ANI Pharmaceuticals Reports Third Quarter 2022 Financial Results; Reports Record Net Revenues
Third Quarter 2022 Results:
-- Net revenues of
-- Adjusted non-GAAP EBITDA of
-- Year-over-year net revenue growth of 61% resulting in record quarterly net revenues --
-- Lead Rare Disease asset, Purified Cortrophin® Gel (Repository Corticotrophin Injection USP) 80 U/ml (Cortrophin) net sales of
Full-Year 2022 Guidance:
-- Reiterates total Company net revenue guidance of
Company Highlights:
-- Achieved strong Cortrophin revenue growth with 765+ cases initiated by 380 unique prescribers; continued expansion in market access and investment in launch initiatives --
-- Launched several limited-competition new products; completed acquisition of four ANDAs from
-- Consolidation of manufacturing network on track with expected closing of
-- Built out leadership team with the appointments of
“Our third quarter results reflect clarity in our strategy and strong focus on operational execution. We are pleased to share that ANI delivered record net revenues of
“Our Generics business revenues grew 51% over the prior year on the strength of our acquisition execution and success in bringing several limited-competition drugs to market. We continue to invest in our Generics and 505(b)(2) R&D platform to fuel future growth. These internal efforts are supplemented through business development opportunities, such as the acquisition of four abbreviated new drug applications from
Third Quarter 2022 Financial Highlights:
-
Net revenues were
$83.8 million compared to$52.1 million in Q3 2021. -
GAAP net loss available to common shareholders was
$(9.0) million , and diluted GAAP loss per share was$(0.55) . -
Adjusted non-GAAP EBITDA was
$19.6 million compared to$16.6 million in Q3 2021. -
Adjusted non-GAAP diluted earnings per share was
$0.64 , compared to diluted earnings per share of$1.01 in Q3 2021. -
Cash and cash equivalents were
$56.3 million , net accounts receivable was$140.4 million , and face value of debt was$297.8 million as ofSeptember 30, 2022 .
Cortrophin Launch Update:
The Company is reiterating its 2022 revenue guidance for Cortrophin of between
Key highlights (as of
- Launch Trajectory: Cumulative new patient cases initiated increased by more than 50% to 765+ cases. The Company made further investments in its hub, patient support services and distribution network.
- Physician Interest: The prescriber base increased by greater than 50% since the Company’s last report to 380 unique prescribers and approximately one third of the prescribers have written more than one prescription. Prescriptions continue to be distributed across our targeted specialties.
- Patient Access: The Company remains focused on market access and bringing savings to the healthcare system. Our efforts continue to yield improved access for patients across the country.
Generics Growth Engine Update:
Sales of generic pharmaceuticals products grew 51% year-over-year in the third quarter. The Company continued to focus on bringing limited-competition products to market and driving cost competitiveness.
- Focus on R&D Excellence: During the first nine months of 2022, ANI filed 11 ANDAs and in the third quarter successfully launched multiple limited-competition products, including Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg; and Acebutolol Hydrochloride Capsules. The Company continues to invest significantly in R&D and initiated work on several new product development projects to fuel future growth.
-
Operational Synergies: The previously announced plan to consolidate manufacturing operations and cease operations at the
Oakville, Ontario, Canada manufacturing facility in the first quarter of 2023 is on track. The Company has begun manufacturing and packaging manyOakville products in ourU.S. facilities and is beginning to recognize the operational efficiencies from this initiative. The Company is actively engaged and has made meaningful progress with potential buyers forOakville . Once fully executed, this operational efficiency is expected to improve profitability and cash flow by$7 million to$8 million on an annualized basis. The Company currently expects one-time cash charges of approximately$2.7 million and non-cash charges of$4.4 million in conjunction with this action. - Business Development: The Company continues to be active on the business development front, completing the acquisition of four limited-competition ANDAs from Oakrum Pharma in July.
