Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq:
ASRT), a pharmaceutical company with comprehensive commercial
capabilities offering differentiated products to patients, today
reported financial results for the third quarter ended
September 30, 2024.
“Third quarter results reflected solid performance as we
continue to establish Rolvedon as our lead asset and drive economic
returns from our commercial portfolio,” said Brendan O’Grady, Chief
Executive Officer. “Rolvedon has been well received by physicians,
posting another quarter of stable performance and the continued
expansion of our customer base. The Rolvedon same day dosing trial
has concluded and the results have been accepted for presentation
at the San Antonio Breast Cancer Symposium in December 2024.”
“Additionally, we have implemented new sales and marketing
tactics for Sympazan, which are designed to drive prescriber
awareness and prescription growth in key markets. We are
maintaining our share of Indocin and working to maximize the value
of this product and our other commercial assets moving forward. We
are also evaluating new approaches to grow existing assets as well
as the acquisition of additional assets to fuel further
growth.”
Financial Highlights (unaudited):
|
Three Months Ended |
|
Nine Months Ended |
(in millions, except per share
amounts) |
September 30, 2024 |
|
June 30, 2024 |
|
September 30, 2023 |
|
September 30, 2024 |
|
September 30, 2023 |
Net Product Sales (GAAP) |
$ |
28.7 |
|
|
$ |
30.7 |
|
|
$ |
35.1 |
|
|
$ |
91.3 |
|
|
$ |
117.0 |
|
Net Loss
(GAAP) |
$ |
(2.9 |
) |
|
$ |
(3.7 |
) |
|
$ |
(279.5 |
) |
|
$ |
(11.1 |
) |
|
$ |
(274.6 |
) |
Loss Per Share
(GAAP) |
$ |
(0.03 |
) |
|
$ |
(0.04 |
) |
|
$ |
(3.42 |
) |
|
$ |
(0.12 |
) |
|
$ |
(4.35 |
) |
Adjusted EBITDA
(Non-GAAP)1 |
$ |
5.3 |
|
|
$ |
5.0 |
|
|
$ |
12.9 |
|
|
$ |
17.7 |
|
|
$ |
63.3 |
|
Adjusted Earnings Per
Share (Non-GAAP)1 |
$ |
0.03 |
|
|
$ |
0.02 |
|
|
$ |
0.01 |
|
|
$ |
0.09 |
|
|
$ |
0.46 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Third quarter results included the following highlights (our
discussion below focuses on a comparison of third quarter 2024 to
second quarter 2024 given the acquisition of Spectrum and the
generic competition of Indocin introduced in the third quarter
2023):
- Rolvedon net product sales were stable at $15.0 million in the
third quarter, from $15.1 million in the second quarter, driven by
continued volume growth offset by lower net pricing.
- Indocin net product sales in the third quarter were $5.7
million, decreased from $6.9 million in the second quarter, due to
the previously announced generic competition affecting
pricing.
- Gross margin2 in the third quarter increased to 74%, from 71%
in the second quarter, primarily due a decrease in the level of
inventory write downs in late life-cycle stage products and the
completion of Rolvedon inventory step-up amortization.
- SG&A expense in the third quarter was $16.7 million,
decreased from $18.4 million in the second quarter. The decrease
was primarily due to lower sales and marketing and other general
and administrative costs, partially offset by net higher legal
related charges.
- Adjusted EBITDA3 was $5.3 million in the third quarter,
increased from $5.0 million in the second quarter, primarily due to
lower SG&A expense, partially offset by lower net product
sales.
Balance Sheet and Cash Flow
- For the quarter ended September 30, 2024, cash, cash
equivalents and short-term investments were $88.6 million,
compared with $88.4 million at June 30, 2024. Cash flow generation
during the quarter was impacted by the timing of working capital as
well as lower net product sales.
- Debt at September 30, 2024 was $40.0 million, comprised of
the Company’s 6.5% convertible notes, with no maturities until
September 2027.
Board Updates
Peter Staple retired from the board after more than 20 years as
an independent director. Also, Dr. Jeffrey Vacirca has elected to
depart from the board to focus on his other business interests.
Both departures were effective November 7, 2024.
Assertio announced the appointment of Heather Mason as Board
Chair. Mason has served as an independent director since 2019 and
as interim CEO of Assertio from January to May of 2024. Further,
David Stark was appointed to the board as an independent director
and member of the Nominating and Corporate Governance Committee.
Stark was previously Executive Vice President and Chief Legal
Officer at Teva Pharmaceutical Industries Limited.
“I want thank Jeff and Peter for their service to Assertio and
its shareholders,” said Mason. “Jeff’s insight into the oncology
market since joining the board as part of the Spectrum transaction
has been invaluable. Peter has served for more than 20 years on the
Assertio board, offering calm leadership and wise counsel through
transitions and challenges faced by the organization during his
tenure. I also appreciate Peter extending his board service during
the time of transition to Brendan O’Grady as the new CEO. I want to
welcome David to the board and look forward to his partnership.
