LNTH Lantheus Holdings Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
1095
Prostate Cancer
|
Phase 2
Phase 2
|
Phase 2 enrolment has paused due to COVID-19.
|
|
flurpiridaz F 18
Coronary artery disease (CAD)
|
Phase 3
Phase 3
|
Phase 3 trial ongoing.
|
|
PyL
Prostate cancer
|
NDA Filing
NDA Filing
|
NDA filing announced September 30, 2020.
|
|
Subcutaneous RELISTOR
Chronic pain
|
Approved
Approved
|
Approved September 29, 2014.
|
|
Oral RELISTOR
Chronic pain
|
Approved
Approved
|
Approved July 19 2016.
|
|
1404
Help visualize prostate cancer by targeting prostate specific membrane antigen (PSMA)
|
Phase 3
Phase 3
|
Phase 3 trial met one of two co-primary endpoints.
|
|
Azedra
Pheochromocytoma
|
Approved
Approved
|
FDA approval announced July 30, 2018.
|
|
DEFINITY (BENEFIT 1)
Left Ventricular Ejection Fraction
|
Phase 3
Phase 3
|
Phase 3 trial did not meet primary endpoint - February 3, 2020.
|
Latest News
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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 announced Bob Marshall, Chief Financial Officer and Treasurer, will present at the 2020 Evercore ISI HealthCONx Conference at 3:30 p.m. ET on Tuesday, December 1.
To access a live webcast of the presentation, please visit the Investors section of the Company's website at www.lantheus.com. A replay of the webcast will be available on the Company's website for 30 days following the live presentation.
About Lantheus Holdings, Inc.
Lantheus Holdings, Inc. is 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. 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201124005260/en/
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Commercially Available in Early 2021
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 announced the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for DEFINITY® Room Temperature (DEFINITY RT) (Perflutren Lipid Microsphere) Injectable Suspension.
"With the approval of DEFINITY RT, we expand our microbubble franchise offering to include a room temperature formulation, in addition to our market leading, refrigerated DEFINITY that our customers and patients have trusted to enhance suboptimal echocardiograms for 19 years. This approval will enable those customers who prefer a non-refrigerated product to be able to continue to benefit from our DEFINITY microbubble products," said Paul Blanchfield, Chief Commercial Officer.
Mary Anne Heino, President and Chief Executive Officer, added, "We continue to expand the offerings in our microbubble franchise. The addition of DEFINITY RT recognizes the increasing need for portability in delivery of healthcare services, as well as our commitment to partnering with innovators developing complex product formulations which include a microbubble. I am thankful to the entire Lantheus team who worked diligently to bring this new formulation to the market."
DEFINITY RT is a modified formulation of DEFINITY that allows both storage and shipment at room temperature (DEFINITY's previously approved formulation requires refrigerated storage). The activation of DEFINITY RT will be achieved using the VIALMIX® RFID device, which was approved in August 2020. This modified formulation provides clinicians an additional choice and allows for greater utility of this formulation in broader clinical settings.
The composition of matter U.S. issued patent for DEFINITY RT has an expiration date of 2035 and will be listed in the Orange Book.
About DEFINITY® and DEFINITY® RT
DEFINITY Vial for (Perflutren Lipid Microsphere) Injectable Suspension and DEFINITY RT (Perflutren Lipid Microsphere) Injectable Suspension (activated) are ultrasound enhancing agents for use in patients with suboptimal echocardiograms (see Indications and Important Safety Information below and find full Prescribing Information at www.definityimaging.com).1,2 DEFINITY and DEFINITY RT are engineered to produce small and consistently sized durable microbubbles to fully evaluate the left ventricle.1,2 DEFINITY has extensive safety experience and a consistent safety profile.3 Since its launch in 2001, more than 14 million echo studies have been performed with DEFINITY, and it is the most prescribed ultrasound enhancing agent in the U.S.4
DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension
DEFINITY® RT (Perflutren Lipid Microsphere) Injectable SuspensionINDICATIONS
Activated DEFINITY® and activated DEFINITY® RT (Perflutren Lipid Microsphere) Injectable Suspension are indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.
CONTRAINDICATIONS
Do not administer DEFINITY® and DEFINITY® RT to patients with known or suspected hypersensitivity to perflutren lipid microsphere or its components.
IMPORTANT SAFETY INFORMATION
WARNING: Serious Cardiopulmonary Reactions
Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration [see Warnings and Precautions (5.1)]. Most serious reactions occur within 30 minutes of administration.
- Assess all patients for the presence of any condition that precludes DEFINITY® and DEFINITY® RT administration [see Contraindications (4)].
- Always have resuscitation equipment and trained personnel readily available.
In post-marketing use, rare but serious cardiopulmonary or hypersensitivity reactions have been reported during or shortly following perflutren-containing microsphere administration [see Adverse Reactions (6)]. The risk for these reactions may be increased among patients with unstable cardiopulmonary conditions [see Adverse Reactions (6.2)]. It is not always possible to reliably establish a causal relationship to drug exposure due to the presence of underlying cardiopulmonary disease.
Please see accompanying full Prescribing Information, including boxed WARNING regarding serious cardiopulmonary reactions, on www.definityimaging.com.
About Lantheus Holdings, Inc.
Lantheus Holdings, Inc. is 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. 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.
