GlobeNewswire Inc | Nov 4, 2021 07:00AM EDT

November 04, 2021

-- Worldwide revenue of $102.1 million for the third quarter 2021, representing an increase of 15.3% from the prior year period -- GAAP net loss of $13.4 million for the third quarter 2021, compared to GAAP net loss of $6.4 million in the prior year period -- GAAP fully diluted net loss of $0.20 for the third quarter 2021, compared to GAAP fully diluted net loss of $0.10 in the prior year period; adjusted fully diluted EPS of $0.08 for the third quarter 2021, compared to adjusted fully diluted EPS of $0.04 in the prior year period -- Net cash provided by operating activities was $4.3 million for the third quarter 2021. Free cash flow was $1.9 million in the third quarter 2021 -- The Company reported that, following an interim analysis of the ongoing ARROW Phase 2 study of 1095, a PSMA-targeted therapeutic, in metastatic castration resistant prostate cancer patients, the Independent Data Monitoring Committee recommended the study continue without modifications -- The Company provides fourth quarter 2021 revenue and adjusted diluted earnings per share guidance; increases full year guidance

NORTH BILLERICA, Mass., Nov. 04, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc.(NASDAQ: LNTH) (Lantheus), 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, today reported financial results for its third quarter ended September 30, 2021.

The Companys worldwide revenue for the third quarter of 2021 totaled $102.1 million, compared with $88.5 million for the third quarter of 2020, representing an increase of 15.3% from the prior year period.

The Companys third quarter 2021 GAAP net loss was $13.4 million, or $0.20 per fully diluted share, as compared to GAAP net loss of $6.4 million, or $0.10 per fully diluted share for the third quarter of 2020.

The Companys third quarter 2021 adjusted fully diluted earnings per share were $0.08, as compared to $0.04 for the third quarter of 2020, representing an increase of 127.4% from the prior year period.

Lastly, net cash provided by operating activities was $4.3 million for the third quarter 2021. Free Cash Flow was $1.9 million in the third quarter of 2021, representing a decrease of approximately $2.9 million from the prior year period.

We delivered a strong quarter, with revenue up 15% year-over-year, highlighted by the robust adoption of PYLARIFY, the first and only commercially available PSMA PET imaging agent, said Mary Anne Heino, President and CEO. Although COVID-19 continued to impact some aspects of our business, we were able to grow our three largest products DEFINITY, TechneLite and PYLARIFY. We look forward to driving sustainable growth across our portfolio of diagnostic and therapeutic solutions as we find, fight and follow diseases to deliver better patient outcomes.

We are pleased with the first full quarter of PYLARIFY sales and continue to invest in our commercial launch, including in manufacturing capacity, to meet the increasing demand for this game changing product. We completed the build-out of our commercial infrastructure, which represents the industrys largest PSMA PET-dedicated sales and market access teams, said Paul Blanchfield, Chief Commercial Officer. We remain focused on fostering customer adoption and expanding our geographic and market access coverage in service of our customers and the U.S. Prostate Cancer community.

Outlook

The Company updates its guidance for full year 2021 and offers the following guidance for the fourth quarter.

Q4 Guidance Issued Previous Guidance Issued November 4, 2021 July 28, 2021Q4 FY 2021 Revenue $110 million - $115 N/A millionQ4 FY 2021 Adjusted $0.15 - $0.18 N/ADiluted EPS FY Guidance Updated FY Guidance Issued July November 4, 2021 28, 2021FY 2021 Revenue $405 million - $410 $395 million - $402 million millionFY 2021 Adjusted $0.40 - $0.43 $0.38 - $0.42Diluted EPS

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 Companys 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 Thursday, November 4, 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 6775813. A live webcast will be available in the Investors section of the Companys 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 Companys management believes that the presentation of these measures provides useful information to investors. These measures may assist investors in evaluating the Companys 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 Companys 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 believe, could, estimate, expect, look forward to, may, plan, predict, 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 and prospects; (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 modified formulation of DEFINITY (DEFINITY RT) to be commercially manufactured at Samsung Biologics, including our ability to renew, modify or replace those agreements as may be necessary; (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) our ability to successfully launch aPROMISE, also referred to as PYLARIFY AI, as a commercial product; (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; (x) the efforts and timing for clinical development of our product candidates and new clinical applications for our products, in each case, that we or our strategic partners may develop, including 1095 and flurpiridaz F 18; (xi) our ability to develop highly contextualized assessments of disease burden using artificial intelligence (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).