David brings extensive litigation, compliance and acquisition
experience from his time at Teva and earlier in private law firm
practice.”
Conference Call and Investor Presentation
Information
Assertio’s management will host a conference call to discuss its
third quarter 2024 financial results today:
Date: |
Monday, November 11, 2024 |
Time: |
4:30 p.m. Eastern Time |
Webcast (live and archive): |
http://investor.assertiotx.com/overview/default.aspx(Events &
Webcasts, Investor Page) |
Dial-in numbers: |
1-646-307-1963, Conference ID 3278948 |
|
|
To access the live webcast, the recorded conference call replay,
and other materials, please visit Assertio’s investor relations
website at http://investor.assertiotx.com/overview/default.aspx.
Please connect at least 15 minutes prior to the live webcast to
ensure adequate time for any software download that may be needed
to access the webcast. The replay will be available approximately
two hours after the call on Assertio’s investor website.
1 Non-GAAP measures are reconciled to the corresponding GAAP
measures in the schedules attached.2 Gross margin represents the
ratio of net product sales less cost of sales to net product
sales.3 See “Non-GAAP Financial Measures” below for information
about reconciling our Adjusted EBITDA guidance to Net Loss.
About Assertio
Assertio is a commercial pharmaceutical company with
comprehensive commercial capabilities offering differentiated
products to patients. We have built our commercial portfolio
through acquisition or licensing of approved products. Our
commercial capabilities include marketing through both a sales
force and a non-personal promotion model, market access through
payor contracting, and trade and distribution. To learn more about
Assertio, visit www.assertiotx.com.
Investor Contact
Matt Kreps, Managing DirectorDarrow AssociatesM:
214-597-8200mkreps@darrowir.com
Forward Looking Statements
The statements in this communication include forward-looking
statements. Forward-looking statements may discuss goals,
intentions and expectations as to future plans, trends, events,
results of operations or financial condition, or otherwise, based
on current beliefs. Forward-looking statements speak only as of the
date they are made or as of the dates indicated in the statements
and should not be relied upon as predictions of future events, as
there can be no assurance that the events or circumstances
reflected in these statements will be achieved or will occur.
Forward-looking statements can often, but not always, be identified
by the use of forward-looking terminology such as “anticipate,”
“approximate”, “believe,” “could,” “estimate,” “expect,” “goal,”
“intend,” “may,” “might,” “opportunity,” “plan,” “potential,”
“project,” “prospective,” “pursue,” “seek,” “should,” “strategy,”
“target,” “will,” or the negative of these words and phrases, other
variations of these words and phrases or comparable terminology.
These forward-looking statements involve risks and uncertainties
that could cause actual results to differ materially from those
contemplated by the statements, including: Assertio’s ability to
grow sales of, and the commercial success and market acceptance of,
Rolvedon and Assertio’s other products; Assertio’s ability to
successfully develop and execute its sales, marketing and promotion
strategies using its sales force and non-personal promotion model
capabilities; the impact on sales and profits from the entry and
sales of generics of Assertio’s products and/or other products
competitive with any of Assertio’s products (including indomethacin
suppositories compounded by hospitals and other institutions
including a 503B compounder which we believe to be violation of
certain provisions of the Food, Drug and Cosmetic Act); the timing
and impact of additional generic approvals and uncertainty around
the recent approvals and launches of generic Indocin products
(which are not patent protected and now face generic competition as
a result of the August 2023 approval and launch of generic
indomethacin suppositories and January 2024 approval and subsequent
launch of a generic indomethacin oral suspension product); risks
that any new businesses will not be integrated successfully or that
the combined company will not realize estimated cost savings, value
of certain tax assets, synergies and growth, or that such benefits
may take longer and/or cost more to realize than expected; expected
industry trends, including pricing pressures and managed healthcare
practices; Assertio’s ability to attract and retain executive
leadership and key employees; the ability of Assertio’s third-party
manufacturers to manufacture adequate quantities of commercially
salable inventory and active pharmaceutical ingredients for each of
Assertio’s products on commercially reasonable terms and in
compliance with their contractual obligations to Assertio, and
Assertio’s ability to maintain its supply chain which relies on
single-source suppliers; the outcome of, and Assertio’s intentions
with respect to, any litigation or government investigations,
including pending and potential future shareholder litigation
relating to the Spectrum Merger and/or the recent approval and
launch of generic indomethacin suppositories, opioid-related
government investigations and opioid-related litigation, the
recently unsealed qui tam litigation, as well as Spectrum’s legacy
shareholder and other litigation and, and other disputes and
litigation, and the costs and expenses associated therewith;
Assertio’s financial cost and outcomes of clinical trials,
including the extent to which data from the Rolvedon same-day
dosing trial may support ongoing commercialization efforts;
Assertio’s compliance with legal and regulatory requirements
related to the development or promotion of its products; variations
in revenues obtained from commercialization agreements and the
accounting treatment with respect thereto; Assertio’s common stock
maintaining compliance with The Nasdaq Capital Market’s minimum
closing bid requirement of at least $1.00 per share, particularly
in light of Assertio’s stock trading below or only slightly above
$1.00 per share recently as well as recent market activity by a
short seller; and Assertio’s ability to obtain and maintain
intellectual property protection for its products and operate its
business without infringing the intellectual property rights of
others. For a discussion of additional factors that could cause
actual results to differ materially from those contemplated by
forward-looking statements, see the risks described in Assertio’s
Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and
other filings with the Securities and Exchange Commission. Many of
these risks and uncertainties may be exacerbated by public health
emergencies and general macroeconomic conditions. Assertio does not
assume, and hereby disclaims, any obligation to update
forward-looking statements, except as may be required by law.
