Radiopharmaceutical Oncology

- PYLARIFY

- Other Radiopharmaceutical Oncology

Precision Diagnostics

- DEFINITY

- TechneLite

- Other Precision Diagnostics

Strategic Partnerships and Other Revenue

Total Revenue

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72720ce514718788c2b1548f5d38edef339b129ebd495b294cd33eeeca8d36af

Adjustments for Non-Cash Items (USD, thousands)

Stock-Based Compensation (USD, thousands)

Changes in Working Capital (USD, thousands)

Capital Expenditures (CapEx) (USD, thousands)

Proceeds from / Repayments of Debt (USD, thousands)

Share Repurchases (USD, thousands)

Dividend Payments (USD, thousands)

Net Change in Cash (USD, thousands)

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| Name                  | Position                                                                 | Start Date         | Short Bio                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       |
|-----------------------|--------------------------------------------------------------------------|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Brian Markison        | Chief Executive Officer; Director                                        | March 1, 2024      | Brian Markison was appointed as CEO effective **March 1, 2024**. He has been a member of the Lantheus Board of Directors since September 2012 and served as Chairman from January 2013 until his appointment as CEO. He has over 40 years of experience in the healthcare industry, including executive roles at King Pharmaceuticals, Fougera Pharmaceuticals, and RVL Pharmaceuticals plc, as well as senior positions at Bristol-Myers Squibb  **[0001193125-24-012605_d731182d8k.htm:1]** **[0001193125-24-012605_d731182dex991.htm:0]** **[0001628280-24-006158_lnth-20231231.htm:112]** . |
| Robert J. Marshall, Jr.| Chief Financial Officer and Treasurer                                    | September 2018     | Robert J. Marshall, Jr. joined Lantheus in **September 2018**. He has over 30 years of finance experience, including expertise in mergers and acquisitions, capital markets, and investor relations. Before joining Lantheus, he held various senior leadership roles at Zimmer Biomet Holdings, Inc.  **[0001193125-24-068590_d634045ddef14a.htm:73]** .                                                                                                                                                                                                 |
| Paul M. Blanchfield   | President                                                                 | March 20, 2023     | Paul M. Blanchfield joined Lantheus in January 2020 as Chief Commercial Officer, was promoted to Chief Operating Officer in June 2022, and subsequently to President on **March 20, 2023**. He has held various leadership roles in sales, marketing, strategy, and operations throughout his career  **[0001193125-24-068590_d634045ddef14a.htm:73]** **[0001193125-23-074198_d405671d8ka.htm:1]** **[0001193125-24-068590_d634045ddef14a.htm:60]** .                                                                                                                                                                                   |
| Etienne Montagut      | Chief Business Officer                                                   | September 2018     | Etienne Montagut joined Lantheus as Senior Vice President, Corporate Development in **September 2018**. He is responsible for Business Development, Strategic Planning, and Portfolio Management, and oversees Pharma Solutions and Digital Solutions (EXINI)  **[0001193125-24-068590_d634045ddef14a.htm:74]** **[0001193125-23-073213_d451886ddef14a.htm:71]** .                                                                                                                                                                                                                           |
| Amanda Morgan         | Chief Commercial Officer                                                 | March 25, 2024     | Amanda Morgan joined Lantheus in November 2022 as Senior Vice President, Commercial, and was promoted to Chief Commercial Officer, effective **March 25, 2024**. She has over 20 years of experience in the healthcare industry  **[0001193125-24-068590_d634045ddef14a.htm:74]** **[0001193125-24-068590_d634045ddef14a.htm:73]** .                                                                                                                                                                                                                                                         |
| Daniel M. Niedzwiecki | Chief Administrative Officer, General Counsel, and Corporate Secretary   | March 2023         | Daniel M. Niedzwiecki joined Lantheus in 2013 and was promoted to his current role in **March 2023**. He has over 20 years of experience in legal and business matters, including corporate, securities, capital markets, and compliance  **[0001193125-24-068590_d634045ddef14a.htm:75]** **[0001193125-24-068590_d634045ddef14a.htm:73]** .                                                                                                                                                                                                                                               |
| Dr. Jean-Claude Provost| Chief Science Officer                                                    | May 28, 2024       | Dr. Jean-Claude Provost was appointed as the Chief Science Officer effective **May 28, 2024**. He previously served as Chief Medical Officer and has over 30 years of experience in the international development of therapeutic drugs and diagnostic agents  **[0001193125-24-139440_d824247dex991.htm:0]** **[0001193125-24-139440_d824247d8k.htm:1]** .                                                                                                                                                                                                                           |
| Jeffrey S. Humphrey   | Chief Medical Officer                                                    | May 28, 2024       | Jeffrey S. Humphrey, MD, was appointed as the Chief Medical Officer effective **May 28, 2024**. He is a seasoned leader in drug development with over 30 years of experience in clinical oncology, neuroscience, cancer research, and drug discovery  **[0001193125-24-139440_d824247dex991.htm:0]** .                                                                                                                                                                                                                                      |
| Kimberly Brown        | Chief Accounting Officer                                                 | July 1, 2024       | Kimberly Brown was appointed as the Chief Accounting Officer on **June 17, 2024**, with her role becoming effective on **July 1, 2024**. She officially took over as the company's principal accounting officer on **August 1, 2024**  **[0001193125-24-167026_d826874d8k.htm:1]** .                                                                                                                                                                                                                                                      |
| Julie Eastland        | Board Member                                                             | September 3, 2024  | Julie Eastland was appointed as a Board Member on **September 3, 2024**. She is an experienced biotechnology and financial executive and serves as an independent director on the Board's Audit Committee  **[0001193125-24-213726_d886086dex991.htm:0]** **[0001193125-24-213726_d886086d8k.htm:1]** .                                                                                                                                                                                                                                                                             |

