UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 3, 2022
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||
| (Address of principal executive offices) | (Zip Code) | |||||||
Registrant’s telephone number, including area code: (978 ) 671-8001
Not Applicable | ||
| (Former name or former address, if changed since last report.) | ||
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02. Results of Operations and Financial Condition.
On November 3, 2022 , Lantheus Holdings, Inc. (the “Company”) announced via press release its financial results as of and for the three and nine months ended September 30, 2022. A copy of that press release is being furnished as Exhibit 99.1 and is hereby incorporated by reference.
The information furnished pursuant to this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities under that Section and shall not be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |||||||
| 99.1* | ||||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |||||||
* Exhibit 99.1 attached hereto is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| LANTHEUS HOLDINGS, INC. | |||||
By: | /s/ Daniel M. Niedzwiecki | ||||
Name: | Daniel M. Niedzwiecki | ||||
Title: | Senior Vice President and General Counsel | ||||
Date: November 3, 2022
Exhibit 99.1
 | 331 Treble Cove Road North Billerica, MA 01862 | 800.362.2668 www.lantheus.com | ||||||
Lantheus Reports Third Quarter 2022 Financial Results
•Worldwide revenue of $239.3 million for the third quarter 2022, representing an increase of 134.4% from the prior year period
•GAAP net income of $61.2 million for the third quarter 2022, compared to GAAP net loss of $13.4 million in the prior year period
•GAAP fully diluted net income per share of $0.86 for the third quarter 2022, compared to GAAP fully diluted net loss per share of $0.20 in the prior year period; adjusted fully diluted net income per share of $0.99 for the third quarter 2022, compared to adjusted fully diluted net income per share of $0.08 in the prior year period
•Net cash provided by operating activities was $93.6 million for the third quarter 2022. Free cash flow was $87.5 million in the third quarter 2022
•The Company provides fourth quarter 2022 revenue and adjusted diluted earnings per share guidance; increases full year guidance
NORTH BILLERICA, MA., November 3, 2022 - Lantheus Holdings, Inc. (NASDAQ: LNTH) (Lantheus), a company committed to improving patient outcomes through diagnostics, radiotherapeutics and artificial intelligence solutions that enable clinicians to Find, Fight and Follow disease, today reported financial results for its third quarter ended September 30, 2022.
The Company’s worldwide revenue for the third quarter of 2022 totaled $239.3 million, compared with $102.1 million for the third quarter of 2021, representing an increase of 134.4% from the prior year period.
The Company’s third quarter 2022 GAAP net income was $61.2 million, or $0.86 per fully diluted share, as compared to GAAP net loss of $13.4 million, or $0.20 per fully diluted share for the third quarter of 2021.
The Company’s third quarter 2022 adjusted fully diluted net income per share, or earnings per share ("EPS"), were $0.99, as compared to $0.08 for the third quarter of 2021, representing an increase of approximately $0.91 from the prior year period.
Lastly, net cash provided by operating activities was $93.6 million for the third quarter 2022. Free Cash Flow was $87.5 million in the third quarter of 2022, representing an increase of approximately $85.6 million from the prior year period.
“This quarter, we executed on our strategy and delivered outstanding results,” said Mary Anne Heino, President and Chief Executive Officer. “Through the dedicated efforts of our employees, we grew our market-leading franchises while also investing in our business. As we plan for the future, we believe our leading franchises and strong balance sheet will help us to drive sustainable growth.”
The Company updates its guidance for full year 2022 and offers the following guidance for the fourth quarter:
Q4 Guidance Issued November 3, 2022 | Previous Guidance Issued August 4, 2022 | |||||||||||||
Q4 FY 2022 Revenue | $243 million - $247 million | N/A | ||||||||||||
Q4 FY 2022 Adjusted Fully Diluted EPS | $0.95 - $0.98 | N/A | ||||||||||||
FY Guidance Updated November 3, 2022 | FY Guidance Issued August 4, 2022 | |||||||||||||
FY 2022 Revenue | $915 million - $919 million | $885 million - $905 million | ||||||||||||
FY 2022 Adjusted Fully Diluted EPS | $3.80 - $3.83 | $3.50 - $3.60 | ||||||||||||
On a forward-looking basis, the Company does not provide GAAP income per common share guidance or a reconciliation of adjusted fully diluted EPS to GAAP income per common share because the Company is unable to predict with reasonable certainty business development and acquisition related expenses, purchase accounting fair value adjustments, and any one-time, non-recurring charges. These items are uncertain, depend on various factors, and could be material to results computed in accordance with GAAP. As a result, it is the Company’s view that a quantitative reconciliation of adjusted fully diluted EPS on a forward-looking basis is not available without unreasonable effort.