Non-GAAP Financial Measures
To supplement the Company’s financial results presented on a
U.S. generally accepted accounting principles (“GAAP”) basis, the
Company has included information about non-GAAP measures of EBITDA,
adjusted EBITDA, adjusted earnings, and adjusted earnings per share
as useful operating metrics. The Company believes that the
presentation of these non-GAAP financial measures, when viewed with
results under GAAP and the accompanying reconciliation, provides
supplementary information to analysts, investors, lenders, and the
Company’s management in assessing the Company’s performance and
results from period to period. The Company uses these non-GAAP
measures internally to understand, manage and evaluate the
Company’s performance, and in part, in the determination of bonuses
for executive officers and employees. These non-GAAP financial
measures should be considered in addition to, and not a substitute
for, or superior to, net income or other financial measures
calculated in accordance with GAAP. Non-GAAP financial measures
used by us may be calculated differently from, and therefore may
not be comparable to, non-GAAP measures used by other
companies.
Specified Items
Non-GAAP measures presented within this release exclude
specified items. The Company considers specified items to be
significant income/expense items not indicative of current
operations. Specified items may include adjustments to interest
expense and interest income, income tax expense (benefit),
depreciation expense, amortization expense, sales reserves
adjustments for products the Company is no longer selling,
stock-based compensation expense, fair value adjustments to
contingent consideration or derivative liability, restructuring
charges, amortization of fair value inventory step-up as a result
of purchase accounting, transaction-related costs, gains, losses or
impairments from adjustments to long-lived assets and assets not
part of current operations, changes in valuation allowances on
deferred tax assets, and gains or losses resulting from debt
refinancing or extinguishment.
|
CONDENSED
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS(in
thousands, except per share
amounts)(unaudited) |
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
September 30,2024 |
|
June 30,2024 |
|
September 30,2023 |
|
September 30,2024 |
|
September 30,2023 |
Revenues: |
|
|
|
|
|
|
|
|
|
Product sales, net |
$ |
28,705 |
|
|
$ |
30,695 |
|
|
$ |
35,137 |
|
|
$ |
91,262 |
|
|
$ |
116,989 |
|
Royalties and milestones |
|
499 |
|
|
|
431 |
|
|
|
490 |
|
|
|
1,516 |
|
|
|
1,910 |
|
Other revenue |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
185 |
|
Total revenues |
|
29,204 |
|
|
|
31,126 |
|
|
|
35,627 |
|
|
|
92,778 |
|
|
|
119,084 |
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
Cost of sales |
|
7,550 |
|
|
|
8,889 |
|
|
|
7,060 |
|
|
|
27,616 |
|
|
|
17,299 |
|
Research and development expenses |
|
1,005 |
|
|
|
798 |
|
|
|
1,316 |
|
|
|
2,536 |
|
|
|
1,819 |
|
Selling, general and administrative expenses |
|
16,726 |
|
|
|
18,385 |
|
|
|
21,005 |
|
|
|
53,635 |
|
|
|
54,680 |
|
Change in fair value of contingent consideration |
|
300 |
|
|
|
— |
|
|
|
(17,532 |
) |
|
|
300 |
|
|
|
(8,124 |
) |
Amortization of intangible assets |
|
6,671 |
|
|
|
6,671 |
|
|
|
10,184 |
|
|
|
18,973 |
|
|
|
22,752 |
|
Loss on impairment of intangible assets |
|
— |
|
|
|
— |
|
|
|
238,831 |
|
|
|
— |
|
|
|
238,831 |
|
Restructuring charges |
|
— |
|
|
|
— |
|
|
|
3,034 |
|
|
|
720 |
|
|
|
3,034 |
|
Total costs and expenses |
|
32,252 |
|
|
|
34,743 |
|
|
|
263,898 |
|
|
|
103,780 |
|
|
|
330,291 |
|
Loss from operations |
|
(3,048 |
) |
|
|
(3,617 |
) |
|
|
(228,271 |
) |
|
|
(11,002 |
) |
|
|
(211,207 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
Debt-related expenses |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(9,918 |