Third Quarter 2022 Financial Results
|
Three Months Ended |
||||||||||||||
| (in thousands) |
2022 |
2021 |
Change |
% Change |
||||||||||
| Generics, Established Brands, and Other Segment | ||||||||||||||
| Generic pharmaceutical products |
$ |
53,136 |
$ |
35,140 |
$ |
17,996 |
|
51.2 |
|
% |
||||
| Established brand pharmaceutical products |
|
9,816 |
|
14,313 |
|
(4,497 |
) |
(31.4 |
) |
% |
||||
| Contract manufacturing |
|
4,779 |
|
2,382 |
|
2,397 |
|
100.6 |
|
% |
||||
| Royalty and other |
|
3,488 |
|
226 |
|
3,262 |
|
NM |
|
(1) |
||||
| Generics, established brands, and other segment total net revenues |
$ |
71,219 |
$ |
52,061 |
$ |
19,158 |
|
36.8 |
|
% |
||||
| Rare Disease Segment | ||||||||||||||
| Rare disease pharmaceutical products |
$ |
12,602 |
|
— |
$ |
12,602 |
|
NM |
|
(1) |
||||
| Total net revenues |
$ |
83,821 |
$ |
52,061 |
$ |
31,760 |
|
61.0 |
|
% |
||||
|
(1) Not meaningful. |
||||||||||||||
Net revenues for generic pharmaceutical products were
Net revenues for established brand pharmaceutical products were
Contract manufacturing revenues were
Royalty and other revenues were
Net revenues of rare disease pharmaceutical products, which consist entirely of sales of Cortrophin, were
Operating expenses increased by 60% to
Cost of sales, excluding depreciation and amortization, increased by
Research and development expenses were
Selling, general and administrative expenses increased to
Depreciation and amortization increased by 25% in the third quarter of 2022 to
Net loss available to common shareholders for the third quarter of 2022 was
Adjusted non-GAAP diluted earnings per share was
For reconciliations of adjusted non-GAAP EBITDA and adjusted non-GAAP diluted earnings per share to the most directly comparable GAAP financial measure, please see Table 3 and Table 4, respectively.
Liquidity
As of
2022 Guidance
The Company reiterates its 2022 guidance:
- Net Revenue between
- Cortrophin Net Revenue between
- Adjusted non-GAAP EBITDA between
- Adjusted non-GAAP Diluted Earnings per Share between
Conference Call
As previously announced, ANI management will host its third quarter 2022 conference call as follows:
|
Date |
|
|
||||
|
Time |
|
|
||||
|
Toll free ( |
|
800-245-3047 |
||||
|
Global |
|
203-518-9765 |
Webcast (live and replay) www.anipharmaceuticals.com, under the “Investors” section
A replay of the conference call will be available within two hours of the call’s completion and will remain accessible for one week by dialing 800-753-6120 and entering access code 1159760.
Non-GAAP Financial Measures
Adjusted non-GAAP EBITDA
ANI’s management considers adjusted non-GAAP EBITDA to be an important financial indicator of ANI’s operating performance, providing investors and analysts with a useful measure of operating results unaffected by non-cash stock-based compensation and differences in capital structures, tax structures, capital investment cycles, ages of related assets, and compensation structures among otherwise comparable companies. Management uses adjusted non-GAAP EBITDA when analyzing Company performance.
Adjusted non-GAAP EBITDA is defined as net (loss)/income, excluding tax expense or benefit, interest expense, (net), other expense, (net), depreciation, amortization, the excess of fair value over cost of acquired inventory, non-cash stock-based compensation expense, Novitium transaction expenses, Cortrophin pre-launch charges, contingent consideration fair value adjustment, and certain other items that vary in frequency and impact on ANI’s results of operations. Adjusted non-GAAP EBITDA should be considered in addition to, but not in lieu of, net income or loss reported under GAAP. A reconciliation of adjusted non-GAAP EBITDA to the most directly comparable GAAP financial measure is provided below.
ANI is not providing a reconciliation for the forward-looking full year 2022 adjusted EBITDA guidance because it does not currently have sufficient information to accurately estimate all of the variables and individual adjustments for such reconciliation, including “with” and “without” tax provision information. As such, ANI’s management cannot estimate on a forward-looking basis without unreasonable effort the impact these variables and individual adjustments will have on its reported results.
