On August 8, 2024 Eli Lilly and Company (NYSE: LLY) reported its financial results for the second quarter of 2024 (Press release, Eli Lilly, AUG 8, 2024, View Source [SID1234645595]).

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"Mounjaro, Zepbound and Verzenio led our strong financial performance in the second quarter as we advanced our manufacturing expansion agenda, and it is equally exciting to see the growth around the world of our medicines for cancer, neurological disorders and autoimmune diseases," said David A. Ricks, Lilly’s chair and CEO. "We also recently received approval of Kisunla to help people with Alzheimer’s disease, a moment that was decades in the making. Lilly’s performance and progress in Alzheimer’s, metabolic disorders and many other serious diseases highlight the tenacity, focus and capability of our scientists, clinicians, engineers, customer teams and collaborators."

Lilly shared numerous updates recently on key regulatory, clinical, business development and other events, including:

U.S. Food and Drug Administration (FDA) approval of Kisunla (donanemab-azbt) for the treatment of Alzheimer’s disease;
Approval of Jaypirca in Japan for people with relapsed or refractory mantle cell lymphoma who are resistant or intolerant to other Bruton tyrosine kinase inhibitors;
Submission of tirzepatide in the U.S. and EU for the treatment of moderate-to-severe obstructive sleep apnea in adults with obesity;
Submission of mirikizumab in Japan for the treatment of moderately to severely active Crohn’s disease;
Positive topline results from the SUMMIT Phase 3 clinical trial evaluating tirzepatide in adults with heart failure with preserved ejection fraction and obesity;
Positive topline results from the QWINT-2 and QWINT-4 Phase 3 clinical trials that showed once-a-week dosing of insulin efsitora alfa in adults with type 2 diabetes delivers A1C reduction and safety profile consistent with daily insulin;
The announcement of an agreement for Lilly to acquire Morphic Holding, Inc. to expand Lilly’s immunology pipeline with oral integrin therapies for treatment of serious chronic diseases;
The commitment of an additional $5.3 billion manufacturing investment in the company’s newest Indiana site to boost API production for tirzepatide and pipeline medicines;
The issuance of an open letter informing the public about potentially serious risks posed by the proliferation of counterfeit, fake, compounded, and other unsafe or untested versions of the company’s FDA-approved tirzepatide medications and about the appropriate use of the company’s authentic medicines; and
Announcements regarding changes to the company’s executive leadership team.
For information on important public announcements, visit the news section of Lilly’s website.

Financial Results

$ in millions, except

per share data

Second Quarter

2024

2023

% Change

Revenue

$ 11,302.8

$ 8,312.1

36 %

Net income – Reported

2,967.0

1,763.2

68 %

Earnings per share – Reported

3.28

1.95

68 %

Net income – Non-GAAP

3,541.2

1,904.4

86 %

Earnings per share – Non-GAAP

3.92

2.11

86 %

A discussion of the non-GAAP financial measures is included below under "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)."

Second-Quarter Reported Results
In Q2 2024, worldwide revenue was $11.30 billion, an increase of 36% compared with Q2 2023, driven by a 27% increase in volume and a 10% increase due to higher realized prices, partially offset by a 1% decrease from the unfavorable impact of foreign exchange rates. The volume increase was primarily driven by growth from Mounjaro, Zepbound, Verzenio, Taltz and Jardiance, partially offset by the sale of rights for Baqsimi in Q2 2023 and declines in Trulicity. Excluding $579.0 million of revenue from the sale of rights for Baqsimi in Q2 2023, revenue in Q2 2024 increased by 46%, and worldwide volume increased by 37%. Excluding the sale of rights for Baqsimi, non-incretin revenue increased 17% worldwide and 25% in the U.S.

Strong performance by the company’s incretin medicines continued, as production increases resulted in improved channel dynamics and stocking levels in the U.S., contributing to sales growth during the quarter. While supply and demand have come into better balance, expected increases in demand may result in periodic supply tightness for certain presentations and dose levels. In the U.S., the company plans to launch Zepbound 2.5 mg and 5 mg single-dose vials in the coming weeks.

Higher realized prices were primarily driven by Mounjaro in the U.S., which saw net price positively impacted by access and savings card dynamics compared with Q2 2023. In the second half of 2024, these savings card dynamics should have a minimal impact on realized price comparisons to base periods, as the $25 non-covered benefit expired on June 30, 2023. New Products(i) revenue grew by $3.46 billion to $4.46 billion in Q2 2024, led by Mounjaro and Zepbound. Growth Products(ii) revenue increased 3% to $5.05 billion in Q2 2024 as growth led by Verzenio, Taltz, and Jardiance was largely offset by lower Trulicity sales.

(i) Lilly defines New Products as select products launched since 2022, which currently consist of Ebglyss, Jaypirca, Mounjaro, Omvoh and Zepbound.

(ii) Lilly defines Growth Products as select products launched prior to 2022, which currently consist of Cyramza, Emgality, Jardiance, Olumiant, Retevmo, Taltz, Trulicity, Tyvyt and Verzenio

Revenue in the U.S. increased 42% to $7.84 billion, driven by a 27% increase in volume and a 15% increase in realized prices. The increase in U.S. volume was driven by Zepbound, Mounjaro and Verzenio, partially offset by the sale of rights for Baqsimi in Q2 2023 and declines in Trulicity. The higher realized prices in the U.S. were primarily driven by Mounjaro. The company fulfilled the majority of prior incretin wholesaler backorders during Q2 2024, improving both wholesaler stocking levels and overall product availability for patients in the U.S. Q2 2024 Mounjaro and Zepbound sales in the U.S. were positively impacted by channel stocking that the company estimates totaled high teens to mid-20s as a percent of U.S. sales.