) |
Interest expense |
|
(761 |
) |
|
|
(758 |
) |
|
|
(752 |
) |
|
|
(2,276 |
) |
|
|
(2,625 |
) |
Interest income |
|
887 |
|
|
|
842 |
|
|
|
605 |
|
|
|
2,441 |
|
|
|
1,713 |
|
Other gain (loss) |
|
45 |
|
|
|
8 |
|
|
|
(467 |
) |
|
|
57 |
|
|
|
(112 |
) |
Total other income
(expense) |
|
171 |
|
|
|
92 |
|
|
|
(614 |
) |
|
|
222 |
|
|
|
(10,942 |
) |
Net loss before income
taxes |
|
(2,877 |
) |
|
|
(3,525 |
) |
|
|
(228,885 |
) |
|
|
(10,780 |
) |
|
|
(222,149 |
) |
Income tax expense |
|
(44 |
) |
|
|
(149 |
) |
|
|
(50,659 |
) |
|
|
(325 |
) |
|
|
(52,409 |
) |
Net loss and comprehensive
loss |
$ |
(2,921 |
) |
|
$ |
(3,674 |
) |
|
$ |
(279,544 |
) |
|
$ |
(11,105 |
) |
|
$ |
(274,558 |
) |
|
|
|
|
|
|
|
|
|
|
Basic net loss per share |
$ |
(0.03 |
) |
|
$ |
(0.04 |
) |
|
$ |
(3.42 |
) |
|
$ |
(0.12 |
) |
|
$ |
(4.35 |
) |
Diluted net loss per
share |
$ |
(0.03 |
) |
|
$ |
(0.04 |
) |
|
$ |
(3.42 |
) |
|
$ |
(0.12 |
) |
|
$ |
(4.35 |
) |
Shares used in computing basic
net loss per share |
|
95,352 |
|
|
|
95,240 |
|
|
|
81,713 |
|
|
|
95,191 |
|
|
|
63,066 |
|
Shares used in computing
diluted net loss per share |
|
95,352 |
|
|
|
95,240 |
|
|
|
81,713 |
|
|
|
95,191 |
|
|
|
63,066 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONDENSED CONSOLIDATED BALANCE SHEETS(in
thousands, except share and per share data) |
|
|
|
|
|
(Unaudited) |
|
|
|
September 30, 2024 |
|
December 31, 2023 |
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
37,981 |
|
|
$ |
73,441 |
|
Short-term investments |
|
50,598 |
|
|
|
— |
|
Accounts receivable, net |
|
44,944 |
|
|
|
47,663 |
|
Inventories, net |
|
39,788 |
|
|
|
37,686 |
|
Prepaid and other current assets |
|
7,845 |
|
|
|
12,272 |
|
Total current assets |
|
181,156 |
|
|
|
171,062 |
|
Property and equipment,
net |
|
624 |
|
|
|
770 |
|
Intangible assets, net |
|
92,359 |
|
|
|
111,332 |
|
Other long-term assets |
|
1,860 |
|
|
|
3,255 |
|
Total assets |
$ |
275,999 |
|
|
$ |
286,419 |
|
LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
13,153 |
|
|
$ |
13,439 |
|
Accrued rebates, returns and discounts |
|
60,482 |
|
|
|
58,137 |
|
Accrued liabilities |
|
12,964 |
|
|
|
18,213 |
|
Contingent consideration, current portion |
|
3,000 |
|
|
|
2,700 |
|
Other current liabilities |
|
505 |
|
|
|
954 |
|
Total current liabilities |
|
90,104 |
|
|
|
93,443 |
|
Long-term debt |
|
38,840 |
|
|
|
38,514 |
|
Other long-term
liabilities |
|
16,537 |
|
|
|
16,459 |
|
Total liabilities |
|
145,481 |
|
|
|
148,416 |
|
Commitments and
contingencies |
|
|
|
Shareholders’ equity: |
|
|
|
Common stock, $0.0001 par value, 200,000,000 shares authorized;
95,360,756 and 94,668,523 shares issued and outstanding as of
September 30, 2024 and December 31, 2023, respectively. |
|
9 |
|
|
|
9 |
|
Additional paid-in capital |
|
793,157 |
|
|
|
789,537 |
|
Accumulated deficit |
|
(662,648 |
) |
|
|
(651,543 |
) |
Total shareholders’ equity |
|
130,518 |
|
|
|
138,003 |
|
Total liabilities and
shareholders' equity |
$ |
275,999 |
|
|
$ |
286,419 |
|
|
|
|
|
|
|
|
|
|
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS(in
thousands)(unaudited) |
|
|
|
Nine Months Ended September 30, |
|
2024 |
|
2023 |
Operating
Activities |
|
|
|
Net loss |
$ |
(11,105 |
) |
|
$ |
(274,558 |
) |
Adjustments to reconcile net loss to net cash from operating
activities: |
|
|
|
Depreciation and amortization |
|
19,118 |
|
|
|
23,321 |
|
Amortization of debt issuance costs and Royalty Rights |
|
326 |
|
|
|
350 |
|
Accretion of interest income from short-term investments |
|
(538 |
) |
|
|
— |
|
Loss on impairment of intangible assets |
|
— |
|
|
|
238,831 |
|
Recurring fair value measurements of assets and liabilities |
|
269 |
|
|
|
(7,612 |
) |
Debt-related expenses |
|
— |
|
|
|
9,918 |
|
Provisions for inventory and other assets |
|
4,982 |
|
|
|
2,129 |
|
Stock-based compensation |
|
3,911 |
|