Adjusted non-GAAP Net (Loss)/Income
ANI’s management considers adjusted non-GAAP net (loss)/income to be an important financial indicator of ANI’s operating performance, providing investors and analysts with a useful measure of operating results unaffected by the excess of fair value over cost of acquired inventory sold, non-cash stock-based compensation, non-cash interest expense, depreciation and amortization, Cortrophin pre-launch charges, Novitium transaction expenses, contingent consideration fair value adjustment, and certain other items that vary in frequency and impact on ANI’s results of operations. Management uses adjusted non-GAAP net (loss)/income when analyzing Company performance.
Adjusted non-GAAP net (loss)/income is defined as net (loss)/income, plus the excess of fair value over cost of acquired inventory sold, non-cash stock-based compensation expense, Novitium transaction expenses, non-cash interest expense, depreciation and amortization expense, Cortrophin pre-launch charges, contingent consideration fair value adjustment, and certain other items that vary in frequency and impact on ANI’s results of operations, less the tax impact of these adjustments calculated using an estimated statutory tax rate. Management will continually analyze this metric and may include additional adjustments in the calculation in order to provide further understanding of ANI’s results. Adjusted non-GAAP net (loss)/income should be considered in addition to, but not in lieu of, net (loss)/income reported under GAAP. A reconciliation of adjusted non-GAAP net (loss)/income to the most directly comparable GAAP financial measure is provided below.
Adjusted non-GAAP Diluted (Loss)/Earnings per Share
ANI’s management considers adjusted non-GAAP diluted (loss)/earnings per share to be an important financial indicator of ANI’s operating performance, providing investors and analysts with a useful measure of operating results unaffected by the excess of fair value over cost of acquired inventory sold, non-cash stock-based compensation, non-cash interest expense, depreciation and amortization, Cortrophin pre-launch charges, Novitium transaction expenses, contingent consideration fair value adjustment, and certain other items that vary in frequency and impact on ANI’s results of operations. Management uses adjusted non-GAAP diluted (loss)/earnings per share when analyzing Company performance.
Adjusted non-GAAP diluted (loss)/earnings per share is defined as adjusted non-GAAP net (loss)/income, as defined above, divided by the diluted weighted average shares outstanding during the period. Management will continually analyze this metric and may include additional adjustments in the calculation in order to provide further understanding of ANI’s results. Adjusted non-GAAP diluted (loss)/earnings per share should be considered in addition to, but not in lieu of, diluted earnings or loss per share reported under GAAP. A reconciliation of adjusted non-GAAP diluted (loss)/earnings per share to the most directly comparable GAAP financial measure is provided below.
About
Forward-Looking Statements