Internet Posting of Information
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The Company routinely posts information that may be important to investors in the “Investors” section of its website at www.lantheus.com. The Company encourages investors and potential investors to consult its website regularly for important information about the Company.
Conference Call and Webcast
As previously announced, the Company will host a conference call and webcast on Thursday, November 3, 2022, at 8:00 a.m. ET. To access the conference call or webcast, participants should register online at https://investor.lantheus.com/news-events/calendar-of-events.
A replay will be available approximately two hours after completion of the webcast and will be archived on the same web page for at least 30 days.
The conference call will include a discussion of non-GAAP financial measures. Reference is made to the most directly comparable GAAP financial measures, the reconciliation of the differences between the two financial measures, and the other information included in this press release, our Form 8-K filed with the SEC today, or otherwise available in the Investor Relations section of our website located at www.lantheus.com.
The conference call may include forward-looking statements. See the cautionary information about forward-looking statements in the safe-harbor section of this press release.
About Lantheus Holdings, Inc.
With more than 60 years of experience in delivering life-changing science, Lantheus is committed to improving patient outcomes through diagnostics, radiotherapeutics and artificial intelligence solutions that enable clinicians to Find, Fight and Follow disease. Lantheus is headquartered in Massachusetts and has offices in New Jersey, Canada and Sweden. For more information, visit www.lantheus.com.
Non-GAAP Financial Measures
The Company uses non-GAAP financial measures, such as adjusted net income and its line components; adjusted net income per share - fully diluted; and free cash flow. The Company’s management believes that the presentation of these measures provides useful information to investors. These measures may assist investors in evaluating the Company’s operations, period over period. However, these measures may exclude items that may be highly variable, difficult to predict and of a size that could have a substantial impact on the Company’s reported results of operations for a particular period. Management uses these and other non-GAAP measures internally for evaluation of the performance of the business, including the allocation of resources and the evaluation of results relative to employee performance compensation targets. Investors should consider these non-GAAP measures only as a supplement to, not as a substitute for or as superior to, measures of financial performance prepared in accordance with GAAP.
Safe Harbor for Forward-Looking and Cautionary Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as “anticipate,” “believe,” “confident,” “continue,” “could,” “estimate,” “expect,” “guidance,” “intend,” “introduce,” “may,” “momentum,” “plan,” “predict,” “progress,” “project,” “promising,” “target,” “will,” “would” and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include: (i) our ability to continue to grow PYLARIFY as a commercial product, including (A) our ability to obtain FDA approval for additional positron emission tomography (“PET”) manufacturing facilities (“PMFs”) to manufacture PYLARIFY, (B) the ability of PMFs to manufacture PYLARIFY to meet product demand, (C) our ability to sell PYLARIFY to customers, (D) our ability to obtain and maintain adequate coding, coverage and payment for PYLARIFY, and (E) our ability to establish PYLARIFY as a leading PSMA PET imaging agent in an increasingly competitive environment in which other PSMA PET imaging agents have been approved and additional ones are in development; (ii) continued market expansion and penetration for our established commercial products, particularly DEFINITY, in the face of segment competition and potential generic competition, including as a result of patent and regulatory exclusivity expirations and challenges; (iii) the global Molybdenum-99 (“Mo-99”) supply; (iv) our ability to have third party manufacturers manufacture our products and our ability to manufacture DEFINITY in our in-house manufacturing facility; (v) our ability to successfully launch PYLARIFY AI as a commercial product; (vi) the continuing impact of the global COVID-19 pandemic on our business, supply chain, financial conditions and prospects; (vii) the efforts and timing for clinical development and regulatory approval of our product candidates and new clinical applications and territories for our products, in each case, that we may develop, including 1095 and NM-01, or that our strategic partners may develop, including piflufolastat F 18 in Europe and flurpiridaz fluorine-18 (“F 18”); (viii) our ability to identify and acquire or in-license additional diagnostic
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and therapeutic product opportunities in oncology and other strategic areas; (ix) the potential reclassification by the FDA of certain of our products and product candidates from drugs to devices with the expense, complexity and potentially more limited competitive protection such reclassification could cause; and (x) the risk and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q).