|
|
6,516 |
|
Deferred income taxes |
|
— |
|
|
|
47,192 |
|
Changes in assets and
liabilities, net of acquisition: |
|
|
|
Accounts receivable |
|
2,719 |
|
|
|
33,865 |
|
Inventories |
|
(7,084 |
) |
|
|
(8,898 |
) |
Prepaid and other assets |
|
5,822 |
|
|
|
6,769 |
|
Accounts payable and other accrued liabilities |
|
(5,255 |
) |
|
|
(21,523 |
) |
Accrued rebates, returns and discounts |
|
2,345 |
|
|
|
(11,027 |
) |
Interest payable |
|
(650 |
) |
|
|
(1,376 |
) |
Net cash provided by operating activities |
|
14,860 |
|
|
|
43,897 |
|
Investing
Activities |
|
|
|
Purchases of property and
equipment |
|
— |
|
|
|
(528 |
) |
Purchase of Sympazan |
|
— |
|
|
|
(280 |
) |
Net cash acquired in Spectrum
Merger |
|
— |
|
|
|
1,950 |
|
Proceeds from sale of
short-term investments |
|
— |
|
|
|
2,194 |
|
Proceeds from maturities of
short-term investments |
|
23,534 |
|
|
|
— |
|
Purchases of short-term
investments |
|
(73,563 |
) |
|
|
— |
|
Net cash (used in) provided by investing activities |
|
(50,029 |
) |
|
|
3,336 |
|
Financing
Activities |
|
|
|
Payments in connection with
2027 Convertible Notes |
|
— |
|
|
|
(10,500 |
) |
Payment of direct transaction
costs related to convertible debt inducement |
|
— |
|
|
|
(1,119 |
) |
Payment of contingent
consideration |
|
— |
|
|
|
(15,408 |
) |
Payments related to the
vesting and settlement of equity awards, net |
|
(291 |
) |
|
|
(7,770 |
) |
Other financing
activities |
|
— |
|
|
|
(489 |
) |
Net cash used in financing activities |
|
(291 |
) |
|
|
(35,286 |
) |
Net (decrease) increase in
cash and cash equivalents |
|
(35,460 |
) |
|
|
11,947 |
|
Cash and cash equivalents at
beginning of year |
|
73,441 |
|
|
|
64,941 |
|
Cash and cash equivalents at
end of period |
$ |
37,981 |
|
|
$ |
76,888 |
|
Supplemental
Disclosure of Cash Flow Information |
|
|
|
Net cash paid for income taxes |
$ |
1,388 |
|
|
$ |
3,424 |
|
Cash paid for interest |
$ |
2,600 |
|
|
$ |
3,651 |
|
|
|
|
|
|
|
|
|
|
RECONCILIATION OF GAAP NET LOSS TO NON-GAAP EBITDA and
ADJUSTED EBITDA(in
thousands)(unaudited) |
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
|
|
September 30, 2024 |
|
June 30, 2024 |
|
September 30, 2023 |
|
September 30, 2024 |
|
September 30, 2023 |
|
Financial
Statement Classification |
GAAP Net Loss |
|
$ |
(2,921 |
) |
|
$ |
(3,674 |
) |
|
$ |
(279,544 |
) |
|
$ |
(11,105 |
) |
|
$ |
(274,558 |
) |
|
|
Interest expense |
|
|
761 |
|
|
|
758 |
|
|
|
752 |
|
|
|
2,276 |
|
|
|
2,625 |
|
|
Interest expense |
Income tax expense |
|
|
44 |
|
|
|
149 |
|
|
|
50,659 |
|
|
|
325 |
|
|
|
52,409 |
|
|
Income tax expense |
Depreciation expense |
|
|
40 |
|
|
|
40 |
|
|
|
172 |
|
|
|
145 |
|
|
|
569 |
|
|
Selling, general and
administrative expenses |
Amortization of intangible assets |
|
|
6,671 |
|
|
|
6,671 |
|
|
|
10,184 |
|
|
|
18,973 |
|
|
|
22,752 |
|
|
Amortization of intangible
assets |
EBITDA
(Non-GAAP) |
|
$ |
4,595 |
|
|
$ |
3,944 |
|
|
$ |
(217,777 |
) |
|
$ |
10,614 |
|
|
$ |
(196,203 |
) |
|
|
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
Legacy product reserves |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(185 |
) |
|
Other revenue |
Stock-based compensation |
|
|
1,296 |
|
|
|
1,408 |
|
|
|
1,864 |
|
|
|
3,911 |
|
|
|
6,516 |
|
|
Selling, general and
administrative expenses |
Change in fair value of contingent consideration(1) |
|
|
300 |
|
|
|
— |
|
|
|
(17,532 |
) |
|
|
300 |
|
|
|
(8,124 |
) |
|
Change in fair value of
contingent consideration |
Debt-related expenses(2) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
9,918 |
|
|
Debt-related expenses |
Transaction-related expenses(3) |
|
|
— |
|
|
|
— |
|
|
|
2,736 |
|
|
|
— |
|
|
|
8,539 |
|
|
Selling, general and
administrative expenses |
Loss on impairment of intangible assets(4) |
|
|
— |
|
|
|
— |
|
|
|
238,831 |
|
|
|
— |
|
|
|
238,831 |
|
|
Loss on impairment of
intangible assets |
