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Lantheus Holdings (LNTH) presents at Baird 2021 Global Healthcare Conference
2021-09-17 18:53
Company Overview - Lantheus has 65 years of imaging innovation and is the most used radiopharmaceutical imaging agent in the U S [7] - Lantheus has three portfolio categories: Precision Diagnostics, Radiopharmaceutical Oncology, and Strategic Partnerships & Other[10] DEFINITY (Precision Diagnostics) - The U S echocardiography market continues to grow by approximately 2% annually, estimating over 35 million echocardiograms in CY 2021[14, 15] - DEFINITY is the 1 ultrasound enhancing agent and as of Q2 2021, over 50% of promotional efforts were in-person, up from approximately 10% at the start of 2021[17] PYLARIFY (Radiopharmaceutical Oncology) - In 2021, there were an estimated 248,530 new cases and approximately 34,130 deaths from prostate cancer in the U S [20] - Approximately 1 in 8 men will be diagnosed with prostate cancer during their lifetime, and over 3 1 million are living with prostate cancer today[20] - The annual potential addressable market for prostate cancer PET imaging is over $600 million, comprised of approximately 170,000 eligible patients[23] AZEDRA (Radiopharmaceutical Oncology) - Each year in the U S , approximately 652 to 2,608 patients are diagnosed with Pheochromocytoma and Paraganglioma (PPGL)[29] - In patients with advanced PPGL, the 5-year overall survival can be as low as 12%[29] Strategic Partnerships & Pipeline - Lantheus has acquired rights to NM-01 from NanoMab, a PD-L1 imaging biomarker product candidate, and NTI-1309 from Ratio Therapeutics, an innovative imaging biomarker that targets fibroblast activation protein (FAP)[32, 33] - Lantheus is progressing with a Phase 2 trial of 1095, a PSMA-targeted small molecule therapeutic for metastatic castration-resistant prostate cancer (mCRPC)[46]
Lantheus Holdings (LNTH) Investor Presentation
2021-09-10 20:05
1 T M Investor Presentation September 2021 w w w . l a n t h e u s . c o m | © 2 0 2 1 L a n t h e u s H o l d i n g s , I n c . A l l r i g h t s r e s e r v e d Safe Harbor Statements 2 Cautionary Statement Regarding Forward-Looking Statements This document 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 ...
Lantheus Holdings(LNTH) - 2021 Q2 - Earnings Call Transcript
2021-07-28 18:48
Financial Data and Key Metrics Changes - Revenue for Q2 2021 was $101.1 million, an increase of 53.1% compared to the prior year quarter [43] - Gross profit margin for Q2 2021 was 52.6%, up from 41.7% in Q2 2020 [47] - Operating profit for the quarter was $10.4 million, an increase of 30.8% over the same period last year [49] - Reported net income for Q2 was a loss of $26.7 million, while adjusted net income was $7.8 million, an increase of 71.6% [53] - Operating cash flow totaled $25.9 million compared to a use of $2.2 million in Q2 2020 [54] Business Line Data and Key Metrics Changes - Precision diagnostics revenue was $90.4 million, a 43.6% increase from the prior year quarter [44] - DEFINITY sales were $59.8 million, up 61.2% compared to the prior year quarter [44] - TechneLite net revenue was $23.8 million, a 27.3% increase from the prior year quarter [44] - AZEDRA sales increased significantly, with a notable rise in patients completing the second dose of therapy [36][37] Market Data and Key Metrics Changes - DEFINITY maintained over 80% market share in the U.S. ultrasound enhancing agent market [10][102] - PYLARIFY has been used in various imaging centers, hospitals, and government facilities, indicating strong initial uptake [25][84] Company Strategy and Development Direction - The company is focused on expanding the availability of PYLARIFY across the U.S. and enhancing its commercial infrastructure [27][30] - A dedicated field sales team and market access team are being established to support PYLARIFY's launch [29][31] - The company aims to leverage PYLARIFY as a companion diagnostic in clinical development with leading pharmaceutical companies [21][99] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth momentum and ability to deliver shareholder value, particularly with the launch of PYLARIFY and strong performance of DEFINITY [61] - The company anticipates that 2022 will be a significant year for PYLARIFY as the launch gains traction [67] Other Important Information - The company has made a strategic decision to exit a TechneLite contract, impacting revenue by $5 million in the second half of the year [57] - The effective tax