07690263409edf589970a99d2fe312bc93c79432a73b0aff2784a898642d24e9

Lantheus Holdings, Inc. is a leading radiopharmaceutical-focused company dedicated to delivering life-changing science to enable clinicians to "Find, Fight and Follow" disease, ultimately improving patient outcomes. The company specializes in developing and marketing products that assist healthcare professionals in detecting, treating, and monitoring diseases, with a strong focus on oncology and cardiology. Lantheus sells its products primarily in the United States and also distributes internationally through direct and third-party channels.

1. **Radiopharmaceutical Oncology** - Develops and markets products for detecting, treating, and monitoring cancer, with a focus on prostate cancer. Key products include PYLARIFY, a leading diagnostic agent in this category  **[0001628280-24-019798_lnth-20240331.htm:42]** **[0001628280-24-045459_lnth-20240930.htm:37]** **[0001628280-24-045456_exhibit991q32024earningspr.htm:0]** .
2. **Precision Diagnostics** - Provides diagnostic information to help healthcare professionals detect and characterize diseases, primarily in cardiology. Notable products include DEFINITY, an ultrasound enhancing agent, and other nuclear imaging products like TechneLite and Xenon  **[0001628280-24-019798_lnth-20240331.htm:42]** **[0001628280-24-006158_lnth-20231231.htm:149]** **[0001628280-24-006158_lnth-20231231.htm:8]** .
3. **Strategic Partnerships and Other Revenue** - Engages in out-licensing arrangements and partnerships to enable precision medicine through biomarkers, digital solutions, and radiotherapeutic platforms. This includes products like MK-6240 and NAV-4694 for Alzheimer's disease imaging  **[0001628280-24-019798_lnth-20240331.htm:42]** **[0001628280-24-045459_lnth-20240930.htm:37]** **[0001628280-24-045459_lnth-20240930.htm:52]** .

8cf2ab83c05d9d1c2ec2e59a375a26df831f98c621bab8bf34b8a479ec8a824f

1. Given the net price compression from strategic partnerships affecting PYLARIFY's Q3 revenues, how do you anticipate this price pressure impacting revenue growth in 2025, and do you expect similar pricing dynamics to continue?  **[LNTH_3406031_8]** **[LNTH_3406031_10]** **[LNTH_3406031_12]** 
2. With the SPLASH study's OS results confounded by high patient crossover to PNT2002, what specific strategies are you considering to address this issue with the FDA, and how might this affect the regulatory timeline for PNT2002's approval?  **[LNTH_3406031_4]** **[LNTH_3406031_16]** 
3. Considering the potential for CMS pricing adjustments and increasing competition for PYLARIFY, how confident are you in maintaining its blockbuster status in 2025 and sustaining long-term growth amidst net price compression from strategic partnerships?  **[LNTH_3406031_8]** **[LNTH_3406031_10]** **[LNTH_3406031_12]** 
4. Can you elaborate on how MK-6240 and NAV-4694 will differentiate themselves from existing imaging agents and emerging blood tests in Alzheimer's diagnostics, and what substantiates your confidence in achieving the projected $1.5 billion market size by the end of the decade?  **[LNTH_3406031_17]** **[LNTH_3406031_13]** 
5. With rising costs in materials, freight, and overhead partially offsetting gross margin improvements, what measures are you implementing to manage these costs and sustain or improve gross margins amid potential pricing pressures and increased R&D investments?  **[LNTH_3406031_5]** 