Revenue outside the U.S. increased 25% to $3.47 billion, driven by a 27% increase in volume, partially offset by a 3% decrease due to the unfavorable impact of foreign exchange rates. The increase in volume outside the U.S. was primarily driven by the launch of Mounjaro KwikPen in various markets.

Gross margin increased 40% to $9.13 billion in Q2 2024. Gross margin as a percent of revenue was 80.8%, an increase of 2.5 percentage points. The increase in gross margin percent was primarily driven by favorable product mix and higher realized prices, partially offset by higher production costs.

In Q2 2024, research and development expenses increased 15% to $2.71 billion, or 24% of revenue, driven by continued investments in the company’s portfolio and its people.

Marketing, selling and administrative expenses increased 10% to $2.12 billion in Q2 2024, primarily driven by investments in the company’s launches and its people.

In Q2 2024, the company recognized acquired in-process research and development (IPR&D) charges of $154.3 million compared with $97.1 million in Q2 2023.

Asset impairment, restructuring and other special charges were $435.0 million in Q2 2024, which was related to anticipated litigation payments. There were no asset impairment, restructuring and other special charges in Q2 2023.

Other income (expense) was expense of $197.6 million in Q2 2024, compared to expense of $36.8 million in Q2 2023. The increase in expense was primarily driven by larger net losses on investments in equity securities in Q2 2024 and higher net interest expenses.

The effective tax rate was 15.6% in both Q2 2024 and Q2 2023. The Q2 2024 tax rate reflects a mix of earnings in higher tax jurisdictions, while the Q2 2023 rate reflects the impact of earnings from the sale of rights for Baqsimi.

In Q2 2024, net income and earnings per share (EPS) were $2.97 billion and $3.28, respectively, compared with net income of $1.76 billion and EPS of $1.95 in Q2 2023. EPS in Q2 2024 included $0.14 of acquired IPR&D charges compared with $0.09 in Q2 2023.

Second-Quarter Non-GAAP Measures
On a non-GAAP basis, Q2 2024 gross margin increased 40% to $9.27 billion. Gross margin as a percent of revenue was 82.0%, an increase of 2.2 percentage points. The increase in gross margin percent was primarily driven by favorable product mix and higher realized prices, partially offset by higher production costs.

The effective tax rate on a non-GAAP basis was 16.5% in Q2 2024 compared with 16.1% in Q2 2023. The Q2 2024 tax rate reflects a mix of earnings in higher tax jurisdictions, while the Q2 2023 rate reflects the impact of earnings from the sale of rights for Baqsimi.

On a non-GAAP basis, Q2 2024 net income and EPS were $3.54 billion and $3.92, respectively, compared with net income of $1.90 billion and EPS of $2.11 in Q2 2023. EPS in Q2 2024 included $0.14 of acquired IPR&D charges compared with $0.09 in Q2 2023.

For further detail on non-GAAP measures, see the reconciliation below as well as the "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)" table later in this press release.

Second Quarter

2024

2023

% Change

Earnings per share (reported)

$ 3.28

$ 1.95

68 %

Asset impairment, restructuring and other special
charges

.38

—

Net losses on investments in equity securities

.14

.05

Amortization of intangible assets

.12

.11

Earnings per share (non-GAAP)

$ 3.92

$ 2.11

86 %

Numbers may not add due to rounding.

Acquired IPR&D

.14

.09

56 %

Selected Revenue Highlights

(Dollars in millions)

Second Quarter

Year-to-Date

Selected Products

2024

2023

% Change

2024

2023

% Change

Mounjaro

$ 3,090.8

$ 979.7

NM

$ 4,897.4

$ 1,548.2

NM

Trulicity

1,245.6

1,812.5

(31) %

2,701.9

3,789.6

(29) %

Verzenio

1,331.9

926.8

44 %

2,382.2

1,677.7

42 %

Zepbound

1,243.2

—

NM

1,760.6

—

NM

Jardiance(a)

769.6

668.3

15 %

1,456.1

1,245.8

17 %

Taltz

824.7

703.9

17 %

1,428.8

1,230.8

16 %

Humalog(b)

631.6

440.4

43 %

1,170.3

901.4

30 %

Total Revenue

11,302.8

8,312.1

36 %

20,070.8

15,272.1

31 %

(a) Jardiance includes Glyxambi, Synjardy and Trijardy XR

(b) Humalog includes Insulin Lispro

NM – not meaningful

Mounjaro
For Q2 2024, worldwide Mounjaro revenue was $3.09 billion compared with $979.7 million in Q2 2023. U.S. revenue was $2.41 billion compared with $915.7 million in Q2 2023, reflecting continued strong demand, improved channel dynamics, and higher realized prices due to savings card dynamics. In the second half of 2024, these savings card dynamics should have a minimal impact on realized price comparisons to base periods, as the $25 non-covered benefit expired on June 30, 2023. Revenue outside the U.S. increased to $677.2 million compared with $64.0 million in Q2 2023, primarily driven by volume associated with the launch of Mounjaro KwikPen in various markets.

Trulicity
For Q2 2024, worldwide Trulicity revenue decreased 31% compared with Q2 2023 to $1.25 billion. U.S. revenue decreased 36% to $876.7 million, driven by decreased sales volume primarily due to competitive dynamics and supply constraints, partially offset by improved wholesaler stocking levels on certain doses. Revenue outside the U.S. decreased 16% to $368.9 million, primarily driven by decreased volume. In addition to the factors affecting U.S. volume, international markets continue to be impacted by actions Lilly has taken to manage demand amid tight supply, including measures to minimize the impact on existing patients by communicating with healthcare practitioners to not start new patients on Trulicity.

