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 5, 2020
(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 5, 2020, Lantheus Holdings, Inc. (the “Company”) announced via press release its financial results as of and for the three and nine months ended September 30, 2020. 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* | ||||||||
* 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/ Michael P. Duffy | ||||
Name: | Michael P. Duffy | ||||
Title: | Senior Vice President and General Counsel | ||||
Date: November 5, 2020
Exhibit 99.1
 | 331 Treble Cove Road North Billerica, MA 01862 | 800.362.2668 www.lantheus.com | ||||||
Lantheus Holdings, Inc. Reports Third Quarter 2020 Financial Results
•Worldwide revenue of $88.5 million for the third quarter 2020, representing an increase of 3.2% from the prior year period
•Net loss of $6.4 million for the third quarter 2020, compared to net income of $4.9 million in the prior year period
•GAAP diluted EPS of $(0.10) for the third quarter 2020, compared to GAAP diluted EPS of $0.12 in the prior year period; adjusted diluted EPS of $0.04 for the third quarter 2020, compared to adjusted diluted EPS of $0.28 in the prior year period
•Net cash provided by operating activities was $8.6 million for the third quarter 2020. Free cash flow was $4.8 million in the third quarter 2020
NORTH BILLERICA, MA., November 5, 2020 - Lantheus Holdings, Inc. (the “Company”) (NASDAQ: LNTH), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, today reported financial results for its third quarter ended September 30, 2020.
The Company’s worldwide revenue for the third quarter of 2020 totaled $88.5 million, compared with $85.8 million for the third quarter of 2019, representing an increase of 3.2% from the prior year period.
The Company’s third quarter 2020 net loss was $6.4 million, or $(0.10) per fully diluted share, as compared to net income of $4.9 million, or $0.12 per fully diluted share for the third quarter of 2019.
The Company’s third quarter 2020 adjusted fully diluted earnings per share were $0.04, as compared to $0.28 for the third quarter of 2019, representing a decrease of 87.1% from the prior year period.
Lastly, net cash provided by operating activities was $8.6 million for the third quarter 2020. Free Cash Flow was $4.8 million in the third quarter of 2020, representing a decrease of approximately $18.3 million from the prior year period.
“We continued to see steady recovery throughout the quarter primarily driven by DEFINITY and complemented by accelerated synergy capture, delivering a strong adjusted EPS performance,” said Mary Anne Heino, President and CEO. “Importantly, despite increased investment during the quarter related to our newly-combined business and our on-going integration efforts, we generated positive free cash flow. We remain committed to executing on our corporate initiatives even during these unprecedented times. In our first quarter as an integrated company, we received approval for VIALMIXRFID and submitted the NDA for our PSMA-targeted PET imaging agent, PyL. We believe these accomplishments and our continued financial discipline position us to drive sustainable future growth and enhanced shareholder value.”
Outlook
On April 9, 2020, the Company withdrew full year 2020 revenue, revenue growth, and adjusted fully diluted earnings per share guidance as a result of the continued uncertainties surrounding the scope, duration and impacts of the COVID-19 pandemic. Due to these uncertainties, and uncertain timing of global recovery and economic normalization, the Company continues to be unable to provide guidance as to the overall impacts on its operations and financial results during the ongoing pandemic.
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 Thursday, November 5, 2020 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 8872902. A live webcast will be available in the Investors section of the Company’s website at www.lantheus.com.