To the extent any statements made in this release deal with information that is not historical, these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, those relating to the commercialization and potential sales of the product and any additional product launches from the Company’s generic pipeline, other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “plans,” “potential,” “future,” “believes,” “intends,” “continue,” other words of similar meaning, derivations of such words and the use of future dates.
Uncertainties and risks may cause the Company’s actual results to be materially different than those expressed in or implied by such forward-looking statements. Uncertainties and risks include, but are not limited to, the costs involved in commercializing Cortrophin, the ability to maintain regulatory approval of the product and maintain sufficiency of the product, the ability to obtain reimbursement from third-party payors for this product, evolving government legislation, the opinions and views of key opinion leaders and physicians who treat patients with chronic diseases and who may prescribe Cortrophin, ANI’s ability to generate projected net product revenue and gain market share on the timeline expected, actions taken by competitors in response to a new market entrant; the ability of the Company to successfully maintain manufacturing capabilities and adequate commercial quantities of Cortrophin at acceptable costs and quality levels; broad acceptance of Cortrophin by physicians, patients and the healthcare community; the acceptance of pricing and placement of Cortrophin on payers’ formularies; risks the Company may face with respect to importing raw materials and delays in delivery of raw materials and other ingredients and supplies necessary for the manufacture of our products from both domestic and overseas sources due to supply chain disruptions or for any other reason; the use of single source suppliers and the time it may take to validate and qualify another supplier, if necessary; manufacturing difficulties or delays, ANI’s reliance on third parties over which it may not always have full control, increased competition and strategies employed by competitors; the ability to realize benefits anticipated from acquisitions, including but not limited to, the Oakrum product acquisition and post-close integration activities related to the Novitium acquisition; disruptions to our operations resulting from the ongoing shutdown and sale process relating to our
More detailed information on these and additional factors that could affect the Company’s actual results are described in the Company’s filings with the
|
|
||||||||||||||||
|
Table 1: US GAAP Statement of Operations |
||||||||||||||||
|
(unaudited, in thousands, except per share amounts) |
||||||||||||||||
|
Three Months Ended |
Nine Months Ended |
|||||||||||||||
|
2022 |
2021 |
2022 |
2021 |
|||||||||||||
| Net Revenues |
$ |
83,821 |
|
$ |
52,061 |
|
$ |
222,153 |
|
$ |
155,207 |
|
||||
| Operating Expenses: | ||||||||||||||||
| Cost of sales (excl. depreciation and amortization) |
|
32,894 |
|
|
24,413 |
|
|
102,459 |
|
|
66,712 |
|
||||
| Research and development |
|
7,657 |
|
|
2,456 |
|
|
17,096 |
|
|
8,229 |
|
||||
| Selling, general, and administrative |
|
30,081 |
|
|
17,181 |
|
|
90,856 |
|
|
53,588 |
|
||||
| Depreciation and amortization |
|
14,167 |
|
|
11,346 |
|
|
42,488 |
|
|
33,568 |
|
||||
| Contingent consideration fair value adjustment |
|
2,476 |
|
|
- |
|
|
2,134 |
|
|
- |
|
||||
| Legal settlement expense |
|
- |
|
|
- |
|
|
- |
|
|
8,400 |
|
||||