Verzenio
For Q2 2024, worldwide Verzenio revenue increased 44% compared with Q2 2023 to $1.33 billion. U.S. revenue was $861.4 million, an increase of 46%, primarily driven by increased demand. Revenue outside the U.S. was $470.5 million, an increase of 39%, driven by increased demand, partially offset by the unfavorable impact of foreign exchange rates.

Zepbound
For Q2 2024, U.S. Zepbound revenue was $1.24 billion. Zepbound launched in the U.S. for the treatment of adult patients with obesity or overweight with weight-related comorbidities in November 2023.

Jardiance
For Q2 2024, the company’s worldwide Jardiance revenue increased 15% compared with Q2 2023 to $769.6 million. U.S. revenue was $428.9 million, an increase of 11%, driven by increased demand. Revenue outside the U.S. was $340.7 million, an increase of 21%, driven by increased volume.

Jardiance is part of the company’s alliance with Boehringer Ingelheim. Lilly reports as revenue royalties received on net sales of Jardiance.

Taltz
For Q2 2024, worldwide Taltz revenue increased 17% compared with Q2 2023 to $824.7 million. U.S. revenue increased 14% to $539.4 million, driven by increased demand and, to a lesser extent, channel dynamics. Revenue outside the U.S. increased 23% to $285.3 million, driven by increased demand.

Humalog
For Q2 2024, worldwide Humalog revenue increased 43% compared with Q2 2023 to $631.6 million. U.S. revenue was $434.7 million, an increase of 89%, driven by higher realized prices primarily due to changes to estimates for rebates and discounts, segment mix and increased demand. Revenue outside the U.S. was $196.9 million, a decrease of 7%, driven by decreased volume, partially offset by higher realized prices.

2024 Financial Guidance
2024 full-year revenue guidance increased by $3.0 billion to the range of $45.4 billion to $46.6 billion, primarily driven by the strong performance of Mounjaro and Zepbound, as well as the company’s non-incretin medicines. Additionally, the company has improved clarity into the timing and pace of the company’s production expansions and planned Mounjaro launches outside the U.S. In Q2 2024, the company achieved a number of supply-related milestones and has increased confidence regarding production expectations for the rest of the year.

The ratio of (Gross Margin – OPEX) / Revenue, where OPEX is defined as the sum of research and development expenses and marketing, selling and administrative expenses, is now expected to be in the range of 36% to 38% on a reported basis and 37% to 39% on a non-GAAP basis. Both ratios reflect the $3.0 billion increase in revenue guidance.

Guidance on a reported basis now includes asset impairment, restructuring and other special charges of $435 million to reflect the Q2 2024 charge, which was associated with anticipated litigation payments.

Other income (expense) guidance is now expected to be a range of ($525) to ($425) million of expense on a reported basis and ($400) to ($300) million of expense on a non-GAAP basis, both reflecting lower expected net interest expense. The reported guidance also reflects net losses on investments in equity securities through Q2 2024.

Tax rate guidance is now expected to be approximately 15% on both a reported and non-GAAP basis, driven by changes in the company’s forecasted mix of earnings in higher tax jurisdictions.

Based on these changes, EPS guidance increased to the ranges of $15.10 to $15.60 on a reported basis and $16.10 to $16.60 on a non-GAAP basis. The company’s 2024 financial guidance reflects adjustments shown in the reconciliation table below.

2024

Guidance(1)

Earnings per share (reported)

$15.10 to $15.60

Amortization of intangible assets

.49

Asset impairment, restructuring, and other special charges

.38

Net losses on investments in equity securities

.12

Earnings per share (non-GAAP)

$16.10 to $16.60

Numbers may not add due to rounding

(1) Reported and Non-GAAP EPS guidance both include $0.24 of Acquired IPR&D charges incurred through Q2 2024.

The following table summarizes the company’s 2024 financial guidance:

2024 Guidance(1)

Prior

Updated(3)

Revenue

$42.4 to $43.6 billion

$45.4 to $46.6 billion

(Gross Margin – OPEX(2)) / Revenue:

(reported)

32% to 34%

36% to 38%

(non-GAAP)

33% to 35%

37% to 39%

Other Income/(Expense) (reported)

($500) to ($400) million

($525) to ($425) million

Other Income/(Expense) (non-GAAP)

($500) to ($400) million

($400) to ($300) million

Tax Rate

Approx. 14%

Approx. 15%

Earnings per Share (reported)

$13.05 to $13.55

$15.10 to $15.60

Earnings per Share (non-GAAP)

$13.50 to $14.00

$16.10 to $16.60

(1) Non-GAAP guidance reflects adjustments presented in the earnings per share reconciliation table above.

(2) OPEX is defined as the sum of research and development expenses and marketing, selling and administrative expenses.

(3) Guidance includes Acquired IPR&D charges through Q2 2024 of $264.8 million or $0.24 on a per share basis. Guidance does not include Acquired IPR&D either incurred, or expected to be incurred, after Q2 2024.

Webcast of Conference Call
As previously announced, investors and the general public can access a live webcast of the Q2 2024 financial results conference call through a link on Lilly’s website at investor.lilly.com/webcasts-and-presentations. The conference call will begin at 10 a.m. Eastern time today and will be available for replay via the website.

On August 8, 2024 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, reported second quarter 2024 financial results and provided a business update (Press release, CytomX Therapeutics, AUG 8, 2024, View Source [SID1234645594]).

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"We are encouraged by the initial CX-904 Phase 1a data we shared in the second quarter that demonstrated single agent anti-cancer activity and a favorable therapeutic window for the high potential and previously undruggable target combination of EGFR and CD3, underscoring the potential of our PROBODY therapeutic platform," said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX.

"Based on our clinical observations for CX-904 to date, patient enrollment is now principally focused in pancreatic cancer, where we have already shown confirmed partial responses, and in non-small cell lung cancer and head and neck cancer. We are highly focused on generating additional data during the second half of 2024 and look forward to ongoing strategic dialogue with our global development partner Amgen."