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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 a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; 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, Puerto Rico, 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, 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 or prospects, or 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 as a result of patent and regulatory exclusivity expirations; (iii) the global Molybdenum-99 supply; (iv) our products manufactured at Jubilant HollisterStier and our plans to develop a modified formulation of DEFINITY with Samsung Biologics; (v) our efforts in new product development, including for PyL, the Progenics prostate cancer diagnostic imaging agent, including our ability to obtain FDA approval of PyL in 2021, and new clinical applications for our products; (vi) our dependence upon third parties for the manufacture and supply of PyL and the timing of that manufacturing capacity becoming available; (vii) the continued integration of the Progenics product and product candidate portfolio following the consummation of the Progenics transaction; (viii) our capacity to use in-house manufacturing; and (ix) our ability to commercialize our products in new ex-U.S. markets; (x) the expected timing for commercialization of products we or our strategic partners may develop, including flurpiridaz F 18; (xi) our ability to develop highly contextualized assessments of disease burden using PSMA AI and (xii) 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, | |||||||||||||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||||||||||||
| Revenues | $ | 88,544 | $ | 85,776 | $ | 245,258 | $ | 257,991 | ||||||||||||||||||
| Cost of goods sold | 52,284 | 44,187 | 145,148 | 127,745 | ||||||||||||||||||||||
| Gross profit | 36,260 | 41,589 | 100,110 | 130,246 | ||||||||||||||||||||||
| Operating expenses | ||||||||||||||||||||||||||
| Sales and marketing | 11,609 | 10,151 | 28,044 | 31,496 | ||||||||||||||||||||||
| General and administrative | 18,217 | 18,061 | 55,586 | 43,943 | ||||||||||||||||||||||
| Research and development | 11,684 | 4,860 | 20,150 | 15,584 | ||||||||||||||||||||||
| Total operating expenses | 41,510 | 33,072 | 103,780 | 91,023 | ||||||||||||||||||||||
| Operating (loss) income | (5,250) | 8,517 | (3,670) | 39,223 | ||||||||||||||||||||||
| Interest expense | 2,808 | 2,356 | 6,668 | 11,491 | ||||||||||||||||||||||
| Loss on extinguishment of debt | — | — | — | 3,196 | ||||||||||||||||||||||
| Other (income) loss | (596) | 804 | (1,702) | (1,695) | ||||||||||||||||||||||
| (Loss) income before income taxes | $ | (7,462) | $ | 5,357 | $ | (8,636) | $ | 26,231 | ||||||||||||||||||
| Income tax (benefit) expense | (1,076) | 501 | 1,425 | 5,014 | ||||||||||||||||||||||
| Net (loss) income | $ | (6,386) | $ | 4,856 | $ | (10,061) | $ | 21,217 | ||||||||||||||||||
| Net (loss) income per common share: | ||||||||||||||||||||||||||
| Basic | $ | (0.10) | $ | 0.12 | $ | (0.20) | $ | 0.55 | ||||||||||||||||||
| Diluted | $ | (0.10) | $ | 0.12 | $ | (0.20) | $ | 0.53 | ||||||||||||||||||
| Weighted-average common shares outstanding: | ||||||||||||||||||||||||||
| Basic | 66,820 | 39,123 | 49,858 | 38,901 | ||||||||||||||||||||||
| Diluted | 66,820 | 40,286 | 49,858 | 40,123 | ||||||||||||||||||||||
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Lantheus Holdings, Inc.