- Tables Follow -
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Lantheus Holdings, Inc.
Consolidated Statements of Operations
(in thousands, except per share data – unaudited)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||||||||||||
| Revenues | $ | 239,292 | $ | 102,073 | $ | 671,895 | $ | 295,646 | ||||||||||||||||||
| Cost of goods sold | 91,859 | 59,404 | 257,363 | 165,859 | ||||||||||||||||||||||
| Gross profit | 147,433 | 42,669 | 414,532 | 129,787 | ||||||||||||||||||||||
| Operating expenses | ||||||||||||||||||||||||||
| Sales and marketing | 25,414 | 17,195 | 73,260 | 48,999 | ||||||||||||||||||||||
| General and administrative | 23,759 | 28,550 | 93,945 | 87,865 | ||||||||||||||||||||||
| Research and development | 12,517 | 11,252 | 39,455 | 33,673 | ||||||||||||||||||||||
| Total operating expenses | 61,690 | 56,997 | 206,660 | 170,537 | ||||||||||||||||||||||
| Gain on sale of assets | — | — | — | 15,263 | ||||||||||||||||||||||
| Operating income (loss) | 85,743 | (14,328) | 207,872 | (25,487) | ||||||||||||||||||||||
| Interest expense | 1,626 | 1,569 | 4,604 | 6,224 | ||||||||||||||||||||||
| Gain on extinguishment of debt | — | — | — | (889) | ||||||||||||||||||||||
| Other income | 1,101 | 3,940 | 306 | 3,209 | ||||||||||||||||||||||
| Income (loss) before income taxes | 83,016 | (19,837) | 202,962 | (34,031) | ||||||||||||||||||||||
| Income tax expense (benefit) | 21,784 | (6,422) | 55,710 | (2,967) | ||||||||||||||||||||||
| Net income (loss) | $ | 61,232 | $ | (13,415) | $ | 147,252 | $ | (31,064) | ||||||||||||||||||
| Net income (loss) per common share: | ||||||||||||||||||||||||||
| Basic | $ | 0.89 | $ | (0.20) | $ | 2.15 | $ | (0.46) | ||||||||||||||||||
| Diluted | $ | 0.86 | $ | (0.20) | $ | 2.08 | $ | (0.46) | ||||||||||||||||||
| Weighted-average common shares outstanding: | ||||||||||||||||||||||||||
| Basic | 68,756 | 67,623 | 68,482 | 67,409 | ||||||||||||||||||||||
| Diluted | 71,075 | 67,623 | 70,669 | 67,409 | ||||||||||||||||||||||
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Lantheus Holdings, Inc.