"During the second quarter we also made rapid progress in early Phase 1 dose escalation for CX-2051 and have reached our third dose level, keeping us on track for initial data to be shared externally in the first half of 2025. Also during the second quarter, we opened our first clinical site for CX-801, setting the stage for multiple clinical data readouts over the next 12 to 18 months from our multi-modality, differentiated PROBODY therapeutic pipeline," continued Dr. McCarthy.

Second Quarter Business Highlights and Recent Developments

Pipeline

CX-904, PROBODY T-cell-engager (TCE) targeted to EGFRxCD3; ongoing enrollment into Phase 1a dose escalation continues focused in PDAC, NSCLC, and HNSCC.

In May 2024, the Company announced (Link) positive initial Phase 1 dose escalation data in 35 heavily pre-treated patients (median of 4 prior lines of therapy) with advanced metastatic solid tumor types that are generally known to express EGFR. CX-904 demonstrated a favorable and manageable safety profile and initial signs of anti-tumor activity, including 2 of 6 (33%) efficacy-evaluable pancreatic cancer patients with confirmed partial responses per RECIST 1.1 and translational data supporting the CX-904 mechanism of action.
CX-904 Phase 1a dose escalation continues, with future enrollment focused in PDAC, HNSCC and NSCLC and on determining a recommended Phase 1b dose or doses.
CX-2051, an EpCAM-directed PROBODY antibody drug conjugate; Phase 1 dose escalation continues, initial data expected in 2025.

In April 2024, the first patient was dosed as part of the Phase 1 dose escalation study of CX-2051 in patients with solid tumors generally known to express EpCAM.
The third cohort has been opened in the Phase 1 study and dose escalation continues with initial enrollment focused primarily in CRC.
CX-801, PROBODY interferon-alpha 2b; Phase 1a dose escalation study initiated.

The first clinical site has been activated in the CX-801 Phase 1 dose escalation study in patients with solid tumors including melanoma, renal, and head and neck squamous cell carcinoma. The Phase 1 study will evaluate safety and signs of clinical activity for CX-801 monotherapy and for CX-801 in combination with KEYTRUDA.
In April 2024, the Company announced a clinical collaboration agreement with Merck to supply KEYTRUDA for combination with CX-801 in the Phase 1 study.
CytomX continues to make progress in its R&D partnerships.

CytomX has multiple active research and development partnerships and more than 10 ongoing research programs with major biotechnology and pharmaceutical companies (Amgen, Astellas, Bristol Myers Squibb, Moderna, and Regeneron).
In 2024 to-date, CytomX has achieved $10.0 million in preclinical milestones under its multi-target T-cell Engager collaboration with Astellas related to two separate PROBODY TCE programs.
Corporate

Chris Ogden promoted to Chief Financial Officer.

Mr. Ogden joined CytomX in August of 2021 as Vice President, Finance and Accounting and has since served in roles of increasing responsibility spanning finance, accounting, investor relations, capital raising, information technology, and facilities, most recently as Senior Vice President, Finance and Accounting. Mr. Ogden joined CytomX after a 16-year tenure at Eli Lilly and Company, where he held senior financial leadership positions, including most recently as chief financial officer of Lilly Diabetes.

Priorities and Key Milestones:

CX-904 (EGFRxCD3):
Continued Phase 1a dose escalation in PDAC, HNSCC and NSCLC focused on the selection of recommended Phase 1b dose(s)
Ongoing strategic dialogue with CytomX partner, Amgen
A CX-904 Phase 1 program update is expected by the end of 2024, including a potential decision to initiate Phase 1b expansion cohorts in specific EGFR positive tumor types
CX-2051 (EpCAM):
Continued Phase 1 dose escalation in solid tumors, primarily CRC
Initial Phase 1a data expected in the first half of 2025
CX-801 (IFNα2b):
Continued Phase 1 dose escalation progress in solid tumors including melanoma, renal, and head and neck squamous cell carcinoma
Initial Phase 1a data expected in the second half of 2025
Q2 2024 Financial Results

Cash, cash equivalents and investments totaled $137.2 million as of June 30, 2024, compared to $150.3 million as of March 31, 2024. Cash inflows in the quarter included $10.0 million from milestone payments earned in the Astellas collaboration and $4.8 million of proceeds raised through our At-the-market (ATM) facility. Operational cash uses in the quarter included a one-time milestone payment of $5.0 million to AbbVie (formerly ImmunoGen) for the Phase 1 initiation of CX-2051.

Total revenue was $25.1 million for the three months ended June 30, 2024 compared to $24.7 million for the corresponding period in 2023. The increase in revenue was driven primarily by a higher percentage of completion of research activities related to the Regeneron and Moderna collaborations.

Research and development expenses increased by $4.5 million for the three months ended June 30, 2024 to $25.2 million, compared to $20.7 million for the corresponding period of 2023. This was primarily due to the milestone payment to AbbVie (formerly ImmunoGen) related to the Phase 1 initiation of CX-2051.

General and administrative expenses increased by $1.0 million for the three months ended June 30, 2024 to $8.4 million compared to $7.4 million for the corresponding period of 2023, primarily due to higher consulting services, personnel costs, and intellectual property related expenses.

Conference Call & Webcast
CytomX management will host a conference call and simultaneous webcast today at 5 p.m. EDT (2 p.m. PDT) to discuss the financial results and provide a business update. Participants may access the live webcast of the conference call from the Events and Presentations page of CytomX’s website at View Source Participants may register for the conference call here and are advised to do so at least 10 minutes prior to joining the call. An archived replay of the webcast will be available on the company’s website.