rate for the quarter was 9.9%, influenced by the divestiture of the Puerto Rico operation [52] Q&A Session Summary Question: What is the anticipated contribution of PYLARIFY for Q3? - Management indicated that while specific guidance on PYLARIFY is not provided, the launch is just beginning and the forecast includes some contribution from PYLARIFY [67] Question: What was the reason for exiting the TechneLite contract? - Management stated that the decision was based on the contract's unfavorable terms and that such contracts are negotiated annually [69] Question: How many PET manufacturing facilities will be operational in 2022? - There are currently 12 PMF sites activated, with plans to expand to over 30 by year-end [75] Question: What is the competitive landscape for DEFINITY? - DEFINITY maintains approximately 80% market share and continues to grow, with strong performance exceeding pre-pandemic levels [102] Question: How does the approval of Novartis' prostate cancer therapeutic impact the company? - Management noted that the approval highlights the role of isotopes in treatment and diagnostics, which aligns with the company's strategic focus [99]
Lantheus Holdings(LNTH) - 2021 Q2 - Earnings Call Presentation
2021-07-28 12:48
Second Quarter 2021 Financial Results FIND July 28, 2021 w w w . l a n t h e u s . c o m | © 2 0 2 1 L a n t h e u s H o l d i n g s , I n c . A l l r i g h t s r e s e r v e d 1 Mary Anne Heino President and CEO Bob Marshall CFO and Treasurer Paul Blanchfield Chief Commercial Officer Mark Kinarney Sr. Director, Investor Relations | --- | --- | --- | |-------|--------------------------------------|-------| | | | | | | | | | | Q2 2021 Highlights & Business Update | | w w w . l a n t h e u s . c o m | © 2 0 2 ...
Lantheus Holdings(LNTH) - 2021 Q2 - Quarterly Report
2021-07-28 11:51
PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements for the three and six months ended June 30, 2021, including balance sheets, statements of operations, cash flows, and notes on key events [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2021, total assets slightly decreased to $857.8 million from $869.8 million at year-end 2020, reflecting a stable balance sheet Condensed Consolidated Balance Sheets (in thousands) | Balance Sheet Items (in thousands) | June 30, 2021 | December 31, 2020 | | :--- | :--- | :--- | | **Total Assets** | **$857,802** | **$869,821** | | Total Current Assets | $186,213 | $184,225 | | Intangibles, net | $365,259 | $376,012 | | Goodwill | $61,189 | $58,632 | | **Total Liabilities** | **$349,662** | **$355,616** | | Total Current Liabilities | $73,826 | $80,504 | | Long-term debt, net | $169,249 | $197,699 | | **Total Stockholders' Equity** | **$508,140** | **$514,205** | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) In Q2 2021, revenues grew 53.1% to $101.1 million, but increased operating expenses led to a net loss of $26.7 million, compared to a $7.0 million net loss in Q2 2020 Condensed Consolidated Statements of Operations (in thousands) | (in thousands) | Q2 2021 | Q2 2020 | Six Months 2021 | Six Months 2020 | | :--- | :--- | :--- | :--- | :--- | | **Revenues** | **$101,064** | **$66,010** | **$193,573** | **$156,714** | | Gross Profit | $46,088 | $25,848 | $87,118 | $63,850 | | Total Operating Expenses | $72,869 | $31,393 | $113,540 | $62,270 | | Operating (Loss) Income | $(26,781) | $(5,545) | $(11,159) | $1,580 | | **Net Loss** | **$(26,657)** | **$(7,012)** | **$(17,649)** | **$(3,675)** | | Diluted Net Loss per Share | $(0.39) | $(0.16) | $(0.26) | $(0.09) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash from operating activities significantly increased to $35.7 million for the six months ended June 30, 2021, while financing activities used $35.5 million mainly for debt repayments Cash Flow Summary (in thousands) | (in thousands) | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | | Net cash provided by operating activities | $35,687 | $7,252 | | Net cash provided by investing activities | $10,647 | $2,609 | | Net cash used in financing activities | $(35,506) | $(10,218) | | **Net increase (decrease) in cash** | **$10,948** | **$(469)** | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail key accounting events, including the Progenics acquisition and PYLARIFY FDA approval, revenue drivers, contingent liability changes, the sale of the Puerto Rico subsidiary, and segment restructuring - The company completed its acquisition of Progenics on June 19, 2020. **PYLARIFY**, a key product