63a5b36f28357d69a36a9f0e8dd49aaa92a07ff23e14343655858fa472964d5e

- Lantheus is focused on delivering over **$1 billion in sales** for **PYLARIFY** in 2024, aiming to make it the **first ever PET imaging blockbuster**.  **[LNTH_3382213_20]** **[LNTH_3382213_9]**
- Growth in PYLARIFY usage is driven by **market expansion**, increased utilization among existing prescribers, and **successful marketing initiatives**, including salesforce expansion, strategic partnerships, and enhancement of their PMF network to **58 active sites**.  **[LNTH_3382213_9]** **[LNTH_3382213_13]**
- The company is leveraging its strong cash position, with a **record free cash flow of $118 million**, to invest in **business development and M&A** to expand their pipeline, particularly in **radioligand therapy**, which is expected to drive future growth.  **[LNTH_3382213_14]** **[LNTH_3382213_17]**

612f2a73aa27ae463ed80904aef2c444f0ed5e4a8232f80713b3175270f5788c

- **Potential expiration of PYLARIFY's transitional pass-through status may negatively impact revenue**, and the company's mitigation strategies might not fully offset this risk.  **[LNTH_3374570_11]**
- **Competitors may introduce new products that restart the transitional pass-through clock**, challenging LNTH's market share and revenue growth for PYLARIFY.  **[LNTH_3374570_21]**
- **Uncertainty around PNT2002 development and investment**, as the company awaits more data before committing resources, may delay potential future revenue streams.  **[LNTH_3374570_14]**

d232dd4a6273cc042dd8e4f65e18df8b291847a1037b1a90b0734bacc0b916ae

- **Lantheus's advanced Alzheimer's diagnostic agents**, **MK-6240** and **NAV-4694**, are potentially best-in-class with high sensitivity and low off-target binding, offering significant market potential as the U.S. market for Alzheimer's radiodiagnostics could reach **$1.5 billion by the end of the decade** and **$2.5 billion by mid-2030s**.  **[LNTH_3406031_13]** **[LNTH_3406031_3]**  They expect to submit NDAs for MK-6240 in **2025** and NAV-4694 in **2026**.  **[LNTH_3406031_3]**
- **PYLARIFY**, their **#1 PSMA PET imaging agent**, continues to be the market leader, expected to reach **blockbuster status with more than $1 billion in sales in 2025**, with continued growth anticipated in the PSMA PET imaging market, which could expand from **$2 billion to $3 billion by the end of the decade**.  **[LNTH_3406031_10]** **[LNTH_3406031_12]**
- **Additional revenue streams** from royalties on products like **FLYRCADO (Flurpiridaz)**, approved for enhanced diagnosis of coronary artery disease, and **Pocari** in Europe provide further growth opportunities, with Lantheus receiving **tiered double-digit royalties in the U.S.** and **mid-single-digit royalties outside the U.S.**.  **[LNTH_3406031_18]**