On August 8, 2024 Cullinan Therapeutics, Inc. (Nasdaq: CGEM; "Cullinan"), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, reported recent and anticipated business highlights and announced its financial results for the second quarter ended June 30, 2024 (Press release, Cullinan Oncology, AUG 8, 2024, View Source [SID1234645593]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We are keenly focused on executing on the strategic plans we made during the first half of 2024, including our expansion into autoimmune diseases and continued advancement of our oncology pipeline, each facilitated by our recent oversubscribed financing," said Nadim Ahmed, Chief Executive Officer of Cullinan Therapeutics. "During the second half of 2024, we will advance CLN-978 toward a first global clinical study in systemic lupus erythematosus (SLE) and remain on track to file an investigational new drug (IND) application in the third quarter of this year. We are committed to exploring the broad potential of CLN-978 across autoimmune diseases and will pursue rheumatoid arthritis (RA) as our next indication, where there is both significant unmet patient need and clinical validation for CD19 T cell engagers. We are excited to collaborate with FAU Erlangen-Nuremberg and Università Cattolica del Sacro Cuore, Rome to conduct a clinical trial of CLN-978 in patients with RA. Both are pioneering centers of excellence in the field of T cell redirecting therapies for autoimmune diseases and the first to demonstrate the potential of a CD19 T cell engager in RA. Finally, to focus our resources on our most promising programs, we will discontinue development of CLN-418 based on initial clinical observations."

"At FAU, we are excited about the prospect of a clinical trial of a new T cell engager in RA," said Dr. Ricardo Grieshaber-Bouyer, M.D., Ph.D., Professor of Clinical Systems Immunology and Head of the Clinical Trials Unit at FAU Erlangen-Nuremberg, "There is a significant unmet need in treating patients with RA who are refractory to currently available treatments. Our team at Erlangen has already demonstrated that a T cell engager targeting CD19 has potential to dramatically alter the course of disease in these patients, and we look forward to furthering our initial groundbreaking work in this area with CLN-978, which could potentially offer significant benefit to patients with convenient, off-the-shelf subcutaneous administration and a favorable safety profile."

Portfolio Highlights

Immunology

•
CLN-978 (CD19xCD3 T cell engager): Systemic lupus erythematosus and rheumatoid arthritis
o
Cullinan remains on-track to submit an IND application for the global SLE study to the U.S. Food and Drug Administration in the third quarter of 2024.
o
The company plans to explore CLN-978 in rheumatoid arthritis as its second autoimmune indication and will collaborate with FAU Erlangen-Nuremberg in Germany and Università Cattolica del Sacro Cuore, Rome to conduct a company sponsored clinical trial in that indication.
Oncology

•
CLN-619 (Anti-MICA/MICB monoclonal antibody): Solid tumors and hematological malignancies
o
Cullinan presented initial data from the combination dose escalation module, as well as an update on the monotherapy dose escalation, during a poster session at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting on June 1, 2024.
o
The combination therapy data demonstrated objective responses in patients with non-small cell lung cancer (NSCLC) with oncogenic mutations, which is typically unresponsive to checkpoint inhibitors. The monotherapy data demonstrated durability of clinical benefit with longer follow-up.
o
Based on the observed data, the company announced additional disease expansion cohorts for both monotherapy and in combination with pembrolizumab in NSCLC as well as in combination with chemotherapy in platinum resistant ovarian cancer.
o
Cullinan remains on track to report initial data from disease-specific dose expansion cohorts in endometrial and cervical cancers in the first half of 2025.
•
Zipalertinib (EGFR ex20ins inhibitor), collaboration with Taiho Oncology: EGFR ex20ins NSCLC
o
In June, Cullinan announced positive initial data from the pivotal Phase 2b portion of the REZILIENT1 study in patients with EGFR ex20ins NSCLC who have progressed after prior chemotherapy as well as the exon 20 targeted therapy amivantamab. The results in this emerging patient population showed similar efficacy and safety for zipalertinib as seen in patients progressing after prior chemotherapy alone.
o
An update to these initial REZILIENT1 results in patients with EGFR ex20ins NSCLC who have progressed after both prior chemotherapy and amivantamab will be presented in a mini oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) meeting in September.
o
Cullinan expects to complete enrollment in the pivotal Phase 2b portion of REZILIENT1 by year-end 2024.

•
CLN-049 (FLT3xCD3 T cell-engaging bispecific antibody): AML and MDS
o
Following a review of the data from the Phase 1 study of CLN-049, Cullinan is reporting that in the ongoing Phase 1 study in patients with relapsed/refractory AML and MDS, dose-limiting injection site reactions were observed during dose escalation with subcutaneous administration. Based on these findings, together with observations of preliminary clinical activity, dose escalation is now continuing in the study with IV administration.
•
CLN-617 (IL-2 and IL-12 cytokine fusion protein): Solid tumors
o
Enrollment continues in the ongoing Phase 1 study in patients with advanced solid tumors.
•
CLN-418 (B7H4x4-1BB bispecific immune activator): Solid tumors
o
Following a review of the data from the Phase 1 study of CLN-418, Cullinan plans to discontinue development and has notified Harbour BioMed of termination of the license agreement. In connection with the termination, Cullinan will return development and commercial rights to Harbour BioMed.
Corporate Updates

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In April, the Company completed an oversubscribed private placement of common stock grossing $280 million. The financing included new and existing leading life sciences institutional investors.

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In August, the Company added experienced biotech executive Mary Thistle to its Board of Directors. Ms. Thistle brings thirty years of operational and business development expertise, including experience in autoimmune diseases, that will add significant value to Cullinan’s growth strategy.

Second Quarter 2024 Financial Results

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Cash Position: Cash, cash equivalents, investments, and interest receivable were $664.9 million as of June 30, 2024. Cullinan continues to expect its cash resources to provide runway into 2028 based on its current operating plan.

