8-K
Lantheus Holdings, Inc. (LNTH)
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): July 28, 2021
LANTHEUS HOLDINGS, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-36569 | 35-2318913 | |||
|---|---|---|---|---|---|
| (State or other jurisdiction<br>of incorporation) | (Commission<br>File Number) | (IRS Employer<br>Identification No.) | 331 Treble Cove Road, North Billerica, MA | 01862 | |
| --- | --- | ||||
| (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):
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common stock, par value $0.01 per share | LNTH | The Nasdaq Global Market |
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 July 28, 2021, Lantheus Holdings, Inc. (the “Company”) announced via press release its financial results as of and for the three and six months ended June 30, 2021. 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* | Press release of Lantheus Holdings, Inc. dated July 28, 2021, entitled "Lantheus Holdings, Inc. Reports Second Quarter 2021 Financial Results" |
| 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: July 28, 2021
Document
Exhibit 99.1
| 331 Treble Cove Road<br>North Billerica, MA 01862 | 800.362.2668<br>www.lantheus.com |
|---|
Lantheus Holdings, Inc. Reports Second Quarter 2021 Financial Results
•Worldwide revenue of $101.1 million for the second quarter 2021, representing an increase of 53.1% from the prior year period
• GAAP net loss of $26.7 million for the second quarter 2021, compared to GAAP net loss of $7.0 million in the prior year period
• GAAP fully diluted net loss of $0.39 for the second quarter 2021, compared to GAAP fully diluted net loss of $0.16 in the prior year period; adjusted fully diluted EPS of $0.11 for the second quarter 2021, compared to adjusted fully diluted EPS of $0.10 in the prior year period
• Net cash provided by operating activities was $25.9 million for the second quarter 2021. Free cash flow was $23.2 million in the second quarter 2021
•The Company provides third quarter 2021 revenue and adjusted diluted earnings per share guidance; increases full year guidance
NORTH BILLERICA, MA., July 28, 2021 - Lantheus Holdings, Inc. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to find, fight and follow serious medical conditions, today reported financial results for its second quarter ended June 30, 2021.
The Company’s worldwide revenue for the second quarter of 2021 totaled $101.1 million, compared with $66.0 million for the second quarter of 2020, representing an increase of 53.1% from the prior year period.
The Company’s second quarter 2021 GAAP net loss was $26.7 million, or $0.39 per fully diluted share, as compared to GAAP net loss of $7.0 million, or $0.16 per fully diluted share for the second quarter of 2020.
The Company’s second quarter 2021 adjusted fully diluted earnings per share were $0.11, as compared to $0.10 for the second quarter of 2020, representing an increase of 8.1% from the prior year period.
Lastly, net cash provided by operating activities was $25.9 million for the second quarter 2021. Free Cash Flow was $23.2 million in the second quarter of 2021, representing an increase of approximately $27.6 million from the prior year period.
“Our second quarter was highlighted by the FDA approval of PYLARIFY, the first and only commercially available PSMA PET imaging agent for prostate cancer, and the strong performance of DEFINITY which exceeded pre COVID-19 levels,” said Mary Anne Heino, President and Chief Executive Officer. “With the investments Lantheus has made and continues to make in the business, we’ve laid the foundation to take full advantage of our diversified portfolio of products. We remain committed to delivering on our financial commitments while positively impacting the lives of the patients we serve and delivering shareholder value.”
Outlook
The Company updates its guidance for full year 2021 and offers the following guidance for the third quarter.
| Q3 Guidance Issued July 28, 2021 | Previous Guidance Issued May 4, 2021 | |
|---|---|---|
| Q3 FY 2021 Revenue | $95 million - $100 million | N/A |
| Q3 FY 2021 Adjusted Diluted EPS | $0.05 - $0.07 | N/A |
| FY Guidance Updated July 28, 2021 | FY Guidance Issued May 4, 2021 | |
| FY 2021 Revenue | $395 million - $402 million | $390 million - $400 million |
| FY 2021 Adjusted Diluted EPS | $0.38 - $0.42 | $0.36 - $0.41 |
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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 (including liability accruals relating to the contingent value rights issued as part of the Progenics Pharmaceuticals, Inc. acquisition), 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
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 Wednesday, July 28, 2021 at 8:00 a.m. ET. To access the live conference call via telephone, please dial 1-866-498-8390 (U.S. callers) or 1-678-509-7599 (international callers) and provide passcode 6149638. A live webcast will be available in the Investors section of the Company’s website at www.lantheus.com.