e780eb8b3e2238b6cf09df11f9e469c244f551a083361b9f0620e7d10a6914a8

- **PYLARIFY, Lantheus's leading PSMA PET imaging agent, maintains a stable market share in the mid-60% range, has been used in over 400,000 scans since launch, and is expected to grow in the mid-20% range this year, predominantly driven by volume.** Despite competition from three other commercial competitors, PYLARIFY continues to expand in a market where only **30%** of prostate cancer scans use PSMA PET imaging, highlighting significant growth potential as the total addressable market is expected to grow from over **$2 billion** in 2024 to over **$3 billion** by 2029.  **[LNTH_3395312_12]** ,  **[LNTH_3395312_10]**
- **Lantheus is well-positioned in the rapidly expanding Alzheimer's diagnostics market with two next-generation agents, MK-6240 and NAV-4694, which demonstrate higher sensitivity and specificity.** MK-6240 is involved in over **90 trials**, and following a recent pre-NDA meeting with the FDA, the company plans to submit an NDA in **2025**. The Alzheimer's field has a total addressable market in excess of **$1 billion**, and recent therapeutic innovations suggest the market is poised for significant growth.  **[LNTH_3395312_13]** ,  **[LNTH_3395312_9]** ,  **[LNTH_3395312_16]**
- **The company is leveraging its existing manufacturing and commercial infrastructure to bring new products to market, including PNT2002, enhancing their pipeline and future growth potential.** With relationships across **58** PET manufacturing facilities and access to approximately **2,000** PET CT sites and over **300** radiopharmaceutical therapeutic sites, Lantheus is well-positioned to commercialize new agents efficiently. They are encouraged by the SPLASH trial results for PNT2002, having met the primary endpoint and expecting additional data this quarter.  **[LNTH_3395312_15]** ,  **[LNTH_3395312_16]**

689355d1445fc3e4a3e771f144cec8c96922035dd9f6f8024b1936f76ca58cb8

- **Delay in MK-6240 NDA submission to 2025** may impact the company's pipeline progression and future revenue growth. Lantheus anticipates submitting the NDA for MK-6240 in 2025, which was unexpected by analysts.  **[LNTH_3395312_13]**
- **Competitive pressures** in the PSMA PET imaging market could affect PYLARIFY's market share and growth prospects. The company acknowledges the presence of **three other commercial competitors**, with market share remaining relatively stable in the **mid-60% range**.  **[LNTH_3395312_12]** ,  **[LNTH_3395312_11]**
- **Lowered adjusted EPS guidance** due to increased R&D expenses and dilution from convertible debt. The company adjusted its fully diluted adjusted EPS guidance to a range of **$6.60 to $6.70**, down from the prior guidance of $7.00 to $7.20.  **[LNTH_3395312_5]**

832fdc6805dc132c6b044c94a06bd086bd7b995bf4704b71306ad9213a70229c

- **Lantheus' MK6240**, an imaging biomarker for Alzheimer's disease, is currently used in **over 90 clinical trials** and has an estimated addressable market of **approximately $1.5 billion by the end of the decade**, representing a significant future revenue opportunity.  **[LNTH_3374570_16]**
- **PYLARIFY** is expected to grow **mid-teens** this year, driven primarily by volume growth and a **6% WAC price increase**, solidifying its position as the market leader in PSMA PET imaging for prostate cancer. The company is undertaking proactive strategies, including long-term strategic partnerships and advocating for favorable reimbursement legislation, to ensure **PYLARIFY** remains the preferred agent despite potential reimbursement challenges.  **[LNTH_3374570_10]** **[LNTH_3374570_11]**
- **PNT2002**, Lantheus' PSMA-targeted radiotherapeutic, has shown encouraging results from the SPLASH trial data, with a formal prespecified data review planned for the third quarter. Positive outcomes could lead to further clinical development and value creation.  **[LNTH_3374570_14]**

18e24545be800543550af6373a5c43e5321cbba2cf23e5f59515fac9c38790b8

- **PYLARIFY revenue experienced a sequential decline in Q3 due to net price compression from strategic partnerships and intentional trade-offs due to product availability, and may continue to face pricing pressures into 2025.**  **[LNTH_3406031_8]** ,  **[LNTH_3406031_10]** ,  **[LNTH_3406031_12]**
- **The PNT2002 Phase III trial may face delays as the FDA could require completion of 100% of overall survival events, potentially extending into the first quarter or beyond, impacting the regulatory timeline.**  **[LNTH_3406031_15]**
- **Financial contributions from global partnerships, such as with Curium for PYLARIFY/[Poclari] and GE Healthcare for FLYRCADO (Flurpiridaz), are expected to be minimal in the near term, limiting immediate revenue growth from these collaborations.**  **[LNTH_3406031_18]**

afe04e6f9384d4aa2ab4cd3e9411ef3e221b06ac2d9d7b21482c62f16d658e85

1. **PYLARIFY Revenue Outlook**  
   **Q:** Why use "sustain" instead of "grow" for PYLARIFY's $1B franchise?  
   **A:** Management clarified they expect PYLARIFY volume to **grow** next year, but due to net price compression from strategic partnerships, revenue impact will normalize over 2025. They remain positive on the market's growth and are confident in sustaining the **$1 billion** franchise.  **[LNTH_3406031_10]** 