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R&D Expenses: Research and development (R&D) expenses were $36.3 million for the second quarter of 2024, compared to $27.4 million for the second quarter of 2023. R&D expenses for the second quarter of 2024 and 2023 included $3.9 million and $3.2 million, respectively, of equity-based compensation expenses. The increase in R&D expenses, excluding equity-based compensation, was primarily related to increases in clinical costs, chemistry, manufacturing and controls costs, and preclinical costs, along with increases in personnel costs relating to additional headcount.
R&D expenses were $66.9 million for the first six months of 2024, compared to $79.5 million for the first six months of 2023. R&D expenses for the first six months of 2024 and 2023 included $7.0 million and $6.3 million, respectively, of equity-based compensation expenses. The decrease in R&D expenses, excluding equity-based compensation, was primarily due to the one-time upfront in-licensing fee for CLN-418 in 2023, partially offset by increases in clinical and preclinical costs, and increased personnel costs relating to additional headcount.

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G&A Expenses: General and administrative (G&A) expenses were $13.8 million for the second quarter of 2024, compared to $10.2 million for the second quarter of 2023. G&A expenses in the second quarter of 2024 and 2023 included $6.7 million and $4.7 million, respectively, of equity-based compensation expenses. The increase in G&A expenses, excluding equity-based compensation, was primarily driven by increased personnel costs relating to additional headcount.
G&A expenses were $26.1 million for the first six months of 2024, compared to $20.9 million for the first six months of 2023. G&A expenses in the first six months of 2024 and 2023 included $11.8 million and $8.9 million, respectively, of equity-based compensation expenses. The increase in G&A expenses, excluding equity-based compensation, was primarily driven by increased personnel costs relating to additional headcount.

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Net Loss: Net loss (before items attributable to noncontrolling interest) for the second quarter of 2024 was $42.0 million, compared with net loss of $32.2 million for the second quarter of 2023. Net losses resulted from the expenses described above, partially offset by interest income of $8.1 million and $5.3 million in the second quarter of 2024 and 2023, respectively.
Net loss (before items attributable to noncontrolling interest) for the first six months of 2024 was $79.4 million, compared with net loss of $90.4 million for the six months of 2023. Net losses resulted from the expenses described above, partially offset by interest income of $13.8 million and $9.8 million in the first six months of 2024 and 2023, respectively.

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Shares Outstanding: As of July 31, 2024, Cullinan had 57,976,641 shares of common stock outstanding, plus pre-funded warrants outstanding that are convertible into 315,790 shares of common stock, and non-voting preferred stock outstanding that is convertible into 6,475,000 shares of common stock.

On August 8, 2024 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors, reported financial results for the second quarter ended June 30, 2024 (Press release, Crinetics Pharmaceuticals, AUG 8, 2024, View Source [SID1234645592]).

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"The second quarter of 2024 has been yet another successful period of executing our strategy to become the world’s premier endocrine company," said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. "Our strong presence at the ENDO 2024 meeting in June showcased the breadth and depth of our pipeline. Our second internally-developed candidate atumelnant* showed profoundly positive initial results in the treatment of both congenital adrenal hyperplasia and Cushing’s disease. We anticipate reporting additional data in both indications later in 2024. Data presentations from the paltusotine program continue to demonstrate clinical benefits for patients, providing even more compelling support for its potential to treat people with acromegaly. We remain on track for our planned paltusotine NDA filing in acromegaly later this year, and multiple workstreams are underway in anticipation of an expected market launch in 2025."

Crinetics today also announced that Marc Wilson will be transitioning from his role as Chief Financial Officer for personal reasons and the Company has initiated a search for a successor. Mr. Wilson will continue to serve at full capacity until a successor is named and will provide all necessary support to ensure a seamless transition.

"Marc has been an invaluable member of the Crinetics team over the last six years and we thank him for his outstanding contributions," said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. "His leadership has been instrumental in the success of our capital markets activities, the build-out of our finance and corporate affairs functions, and the maturation of our organization and culture. During his tenure, we have successfully raised a significant amount of capital to fund development of our differentiated pipeline, our rapidly growing clinical and research programs, and our anticipated commercial launch."

"I am proud of what Crinetics has accomplished, and it has been a privilege to work with such a talented and dedicated team over the last six years," said Mr. Wilson. "The company is in a strong financial position to invest across its deep pipeline, and I have unwavering confidence in the team’s ability to continue discovering new, meaningful therapies and advance them through the clinic to reach as many patients as possible. I will continue to support the company through this transition and look forward to following the company’s continued success."