A replay of the audio webcast will be available in the Investors section of our website at www.lantheus.com approximately two hours after completion of the call and will be archived for 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.
Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc. and EXINI Diagnostics AB and an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find Fight and Follow® serious medical conditions. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, 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,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “will” 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,
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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) the impact of the global COVID-19 pandemic on our business, financial conditions and prospects, and on the timing and enrollment of our clinical trials; (ii) continued market expansion and penetration for our commercial products, particularly DEFINITY, in the face of segment competition and potential generic competition, including as a result of patent and regulatory exclusivity expirations; (iii) our ability to successfully launch PYLARIFY as a commercial product, including (A) our ability to obtain U.S. Food and Drug Administration approval for additional PET manufacturing facilities (“PMFs”) that could manufacture PYLARIFY, (B) the ability of those PMFs to supply PYLARIFY to customers, and (C) our ability to sell PYLARIFY to customers; (iv) the global Molybdenum-99 supply; (v) our products manufactured at Jubilant HollisterStier and our recently-approved modified formulation of DEFINITY (“DEFINITY RT”) to be commercially manufactured at Samsung Biologics; (vi) the continued integration of the Progenics products and product candidate portfolio into our business following the Progenics Acquisition; (vii) our ability to use in-house manufacturing capacity; (viii) the efforts and timing for commercialization of products or new clinical applications for our products that we or our strategic partners may develop, including flurpiridaz F 18; (ix) our ability to develop highly contextualized assessments of disease burden using artificial intelligence (“AI”); 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 <br>June 30, | Six Months Ended <br>June 30, | |||||||
|---|---|---|---|---|---|---|---|---|
| 2021 | 2020 | 2021 | 2020 | |||||
| Revenues | $ | 101,064 | $ | 66,010 | $ | 193,573 | $ | 156,714 |
| Cost of goods sold | 54,976 | 40,162 | 106,455 | 92,864 | ||||
| Gross profit | 46,088 | 25,848 | 87,118 | 63,850 | ||||
| Operating expenses | ||||||||
| Sales and marketing | 17,631 | 6,305 | 31,804 | 16,435 | ||||
| General and administrative | 43,177 | 20,670 | 59,315 | 37,369 | ||||
| Research and development | 12,061 | 4,418 | 22,421 | 8,466 | ||||
| Total operating expenses | 72,869 | 31,393 | 113,540 | 62,270 | ||||
| Gain on sale of assets | — | — | 15,263 | — | ||||
| Operating (loss) income | (26,781) | (5,545) | (11,159) | 1,580 | ||||
| Interest expense | 1,937 | 1,914 | 4,655 | 3,860 | ||||
| Gain on extinguishment of debt | — | — | (889) | — | ||||
| Other income | (182) | (756) | (731) | (1,106) | ||||
| Loss before income taxes | (28,536) | (6,703) | (14,194) | (1,174) | ||||
| Income tax (benefit) expense | (1,879) | 309 | 3,455 | 2,501 | ||||
| Net loss | $ | (26,657) | $ | (7,012) | $ | (17,649) | $ | (3,675) |
| Net loss per common share: | ||||||||
| Basic | $ | (0.39) | $ | (0.16) | $ | (0.26) | $ | (0.09) |
| Diluted | $ | (0.39) | $ | (0.16) | $ | (0.26) | $ | (0.09) |
| Weighted-average common shares outstanding: | ||||||||
| Basic | 67,505 | 43,135 | 67,300 | 41,284 | ||||
| Diluted | 67,505 | 43,135 | 67,300 | 41,284 |
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Lantheus Holdings, Inc.