from this acquisition, was approved by the FDA on **May 26, 2021**, and its commercial launch has begun[30](index=30&type=chunk)[31](index=31&type=chunk) Revenue by Product Category (in thousands) | Revenue by Product Category (in thousands) | Q2 2021 | Q2 2020 | Six Months 2021 | Six Months 2020 | | :--- | :--- | :--- | :--- | :--- | | Precision diagnostics | $90,356 | $62,933 | $176,111 | $151,274 | | Radiopharmaceutical oncology | $2,812 | $2,183 | $4,312 | $4,151 | | Strategic partnerships and other | $7,896 | $894 | $13,150 | $1,289 | | **Total revenues** | **$101,064** | **$66,010** | **$193,573** | **$156,714** | - The fair value of contingent consideration liabilities, primarily related to PYLARIFY CVRs, increased from **$15.8 million** at year-end 2020 to **$43.8 million** at June 30, 2021. This change resulted in a non-cash expense of **$25.9 million** for the six-month period[47](index=47&type=chunk)[53](index=53&type=chunk) - On **January 29, 2021**, the company sold its Puerto Rico radiopharmacy subsidiary for **$18.0 million** in cash, resulting in a pre-tax gain of **$15.3 million**[77](index=77&type=chunk)[78](index=78&type=chunk)[82](index=82&type=chunk) - In the **first quarter of 2021**, the company changed its operating and reporting structure to a **single business segment**, reflecting a consolidated worldwide management approach[108](index=108&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial performance, highlighting 53.1% Q2 2021 revenue growth driven by DEFINITY and Progenics, key factors like PYLARIFY launch and Mo-99 supply, and strong liquidity with $35.7 million operating cash flow [Key Factors Affecting Our Results](index=29&type=section&id=Key%20Factors%20Affecting%20Our%20Results) Key factors influencing performance include ongoing COVID-19 impacts, the PYLARIFY launch requiring significant investment, anticipated growth for DEFINITY, and challenges with Mo-99 supply chain and third-party manufacturing reliance - On **May 27, 2021**, the FDA approved **PYLARIFY**, a PET imaging agent for prostate cancer. The commercial launch is underway, with availability expanding across the U.S. throughout **2021**[121](index=121&type=chunk)[122](index=122&type=chunk) - The company anticipates continued sales growth for **DEFINITY**, its fastest-growing and highest-margin product, which held an estimated **80% U.S. market share** as of **December 31, 2020**[133](index=133&type=chunk) - The company faces logistical and supplier challenges in its **Mo-99 supply chain**, which is critical for its TechneLite generators. A prolonged disruption from one of its **three main suppliers** could have a substantial negative effect on business[140](index=140&type=chunk) - The integration of the **Progenics acquisition** has increased the complexity of the business and added substantial clinical development expenses for pipeline products like **1095** and **AZEDRA**[145](index=145&type=chunk)[148](index=148&type=chunk)[150](index=150&type=chunk) [Results of Operations](index=39&type=section&id=Results%20of%20Operations) Q2 2021 revenues increased 53.1% to $101.1 million driven by DEFINITY sales, but operating expenses more than doubled to $72.9 million due to contingent liability adjustments and PYLARIFY launch costs, resulting in a $26.7 million net loss Results of Operations Summary (in thousands) | (in thousands) | Q2 2021 | Q2 2020 | Change $ | Change % | | :--- | :--- | :--- | :--- | :--- | | **Revenues** | **$101,064** | **$66,010** | **$35,054** | **53.1%** | | Gross Profit | $46,088 | $25,848 | $20,240 | 78.3% | | Total Operating Expenses | $72,869 | $31,393 | $41,476 | 132.1% | | **Net Loss** | **$(26,657)** | **$(7,012)** | **$(19,645)** | **280.2%** | - The increase in General and Administrative expenses of **$22.5 million** in Q2 2021 was primarily driven by a **$25.6 million** fair value adjustment to contingent assets and liabilities, mainly related to the **PYLARIFY CVRs**[168](index=168&type=chunk) - Sales and Marketing expenses increased by **$11.3 million** in Q2 2021 due to the integration of the **Progenics organization** and preparation activities for the **PYLARIFY launch**[166](index=166&type=chunk) [Liquidity and Capital Resources](index=43&type=section&id=Liquidity%20and%20Capital%20Resources) The company maintained solid liquidity with $91.5 million cash and $35.7 million operating cash flow for H1 2021, making $38.1 million debt payments including the $30.9 million Progenics loan, and has access to a $200.0 million