Lantheus Holdings, Inc.Consolidated Statements of Operations(in thousands, except per share data unaudited)

Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020Revenues $ 102,073 $ 88,544 $ 295,646 $ 245,258 Cost of goods 59,404 52,284 165,859 145,148 soldGross profit 42,669 36,260 129,787 100,110 Operating expensesSales and 17,195 11,609 48,999 28,044 marketingGeneral and 28,550 18,217 87,865 55,586 administrativeResearch and 11,252 11,684 33,673 20,150 developmentTotal operating 56,997 41,510 170,537 103,780 expensesGain on sale of ? ? 15,263 ? assets Operating (14,328 ) (5,250 ) (25,487 ) (3,670 ) lossInterest expense 1,569 2,808 6,224 6,668 Gain onextinguishment ? ? (889 ) ? of debtOther loss 3,940 (596 ) 3,209 (1,702 ) (income)Loss before (19,837 ) (7,462 ) (34,031 ) (8,636 ) income taxesIncome tax(benefit) (6,422 ) (1,076 ) (2,967 ) 1,425 expenseNet loss $ (13,415 ) $ (6,386 ) $ (31,064 ) $ (10,061 ) Net loss per common share:Basic $ (0.20 ) $ (0.10 ) $ (0.46 ) $ (0.20 ) Diluted $ (0.20 ) $ (0.10 ) $ (0.46 ) $ (0.20 ) Weighted-averagecommon shares outstanding:Basic 67,623 66,820 67,409 49,858 Diluted 67,623 66,820 67,409 49,858

Lantheus Holdings, Inc.Consolidated Revenues Analysis(in thousands unaudited)

Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 ^(1) % Change 2021 2020 ^(1) % ChangeDEFINITY $ 57,636 $ 50,359 14.5 % $ 173,448 $ 139,989 23.9 %TechneLite 22,680 21,113 7.4 % 69,252 62,560 10.7 %Other precision 7,563 8,585 (11.9 ) % 21,289 28,782 (26.0 ) %diagnosticsTotal precision 87,879 80,057 9.8 % 263,989 231,331 14.1 %diagnosticsRadiopharmaceutical 8,890 3,323 167.5 % 13,203 7,474 76.7 %oncologyStrategic partnerships and 5,304 5,164 2.7 % 18,454 6,453 186.0 %otherTotal revenues $ 102,073 $ 88,544 15.3 % $ 295,646 $ 245,258 20.5 %

-- The Company reclassified rebates and allowances of $5.5million and $13.8million within each product category, which included $5.1million and $12.6million for DEFINITY, $0.3million and $0.9million for TechneLite and $0.1million and $0.2million for other precision diagnostics, for the three and nine months ended September 30, 2020, respectively.

Lantheus Holdings, Inc.Reconciliation of GAAP to Non-GAAP Financial Measures(in thousands, except per share data unaudited)

Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020Net loss $ (13,415 ) $ (6,386 ) $ (31,064 ) $ (10,061 ) Stock and incentive 3,867 3,992 11,772 10,452 plan compensationAmortization ofacquired intangible 8,374 4,768 19,133 6,087 assetsAcquired debt fair ? (385 ) (307 ) (385 ) value adjustmentContingentconsideration fair 2,600 800 28,500 800 value adjustmentsNon-recurringrefinancing related ? ? ? 460 feesNon-recurringseverance related (6 ) ? 522 ? feesExtinguishment of ? ? (889 ) ? debtGain on sale of ? ? (15,263 ) ? assetsIntegration costs 63 855 93 4,428 Acquisition-related 62 1,593 726 10,522 costsImpairment of 9,540 ? 9,540 7,275 long-lived assetsOther 7 ? 60 (75 ) Income tax effectof non-GAAP (5,411 ) (2,819 ) (6,059 ) (8,265 ) adjustments^(a)Adjusted net income $ 5,681 $ 2,418 $ 16,764 $ 21,238 Adjusted netincome, as a 5.6 % 2.7 % 5.7 % 8.7 %percentage ofrevenues

Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020Net loss per share - $ (0.20 ) $ (0.10 ) $ (0.46 ) $ (0.20 ) dilutedStock and incentive 0.05 0.06 0.18 0.21 plan compensationAmortization ofacquired intangible 0.12 0.08 0.28 0.12 assetsAcquired debt fair ? (0.01 ) (0.01 ) (0.01 ) value adjustmentContingentconsideration fair 0.04 0.01 0.42 0.01 value adjustmentsNon-recurringrefinancing related ? ? ? 0.01 feesNon-recurring severance ? ? 0.01 ? related feesExtinguishment of debt ? ? (0.01 ) ? Gain on sale of assets ? ? (0.23 ) ? Integration costs ? 0.01 ? 0.09 Acquisition-related 0.01 0.02 0.01 0.21 costsImpairment of 0.14 ? 0.14 0.14 long-lived assetsOther ? ? ? ? Income tax effect ofnon-GAAP adjustments^ (0.08 ) (0.03 ) (0.09 ) (0.16 ) (a)Adjusted net income per $ 0.08 $ 0.04 $ 0.24 $ 0.42 share - dilutedWeighted-average commonshares outstanding - 69,237 67,006 68,674 50,210 diluted

(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.

Lantheus Holdings, Inc.Reconciliation of Free Cash Flow(in thousands unaudited)

Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020Net cashprovided by $ 4,340 $ 8,575 $ 40,027 $ 15,827 operatingactivitiesCapital (2,420 ) (3,736 ) (7,596 ) (8,689 ) expendituresFree cash $ 1,920 $ 4,839 $ 32,431 $ 7,138 flow Net cash(used in)provided by $ (2,420 ) $ (3,736 ) $ 8,227 $ (1,127 ) investingactivitiesNet cashused in $ (1,726 ) $ (7,270 ) $ (37,232 ) $ (17,488 ) financingactivities

Lantheus Holdings, Inc.Condensed Consolidated Balance Sheets(in thousands unaudited)

September December 31, 30, 2020 2021Assets Current assets Cash and cash equivalents $ 91,475 $ 79,612 Accounts receivable, net 64,054 54,002 Inventory 33,949 35,744 Other current assets 12,043 9,625 Assets held for sale ? 5,242 Total current assets 201,521 184,225 Property, plantand equipment, net 116,441 120,171 Intangibles, net 356,883 376,012 Goodwill 61,189 58,632 Deferred tax assets, net 66,493 70,147 Other long-term assets 45,289 60,634 Total assets $ 847,816 $ 869,821 Liabilities and stockholders? equity Current liabilities Current portion of long-term debt and other $ 10,356 $ 20,701 borrowingsAccounts payable 20,508 16,284 Accrued expenses and other liabilities 46,039 41,726 Liabilities held for sale ? 1,793 Total current liabilities 76,903 80,504 Asset retirement obligations 15,185 14,020 Long-term debt, net and other borrowings 166,741 197,699 Other long-term liabilities 89,643 63,393 Total liabilities 348,472 355,616 Total stockholders? equity 499,344 514,205 Total liabilities and stockholders? equity $ 847,816 $ 869,821

Contacts: Mark Kinarney Senior Director, Investor Relations 978-671-8842ir@lantheus.com

Melissa Downs Director, Corporate Communications 646-975-2533media@lantheus.com