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) our future operating results; (ii) the impact of the COVID-19 pandemic on our business, financial condition and prospects; (iii) the Company's ability to successfully launch DEFINITY RT as a commercial product and the timing of the launch; (iv) the intellectual property protection of DEFINITY RT; (v) expectations for future clinical trials, the timing and potential outcomes of clinical studies and filings and other interactions with regulatory authorities; and (vi) 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).
1 DEFINITY® (Package Insert), North Billerica, MA, Lantheus Medical Imaging, Inc.
2 DEFINITY® RT (Package Insert), North Billerica, MA, Lantheus Medical Imaging, Inc.
3 Data on file, Lantheus Medical Imaging, Inc.
4 ©2020 Millennium Research Group, Inc. All rights reserved. Reproduction, distribution, transmission or publication is prohibited.
Reprinted with permission.View source version on businesswire.com: https://www.businesswire.com/news/home/20201118006059/en/
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Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), 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, announced the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the use of Lantheus' artificial intelligence enabled automated bone scan index (aBSI) product on GE Healthcare's Xeleris platform.
"Lantheus is delighted by the U.S. approval of our digital AI solution for prostate cancer, aBSI, on GE Healthcare's platform. As a leading multinational medical technology company with deep experience in medical imaging and diagnostics, GE Healthcare presents the ideal attributes to provide global access to this unique digital solution," said Etienne Montagut, Sr. Vice President of Corporate Development. "aBSI has demonstrated clinical value in quantifying and managing disease progression in advanced prostate cancer patients with the potential to support critical clinical decisions. Lantheus will continue to develop AI solutions to augment and expand the utility of imaging diagnostics for precision medicine in oncology," Mr. Montagut added.
In October 2019, the Company entered into a global software licensing agreement with GE Healthcare for the rights to aBSI, a vendor neutral stand-alone platform that is enabled with artificial intelligence, which has been trained to automate the detection of hotspots in bone indicative of metastatic disease and calculate the aBSI. The platform offers a fast and reliable alternative to manual interpretation of bone scan images of metastatic prostate cancer. Recent investigations have demonstrated the clinical utility of aBSI as a prognostic and a response imaging biomarker in patients with metastatic prostate cancer.1,2
"The pandemic has proven that data, analytics, AI and connectivity will only become more central to delivering care," said Erez Levy, General Manager, Nuclear Medicine, GE Healthcare. "For GE Healthcare, that means continuing to advance intelligent and innovative technologies, like aBSI, and deliver precision health to promote better patient outcomes around the world."
Under the terms of the non-exclusive agreement, GE Healthcare acquired from Lantheus the software license for aBSI for integration into GE Healthcare's Xeleris platform, excluding the use of aBSI in Japan. Under the agreement with GE Healthcare, Lantheus will receive tiered licensing fees per license sold.
About aBSI
The aBSI product is vendor neutral stand-alone software as a medical device which calculates the automated bone scan index in Technetium-99m bone scintigraphy. aBSI received FDA clearance in 2019 (K191262). The product is enabled with a neural network that has been trained to automate the detection of hotspots and calculate the aBSI value.
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.
About GE Healthcare
GE Healthcare is the $16.7 billion healthcare business of GE (NYSE:GE). As a leading global medical technology and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform. With over 100 years of healthcare industry experience and around 50,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping drive productivity and improve outcomes for patients, providers, health systems and researchers around the world.
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 market receptivity to aBSI and to GEHC's XELERIS platform; (ii) the intellectual property protection of aBSI; and (iii) 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).
_________________
1 Armstrong AJ, Anand A, Edenbrandt L,et al. Phase 3 Assessment of the Automated Bone Scan Index as a Prognostic Imaging Biomarker of Overall Survival in Men With Metastatic Castration-Resistant Prostate Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2018 Jul 1;4(7):944-951.
2 Ali A, Hoyle AP, Parker CC, et al. The Automated Bone Scan Index as a Predictor of Response to Prostate Radiotherapy in Men with Newly Diagnosed Metastatic Prostate Cancer: An Exploratory Analysis of STAMPEDE's "M1|RT Comparison". European Urology. 2020 Aug; 3(4): 412-419View source version on businesswire.com: https://www.businesswire.com/news/home/20201113005122/en/
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Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), 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, today announced that management will present at two investor conferences in November.
-
Credit Suisse 29th Annual Virtual Healthcare Conference
- Date: Wednesday, November 11, 2020
- Time: 9:30am Eastern Time
- Participants: Mary Anne Heino, President and Chief Executive Officer and Bob Marshall, Chief Financial Officer and Treasurer
-
Jefferies Virtual London Healthcare Conference
- Date: Tuesday, November 17, 2020
- Time: 7:20am Eastern Time
- Participant: Bob Marshall, Chief Financial Officer and Treasurer
To access a live webcast of the presentation, please visit the Investors section of the Company's website at www.lantheus.com. A replay of the webcast will be available on the Company's website for 30 days following the live presentation.
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201109005984/en/
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Credit Suisse 29th Annual Virtual Healthcare Conference
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- 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
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.
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 -
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
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)
%
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
- 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.
- Diluted shares may differ for non-GAAP measures as compared to GAAP due to a GAAP net loss position.
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
Lantheus Holdings, Inc.
Condensed Consolidated Balance Sheets
(in thousands – unaudited)
September 30,
2020December 31,
2019Assets
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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