Consolidated Revenues Analysis
(in thousands – unaudited)
| Three Months Ended <br>June 30, | Six Months Ended <br>June 30, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2021 | 2020 (1) | % Change | 2021 | 2020 (1) | % Change | |||||||
| DEFINITY | $ | 59,842 | $ | 37,125 | 61.2 | % | $ | 115,813 | $ | 89,630 | 29.2 | % |
| TechneLite | 23,772 | 18,668 | 27.3 | % | 46,572 | 41,447 | 12.4 | % | ||||
| Other precision diagnostics | 6,742 | 7,140 | (5.6) | % | 13,726 | 20,197 | (32.0) | % | ||||
| Total precision diagnostics | 90,356 | 62,933 | 43.6 | % | 176,111 | 151,274 | 16.4 | % | ||||
| Radiopharmaceutical oncology | 2,812 | 2,183 | 28.8 | % | 4,312 | 4,151 | 3.9 | % | ||||
| Strategic partnerships and other | 7,896 | 894 | 783.2 | % | 13,150 | 1,289 | 920.2 | % | ||||
| Total revenues | $ | 101,064 | $ | 66,010 | 53.1 | % | $ | 193,573 | $ | 156,714 | 23.5 | % |
________________________________
1.The Company reclassified rebates and allowances of $3.5 million and $8.2 million within each product category, which included $3.2 million and $7.5 million for DEFINITY, $0.3 million and $0.6 million for TechneLite and zero and $0.1 million for other precision diagnostics, for the three and six months ended June 30, 2020, respectively.
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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 <br>June 30, | Six Months Ended <br>June 30, | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2021 | 2020 | 2021 | 2020 | |||||||||||||||||||
| Net loss | $ | (26,657) | $ | (7,012) | $ | (17,649) | $ | (3,675) | ||||||||||||||
| Stock and incentive plan compensation | 4,588 | 3,385 | 7,905 | 6,460 | ||||||||||||||||||
| Amortization of acquired intangible assets | 6,074 | 927 | 10,759 | 1,319 | ||||||||||||||||||
| Acquired debt fair value adjustment | — | — | (307) | — | ||||||||||||||||||
| Contingent consideration fair value adjustments | 25,600 | — | 25,900 | — | ||||||||||||||||||
| Non-recurring refinancing related fees | — | 460 | — | 460 | ||||||||||||||||||
| Non-recurring severance related fees | 92 | — | 528 | — | ||||||||||||||||||
| Extinguishment of debt | — | — | (889) | — | ||||||||||||||||||
| Gain on sale of assets | — | — | (15,263) | — | ||||||||||||||||||
| Integration costs | 11 | 1,201 | 30 | 3,573 | ||||||||||||||||||
| Acquisition-related costs | 767 | 7,517 | 664 | 8,929 | ||||||||||||||||||
| Impairment of long-lived assets | — | — | — | 7,275 | ||||||||||||||||||
| Other | 43 | — | 53 | (75) | ||||||||||||||||||
| Income tax effect of non-GAAP adjustments(a) | (2,731) | (1,940) | (648) | (5,446) | ||||||||||||||||||
| Adjusted net income | $ | 7,787 | $ | 4,538 | $ | 11,083 | $ | 18,820 | ||||||||||||||
| Adjusted net income, as a percentage of revenues | 7.7 | % | 6.9 | % | 5.7 | % | 12.0 | % | Three Months Ended <br>June 30, | Six Months Ended <br>June 30, | ||||||||||||
| --- | --- | --- | --- | --- | --- | --- | --- | --- | ||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||||||||
| Net loss per share - diluted | $ | (0.39) | $ | (0.16) | $ | (0.26) | $ | (0.09) | ||||||||||||||
| Stock and incentive plan compensation | 0.07 | 0.08 | 0.12 | 0.14 | ||||||||||||||||||
| Amortization of acquired intangible assets | 0.08 | 0.02 | 0.16 | 0.03 | ||||||||||||||||||