Second Quarter 2024 and Recent Highlights:
Presented positive initial results from atumelnant studies at the Endocrine Society’s Annual Meeting (ENDO 2024). In June, Crinetics presented positive initial results from its ongoing, open-label studies of atumelnant for the treatment of ACTH-dependent Cushing’s syndrome and congenital adrenal hyperplasia (CAH) at ENDO 2024 in Boston.
Presented data from paltusotine development program at ENDO 2024. In June, Crinetics presented findings from its paltusotine development program in acromegaly. Data presented included results of the Phase 3 PATHFNDR-2 trial, a new analysis of patient reported outcome data from the Phase 3 PATHFNDR-1 trial, and interim long-term efficacy and safety results at 42 months from the open-label ACROBAT Advance extension study.
Selected development candidates in two programs. Crinetics has identified an oral parathyroid hormone antagonist development candidate for the treatment of hyperparathyroidism and IND-enabling studies have commenced. In addition, a development candidate in the SST3 agonist program was selected for the treatment of autosomal dominant polycystic kidney disease.
Scott Struthers, Ph.D., founder and chief executive officer of Crinetics, was named an Entrepreneur of The Year 2024 Pacific Southwest Award winner.
Strengthened scientific leadership team. In April, Crinetics appointed Lise Kjems, M.D., Ph.D. as Senior Vice President of Endocrinology Clinical Research, and in May, Crinetics appointed Robert M. Cuddihy, M.D., as Senior Vice President of Medical Affairs.
Key Upcoming Milestones
Topline data and additional data from the ongoing Phase 2 studies of atumelnant in CAH and ACTH-dependent Cushing’s syndrome, respectively, are anticipated by the end of 2024.
Submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking regulatory approval of paltusotine for the treatment of acromegaly is on track for the second half of 2024.
Initiation of a Phase 3 program of paltusotine for carcinoid syndrome is expected by the end of 2024, following consultation with the FDA.
Additional research pipeline updates are expected by the end of 2024.
Second Quarter 2024 Financial Results
Research and development expenses were $58.3 million for the three months ended June 30, 2024, compared to $40.6 million for the same period in 2023. The increase was primarily attributable to higher personnel costs and manufacturing and development activities, both of which were driven by the advancement of our clinical programs and the expansion of our preclinical portfolio.
General and administrative expenses were $24.8 million for the three months June 30, 2024, compared to $13.3 million for the same period in 2023. The increase was primarily driven by higher personnel and commercial planning costs.
Net loss for the three months ended June 30, 2024, was $74.1 million, compared to a net loss of $51.0 million for the same period in 2023.
Revenues were $0.4 million for the three months ended June 30, 2024, compared to $1.0 million for the same period in 2023. Revenues during the current year’s quarter were derived from the paltusotine licensing arrangement with our Japanese partner, Sanwa Kagaku Kenkyusho.
Unrestricted cash, cash equivalents, and investments totaled $863.0 million as of June 30, 2024, compared to $558.6 million as of December 31, 2023. Based on its current projections, Crinetics expects that its cash, cash equivalents and short-term investments will be sufficient to fund its current operating plan into 2028.
Conference Call and Webcast Details
Management will hold a live conference call and webcast today, Thursday, August 8, 2024 at 4:30 p.m. ET. To participate, please dial 1-800-267-6316 (domestic) or 1-203-518-9783 (international) and refer to Conference ID CRNXQ2. To access the webcast, click here. Following the live event, a replay of the call will be available on the Investors section of the Company’s website.

*Proposed international nonproprietary name under review.

On August 8, 2024 Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS), reported financial results for the quarter ended June 30, 2024 and recent business highlights (Press release, Coherus Biosciences, AUG 8, 2024, View Source [SID1234645591]):

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RECENT BUSINESS HIGHLIGHTS

UDENYCA RESULTS
UDENYCA net product sales were $50.9 million in Q2 2024, an increase of 19% compared to $42.7 million in Q1 2024 and a 60% increase compared to $31.7 million in Q2 2023.

Total unit demand increased 25% in Q2 2024 compared to Q1 2024, and 138% compared to Q2 2023.
Based on data from IQVIA, UDENYCA franchise market share for Q2 2024 was 29.0%, an increase of 4 market share points from Q1 2024.
LOQTORZI LAUNCH UPDATE

LOQTORZI, the first and only FDA-approved treatment for recurrent, locally advanced or metastatic nasopharyngeal carcinoma (NPC), commercially launched on January 2, 2024.
LOQTORZI net sales in Q2 2024 of $3.8 million, with new patient uptake primarily in relapsed locally advanced and 1L metastatic disease, a potential driver of long-term revenue growth.
LOQTORZI can now be ordered in all 33 National Comprehensive Cancer Network (NCCN) institutions.
The Centers for Medicare and Medicaid Services granted LOQTORZI a product-specific, permanent J Code, which was implemented on July 1, 2024.
ADVANCEMENT OF PROMISING IMMUNO-ONCOLOGY PIPELINE

Clinical data from the dose escalation stage of the Phase 1 study of CHS-114, a highly selective cytolytic anti-CCR8 antibody, was presented at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting in June. These data showed selective depletion of peripheral CCR8+ regulatory T cells, establishing proof of mechanism for CHS-114, and an acceptable safety profile with no dose-limiting toxicities, and a disease control rate of 47% in heavily pretreated patients with solid tumors. Expansion cohorts evaluating CHS-114 as monotherapy and in combination with toripalimab are currently enrolling patients with advanced/metastatic head and neck squamous cell carcinoma (HNSCC).
A Phase 2 study evaluating casdozokitug, an immune regulatory IL-27 antagonizing antibody, in combination with toripalimab and bevacizumab in treatment naïve patients with unresectable locally advanced or metastatic hepatocellular carcinoma is expected to begin enrolling patients in Q4 2024.
An Investigational New Drug (IND) application for CHS-1000, a novel humanized Fc-modified IgG1 monoclonal antibody specifically targeting ILT4 (LILRB2), was filed with the U.S. Food and Drug Administration (FDA) in Q2 2024 and received clearance. Coherus plans to initiate a Phase 1 study in the coming months.
"The first half of 2024 has been a period of disciplined execution of our strategy, which included improving our capital structure, advancing our innovative oncology pipeline and driving increasing sales of our commercial portfolio. We continue to streamline our operations, solidifying our focus on our oncology business," said Denny Lanfear, Coherus’ Chairman and Chief Executive Officer. "Bryan McMichael, our newly appointed Chief Financial Officer, will play a key role on our management team as we further translate this oncology focus into shareholder value."

"I am honored to carry forward my work at Coherus in the role of Chief Financial Officer. The strength of the team, commercial portfolio, and pipeline gives me great confidence in the Company’s future," said Bryan McMichael, Coherus’ Chief Financial Officer. "I look forward to continuing in my partnership with Denny, the Board, and other members of management to execute our strategy and bring value to shareholders."