Restructuring costs(5) |
|
|
— |
|
|
|
— |
|
|
|
3,034 |
|
|
|
720 |
|
|
|
3,034 |
|
|
Restructuring charges |
Other(6) |
|
|
(887 |
) |
|
|
(366 |
) |
|
|
1,755 |
|
|
|
2,123 |
|
|
|
967 |
|
|
Multiple |
Adjusted EBITDA
(Non-GAAP) |
|
$ |
5,304 |
|
|
$ |
4,986 |
|
|
$ |
12,911 |
|
|
$ |
17,668 |
|
|
$ |
63,293 |
|
|
|
(1) |
|
The fair value of the contingent consideration is remeasured each
reporting period, with changes in the fair value resulting from
changes in the underlying inputs being recognized as a benefit or
expense in operating expenses until the contingent consideration
arrangement is settled. |
(2) |
|
Debt-related expenses consist of an induced conversion expense of
approximately $8.8 million and direct transaction costs of
approximately $1.1 million incurred as a result of the
privately negotiated exchange of $30.0 million principal amount of
the Company’s 6.5% Convertible Senior Notes due 2027 in the first
quarter of 2023. |
(3) |
|
Represents transaction-related expenses associated with the
acquisition of Spectrum, which closed effective July 31, 2023. |
(4) |
|
Represents the charge in the period for the impairment of
intangible assets resulting from the revaluation of the Company’s
long-lived assets. |
(5) |
|
Restructuring costs represent non-recurring costs associated with
the Company’s announced restructuring plans. |
(6) |
|
Other for the three and nine months ended September 30, 2024
and 2023, and the three months ended June 30, 2024, represents
the following adjustments (in thousands): |
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
|
|
September 30, 2024 |
|
June 30, 2024 |
|
September 30, 2023 |
|
September 30, 2024 |
|
September 30, 2023 |
|
Financial
Statement Classification |
Amortization
of inventory step-up |
|
$ |
— |
|
|
$ |
476 |
|
|
$ |
1,848 |
|
|
$ |
4,564 |
|
|
$ |
2,168 |
|
|
Cost of
sales |
Interest income |
|
|
(887 |
) |
|
|
(842 |
) |
|
|
(605 |
) |
|
|
(2,441 |
) |
|
|
(1,713 |
) |
|
Interest income |
Derivative fair value
adjustment |
|
|
— |
|
|
|
— |
|
|
|
512 |
|
|
|
— |
|
|
|
512 |
|
|
Other gain (loss) |
Total Other |
|
$ |
(887 |
) |
|
$ |
(366 |
) |
|
$ |
1,755 |
|
|
$ |
2,123 |
|
|
$ |
967 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
RECONCILIATION OF GAAP NET LOSS and NET LOSS PER SHARE
TONON-GAAP ADJUSTED EARNINGS and ADJUSTED EARNINGS
PER SHARE(1)(in thousands, except per share
amounts)(unaudited) |
|
|
|
Three Months Ended |
|
September 30, 2024 |
|
June 30, 2024 |
|
September 30, 2023 |
|
Amount |
|
Diluted EPS(2) |
|
Amount |
|
Diluted EPS(2) |
|
Amount |
|
Diluted EPS(2) |
Net loss (GAAP)(2) |
$ |
(2,921 |
) |
|
$ |
(0.03 |
) |
|
$ |
(3,674 |
) |
|
$ |
(0.04 |
) |
|
$ |
(279,544 |
) |
|
$ |
(3.42 |
) |
Add: Convertible debt interest
expense and other income statement impacts, net of tax(2) |
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
Amortization of intangible assets |
|
6,671 |
|
|
|
|
|
6,671 |
|
|
|
|
|
10,184 |
|
|
|
Stock-based compensation |
|
1,296 |
|
|
|
|
|
1,408 |
|
|
|
|
|
1,864 |
|
|
|
Change in fair value of contingent consideration |
|
300 |
|
|
|
|
|
— |
|
|
|
|
|
(17,532 |
) |
|
|
Contingent consideration cash payable(3) |
|
(253 |
) |
|
|
|
|
— |
|
|
|
|
|
(3,590 |
) |
|
|
Transaction-related expenses |
|
— |
|
|
|
|
|
— |
|
|
|
|
|
2,736 |
|
|
|
Loss on impairment of intangible assets(4) |
|
— |
|
|
|
|
|
— |
|
|
|
|
|
238,831 |
|
|
|
Restructuring costs |
|
— |
|
|
|
|
|
— |
|
|
|
|
|
3,034 |
|
|
|
Other |
|
(887 |
) |
|
|
|
|
(366 |
) |
|
|
|
|
1,755 |
|
|
|
Increase in deferred tax asset valuation allowance(5) |
|
— |
|
|
|
|
|
— |
|
|
|
|
|
43,035 |
|
|
|
Income tax benefit expense, as adjusted(6) |
|
(1,782 |
) |
|
|
|
|
(1,928 |
) |
|
|
|
|
387 |
|
|
|
Adjusted earnings
(Non-GAAP) |
$ |
2,424 |
|
|
$ |
0.03 |
|
|
$ |
2,111 |
|
|
$ |
0.02 |
|
|
$ |
1,160 |
|
|
$ |