Consolidated Segment Revenues Analysis
(in thousands – unaudited)
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||||||||||||||
| 2020 | 2019 | % Change | 2020 | 2019 | % Change | ||||||||||||||||||||||||||||||
| United States | |||||||||||||||||||||||||||||||||||
| DEFINITY | $ | 53,792 | $ | 50,917 | 5.6 | % | $ | 148,346 | $ | 154,099 | (3.7) | % | |||||||||||||||||||||||
| TechneLite | 17,652 | 18,281 | (3.4) | % | 52,599 | 55,204 | (4.7) | % | |||||||||||||||||||||||||||
| Other nuclear | 11,571 | 9,355 | 23.7 | % | 26,437 | 28,006 | (5.6) | % | |||||||||||||||||||||||||||
| Rebates and allowances | (5,540) | (3,903) | 41.9 | % | (13,763) | (12,035) | 14.4 | % | |||||||||||||||||||||||||||
| Total United States | 77,475 | 74,650 | 3.8 | % | 213,619 | 225,274 | (5.2) | % | |||||||||||||||||||||||||||
| International | |||||||||||||||||||||||||||||||||||
| DEFINITY | 1,637 | 1,478 | 10.8 | % | 4,239 | 4,036 | 5.0 | % | |||||||||||||||||||||||||||
| TechneLite | 3,837 | 3,466 | 10.7 | % | 10,897 | 10,794 | 1.0 | % | |||||||||||||||||||||||||||
| Other nuclear | 5,596 | 6,186 | (9.5) | % | 16,507 | 17,901 | (7.8) | % | |||||||||||||||||||||||||||
| Rebates and allowances | (1) | (4) | (75.0) | % | (4) | (14) | (71.4) | % | |||||||||||||||||||||||||||
| Total International | 11,069 | 11,126 | (0.5) | % | 31,639 | 32,717 | (3.3) | % | |||||||||||||||||||||||||||
| Worldwide | |||||||||||||||||||||||||||||||||||
| DEFINITY | 55,429 | 52,395 | 5.8 | % | 152,585 | 158,135 | (3.5) | % | |||||||||||||||||||||||||||
| TechneLite | 21,489 | 21,747 | (1.2) | % | 63,496 | 65,998 | (3.8) | % | |||||||||||||||||||||||||||
| Other nuclear | 17,167 | 15,541 | 10.5 | % | 42,944 | 45,907 | (6.5) | % | |||||||||||||||||||||||||||
| Rebates and allowances | (5,541) | (3,907) | 41.8 | % | (13,767) | (12,049) | 14.3 | % | |||||||||||||||||||||||||||
| Total Revenues | $ | 88,544 | $ | 85,776 | 3.2 | % | $ | 245,258 | $ | 257,991 | (4.9) | % | |||||||||||||||||||||||
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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, | |||||||||||||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||||||||||||
| Net (loss) income | $ | (6,386) | $ | 4,856 | $ | (10,061) | $ | 21,217 | ||||||||||||||||||
| Stock and incentive plan compensation | 3,992 | 3,423 | 10,452 | 9,580 | ||||||||||||||||||||||
| Amortization of acquired intangible assets | 4,768 | 451 | 6,087 | 1,353 | ||||||||||||||||||||||
| Acquired debt fair value adjustment | (385) | — | (385) | — | ||||||||||||||||||||||
| Contingent consideration fair value adjustments | 800 | — | 800 | — | ||||||||||||||||||||||
| Non-recurring refinancing related fees | — | — | 460 | — | ||||||||||||||||||||||
| Extinguishment of debt | — | — | — | 3,196 | ||||||||||||||||||||||
| Strategic collaboration and license costs | — | — | — | 300 | ||||||||||||||||||||||
| Integration costs | 855 | — | 4,428 | — | ||||||||||||||||||||||
| Acquisition-related costs | 1,593 | 5,176 | 10,522 | 5,176 | ||||||||||||||||||||||
| Impairment of long-lived assets | — | — | 7,275 | — | ||||||||||||||||||||||
| Other | — | — | (75) | — | ||||||||||||||||||||||
Income tax effect of non-GAAP adjustments(a) | (2,819) | (2,653) | (8,265) | (7,449) | ||||||||||||||||||||||
| Adjusted net income | $ | 2,418 | $ | 11,253 | $ | 21,238 | $ | 33,373 | ||||||||||||||||||
| Adjusted net income, as a percentage of revenues | 2.7 | % | 13.1 | % | 8.7 | % | 12.9 | % | ||||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||||||||||||
| Net (loss) income per share - diluted | $ | (0.10) | $ | 0.12 | $ | (0.20) | $ | 0.53 | ||||||||||||||||||