SECOND QUARTER 2024 FINANCIAL RESULTS

Net revenue was $65.0 million during the three months ended June 30, 2024, and included $50.9 million of net sales of UDENYCA, $3.8 million of net sales of LOQTORZI, which was launched on January 2, 2024, $3.8 million of net sales of YUSIMRY, which was divested to Hong Kong King-Friend Industrial Company Ltd. ("HKF") on June 26, 2024, and other revenue of $6.5 million which included the $6.3 million up-front cash payment received for the outlicense to Apotex, Inc. of the Canadian rights to LOQTORZI on June 27, 2024. Net revenue was $58.7 million during the three months ended June 30, 2023 and included $26.7 million in revenues for CIMERLI, which was divested on March 1, 2024. Net revenue was $142.0 million and $91.2 million for the six months ended June 30, 2024 and 2023, respectively. Total net revenues attributable to the Company’s divested products, CIMERLI and YUSIMRY, during the first half of 2024 and 2023 were $35.9 million and $32.9 million, respectively.

Cost of goods sold (COGS) was $28.4 million and $24.8 million during the three months ended June 30, 2024 and 2023, respectively, and $63.0 million and $41.7 million during the six months ended June 30, 2024 and 2023, respectively. UDENYCA COGS included a mid-single digit royalty on net sales which expired on July 1, 2024. The increases in COGS in both 2024 periods were primarily driven by increased unit volumes, and in the second quarter of 2024, a $4.5 million fee for a contract change with a CMO, partially offset by a $9.7 million decrease in royalty costs in the second quarter of 2024, due to the CIMERLI divestiture on March 1, 2024.

Research and development (R&D) expenses were $22.0 million and $23.3 million for the three months ended June 30, 2024 and 2023, respectively, and $50.4 million and $57.4 million for the six months ended June 30, 2024 and 2023, respectively. The decreases were primarily due to savings from reduced headcount and lower costs related to biosimilar products, partially offset by increased costs for development of casdozokitug and CHS-114.

Selling, general and administrative (SG&A) expenses were $35.2 million and $45.1 million during the three months ended June 30, 2024 and 2023, respectively, and $91.7 million and $94.3 million during the six months ended June 30, 2024 and 2023, respectively. The declines in SG&A compared to the prior year periods were driven primarily by lower headcount. The decrease for the six-month period was partially offset by the net $6.8 million charge in the first quarter of 2024 associated with the full write-off of the outlicense intangible asset and associated release of the CVR liability related to NZV930, obtained in the Surface Oncology, Inc. acquisition.

Gain on Sale Transactions, Net which included the divestiture of the YUSIMRY franchise, which closed during the three months ended June 30, 2024, was $22.9 million, and reflects total cash proceeds of $40.0 million, net of assets transferred to HKF, liabilities derecognized, and transactions costs of $0.9 million. Gain on Sale Transactions, net for the first half of 2024 was $177.7 million and included a $154.8 million gain on the divestiture of the CIMERLI franchise, which closed during the three months ended March 31, 2024. There was no gain on Sale Transactions in the first half of 2023.

Interest expense was $5.3 million and $9.9 million during the three months ended June 30, 2024 and 2023, respectively, and $16.5 million and $19.7 million during the six months ended June 30, 2024 and 2023, respectively. The declines in both periods were primarily due to prepaying $175.0 million of the principal amount of the senior secured term loan facility that was entered into on January 5, 2022 on April 1, 2024 and prepaying the remaining $75.0 million principal amount on May 8, 2024. This was offset by interest on the $38.7 million principal amount of the new term loan facility and the revenue participation right purchase and sale agreement, both commencing May 8, 2024, as well as an average higher variable rate in the first half of 2024 compared to the first half of 2023.

Net loss for the second quarter of 2024 was $12.9 million, or $(0.11) per share on a diluted basis, compared to a net loss of $42.9 million, or $(0.49) per share on a diluted basis for the same period in 2023. Net income for the first half of 2024 was $90.0 million, or $0.73 per share on a diluted basis, compared to a net loss of $118.6 million, or $(1.42) per share on a diluted basis for the first half of 2023.

Non-GAAP net loss for the second quarter of 2024 was $16.4 million, or $(0.14) per share on a diluted basis, compared to $32.8 million, or $(0.38) per share for the same period in 2023. Non-GAAP net loss for the first half of 2024 was $52.2 million, or $(0.46) per share on a diluted basis, compared to $92.3 million, or $(1.11) per share for the first half of 2023. See "Non-GAAP Financial Measures" below for a discussion on how Coherus calculates non-GAAP net loss and a reconciliation to the most directly comparable GAAP measures.

Cash, cash equivalents and investments in marketable securities were $159.2 million as of June 30, 2024, compared to $117.7 million as of December 31, 2023.

2024 R&D and SG&A Expense Guidance
Coherus projects combined R&D and SG&A expenses for 2024 to be in the range of $250 to $265 million. This guidance includes approximately $40 million of stock-based compensation expense and excludes the effects of acquisitions, collaborations, investments, divestitures including expenses incurred on behalf of and reimbursed by Sandoz and HKF to satisfy Coherus’ obligations under the transition services agreements with those entities, restructuring, the exercise of rights or options related to collaboration programs, and any other transactions or circumstances not yet identified or quantified. This guidance is subject to a number of risks and uncertainties. See Forward-Looking Statements described in the section below.

Conference Call Information

When: Thursday, August 8, 2024, starting at 5:00 p.m. Eastern Daylight Time

To access the conference call, please pre-register through the following link to receive dial-in information and a personal PIN to access the live call: https://register.vevent.com/register/BI9dd3f986eeb7428485a66ce1fb34999f
Please dial in 15 minutes early to ensure a timely connection to the call.

Webcast: View Source

An archived webcast will be available on the "Investors" section of the Coherus website at View Source