| Purified Cortrophin Gel pre-launch charges |
|
- |
|
|
227 |
|
|
- |
|
|
780 |
|
||||
| Restructuring activities |
|
1,541 |
|
|
- |
|
|
4,111 |
|
|
- |
|
||||
| Intangible asset impairment charge |
|
- |
|
|
- |
|
|
112 |
|
|
- |
|
||||
| Total Operating Expenses |
|
88,816 |
|
|
55,623 |
|
|
259,256 |
|
|
171,277 |
|
||||
| Operating Loss |
|
(4,995 |
) |
|
(3,562 |
) |
|
(37,103 |
) |
|
(16,070 |
) |
||||
| Other Expense, net | ||||||||||||||||
| Interest expense, net |
|
(7,264 |
) |
|
(2,497 |
) |
|
(20,546 |
) |
|
(7,482 |
) |
||||
| Other income/(expense), net |
|
37 |
|
|
(1,071 |
) |
|
712 |
|
|
(1,653 |
) |
||||
| Loss Before Benefit for Income Taxes |
|
(12,222 |
) |
|
(7,130 |
) |
|
(56,937 |
) |
|
(25,205 |
) |
||||
| Benefit for income taxes |
|
3,622 |
|
|
2,683 |
|
|
13,284 |
|
|
6,738 |
|
||||
| Net Loss |
$ |
(8,600 |
) |
$ |
(4,447 |
) |
$ |
(43,653 |
) |
$ |
(18,467 |
) |
||||
| Dividends on Series A Convertible Preferred Stock |
|
(406 |
) |
|
- |
|
|
(1,218 |
) |
|
- |
|
||||
| Net Loss Available to Common Shareholders |
$ |
(9,006 |
) |
$ |
(4,447 |
) |
$ |
(44,871 |
) |
$ |
(18,467 |
) |
||||
| Basic and Diluted Loss Per Share: | ||||||||||||||||
| Basic Loss Per Share |
$ |
(0.55 |
) |
$ |
(0.37 |
) |
$ |
(2.76 |
) |
$ |
(1.53 |
) |
||||
| Diluted Loss Per Share |
$ |
(0.55 |
) |
$ |
(0.37 |
) |
$ |
(2.76 |
) |
$ |
(1.53 |
) |
||||
| Basic Weighted-Average Shares Outstanding |
|
16,303 |
|
|
12,107 |
|
|
16,238 |
|
|
12,066 |
|
||||
| Diluted Weighted-Average Shares Outstanding |
|
16,303 |
|
|
12,107 |
|
|
16,238 |
|
|
12,066 |
|
||||
|
|
||||||||
|
Table 2: US GAAP Balance Sheets |
||||||||
|
(unaudited, in thousands) |
||||||||
|
2022 |
2021 |
|||||||
| Current Assets | ||||||||
| Cash and cash equivalents |
$ |
56,281 |
|
$ |
100,300 |
|
||
| Accounts receivable, net |
|
140,433 |
|
|
128,526 |
|
||
| Inventories, net |
|
95,893 |
|
|
81,693 |
|
||
| Prepaid income taxes |
|
3,778 |
|
|
3,667 |
|
||
| Assets held for sale |
|
8,020 |
|
|
- |
|
||
| Prepaid expenses and other current assets |
|
4,972 |
|
|
7,589 |
|
||
| Total Current Assets |
|
309,377 |
|
|
321,775 |
|
||
| Non-current Assets | ||||||||
| Property and equipment |
|
72,935 |
|
|
75,627 |
|
||
| Accumulated depreciation |
|
(30,105 |
) |
|
(22,956 |
) |
||
| Property and equipment, net |
|
42,830 |
|
|
52,671 |
|
||
| Restricted cash |
|
5,003 |
|
|
5,001 |
|
||
| Deferred tax assets, net of deferred tax liabilities and valuation allowance |
|
77,340 |
|
|
67,936 |
|
||
| Intangible assets, net |
|
264,237 |
|
|
294,122 |
|
||
|
|
28,221 |
|
|
27,888 |
|
|||
| Derivatives and other non-current assets |
|
12,102 |
|
|
2,205 |
|
||
| Total Assets |
$ |
739,110 |
|
$ |
771,598 |
|
||
| Current Liabilities | ||||||||
| Current debt, net of deferred financing costs |
$ |
850 |
|
$ |
850 |
|
||
| Accounts payable |
|
18,992 |
|
|
22,967 |
|
||
| Accrued royalties |
|
6,585 |
|
|
6,225 |
|
||
| Accrued compensation and related expenses |
|
7,745 |
|
|
8,522 |
|
||
| Accrued government rebates |
|
8,745 |
|
|
5,492 |
|
||
| Returned goods reserve |
|
33,984 |
|
|
35,831 |
|
||
| Accrued expenses and other |
|
4,726 |
|
|
7,650 |
|
||
| Total Current Liabilities |
|
81,627 |
|
|
87,537 |
|
||
| Non-current Liabilities | ||||||||
| Non-current debt, net of deferred financing costs and current component |
|
285,882 |
|
|