2. **CMS Reimbursement Rates for PYLARIFY**  
   **Q:** Will PYLARIFY's CMS reimbursement rate remain steady in 2025?  
   **A:** The final 2025 CMS payment rate for PYLARIFY matches its existing rate, effectively sustaining payment for 2025. Management feels confident that PYLARIFY will be paid appropriately in 2025, supporting continued growth.  **[LNTH_3406031_9]** **[LNTH_3406031_11]** 

3. **Strategic Partnerships and Price Compression**  
   **Q:** How much impact have strategic partnerships had on pricing?  
   **A:** Strategic partnerships have led to net price compression in Q3, impacting sequential performance. This effect will continue into next year but is expected to normalize over the first half of 2025. The partnerships are multiyear contracts, and management views the impact as transitory.  **[LNTH_3406031_8]** **[LNTH_3406031_12]** 

4. **Alzheimer's Diagnostic Pipeline**  
   **Q:** How do your Alzheimer's assets differentiate from others?  
   **A:** Management is excited about their Alzheimer's portfolio, including **MK-6240**, which appears to be a best-in-class asset with great detection rates and minimal off-target binding. It's in advanced Phase III development. There is significant market potential, forecasted at **$1.5 billion** by the end of the decade.  **[LNTH_3406031_13]** 

5. **PNT2002 Trial and FDA Approval**  
   **Q:** What is the timeline if FDA wants 100% events in PNT2002 trial?  
   **A:** If the FDA requires completion of the study, it's possible it could continue into the first quarter, but the final OS event timing is uncertain. Management prefers not to speculate but continues to work with Lilly and analyze data.  **[LNTH_3406031_15]** 

6. **Q4 Guidance and R&D Expenses**  
   **Q:** Why is there a sequential step down in Q4 guidance?  
   **A:** The expected decrease in EPS from Q3 to Q4 is due to increased **R&D expenses**, representing the biggest step-up in operating expenses and causing the projected earnings to step down.  **[LNTH_3406031_9]** 

7. **Future Pricing and Ability to Adjust Contracts**  
   **Q:** Can you adjust pricing within strategic partnerships?  
   **A:** Management engages in partnerships with key customers to grow together but won't comment on contract details. They believe PYLARIFY will be paid appropriately in 2025 and are positive about maintaining suitable pricing.  **[LNTH_3406031_11]** 

8. **PYLARIFY Market Growth and Multiyear Outlook**  
   **Q:** Do you expect PYLARIFY to grow revenue on a multiyear basis?  
   **A:** Management remains positive about long-term growth in the PSMA PET imaging market. While net price compression will normalize over the first half of next year, they expect overall market growth and for PYLARIFY to continue leading as a sustainable franchise.  **[LNTH_3406031_12]** 

9. **Royalties from Pocari and FLYCARDO**  
   **Q:** Any color on royalties from Pocari and growth of FLYCARDO?  
   **A:** Pocari approvals in Europe are pleasing, but financial impact is minimal in the near term as it ramps up. Regarding FLYCARDO, GE holds commercialization rights, and they are excited about its potential in the large cardiac imaging market.  **[LNTH_3406031_18]** 

344f49cf42cfa3fc86bb265ed563eb1f6a06560d973e55c686086d1d9921b53e

- The potential expiration of the Transitional Pass-Through Payment (TPT) at the end of 2024 could impact approximately **20% of PYLARIFY revenue**, introducing uncertainty around reimbursement and potentially affecting financial performance.  **[LNTH_3382213_2]**
- The product candidate **PNT2003** is pending FDA approval and requires a positive resolution of **Hatch-Waxman litigation**, which could delay its launch until **2026**, posing risks to future revenue growth.  **[LNTH_3382213_4]**
- **Operating expenses** increased significantly, with **operating expenses at 26.8% of net revenue**, **up 538 basis points** from the prior year rate, indicating rising costs and potential pressure on profit margins.  **[LNTH_3382213_6]**

d3f7515cb4d97f9aab91dd883fc287fc7d3e7db0b16d0b6b1496cd11af0f15d4

Lantheus Holdings Inc (LNTH)

Financials