| Acquired debt fair value adjustment | — | — | (0.01) | — | ||||||||||||||||||
| Contingent consideration fair value adjustments | 0.37 | — | 0.38 | — | ||||||||||||||||||
| Non-recurring refinancing related fees | — | 0.01 | — | 0.01 | ||||||||||||||||||
| Non-recurring severance related fees | — | — | 0.01 | — | ||||||||||||||||||
| Extinguishment of debt | — | — | (0.01) | — | ||||||||||||||||||
| Gain on sale of assets | — | — | (0.23) | — | ||||||||||||||||||
| Integration costs | — | 0.03 | — | 0.09 | ||||||||||||||||||
| Acquisition-related costs | 0.02 | 0.18 | 0.01 | 0.22 | ||||||||||||||||||
| Impairment of long-lived assets | — | — | — | 0.18 | ||||||||||||||||||
| Other | — | — | — | — | ||||||||||||||||||
| Income tax effect of non-GAAP adjustments(a) | (0.04) | (0.06) | (0.01) | (0.13) | ||||||||||||||||||
| Adjusted net income per share - diluted | $ | 0.11 | $ | 0.10 | $ | 0.16 | $ | 0.45 | ||||||||||||||
| Weighted-average common shares outstanding - diluted | 68,705 | 43,303 | 68,281 | 41,702 |
(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 <br>June 30, | Six Months Ended <br>June 30, | |||||||
|---|---|---|---|---|---|---|---|---|
| 2021 | 2020 | 2021 | 2020 | |||||
| Net cash provided by (used in) operating activities | $ | 25,869 | $ | (2,156) | $ | 35,687 | $ | 7,252 |
| Capital expenditures | (2,656) | (2,255) | (5,176) | (4,953) | ||||
| Free cash flow | $ | 23,213 | $ | (4,411) | $ | 30,511 | $ | 2,299 |
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Lantheus Holdings, Inc.
Condensed Consolidated Balance Sheets
(in thousands – unaudited)
| June 30,<br>2021 | December 31,<br>2020 | |||
|---|---|---|---|---|
| Assets | ||||
| Current assets | ||||
| Cash and cash equivalents | $ | 91,500 | $ | 79,612 |
| Accounts receivable, net | 54,892 | 54,002 | ||
| Inventory | 31,719 | 35,744 | ||
| Other current assets | 8,102 | 9,625 | ||
| Assets held for sale | — | 5,242 | ||
| Total current assets | 186,213 | 184,225 | ||
| Property, plant and equipment, net | 118,493 | 120,171 | ||
| Intangibles, net | 365,259 | 376,012 | ||
| Goodwill | 61,189 | 58,632 | ||
| Deferred tax assets, net | 64,777 | 70,147 | ||
| Other long-term assets | 61,871 | 60,634 | ||
| Total assets | $ | 857,802 | $ | 869,821 |
| Liabilities and stockholders’ equity | ||||
| Current liabilities | ||||
| Current portion of long-term debt and other borrowings | $ | 10,372 | $ | 20,701 |
| Accounts payable | 21,471 | 16,284 | ||
| Accrued expenses and other liabilities | 41,983 | 41,726 | ||
| Liabilities held for sale | — | 1,793 | ||
| Total current liabilities | 73,826 | 80,504 | ||
| Asset retirement obligations | 14,797 | 14,020 | ||
| Long-term debt, net and other borrowings | 169,249 | 197,699 | ||
| Other long-term liabilities | 91,790 | 63,393 | ||
| Total liabilities | 349,662 | 355,616 | ||
| Total stockholders’ equity | 508,140 | 514,205 | ||
| Total liabilities and stockholders’ equity | $ | 857,802 | $ | 869,821 |
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Contacts:
Mark Kinarney
Senior Director, Investor Relations
978-671-8842
ir@lantheus.com
Melissa Downs
Director, Corporate Communications
646-975-2533
media@lantheus.com
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