0.01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted shares used in
calculation (GAAP)(2) |
|
95,352 |
|
|
|
|
|
95,240 |
|
|
|
|
|
81,713 |
|
|
|
Add: Dilutive effect of
stock-based awards and equivalents(2) |
|
933 |
|
|
|
|
|
394 |
|
|
|
|
|
2,191 |
|
|
|
Add: Dilutive effect of 2027
Convertible Notes(2) |
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
Diluted shares used in
calculation (Non-GAAP)(2) |
|
96,285 |
|
|
|
|
|
95,634 |
|
|
|
|
|
83,904 |
|
|
|
(1) |
|
Certain adjustments included here are the same as those reflected
in the Company’s reconciliation of GAAP net loss to non-GAAP
adjusted EBITDA and therefore should be read in conjunction with
that reconciliation and respective footnotes. |
(2) |
|
The Company uses the if-converted method with respect to its
convertible debt to compute GAAP and Non-GAAP diluted earnings per
share when the effect is dilutive. Under the if-converted method,
the Company assumes the 2027 Convertible Notes were converted at
the beginning of each period presented and outstanding. As a
result, interest expense, net of tax, and any other income
statement impact associated with the 2027 Convertible Notes, net of
tax, is added back to net income used in the diluted earnings per
share calculation. |
|
|
For the three months ended September 30, 2024, June 30, 2024, and
September 30, 2023, the Company’s potentially dilutive convertible
debt under the if-converted method and stock-based awards under the
treasury-stock method were not included in the computation of GAAP
net loss and diluted net loss per share, and the potentially
dilutive convertible debt under the if-converted method were not
included in non-GAAP adjusted earnings and adjusted earnings per
share, because to do so would be anti-dilutive. |
|
|
For the three months ended September 30, 2023, the Company’s
potentially dilutive convertible debt under the if-converted method
was not included in the computation of both non-GAAP adjusted
earnings per share and GAAP diluted net loss per share, because to
do so would be anti-dilutive. However, the potentially dilutive
stock-based awards under the treasury-stock method were included in
the computation of non-GAAP adjusted earnings and adjusted earnings
per share because the effect was dilutive. |
(3) |
|
Represents the accrued cash payable, if any, of the INDOCIN
contingent consideration for the respective period based on 20%
royalty for annual INDOCIN net sales over $20.0 million. |
(4) |
|
Represents the charge in the period for the impairment of
intangible assets resulting from the revaluation of the Company’s
long-lived assets. |
(5) |
|
Represents the amount of income tax expense related to the
recognition of a full valuation allowance against deferred tax
assets in the period. |
(6) |
|
Represents the Company’s income tax expense adjustment from the tax
effect of pre-tax adjustments excluded from adjusted earnings. The
tax effect of pre-tax adjustments excluded from adjusted earnings
is computed at the blended federal and state statutory rate of
25%. |
|
|
|
|
RECONCILIATION OF GAAP NET LOSS and NET LOSS PER SHARE
TONON-GAAP ADJUSTED EARNINGS and ADJUSTED EARNINGS
PER SHARE(1)(in thousands, except per share
amounts)(unaudited) |
|
|
|
Nine Months Ended |
|
September 30, 2024 |
|
September 30, 2023 |
|
Amount |
|
Diluted EPS(2) |
|
Amount |
|
Diluted EPS(2) |
Net loss (GAAP)(2) |
$ |
(11,105 |
) |
|
$ |
(0.12 |
) |
|
$ |
(274,558 |
) |
|
$ |
(4.35 |
) |
Add: Convertible debt interest
expense and other income statement impacts, net of tax(2) |
|
— |
|
|
|
|
|
1,969 |
|
|
|
Adjustments: |
|
|
|
|
|
|
|
Amortization of intangible assets |
|
18,973 |
|
|
|
|
|
22,752 |
|
|
|
Legacy products revenue reserves |
|
— |
|
|
|
|
|
(185 |
) |
|
|
Stock-based compensation |
|
3,911 |
|
|
|
|
|
6,516 |
|
|
|
Debt-related expenses, net |
|
— |
|
|
|
|
|
9,639 |
|
|
|
Change in fair value of contingent consideration |