| Stock and incentive plan compensation | 0.06 | 0.08 | 0.21 | 0.24 | ||||||||||||||||||||||
| Amortization of acquired intangible assets | 0.08 | 0.01 | 0.12 | 0.03 | ||||||||||||||||||||||
| Acquired debt fair value adjustment | (0.01) | — | (0.01) | — | ||||||||||||||||||||||
| Contingent consideration fair value adjustments | 0.01 | — | 0.01 | — | ||||||||||||||||||||||
| Non-recurring refinancing related fees | — | — | 0.01 | — | ||||||||||||||||||||||
| Extinguishment of debt | — | — | — | 0.08 | ||||||||||||||||||||||
| Strategic collaboration and license costs | — | — | — | 0.01 | ||||||||||||||||||||||
| Integration costs | 0.01 | — | 0.09 | — | ||||||||||||||||||||||
| Acquisition-related costs | 0.02 | 0.13 | 0.21 | 0.12 | ||||||||||||||||||||||
| Impairment of long-lived assets | — | — | 0.14 | — | ||||||||||||||||||||||
Income tax effect of non-GAAP adjustments(a) | (0.03) | (0.06) | (0.16) | (0.18) | ||||||||||||||||||||||
| Adjusted net income per share - diluted | $ | 0.04 | $ | 0.28 | $ | 0.42 | $ | 0.83 | ||||||||||||||||||
Weighted-average common shares outstanding - diluted(b) | 67,006 | 40,286 | 50,210 | 40,123 | ||||||||||||||||||||||
(a)The income tax effect of the adjustments between GAAP net (loss) income 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.
(b)Diluted shares may differ for non-GAAP measures as compared to GAAP due to a GAAP net loss position.
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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, | ||||||||||||||||||||||
| 2020 | 2019 | 2020 | 2019 | ||||||||||||||||||||
| Net cash provided by operating activities | $ | 8,575 | $ | 26,442 | $ | 15,827 | $ | 57,963 | |||||||||||||||
| Capital expenditures | (3,736) | (3,336) | (8,689) | (17,320) | |||||||||||||||||||
| Free cash flow | $ | 4,839 | $ | 23,106 | $ | 7,138 | $ | 40,643 | |||||||||||||||
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Lantheus Holdings, Inc.
Condensed Consolidated Balance Sheets
(in thousands – unaudited)
| September 30, 2020 | December 31, 2019 | ||||||||||
| Assets | |||||||||||
| Current assets | |||||||||||
| Cash and cash equivalents | $ | 87,994 | $ | 92,919 | |||||||
| Accounts receivable, net | 49,206 | 43,529 | |||||||||
| Inventory | 37,623 | 29,180 | |||||||||
| Other current assets | 9,709 | 7,283 | |||||||||
| Total current assets | 184,532 | 172,911 | |||||||||
| Property, plant and equipment, net | 122,381 | 116,497 | |||||||||
| Intangibles, net | 384,747 | 7,336 | |||||||||
| Goodwill | 57,765 | 15,714 | |||||||||
| Deferred tax assets, net | 69,345 | 71,834 | |||||||||
| Other long-term assets | 60,824 | 21,627 | |||||||||
| Total assets | $ | 879,594 | $ | 405,919 | |||||||
| Liabilities and stockholders’ equity | |||||||||||
| Current liabilities | |||||||||||
| Current portion of long-term debt and other borrowings | $ | 18,138 | $ | 10,143 | |||||||
| Accounts payable | 24,070 | 18,608 | |||||||||
| Accrued expenses and other liabilities | 39,792 | 37,360 | |||||||||
| Total current liabilities | 82,000 | 66,111 | |||||||||
| Asset retirement obligations | 13,962 | 12,883 | |||||||||
| Long-term debt, net and other borrowings | 204,669 | 183,927 | |||||||||
| Other long-term liabilities | 65,384 | 28,397 | |||||||||
| Total liabilities | 366,015 | 291,318 | |||||||||
| Total stockholders’ equity | 513,579 | 114,601 | |||||||||
| Total liabilities and stockholders’ equity | $ | 879,594 | $ | 405,919 | |||||||
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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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