Consolidated Revenues Analysis
(in thousands – unaudited)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||||||||||||||||
| 2022 | 2021 | % Change | 2022 | 2021 | % Change | |||||||||||||||||||||||||||||||||
| DEFINITY | $ | 60,740 | $ | 57,636 | 5.4 | % | $ | 181,374 | $ | 173,448 | 4.6 | % | ||||||||||||||||||||||||||
| TechneLite | 22,094 | 22,680 | (2.6) | % | 64,139 | 69,252 | (7.4) | % | ||||||||||||||||||||||||||||||
| Other precision diagnostics | 6,175 | 7,563 | (18.4) | % | 16,803 | 21,289 | (21.1) | % | ||||||||||||||||||||||||||||||
| Total precision diagnostics | 89,009 | 87,879 | 1.3 | % | 262,316 | 263,989 | (0.6) | % | ||||||||||||||||||||||||||||||
| PYLARIFY | 143,754 | 7,724 | N/A | 366,763 | 7,997 | N/A | ||||||||||||||||||||||||||||||||
| Other radiopharmaceutical oncology | 928 | 1,166 | (20.4) | % | 3,183 | 5,206 | (38.9) | % | ||||||||||||||||||||||||||||||
| Total radiopharmaceutical oncology | 144,682 | 8,890 | 1,527.5 | % | 369,946 | 13,203 | 2702.0 | % | ||||||||||||||||||||||||||||||
| Strategic Partnerships and other revenue | 5,601 | 5,304 | 5.6 | % | 39,633 | 18,454 | 114.8 | % | ||||||||||||||||||||||||||||||
| Total revenues | $ | 239,292 | $ | 102,073 | 134.4 | % | $ | 671,895 | $ | 295,646 | 127.3 | % | ||||||||||||||||||||||||||
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Lantheus Holdings, Inc.
Reconciliation of GAAP to Non-GAAP Financial Measures
(in thousands, except per share data – unaudited)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||||||||||||
| Net income (loss) | $ | 61,232 | $ | (13,415) | $ | 147,252 | $ | (31,064) | ||||||||||||||||||
| Stock and incentive plan compensation | 8,103 | 3,867 | 21,138 | 11,772 | ||||||||||||||||||||||
| Amortization of acquired intangible assets | 8,306 | 8,374 | 24,918 | 19,133 | ||||||||||||||||||||||
| Acquired debt fair value adjustment | — | — | — | (307) | ||||||||||||||||||||||
| Contingent consideration fair value adjustments | (1,500) | 2,600 | 25,400 | 28,500 | ||||||||||||||||||||||
| Non-recurring severance related fees | — | (6) | — | 522 | ||||||||||||||||||||||
| Non-recurring fees | — | — | (384) | — | ||||||||||||||||||||||
| Extinguishment of debt | — | — | — | (889) | ||||||||||||||||||||||
| Gain on sale of assets | — | — | — | (15,263) | ||||||||||||||||||||||
| Strategic collaboration and license costs | — | — | 500 | — | ||||||||||||||||||||||
| Integration costs | — | 63 | — | 93 | ||||||||||||||||||||||
| Acquisition-related costs | 169 | 62 | 868 | 726 | ||||||||||||||||||||||
| Impairment of long-lived assets | — | 9,540 | — | 9,540 | ||||||||||||||||||||||
| ARO Acceleration and other related costs | 1,287 | — | 3,087 | — | ||||||||||||||||||||||
| Other | 106 | 7 | 111 | 60 | ||||||||||||||||||||||
Income tax effect of non-GAAP adjustments(a) | (7,038) | (5,411) | (21,512) | (6,059) | ||||||||||||||||||||||
| Adjusted net income | $ | 70,665 | $ | 5,681 | $ | 201,378 | $ | 16,764 | ||||||||||||||||||
| Adjusted net income, as a percentage of revenues | 29.5 | % | 5.6 | % | 30.0 | % | 5.7 | % | ||||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||||||||||||
| Net income (loss) per share - diluted | $ | 0.86 | $ | (0.20) | $ | 2.08 | $ | (0.46) | ||||||||||||||||||
| Stock and incentive plan compensation | 0.11 | 0.05 | 0.30 | 0.18 | ||||||||||||||||||||||
| Amortization of acquired intangible assets | 0.12 | 0.12 | 0.36 | 0.28 | ||||||||||||||||||||||
| Acquired debt fair value adjustment | — | — | — | (0.01) | ||||||||||||||||||||||
| Contingent consideration fair value adjustments | (0.02) | 0.04 | 0.36 | 0.42 | ||||||||||||||||||||||
| Non-recurring severance related fees | — | — | — | 0.01 | ||||||||||||||||||||||
| Non-recurring fees | — | — | (0.01) | — | ||||||||||||||||||||||
| Extinguishment of debt | — | — | — | (0.01) | ||||||||||||||||||||||
| Gain on sale of assets | — | — | — | (0.23) | ||||||||||||||||||||||
| Strategic collaboration and license costs | — | — | 0.01 | — | ||||||||||||||||||||||
| Integration costs | — | — | — | — | ||||||||||||||||||||||
| Acquisition-related costs | — | 0.01 | 0.01 | 0.01 | ||||||||||||||||||||||
| Impairment of long-lived assets | — | 0.14 | — | 0.14 | ||||||||||||||||||||||
| ARO Acceleration and other related costs | 0.02 | — | 0.04 | — | ||||||||||||||||||||||
| Other | — | — | — | — | ||||||||||||||||||||||
Income tax effect of non-GAAP adjustments(a) | (0.10) | (0.08) | (0.30) | (0.09) | ||||||||||||||||||||||
| Adjusted net income per share - diluted | $ | 0.99 | $ | 0.08 | $ | 2.85 | $ | 0.24 | ||||||||||||||||||
| Weighted-average common shares outstanding - diluted | 71,075 | 69,237 | 70,669 | 68,674 | ||||||||||||||||||||||
(a)The income tax effect of the adjustments between GAAP net loss and non-GAAP adjusted net income takes into account the tax treatment and related tax rate that apply to each adjustment in the applicable tax jurisdiction.