revolving credit facility Cash Flow Summary (in thousands) | Cash Flow Summary (in thousands) | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | | Net cash provided by operating activities | $35,687 | $7,252 | | Net cash provided by investing activities | $10,647 | $2,609 | | Net cash used in financing activities | $(35,506) | $(10,218) | - On **March 31, 2021**, the company voluntarily repaid in full the entire outstanding principal of **$30.9 million** on the **Royalty-Backed Loan** assumed in the **Progenics acquisition**[197](index=197&type=chunk) - As of **June 30, 2021**, the company had **$91.5 million** of cash and cash equivalents and access to a **$200.0 million** revolving credit facility[202](index=202&type=chunk)[190](index=190&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=48&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in several ongoing legal matters inherited from the Progenics acquisition, including European patent opposition proceedings, litigation in Germany over PSMA-617 inventions, and a U.S. patent post-grant review petition - The company is appealing a German court's decision that dismissed its claims of co-ownership of inventions related to **PSMA-617**, which were filed by the **University of Heidelberg**[102](index=102&type=chunk)[105](index=105&type=chunk)[106](index=106&type=chunk) - A competitor, **Advanced Accelerator Applications USA, Inc.**, has filed a petition for post-grant review challenging the validity of claims in one of the company's U.S. patents (**No. 10,640,461**)[107](index=107&type=chunk) [Item 1A. Risk Factors](index=49&type=section&id=Item%201A.%20Risk%20Factors) This section updates key risks, including potential side effects of DEFINITY leading to a new label contraindication, heavy dependence on a few large radiopharmacy customers, and financial risks from Contingent Value Rights (CVRs) related to PYLARIFY sales - In **April 2021**, the FDA and the company agreed to add a contraindication to the **DEFINITY** label for patients with a prior history of allergic reactions to **polyethylene glycol (PEG)**, an inactive ingredient[214](index=214&type=chunk) - The company is heavily dependent on a few large radiopharmacy customers, such as **Cardinal** and **RLS**, for the distribution of its nuclear imaging products in the U.S., creating **customer concentration risk**[215](index=215&type=chunk) - The **CVRs** issued in the **Progenics acquisition** could result in substantial future cash payments based on **PYLARIFY sales** and require recurring fair value estimates, which can impact financial statements and are based on significant management assumptions[218](index=218&type=chunk)[219](index=219&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=51&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During Q2 2021, the company withheld 9,465 shares for employee tax obligations, had no share repurchase program, and reiterated its policy of not paying dividends to retain earnings for growth and debt repayment - The company withheld **9,465 shares** to cover employee taxes on vested equity awards during **Q2 2021**. No formal share repurchase program is in effect[222](index=222&type=chunk)[223](index=223&type=chunk) - The company does not currently intend to pay dividends and expects to retain future earnings to finance **business growth** and **repay debt**[224](index=224&type=chunk) [Other Items (Items 3, 4, 5, 6)](index=51&type=section&id=Other%20Items) This section confirms standard corporate disclosures, reporting no defaults on senior securities, no mine safety disclosures, no other material information, and lists the exhibits filed with the Form 10-Q - The company reported **no defaults on senior securities** (Item 3), **no mine safety disclosures** (Item 4), and **no other information** (Item 5) for the reporting period[225](index=225&type=chunk)[226](index=226&type=chunk)[227](index=227&type=chunk)
Lantheus Holdings(LNTH) - 2021 Q1 - Earnings Call Transcript
2021-05-09 12:50
Lantheus Holdings, Inc. (NASDAQ:LNTH) Q1 2021 Results Earnings Conference Call May 4, 2021 8:00 AM ET Company Participants Mark Kinarney - Senior Director of Investor Relations Mary Anne Heino - President and Chief Executive Officer Robert Marshall - Chief Financial Officer and Treasurer Conference Call Participants Richard Newitter - SVB Leerink Anthony Petrone - Jefferies Larry Solow - CJS Securities Operator Good morning, ladies and gentlemen. Welcome to the Lantheus Holdings First Quarter 2021 Earnings ...