286,520 |
|
||
| Non-current contingent consideration |
|
33,434 |
|
|
31,000 |
|
||
| Derivatives and other non-current liabilities |
|
1,492 |
|
|
7,801 |
|
||
| Total Liabilities |
$ |
402,435 |
|
$ |
412,858 |
|
||
| Mezzanine Equity | ||||||||
| Convertible preferred stock, Series A |
|
24,850 |
|
|
24,850 |
|
||
| Stockholders' Equity | ||||||||
| Common stock |
|
1 |
|
|
1 |
|
||
|
|
(4,975 |
) |
|
(3,135 |
) |
|||
| Additional paid-in capital |
|
399,396 |
|
|
387,844 |
|
||
| Accumulated deficit |
|
(92,636 |
) |
|
(47,765 |
) |
||
| Accumulated other comprehensive income/(loss), net of tax |
|
10,039 |
|
|
(3,055 |
) |
||
| Total Stockholders' Equity |
|
311,825 |
|
|
333,890 |
|
||
| Total Liabilities, Mezzanine Equity, and Stockholders' Equity |
$ |
739,110 |
|
$ |
771,598 |
|
||
|
|
|||||||||||||||||||||||||||||||||||||||||
|
Table 3: Adjusted non-GAAP EBITDA Calculation and US GAAP to Non-GAAP Reconciliation |
|||||||||||||||||||||||||||||||||||||||||
|
(unaudited, in thousands) |
|||||||||||||||||||||||||||||||||||||||||
|
Reconciliation of certain adjusted non-GAAP accounts: |
|||||||||||||||||||||||||||||||||||||||||
|
Net Revenues |
Cost of sales (excl. depreciation and amortization) |
Selling, general, and administrative expenses |
Research and development expenses |
||||||||||||||||||||||||||||||||||||||
|
Three Months Ended
|
Three Months Ended
|
Three Months Ended
|
Three Months Ended
|
Three Months Ended
|
|||||||||||||||||||||||||||||||||||||
|
2022 |
2021 |
2022 |
2021 |
2022 |
2021 |
2022 |
2021 |
2022 |
2021 |
||||||||||||||||||||||||||||||||
| Net Loss |
$ |
(8,600 |
) |
$ |
(4,447 |
) |
As reported: |
$ |
83,821 |
|
$ |
52,061 |
$ |
32,894 |
|
$ |
24,413 |
|
$ |
30,081 |
|
$ |
17,181 |
|
$ |
7,657 |
|
$ |
2,456 |
|
|||||||||||
| Add/(Subtract): | |||||||||||||||||||||||||||||||||||||||||
| Interest expense, net |
|
7,264 |
|
|
2,497 |
|
|||||||||||||||||||||||||||||||||||
| Other (income)/expense, net (1) |
|
(37 |
) |
|
2,271 |
|
|||||||||||||||||||||||||||||||||||
| Benefit for income taxes |
|
(3,622 |
) |
|
(2,683 |
) |
|||||||||||||||||||||||||||||||||||
| Depreciation and amortization |
|
14,167 |
|
|
11,346 |
|
|||||||||||||||||||||||||||||||||||
| Contingent consideration fair value adjustment |
|
2,476 |
|
|
- |
|
|||||||||||||||||||||||||||||||||||
| Restructuring activities |
|
1,541 |
|
|
- |
|
|||||||||||||||||||||||||||||||||||
| Impact of |
|
840 |
|
|
- |
|
Impact of |
|
(969 |
) |
|
- |
|
(681 |
) |
|
- |
|
|
(1,052 |
) |
|
- |
|
|
(76 |
) |
|
- |
|
|||||||||||
| Cortrophin pre-launch charges and sales & marketing expenses(3) |
|
- |
|
|
2,192 |
|
Cortrophin pre-launch charges and sales & marketing expenses(3) |
|
- |
|
|
- |
|
- |
|
|
- |
|
|
- |
|
|
(1,965 |
) |
|
- |
|
|
- |
|
|||||||||||
| Stock-based compensation |
|
3,869 |
|
|
2,807 |
|
Stock-based compensation |
|
- |
|
|
- |
|
(149 |
) |
|
(5 |
) |
|
(3,524 |
) |
|
(2,653 |
) |
|
(196 |
) |
|
(149 |
) |
|||||||||||
| Excess of fair value over cost of acquired inventory |
|
443 |
|
|
2,225 |
|
Excess of fair value over cost of acquired inventory |
|
- |
|
|
- |
|
(443 |
) |
|
(2,225 |
) |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|||||||||||
| Novitium transaction expenses |
|
59 |
|
|
431 |
|
Novitium transaction expenses |
|
- |
|
|
- |
|
- |
|
|
- |
|
|
(59 |
) |
|
(431 |
) |
|
- |
|
|
- |