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Lantheus Holdings, Inc.
Reconciliation of Free Cash Flow
(in thousands – unaudited)
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
| Net cash provided by operating activities | $ | 93,568 | $ | 4,340 | $ | 176,429 | $ | 40,027 | |||||||||||||||
| Capital expenditures | (6,090) | (2,420) | (13,623) | (7,596) | |||||||||||||||||||
| Free cash flow | $ | 87,478 | $ | 1,920 | $ | 162,806 | $ | 32,431 | |||||||||||||||
| Net cash (used in) provided by investing activities | $ | (6,090) | $ | (2,420) | $ | (11,823) | $ | 8,227 | |||||||||||||||
| Net cash used in financing activities | $ | (1,959) | $ | (1,726) | $ | (6,149) | $ | (37,232) | |||||||||||||||
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Lantheus Holdings, Inc.
Condensed Consolidated Balance Sheets
(in thousands – unaudited)
| September 30, 2022 | December 31, 2021 | ||||||||||
| Assets | |||||||||||
| Current assets | |||||||||||
| Cash and cash equivalents | $ | 257,259 | $ | 98,508 | |||||||
| Accounts receivable, net | 197,276 | 89,336 | |||||||||
| Inventory | 34,793 | 35,129 | |||||||||
| Other current assets | 12,570 | 12,818 | |||||||||
| Total current assets | 501,898 | 235,791 | |||||||||
| Property, plant and equipment, net | 120,826 | 116,772 | |||||||||
| Intangibles, net | 323,591 | 348,510 | |||||||||
| Goodwill | 61,189 | 61,189 | |||||||||
| Deferred tax assets, net | 46,806 | 62,764 | |||||||||
| Other long-term assets | 41,628 | 38,758 | |||||||||
| Total assets | $ | 1,095,938 | $ | 863,784 | |||||||
| Liabilities and stockholders’ equity | |||||||||||
| Current liabilities | |||||||||||
| Current portion of long-term debt and other borrowings | $ | 15,372 | $ | 11,642 | |||||||
| Accounts payable | 30,135 | 20,787 | |||||||||
| Accrued expenses and other liabilities | 190,477 | 58,068 | |||||||||
| Total current liabilities | 235,984 | 90,497 | |||||||||
| Asset retirement obligations | 23,358 | 20,833 | |||||||||
| Long-term debt, net and other borrowings | 152,057 | 163,121 | |||||||||
| Other long-term liabilities | 46,489 | 124,894 | |||||||||
| Total liabilities | 457,888 | 399,345 | |||||||||
| Total stockholders’ equity | 638,050 | 464,439 | |||||||||
| Total liabilities and stockholders’ equity | $ | 1,095,938 | $ | 863,784 | |||||||
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###
Contacts:
Mark Kinarney
Vice President, Investor Relations
978-671-8842
ir@lantheus.com
Melissa Downs
Senior Director, Corporate Communications
646-975-2533
media@lantheus.com
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