Lantheus Holdings(LNTH) - 2021 Q1 - Earnings Call Presentation
2021-05-06 14:37
Financial Performance - The company reported revenues of $92.5 million in Q1 2021, a 2% increase year-over-year[39] - Free cash flow was $7.3 million in Q1 2021, compared to $6.7 million in Q1 2020[39] - Adjusted net income was $3.3 million, or $0.05 per share, compared to $14.3 million, or $0.36 per share in Q1 2020[39] - The company had $68.9 million in unrestricted cash and cash equivalents as of March 31, 2021[39] Product Performance - DEFINITY sales increased, driven by sequentially higher volumes, but with regional differences[44] - TechneLite volumes are returning to pre-COVID-19 levels[44] - Other precision diagnostics revenue decreased by 46.5% due to the sale of Puerto Rico operations[44] - Strategic partnerships and other revenue increased by 1,230.1%, driven by newly acquired assets[44] Strategic Initiatives - The company is preparing for the potential FDA approval and commercial launch of PyL[57] - The company acquired exclusive worldwide rights to NTI-1309, an innovative PET oncology imaging agent[34] - The company voluntarily repaid in full the entire outstanding principal on the RELISTOR Royalty-Backed Loan[51] Financial Guidance - The company issued revenue guidance for Q2 2021 of $93 million - $97 million[55] - The company issued adjusted fully diluted EPS guidance for Q2 2021 of $0.03 - $0.06[55] - The company updated FY 2021 revenue guidance to $390 million - $400 million[55] - The company updated FY 2021 adjusted fully diluted EPS guidance to $0.36 - $0.41[55]
Lantheus Holdings(LNTH) - 2021 Q1 - Quarterly Report
2021-05-04 11:44
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-36569 LANTHEUS HOLDINGS, INC. (Exact name of registrant as specified in its charter) | Delaware | 35-2318913 | | ...
Lantheus Holdings(LNTH) - 2020 Q4 - Earnings Call Transcript
2021-02-27 23:22
Lantheus Holdings, Inc. (NASDAQ:LNTH) Q4 2020 Earnings Conference Call February 25, 2021 4:30 PM ET Company Participants Mark Kinarney - Senior Director of Investor Relations Mary Anne Heino - President and CEO Bob Marshall - Chief Financial Officer Conference Call Participants Anthony Petrone - Jefferies Erin Wright - Credit Suisse Lee Jagoda - CJS Securities Erin Fahey - SVB Leerink Operator Good afternoon, ladies and gentlemen. Welcome to Lantheus Holdings Fourth Quarter and Full Year 2020 Financial Resu ...
Lantheus Holdings(LNTH) - 2020 Q4 - Earnings Call Presentation
2021-02-26 18:35
1 Fourth Quarter and Full Year 2020 Financial Results FIND ) February 25, 2021 w w w . l a n t h e u s . c o m | © 2 0 2 1 L a n t h e u s H o l d i n g s , I n c . A l l r i g h t s r e s e r v e d Mary Anne Heino President and CEO Bob Marshall CFO and Treasurer Mark Kinarney Sr. Director, Investor Relations | --- | --- | --- | --- | |-------|---------------------|---------------------------------|-------| | | | Q4 Highlights & Business Update | | | | Q4 Financial Update | | | w w w . l a n t h e u s . c o ...