|
|||||||||||
| In-process research and development charge |
|
1,151 |
|
|
- |
|
In-process research and development charge |
|
- |
|
|
- |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
(1,151 |
) |
|
- |
|
|||||||||||
| Adjusted non-GAAP EBITDA |
$ |
19,551 |
|
$ |
16,639 |
|
As adjusted: |
$ |
82,852 |
|
$ |
52,061 |
$ |
31,621 |
|
$ |
22,183 |
|
$ |
25,446 |
|
$ |
12,132 |
|
$ |
6,234 |
|
$ |
2,307 |
|
|||||||||||
|
(1) Adjustment to other (income)/expense, net excludes |
|||||||||||||||||||||||||||||||||||||||||
|
(2) Impact of |
|||||||||||||||||||||||||||||||||||||||||
|
(3) Beginning in 2022, we no longer adjust for "Cortrophin pre-launch charges and sales and marketing expenses" in arriving at Adjusted non-GAAP EBITDA. |
|||||||||||||||||||||||||||||||||||||||||
|
Reconciliation of certain adjusted non-GAAP accounts: |
|||||||||||||||||||||||||||||||||||||||||
|
Net Revenues |
Cost of sales (excl. depreciation and amortization) |
Selling, general, and administrative expenses |
Research and development expenses |
||||||||||||||||||||||||||||||||||||||
|
Nine Months Ended
|
Nine Months Ended
|
Nine Months Ended
|
Nine Months Ended
|
Nine Months Ended
|
|||||||||||||||||||||||||||||||||||||
|
2022 |
2021 |
2022 |
2021 |
2022 |
2021 |
2022 |
2021 |
2022 |
2021 |
||||||||||||||||||||||||||||||||
| Net Loss |
$ |
(43,653 |
) |
$ |
(18,467 |
) |
As reported: |
$ |
222,153 |
|
$ |
155,207 |
$ |
102,459 |
|
$ |
66,712 |
|
$ |
90,856 |
|
$ |
53,588 |
|
$ |
17,096 |
|
$ |
8,229 |
|
|||||||||||
| Add/(Subtract): | |||||||||||||||||||||||||||||||||||||||||
| Interest expense, net |
|
20,546 |
|
|
7,482 |
|
|||||||||||||||||||||||||||||||||||
| Other (income)/expense, net(1) |
|
38 |
|
|
2,853 |
|
|||||||||||||||||||||||||||||||||||
| Benefit for income taxes |
|
(13,284 |
) |
|
(6,738 |
) |
|||||||||||||||||||||||||||||||||||
| Depreciation and amortization |
|
42,488 |
|
|
33,568 |
|
|||||||||||||||||||||||||||||||||||
| Contingent consideration fair value adjustment |
|
2,134 |
|
|
- |
|
|||||||||||||||||||||||||||||||||||
| Legal settlement expense |
|
- |
|
|
8,400 |
|
|||||||||||||||||||||||||||||||||||
| Intangible asset impairment charge |
|
112 |
|
|
- |
|
|||||||||||||||||||||||||||||||||||
| Restructuring activities |
|
4,111 |
|
|
- |
|
|||||||||||||||||||||||||||||||||||
| Impact of |
|
2,661 |
|
|
- |
|
Impact of |
|
(2,014 |
) |
|
- |
|
(1,930 |
) |
|
- |
|
|
(2,598 |
) |
|
- |
|
|
(147 |
) |
|
- |
|
|||||||||||
| Cortrophin pre-launch charges and sales & marketing expenses(3) |
|
- |
|
|
5,236 |
|
Cortrophin pre-launch charges and sales & marketing expenses(3) |
|
- |
|
|
- |
|
- |
|
|
- |
|
|
- |
|
|
(4,456 |
) |
|
- |
|
|
- |
|
|||||||||||
| Stock-based compensation |
|
10,862 |
|
|
7,520 |
|
Stock-based compensation |
|
- |
|
|
- |
|
(442 |
) |
|
(15 |
) |
|
(9,858 |
) |
|
(7,082 |
) |
|
(562 |
) |
|
(423 |
) |
|||||||||||
| Excess of fair value over cost of acquired inventory |
|
5,246 |
|
|
3,717 |
|
Excess of fair value over cost of acquired inventory |
|
- |
|
|
- |
|
(5,246 |
) |
|
(3,717 |
) |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|||||||||||
| Novitium transaction expenses |
|
1,276 |
|
|
5,064 |
|
Novitium transaction expenses |
|
- |
|
|
- |
|
- |
|
|
- |
|
|
(1,276 |
) |
|
(5,064 |
) |
|
- |
|
|
- |
|
|||||||||||
| In-process research and development charge |