|
300 |
|
|
|
|
|
(8,124 |
) |
|
|
Contingent consideration cash payable(3) |
|
(253 |
) |
|
|
|
|
(11,274 |
) |
|
|
Transaction-related expenses |
|
— |
|
|
|
|
|
8,539 |
|
|
|
Loss on impairment of intangible assets(4) |
|
— |
|
|
|
|
|
238,831 |
|
|
|
Restructuring costs |
|
720 |
|
|
|
|
|
3,034 |
|
|
|
Other |
|
2,123 |
|
|
|
|
|
967 |
|
|
|
Increase in deferred tax asset valuation allowance(5) |
|
— |
|
|
|
|
|
43,035 |
|
|
|
Income tax benefit expense, as adjusted(6) |
|
(6,444 |
) |
|
|
|
|
(5,556 |
) |
|
|
Adjusted earnings
(Non-GAAP) |
$ |
8,225 |
|
|
$ |
0.09 |
|
|
$ |
35,585 |
|
|
$ |
0.46 |
|
|
|
|
|
|
|
|
|
Diluted shares used in
calculation (GAAP)(2) |
|
95,191 |
|
|
|
|
|
63,066 |
|
|
|
Add: Dilutive effect of
stock-based awards and equivalents(2) |
|
503 |
|
|
|
|
|
3,770 |
|
|
|
Add: Dilutive effect of 2027
Convertible Notes(2) |
|
— |
|
|
|
|
|
11,324 |
|
|
|
Diluted shares used in
calculation (Non-GAAP)(2) |
|
95,694 |
|
|
|
|
|
78,160 |
|
|
|
(1) |
|
Certain adjustments included here are the same as those reflected
in the Company’s reconciliation of GAAP net loss to non-GAAP
adjusted EBITDA and therefore should be read in conjunction with
that reconciliation and respective footnotes. |
(2) |
|
The Company uses the if-converted method with respect to its
convertible debt to compute GAAP and Non-GAAP diluted earnings per
share when the effect is dilutive. Under the if-converted method,
the Company assumes the 2027 Convertible Notes were converted at
the beginning of each period presented and outstanding. As a
result, interest expense, net of tax, and any other income
statement impact associated with the 2027 Convertible Notes, net of
tax, is added back to net income used in the diluted earnings per
share calculation. |
|
|
For the nine months ended September 30, 2024, the Company’s
potentially dilutive convertible debt under the if-converted method
and stock-based awards under the treasury-stock method were not
included in the computation of GAAP net loss and diluted net loss
per share, and the potentially dilutive convertible debt under the
if-converted method were not included in non-GAAP adjusted earnings
and adjusted earnings per share, because to do so would be
anti-dilutive. However, the potentially dilutive stock-based awards
under the treasury-stock method were included in the computation of
non-GAAP adjusted earnings and adjusted earnings per share because
the effect was dilutive. |
|
|
For the nine months ended September 30, 2023, the Company’s
potentially dilutive convertible debt under the if-converted method
and stock-based awards under the treasury-stock method were not
included in the computation of GAAP diluted net income per share,
because to do so would be anti-dilutive. However, the potentially
dilutive convertible debt under the if-converted method and
stock-based awards under the treasury-stock method were included in
the computation of non-GAAP adjusted earnings and adjusted earnings
per share because the effect was dilutive. |
(3) |
|
Represents the accrued cash payable, if any, of the INDOCIN
contingent consideration for the respective period based on 20%
royalty for annual INDOCIN net sales over $20.0 million. |
(4) |
|
Represents the charge in the period for the impairment of
intangible assets resulting from the revaluation of the Company’s
long-lived assets. |
(5) |
|
Represents the amount of income tax expense related to the
recognition of a full valuation allowance against deferred tax
assets in the period. |
(6) |
|
Represents the Company’s income tax expense adjustment from the tax
effect of pre-tax adjustments excluded from adjusted earnings. The
tax effect of pre-tax adjustments excluded from adjusted earnings
is computed at the blended federal and state statutory rate of
25%. |
|
|
|
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