoic acid
/ ezetimibe combination tablet are approved in the U.S. and Europe for commercial sale, and despite expending these costs, bempedoic acid
or the bempedoic acid / ezetimibe combination tablet may not be commercially successful drugs. As a public company, we have incurred and
will continue to incur additional costs associated with operating as a public company. As a result, we expect to continue to incur significant
and increasing operating losses for the foreseeable future. Because of the numerous risks and uncertainties associated with developing
pharmaceutical products, we are unable to predict the extent of any future losses or when we will become profitable, if at all. Even if
we do become profitable, we may not be able to sustain or increase our profitability on a quarterly or annual basis.
Forward-Looking Statements
This Form 8-K
contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements
regarding marketing strategy and commercialization plans, restructuring and operational expenses, future operations, commercial products,
clinical development, plans for potential future product candidates, financial condition and outlook, and other statements containing
the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,”
“plan,” “predict,” “project,” “suggest,” “target,” “potential,”
“will,” “would,” “could,” “should,” “continue,” and similar expressions. Any
express or implied statements contained in this Form 8-K that are not statements of historical fact may be deemed to be forward-looking
statements. Forward-looking statements involve risks and uncertainties that could cause the Company’s actual results to differ significantly
from those projected, including, without limitation, the impact of the ongoing COVID-19 pandemic on its business, revenues, results of
operations and financial condition, the net sales, profitability, and growth of its commercial products, clinical activities and results,
supply chain, commercial development and launch plans, and the risks detailed in the Company’s filings with the SEC. Any forward-looking
statements contained in this press release speak only as of the date hereof, and the Company disclaims any obligation or undertaking to
update or revise any forward-looking statements contained in this press release, other than to the extent required by law.