|
1,151 |
|
|
- |
|
In-process research and development charge |
|
- |
|
|
- |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
(1,151 |
) |
|
- |
|
|||||||||||
| Adjusted non-GAAP EBITDA |
$ |
33,688 |
|
$ |
48,635 |
|
As adjusted: |
$ |
220,139 |
|
$ |
155,207 |
$ |
94,841 |
|
$ |
62,980 |
|
$ |
77,124 |
|
$ |
36,986 |
|
$ |
15,236 |
|
$ |
7,806 |
|
|||||||||||
|
(1) Adjustment to other (income)/expense, net excludes |
|||||||||||||||||||||||||||||||||||||||||
|
(2) Impact of |
|||||||||||||||||||||||||||||||||||||||||
|
(3) Beginning in 2022, we no longer adjust for "Cortrophin pre-launch charges and sales and marketing expenses" in arriving at Adjusted non-GAAP EBITDA. |
|||||||||||||||||||||||||||||||||||||||||
|
Table 4: Adjusted non-GAAP Net Income and Adjusted non-GAAP Diluted Earnings per Share Reconciliation |
||||||||||||||||
|
(unaudited, in thousands, except per share amounts) |
||||||||||||||||
|
Three Months Ended |
Nine Months Ended |
|||||||||||||||
|
2022 |
2021 |
2022 |
2021 |
|||||||||||||
| Net Loss Available to Common Shareholders |
$ |
(9,006 |
) |
$ |
(4,447 |
) |
$ |
(44,871 |
) |
$ |
(18,467 |
) |
||||
| Add/(Subtract): | ||||||||||||||||
| Non-cash interest expense |
|
963 |
|
|
559 |
|
|
2,883 |
|
|
1,644 |
|
||||
| Depreciation and amortization expense |
|
14,167 |
|
|
11,346 |
|
|
42,488 |
|
|
33,568 |
|
||||
| Contingent consideration fair value adjustment |
|
2,476 |
|
|
- |
|
|
2,134 |
|
|
- |
|
||||
| Restructuring activities |
|
1,541 |
|
|
- |
|
|
4,111 |
|
|
- |
|
||||
| Legal settlement expense |
|
- |
|
|
- |
|
|
- |
|
|
8,400 |
|
||||
| Intangible asset impairment charge |
|
- |
|
|
- |
|
|
112 |
|
|
- |
|
||||
| Impact of |
|
840 |
|
|
- |
|
|
2,661 |
|
|
- |
|
||||
| Cortrophin pre-launch charges and sales & marketing expenses(2) |
|
- |
|
|
2,192 |
|
|
- |
|
|
5,236 |
|
||||
| Stock-based compensation |
|
3,869 |
|
|
2,807 |
|
|
10,862 |
|
|
7,520 |
|
||||
| Excess of fair value over cost of acquired inventory |
|
443 |
|
|
2,225 |
|
|
5,246 |
|
|
3,717 |
|
||||
| Credit facility ticking fee expense |
|
- |
|
|
2,434 |
|
|
- |
|
|
2,434 |
|
||||
| Novitium transaction expenses |
|
59 |
|
|
431 |
|
|
1,276 |
|
|
5,064 |
|
||||
| In-process research and development charge |
|
1,151 |
|
|
- |
|
|
1,151 |
|
|
- |
|
||||
| Less: | ||||||||||||||||
| Estimated tax impact of adjustments (calc. at 24%) |
|
(6,122 |
) |
|
(5,279 |
) |
|
(17,502 |
) |
|
(16,220 |
) |
||||
| Adjusted non-GAAP Net Income Available to Common Shareholders |
$ |
10,381 |
|
$ |
12,269 |
|
$ |
10,551 |
|
$ |
32,896 |
|
||||
| Diluted Weighted-Average | ||||||||||||||||
| Shares Outstanding |
|
16,303 |
|
|
12,107 |
|
|
16,238 |
|
|
12,066 |
|
||||
| Adjusted Diluted Weighted-Average | ||||||||||||||||
| Shares Outstanding |
|
16,317 |
|
|
12,119 |
|
|
16,252 |
|
|
12,080 |
|
||||
| Adjusted non-GAAP | ||||||||||||||||
| Diluted Earnings per Share |
$ |
0.64 |
|
$ |
1.01 |
|
$ |
0.65 |
|
$ |
2.72 |
|
||||
| (1) Impact of |
||||
| (2) Beginning in 2022, we no longer adjust for "Cortrophin pre-launch charges and sales and marketing expenses" in arriving at Adjusted non-GAAP Net Loss. |
View source version on businesswire.com: https://www.businesswire.com/news/home/20221109005289/en/
Investors:
212-452-2793
lwilson@insitecony.com
Media:
817-807-8044
Faith.pomeroyward@anipharmaceuticals.com
Source: