On August 9, 2023 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported financial results for the second quarter of 2023, raised 2023 full year financial guidance and provided business updates (Press release, Jazz Pharmaceuticals, AUG 9, 2023, View Source [SID1234634080]).

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"Our focused execution delivered strong momentum across all three key growth drivers of our commercial business, with significant demand for Xywav, Epidiolex and Rylaze. We remain confident that our oxybate franchise will reach $2 billion in 2025, underpinned by the durability and growth of low-sodium Xywav. We’ve achieved another quarter of double-digit, year-over-year growth of Epidiolex, as we unleash its blockbuster potential through in-person engagement, compelling data and ongoing educational efforts. We have achieved impressive diversification with 66% of total revenues stemming from Xywav, Epidiolex and Rylaze, and we expect our Oncology therapeutic area to reach approximately $1 billion in annual revenue this year," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. "Our disciplined capital allocation strategy includes investing in our commercial brands to drive top-line growth, investing in our pipeline to drive long-term growth and corporate development, where we remain actively engaged in assessing opportunities and which we continue to believe is an important pillar of growth. Supported by our strong cash flow, we have resumed share repurchases under our existing program. In the second quarter, we completed approximately $100 million of share repurchases of the total $431 million authorized under the program as of March 31, 2023. Our strong operational and financial foundation enables additional investment in growth drivers, and we are well-positioned to execute corporate development and innovate new medicines for patients."

"Since bringing zanidatamab into our pipeline, it has continued to impress, as exemplified by the positive pivotal Phase 2b biliary tract cancers (BTC) data being selected for the 2023 Best of ASCO (Free ASCO Whitepaper) program and published in The Lancet Oncology. We are planning for a potential accelerated approval of zanidatamab in second-line (2L) BTC, and have alignment with FDA on a confirmatory trial in first-line (1L) metastatic BTC. We believe zanidatamab has the potential to address a very large unmet need and raise the standard of care for some of the most difficult-to-treat HER2-expressing cancers. We look forward to the top-line data readout from the zanidatamab Phase 3 gastroesophageal adenocarcinoma (GEA) trial expected in 2024," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development of Jazz Pharmaceuticals. "We are on track for multiple near-term pipeline catalysts, including top-line data from a Phase 2 trial of JZP150 in post-traumatic stress disorder (PTSD) and initial proof of concept of JZP441 in healthy volunteers later this year. In the first half of 2024, we expect to have top-line data from a Phase 2b trial of suvecaltamide in essential tremor (ET), as well as top-line progression-free survival (PFS) data from the Zepzelca 1L combination trial in extensive-stage (ES) small cell lung cancer (SCLC) as early as the end of 2024. As we advance these promising programs, we remain focused on providing the greatest possible impact for patients and their families."

1

Key Highlights

•Achieved significant diversification, with nearly 50% of net product sales from Oncology and Epidiolex and more than 50% of oxybate revenues driven by Xywav.
•Xywav continues to be the oxybate of choice and only FDA-approved treatment for idiopathic hypersomnia (IH), achieving blockbuster status and annualizing at well over $1 billion.
•Epidiolex/Epidyolex global launch continues to gain momentum further positioning it to achieve blockbuster status.
•Rylaze demand grew for the fourth consecutive quarter with a 39% increase in net product sales to $102 million in 2Q23 compared to 2Q22.
•Raised full year 2023 financial guidance:
◦Raised total and Neuroscience revenue guidance at the mid-points.
◦Raised GAAP earnings per diluted share (EPS) to $6.60-$8.15.
◦Raised non-GAAP adjusted EPS by $1.20 at the mid-point to $18.15-$19.00.
•Zanidatamab Phase 2b HERIZON-BTC-01 results were featured as an oral presentation at ASCO (Free ASCO Whitepaper) 2023 and concurrently published in The Lancet Oncology.

Business Updates

Key Commercial Products
Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution:
•Xywav net product sales increased 39% to $326.6 million in 2Q23 compared to the same period in 2022.
•There were approximately 11,500 active Xywav patients exiting 2Q23.
•The Company presented robust data sets at two medical meetings in 2Q23, emphasizing leadership in neuroscience and commitment to advancing the understanding of sleep disorders.
◦Six presentations at American Academy of Neurology Annual Meeting, including a study that explored the increased risk of hypertension onset among patients with narcolepsy newly treated with Xyrem. The study detected increased risk of new-onset hypertension, within 180 days, among normotensive patients with narcolepsy initiating treatment with high-sodium oxybate, even among patients without a history of cardiovascular disease.
◦Seven presentations at SLEEP 2023, including real-world TENOR study of adults with narcolepsy that demonstrated most patients preferred Xywav over Xyrem due to its lower sodium content.

Xywav for Narcolepsy:
•There were approximately 9,300 narcolepsy patients taking Xywav exiting 2Q23.
•The benefits of reducing sodium intake continue to resonate with patients and prescribers.
•FDA continues to recognize seven years of Orphan Drug Exclusivity (ODE), through July 2027, for Xywav in narcolepsy. FDA published its summary of clinical superiority findings stating that "Xywav is clinically superior to Xyrem by means of greater safety because Xywav provides a greatly reduced chronic sodium burden compared to Xyrem." Further, FDA stated that "the differences in the sodium content of the two products at the recommended doses will be clinically meaningful in reducing cardiovascular morbidity in a substantial proportion of patients for whom the drug is indicated." For clarity, the authorized generics (AGs) of Xyrem contain the exact same drug product as branded Xyrem.
•FDA has also recognized that the difference in sodium content between Xywav and Lumryz is likely to be clinically meaningful in all patients with narcolepsy and that Xywav is safer than high-sodium oxybate products, including Lumryz, in all such patients. Lumryz is a branded, fixed-dose, high-sodium oxybate that has the same sodium content as Xyrem.
•Xywav is the only approved oxybate therapy that does not carry a warning and precaution related to high sodium intake.

2

Xywav for Idiopathic Hypersomnia (IH):
•There were approximately 2,200 IH patients taking Xywav exiting 2Q23.
•Jazz survey of sleep specialists indicates 70% anticipate increasing their prescribing of Xywav for IH over the next six months, and new prescribers continued to grow in 2Q23.
•Xywav is the first and only treatment approved by FDA to treat the full condition of IH.
•FDA recognized ODE for IH extending regulatory exclusivity to August 2028.

Xyrem (sodium oxybate) oral solution:
•Xyrem net product sales decreased 41% to $159.8 million in 2Q23 compared to the same period in 2022, reflecting the continued adoption of Xywav by patients with narcolepsy and the launch of a high-sodium oxybate AG in January 2023.
•Royalties from high-sodium oxybate AG were $5.5 million in 2Q23. Due to the royalty structures within the AG agreements, we expect the royalties from AGs to be significantly higher in the second half of 2023 relative to the first half.

Oxybate (Xywav and Xyrem):
•Total revenues for the combined oxybate business, including royalties from a high-sodium oxybate AG in 2Q23, decreased 2% to $491.8 million in 2Q23 compared to the same period in 2022.
•Average active Jazz oxybate patients on therapy was approximately 16,200 in 2Q23, a decrease of 5% compared to the same period in 2022.

Epidiolex/Epidyolex (cannabidiol):
•Epidiolex/Epidyolex net product sales increased 15% to $202.2 million in 2Q23 compared to the same period in 2022.
•A pivotal Phase 3 trial of Epidyolex for Dravet syndrome, Lennox-Gastaut syndrome and tuberous sclerosis complex in Japan is enrolling patients.
•Epidiolex/Epidyolex global prescriber base increasing with multiple launches expected outside of the U.S. this year.
•Increased penetration in long-term care setting driven by additional in-person engagement with physicians.
•Additional Epidiolex growth opportunities underscored by BECOME survey’s caregiver reported outcomes beyond seizure control, which further differentiates Epidiolex from other anti-seizure medicines, and compelling data for use of Epidiolex in combination with clobazam.
•Epidyolex global launch continues to gain momentum further positioning Epidiolex/Epidyolex to achieve blockbuster status.

Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn):
•Rylaze net product sales increased for the fourth consecutive quarter; 2Q23 net product sales increased 39% to $101.7 million compared to the same period in 2022.
•Continued strong demand for Rylaze reflects the significant unmet patient need for a high-quality, reliable supply of Erwinia asparaginase for patients with acute lymphoblastic leukemia.
•The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for JZP458 (marketed as Rylaze in the U.S.), recommending the marketing authorization to the European Commission (EC). The Company anticipates EC approval later this year.

Zepzelca (lurbinectedin):
•Zepzelca net product sales increased 3% to $70.3 million in 2Q23 compared to the same period in 2022.
•Zepzelca is the treatment of choice in 2L SCLC setting, with potential to expand into 1L ES SCLC.
•Zepzelca development program highlights:
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◦Phase 3 trial in partnership with F. Hoffmann-La Roche Ltd (Roche) to evaluate 1L use of Zepzelca in combination with Tecentriq (atezolizumab), compared to Tecentriq alone, as maintenance therapy in patients with ES SCLC after induction chemotherapy is ongoing. The Company expects top-line data to readout at the end of 2024 or early 2025.
◦The Company’s partner, PharmaMar, is conducting the Phase 3 confirmatory trial, LAGOON, in 2L SCLC. If positive, this trial could confirm the benefit of Zepzelca in the treatment of SCLC when patients progress following 1L treatment with a platinum-based regimen.
◦The Company has elected to close the EMERGE-201 Phase 2 basket trial evaluating Zepzelca as monotherapy in select relapsed/refractory solid tumors based on limited response in three solid tumor cohorts. The Company is analyzing findings from that trial and continuing to explore additional tumor types that may benefit from treatment with Zepzelca.

Key Pipeline Highlights
Zanidatamab:
•Zanidatamab is a bispecific antibody with a unique design that results in multiple mechanisms of action and potent effector function leading to encouraging antitumor activity in patients.
•The Company believes zanidatamab has the potential to address a very large unmet need in HER2-positive cancers, with initial focus in BTC and GEA and potential to transform the current standard of care in multiple HER2-positive cancers.
•Positive top-line data from the pivotal HERIZON-BTC-01 clinical trial has the potential to support regulatory submissions for zanidatamab as a monotherapy in patients with previously treated HER2-amplifed and expressing BTC.
•The Company is planning for a potential accelerated approval of zanidatamab in 2L BTC, and has alignment with FDA on a confirmatory trial in 1L metastatic BTC, where there remains unmet patient need.
•Data from the HERIZON-BTC-01 clinical trial were featured as an oral presentation at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting and concurrently published in The Lancet Oncology. Results demonstrated meaningful clinical benefit including antitumor activity, confirmed objective response rate (cORR) of 41.3%, median duration of response (DOR) of 12.9 months, and median PFS of 5.5 months (median study follow-up time of 12.4 months).
•The pivotal trial, HERIZON-GEA-01, evaluating zanidatamab in 1L GEA is ongoing and top-line data are expected in 2024.

JZP150:
•JZP150, a selective fatty acid amide hydrolase, or FAAH, inhibitor, is in clinical development for the potential treatment of PTSD.
•Patient enrollment is ongoing in a Phase 2 trial and top-line data readout is anticipated in late 2023.
•The primary endpoint of the Phase 2 trial is clinician-administered PTSD Scale (CAPS-5) total symptom severity score change from baseline to week 12 to establish proof of concept of JZP150 in patients diagnosed with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) PTSD.
•The Company received Fast Track Designation for JZP150 development in PTSD from FDA, underscoring the significant unmet medical needs of patients.

Suvecaltamide (JZP385):
•Suvecaltamide, a highly selective and state dependent modulator of T-type calcium channels, is in clinical development for the treatment of ET and Parkinson’s disease tremor.
•Patient enrollment is ongoing in the Phase 2b ET trial and top-line data readout is anticipated in 1H24.
•A Phase 2 trial in patients with Parkinson’s disease tremor is ongoing.

4

JZP441:
•JZP441, is a potent, highly selective oral orexin-2 receptor agonist designed to activate orexin signaling with the potential to be applicable in the treatment of narcolepsy, IH and other sleep disorders.
•A Phase 1 development program to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of JZP441 in sleep-deprived healthy volunteers is ongoing.
•The Company expects initial proof of concept in healthy volunteers in 2023.

JZP815:
•A Phase 1 trial evaluating JZP815 in patients with advanced or metastatic solid tumors with MAPK pathway alterations is ongoing.
•The pan-RAF inhibitor program is part of a novel class of next-generation precision oncology therapies that has the potential to benefit cancer patients with high unmet needs in multiple different solid tumors.

JZP898:
•JZP898 is an engineered IFNα cytokine pro-drug that is activated specifically within the tumor microenvironment where it can stimulate IFNα receptors on cancer-fighting immune effector cells.
•In July 2023, JZP898 received Investigational New Drug (IND) application clearance. The Company expects to initiate a Phase 1 clinical trial by the end of the year.

Resumption of Repurchases under Previously Announced $1.5 Billion Share Repurchase Program

The Company resumed repurchases of its ordinary shares on the open market in the second quarter of 2023 as part of the Company’s previously authorized and announced share repurchase program. Under the share repurchase program, the Company may repurchase its ordinary shares for up to an aggregate purchase price of $1.5 billion, exclusive of any brokerage commissions. As of June 30, 2023, approximately $336 million remained available and authorized for share repurchases under the program, reflecting the purchase of approximately $100 million shares during the second quarter of 2023. The timing and amount of repurchases under the program will depend on a variety of factors, including the price of the Company’s ordinary shares, alternative investment opportunities, restrictions under the Company’s credit agreement, corporate and regulatory requirements and market conditions.

Irrevocable Election of Settlement Method of $575 Million for the 1.50% Exchangeable Senior Notes due 2024

Jazz Investments I Limited, a wholly-owned subsidiary of the Company, announced that it provided written notice today to the exchange agent, the trustee and the noteholders of its 1.50% exchangeable senior notes due 2024 (2024 Notes) that it has irrevocably elected to fix the settlement method for exchanges of the 2024 Notes to a combination of cash and ordinary shares of the Company with a specified cash amount per $1,000 principal amount of 2024 Notes of $1,000. As a result, for 2024 Notes exchanged subsequent to such notice, an exchanging noteholder will receive (i) up to $1,000 in cash per $1,000 principal amount of 2024 Notes and (ii) ordinary shares of the Company, together with cash in lieu of any fractional shares, for any exchange consideration in excess of $1,000 per $1,000 principal amount of 2024 Notes.

5

Financial Highlights
Three Months Ended
June 30, Six Months Ended
June 30,
(In thousands, except per share amounts) 2023 2022 2023 2022
Total revenues $ 957,317 $ 932,878 $ 1,850,129 $ 1,746,599
GAAP net income $ 104,438 $ 34,665 $ 173,858 $ 36,312
Non-GAAP adjusted net income $ 325,129 $ 305,465 $ 610,390 $ 567,399
GAAP earnings per share $ 1.52 $ 0.55 $ 2.55 $ 0.57
Non-GAAP adjusted EPS $ 4.51 $ 4.30 $ 8.46 $ 8.03

GAAP net income for 2Q23 was $104.4 million, or $1.52 per diluted share, compared to $34.7 million, or $0.55 per diluted share, for 2Q22.
Non-GAAP adjusted net income for 2Q23 was $325.1 million, or $4.51 per diluted share, compared to $305.5 million, or $4.30 per diluted share, for 2Q22.
Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release.

Total Revenues
Three Months Ended
June 30, Six Months Ended
June 30,
(In thousands) 2023 2022 2023 2022
Xywav $ 326,564 $ 235,025 $ 604,325 $ 421,105
Xyrem 159,769 269,421 337,899 516,918
Total Oxybate 486,333 504,446 942,224 938,023
Epidiolex/Epidyolex 202,226 175,289 391,135 333,182
Sativex 2,806 4,142 9,904 8,884
Sunosi1
— 12,966 — 28,844
Total Neuroscience 691,365 696,843 1,343,263 1,308,933
Rylaze 101,693 72,954 187,620 127,174
Zepzelca 70,348 68,285 137,529 127,623
Defitelio/defibrotide 46,108 54,696 85,187 104,185
Vyxeos 34,056 33,890 70,756 67,647
Total Oncology 252,205 229,825 481,092 426,629
Other 3,417 1,632 6,851 2,575
Product sales, net 946,987 928,300 1,831,206 1,738,137
High-sodium oxybate AG royalty revenue 5,514 — 7,610 —
Other royalty and contract revenues 4,816 4,578 11,313 8,462
Total revenues $ 957,317 $ 932,878 $ 1,850,129 $ 1,746,599

___________________________
(1)Divestiture of Sunosi U.S. was completed in May 2022.

Total revenues increased 3% in 2Q23 compared to the same period in 2022.
•Total neuroscience revenue, including high-sodium oxybate AG royalty revenue, was $696.9 million in 2Q23 compared to $696.8 million in 2Q22. Neuroscience net product sales in 2Q23 decreased 1% to $691.4 million compared to the same period in 2022 primarily driven by decreased Xyrem revenues, reflecting the continued strong adoption of Xywav by patients with narcolepsy and the launch of a high-sodium oxybate AG in January 2023, offset by increased Xywav and Epidiolex/Epidyolex net product sales. High-sodium oxybate AG royalty revenue
6

relates to royalty revenue received from Hikma Pharmaceuticals plc on net sales of a high-sodium oxybate AG product.
•Oncology net product sales in 2Q23 increased 10% to $252.2 million compared to the same period in 2022 primarily driven by the continued growth in Rylaze product sales, which increased 39% to $101.7 million.

Operating Expenses and Effective Tax Rate
Three Months Ended
June 30, Six Months Ended
June 30,
(In thousands, except percentages) 2023 2022 2023 2022
GAAP:
Cost of product sales $ 97,537 $ 124,208 $ 226,181 $ 239,492
Gross margin 89.7% 86.6% 87.6% 86.2%
Selling, general and administrative $ 340,844 $ 366,473 $ 638,761 $ 675,286
% of total revenues 35.6% 39.3% 34.5% 38.7%
Research and development $ 209,238 $ 139,047 $ 398,648 $ 269,028
% of total revenues 21.9% 14.9% 21.5% 15.4%
Acquired in-process research and development $ — $ 69,148 $ 1,000 $ 69,148
Income tax benefit $ (24,323) $ (16,112) $ (39,647) $ (15,576)
Effective tax rate 1
(29.7)% (76.7)% (29.0)% (57.0)%

_________________________

(1)The GAAP effective tax rates increased for the three and six months ended June 30, 2023 compared to the same periods in 2022, due to the impact of the disposal of Sunosi in 2022.

Three Months Ended
June 30, Six Months Ended
June 30,
(In thousands, except percentages) 2023 2022 2023 2022
Non-GAAP adjusted:
Cost of product sales $ 65,994 $ 53,245 $ 130,722 $ 101,451
Gross margin 93.0% 94.3% 92.9% 94.2%
Selling, general and administrative $ 276,871 $ 281,493 $ 537,386 $ 540,194
% of total revenues 28.9% 30.2% 29.0% 30.9%
Research and development $ 192,019 $ 123,719 $ 365,937 $ 240,178
% of total revenues 20.1% 13.3% 19.8% 13.8%
Acquired in-process research and development $ — $ 69,148 $ 1,000 $ 69,148
Income tax expense $ 25,210 $ 38,387 $ 65,407 $ 93,610
Effective tax rate 7.2% 11.1% 9.6% 14.0%

Changes in operating expenses in 2Q23 over the prior year period are primarily due to the following:
•Cost of product sales decreased in 2Q23 compared to the same period in 2022, on a GAAP basis, primarily due to lower acquisition accounting inventory fair value step-up expense, partially offset by changes in product mix. Cost of product sales increased in 2Q23 compared to the same period in 2022, on a non-GAAP adjusted basis, primarily due to changes in product mix.
•Selling, general and administrative (SG&A) expenses decreased in 2Q23 compared to the same period in 2022, on a GAAP basis, primarily due to the loss on disposal of Sunosi and transaction and integration expenses related to the acquisition of GW Pharmaceuticals plc incurred in 2Q22, partially offset by costs related to program terminations. SG&A expenses, on a GAAP and on a
7

non-GAAP adjusted basis, included decreased compensation-related expenses primarily driven by lower headcount, increased litigation costs and increased investment in our priority programs.
•Research and development (R&D) expenses increased in 2Q23 compared to the same period in 2022, on a GAAP and on a non-GAAP adjusted basis, primarily due to the inclusion of costs related to zanidatamab, as well as our other key pipeline programs.

Cash Flow and Balance Sheet
As of June 30, 2023, cash, cash equivalents and investments were $1.4 billion, and the outstanding principal balance of the Company’s long-term debt was $5.8 billion. In addition, the Company had undrawn borrowing capacity under a revolving credit facility of $500 million. For the six months ended June 30, 2023, the Company generated $617.5 million of cash from operations, which is an increase of $105.5 million as compared to the same period in 2022, reflecting strong business performance and continued financial discipline.

8

2023 Financial Guidance
The Company is updating its full year 2023 financial guidance as follows:

(In millions) August 9, 2023 May 10, 2023
Revenues $3,725 – $3,875 $3,675 – $3,875
–Neuroscience (includes royalties from high-sodium oxybate AG)
$2,715 – $2,825 $2,675 – $2,825
–Oncology $950 – $1,050 $950 – $1,050

GAAP:
(In millions, except per share amounts and percentages) August 9, 2023 May 10, 2023
Gross margin % 89% 89%
SG&A expenses $1,220 – $1,295 $1,197 – $1,277
SG&A expenses as % of total revenues 31% – 35% 31% – 35%
R&D expenses $739 – $793 $739 – $797
R&D expenses as % of total revenues 19% – 21% 19% – 22%
Effective tax rate (35)% – (15)% (32)% – (8)%
Net income $450 – $565 $410 – $560
Net income per diluted share5
$6.60 – $8.15 $5.90 – $7.90
Weighted-average ordinary shares used in per share calculations5
72 75

Non-GAAP:
(In millions, except per share amounts and percentages) August 9, 2023 May 10, 2023
Gross margin %
93%1,6
93%
SG&A expenses
$1,045 – $1,1052,6
$1,045 – $1,105
SG&A expenses as % of total revenues 27% – 30% 27% – 30%
R&D expenses
$675 – $7253,6
$675 – $725
R&D expenses as % of total revenues 17% – 19% 17% – 20%
Effective tax rate
8% – 10%4,6
9% – 11%
Net income
$1,290 – $1,3406
$1,240 – $1,310
Net income per diluted share5
$18.15 – $19.006
$16.90 – $17.85
Weighted-average ordinary shares used in per share calculations5
72 75

___________________________
1.Excludes $135-$155 million of amortization of acquisition-related inventory fair value step-up and $14-$15 million of share-based compensation expense.
2.Excludes $152-$167 million of share-based compensation expense and $23 million of restructuring costs.
3.Excludes $64-$68 million of share-based compensation expense.
4.Excludes 43%-25% from the GAAP effective tax rate of (35)%-(15)% relating to the income tax effect of adjustments between GAAP net income and non-GAAP adjusted net income, resulting in a non-GAAP adjusted effective tax rate of 8%-10%.
5.Diluted EPS calculations for 2023 include an estimated 8 million shares related to the assumed conversion of the Exchangeable Senior Notes and the associated interest expense add-back to net income of $25 million and $22 million, on a GAAP and on a non-GAAP adjusted basis, respectively, under the "if converted" method. On August 9, 2023, we made the irrevocable election to net share settle our 2024 Notes. This election is expected to impact our full-year net income per diluted share guidance by $0.05 to $0.10 per share, on a GAAP basis, and $0.25 to $0.40 per share, on a Non-GAAP adjusted basis, as a result of an estimated decrease in the weighted-average shares outstanding of 1 million shares.
6.See "Non-GAAP Financial Measures" below. Reconciliations of non-GAAP adjusted guidance measures are included above and, in the table titled "Reconciliation of GAAP to non-GAAP Adjusted 2023 Net Income Guidance" at the end of this press release.

9

Conference Call Details
Jazz Pharmaceuticals will host an investor conference call and live audio webcast today at 4:30 p.m. ET (9:30 p.m. IST) to provide a business and financial update and discuss its 2023 second quarter results.

On August 9, 2023 Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) (the "Company"), reported financial results for the second quarter of 2023 (Press release, Ionis Pharmaceuticals, AUG 9, 2023, View Source [SID1234634079]). Financial results are summarized below:

Three months ended
June 30,

Six months ended
June 30,

2023

2022

2023

2022

(amounts in millions)

Total revenue

$
188

$
134

$
319

$
276

Operating expenses

$
279

$
220

$
523

$
419

Operating expenses on a non-GAAP basis

$
252

$
195

$
469

$
368

Loss from operations

$
(91
)

$
(86
)

$
(204
)

$
(143
)
Loss from operations on a non-GAAP basis

$
(64
)

$
(61
)

$
(150
)

$
(92
)

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Financial Highlights

•
Revenue increased for the second quarter and first half of 2023 by 40% and 16% compared to the same periods last year, respectively, driven by significant partner payments

•
Operating expenses increased in the second quarter and first half of 2023 compared to the prior year as planned, reflecting investments in advancing Ionis’ pipeline and go-to-market activities for eplontersen, olezarsen and donidalorsen

•
Cash and short-term investments of $2.4 billion as of June 30, 2023 enables continued investments to drive increasing value

•
Well-capitalized balance sheet reflects 2024 convertible note refinancing that extended maturity to 2028 while maintaining a low coupon and retaining the flexibility to mitigate potential equity dilution

•
Reaffirmed 2023 financial guidance

1
"Ionis is creating significant value in 2023 as we successfully execute on our strategy to bring a steady cadence of transformational medicines to the market. Our growing late-stage pipeline now includes eight medicines for 10 indications, highlighted by eplontersen. Based on the strong and consistent data generated to date and an attractive self-administration profile, we expect eplontersen to be an important new medicine for people with ATTRv-polyneuropathy. We also added QALSODY to our commercial portfolio, a breakthrough treatment for people with SOD1-ALS further strengthening Ionis’ leadership in RNA-based therapies for neurological diseases," said Brett P. Monia, Ph.D., chief executive officer of Ionis. "In the second half, we expect continued positive momentum including the Phase 3 readout for olezarsen in familial chylomicronemia syndrome and the potential approval of eplontersen for ATTRv-PN in December."

Recent Highlights From Commercial Medicines

•
Biogen presented interim data from the Phase 4 RESPOND study of SMA patients demonstrating improved motor function in most participants treated with SPINRAZA who had unmet medical needs after treatment with gene therapy

•
FDA granted Biogen accelerated approval of QALSODY (tofersen), a first-in-class medicine for patients with SOD1-ALS

Recent Highlights From Near-Term Commercial Opportunities

•
Reported positive results from the Phase 3 NEURO-TTRansform study in patients with ATTRv-PN showing eplontersen continued to halt neuropathy disease progression and improve quality of life through 85 weeks

•
Completed enrollment of the Phase 3 CARDIO-TTRansform study of eplontersen in patients with ATTR cardiomyopathy, the largest study ever conducted in ATTR-CM; on track for data readout as early as H1:2025

•
Licensed eplontersen Latin America rights to AstraZeneca

•
Completed enrollment of the Phase 3 OASIS-HAE study of donidalorsen in patients with hereditary angioedema; on track for data readout in H1:2024

•
Reported positive topline Phase 2 open label extension data of donidalorsen in patients with hereditary angioedema treated for two years

Recent Highlights From Partnered Programs

•
Roche advanced IONIS-FB-LRx into Phase 3 development in patients with immunoglobulin A nephropathy

•
GSK presented durable response data from the Phase 2 B-Sure long-term follow-up study of bepirovirsen in complete responder patients from the Phase 2b B-Clear study of patients with HBV

•
Completed enrollment in the Phase 2 GOLDEN study of IONIS-FB-LRx in patients with geographic atrophy

•
AstraZeneca initiated a Phase 2b study of ION839 (AZD2693) targeting PNPLA3 to treat patients with NASH

•
Entered collaboration with Novartis to advance a next generation program targeting Lp(a) for cardiovascular disease

2
Second Quarter 2023 Financial Results

"Our results for the first half of the year keep us on track to achieve our 2023 guidance. We continued to generate substantial and sustained revenue, that together with our well-capitalized balance sheet, allows us to continue investing in key opportunities across our business," said Elizabeth L. Hougen, chief financial officer of Ionis. "With three near-term commercial opportunities that have a combined multi-billion-dollar peak sales potential and a steady cadence of medicines poised to follow closely behind, we are positioned to drive substantial revenue growth and long-term value for shareholders."

Revenue

Ionis’ revenue was comprised of the following:

Three months ended

Six months ended

June 30,

June 30,

2023

2022

2023

2022

Revenue:

(amounts in millions)

Commercial revenue:

SPINRAZA royalties

$
61

$
60

$
111

$
113

Other commercial revenue:

TEGSEDI and WAYLIVRA revenue, net

11

10

17

17

Licensing and royalty revenue

6

8

18

20

Total commercial revenue

78

78

146

150

Research and development revenue:

Amortization from upfront payments

15

18

29

36

Milestone payments

51

18

74

45

License fees

20

–

20

2

Other services

4

3

6

6

Collaborative agreement revenue

90

39

129

89

Eplontersen joint development revenue

20

17

44

37

Total research and development revenue

110

56

173

126

Total revenue

$
188

$
134

$
319

$
276

Ionis’ revenue increased in the second quarter and first half of 2023 compared to the same periods in 2022 because of increased payments from partnered programs. Ionis believes its substantial and sustainable revenue is an important source of funding that supports the Company’s investments to bring potentially transformational medicines to the market.

Commercial revenue for the second quarter and first half of 2023 included $61 million and $111 million from SPINRAZA royalties, respectively. Global SPINRAZA product sales of $437 million and $880 million were essentially flat for the second quarter and first half of 2023, respectively, compared to the same periods last year reflecting SPINRAZA’s resilience against emerging competition. Ionis’ commercial revenue in the second quarter and first half of 2023 also included royalties from the U.S. launch of QALSODY.

R&D revenue essentially doubled for the second quarter of 2023 and increased more than 35% for the first half of 2023 compared to the same periods in 2022 reflecting the value Ionis’ technology is creating as numerous partnered programs advanced.

Operating Expenses

Ionis’ operating expenses increased in the second quarter and first half of 2023 compared to the same periods in 2022, consistent with expectations. As Ionis advanced its robust pipeline, study costs increased as most of the Company’s Phase 3 studies were either fully enrolled or approaching full enrollment resulting in higher R&D expenses year over year. Additionally, as Ionis prepares to launch eplontersen, olezarsen and donidalorsen, the Company’s SG&A expenses also increased year over year.

Balance Sheet

As of June 30, 2023, Ionis’ cash, cash equivalents and short-term investments increased to $2.4 billion compared to $2.0 billion at December 31, 2022 primarily due to the $500 million Ionis received from Royalty Pharma in January 2023. Ionis’ working capital also increased over the same period primarily due to the Company’s higher cash and short-term investments balance. In the first quarter of 2023 the Company recorded a long-term liability for future royalties due to Royalty Pharma. In June 2023 Ionis issued $575 million of senior convertible notes due in June 2028 with an interest rate of 1.75%. Ionis used the majority of the proceeds to repurchase $434 million of its 2024 convertible notes. The Company plans to utilize the residual proceeds to settle the 2024 notes that remain outstanding.

Webcast

Management will host a conference call and webcast to discuss Ionis’ second quarter 2023 results at 11:30 a.m. Eastern time on Wednesday, August 9, 2023. Interested parties may access the webcast here. A webcast replay will be available for a limited time at the same address. To access the Company’s second quarter 2023 earnings slides click here.

On August 9, 2023 INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, reported its financial results for the second quarter ended June 30, 2023 and provided a strategic update (Press release, Inovio, AUG 9, 2023, View Source [SID1234634078]).

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"We continue to make progress with INO-3107, our candidate for the treatment of recurrent respiratory papillomatosis (RRP). Following positive results from our Phase 1/2 trial earlier this year, we are pleased to announce that we are targeting to have the first patient dosed in a Phase 3 trial in adults in the first quarter of 2024, moving us one step closer to delivering on the promise of DNA medicines for patients suffering from this debilitating disease," said Dr. Jacqueline Shea, INOVIO’s President and Chief Executive Officer. "Based on our interactions with the U.S. Food and Drug Administration (FDA) we believe that we have an acceptable trial design. We are addressing what we believe to be their final questions before we commence our pivotal Phase 3 trial for patients with RRP."

"As we move forward with our pipeline, we are focused on making sure our company is scaled for success in light of the challenging funding environment, particularly for pre-commercial biotech companies like INOVIO," Dr. Shea continued. "With that in mind, we made the difficult decision to further reduce our headcount and operational spending to better align with our strategic priorities. We believe that with the pipeline reprioritization announced today, we are well-positioned to execute on our development plans for INO-3107 while also advancing other promising candidates, such as INO-3112, INO-5401, VGX-3100 for anal HSIL and INO-4201. We expect that our existing cash resources will allow us to achieve important catalysts for these programs. I would like to extend my deepest gratitude to all of our employees – past and present – for their efforts on behalf of the company and contributions to the important progress we’re making."

Pipeline Reprioritization and Corporate Reorganization

INO-3107 – Recurrent Respiratory Papillomatosis (RRP)

INOVIO has announced today that it is further reprioritizing its pipeline to focus on its highest potential, closest to market programs, specifically its late-stage clinical program for INO-3107 as a treatment for RRP. In a Phase 1/2 trial involving RRP patients, treatment with INO-3107 resulted in a statistically significant reduction in the number of surgical interventions required to manage the disease. INOVIO is targeting to commence its pivotal Phase 3 trial in adult patients with RRP, subject to clearance by regulators, in the first quarter of 2024.

On May 5, 2023, data from the Phase 1/2 trial of INO-3107 were presented by lead investigator Dr. Ted Mau at the scientific program of the American Broncho-Esophagological Association (ABEA) at the Combined Otolaryngology Spring Meetings (COSM) in Boston, Massachusetts. The presentation highlighted the safety profile of INO-3107, which was well tolerated by participants in the trial and resulted in mostly low-grade (Grade 1) treatment-emergent adverse effects (TEAEs) such as injection site pain and fatigue. There were no high-grade TEAEs deemed related to treatment and no TEAEs leading to treatment discontinuation. Treatment with INO-3107 induced cellular immune responses against both HPV-6 and HPV-11, with activated CD4 and CD8 T cells, including cytotoxic CD8 T cells thought to be important for clearance of virally infected cells. Preliminary analysis indicates a potential correlation between T-cell responses and reduction of surgeries. T-cell responses were also observed at Week 52, indicating a persistent cellular memory response.

Also in May 2023, INO-3107 was granted orphan drug designation by the European Commission (EU) as a potential treatment for RRP. INO-3107 was granted orphan drug designation from the FDA in July 2020, making it the first RRP product candidate to receive designations from both U.S. and EU regulatory bodies.

VGX-3100 – Cervical High-Grade Squamous Intraepithelial Lesions (HSIL)

INOVIO has decided to cease all further development of VGX-3100 as a potential treatment for cervical HSIL in the United States. This decision is driven by a number of factors, including the recent analysis of biomarker data from REVEAL2 indicating that substantial work would be needed to refine this novel biomarker before it could be used in any further Phase 3 trials. Previously, the U.S. FDA indicated that at least one or more additional well-controlled trials would need to be conducted in the biomarker-positive population before being considered for registration. Given these factors, INOVIO has determined that its resources are best invested in other pipeline candidates with a faster potential path to market. INOVIO remains encouraged by the data collected in both of its completed Phase 3 trials for VGX-3100 in cervical HSIL (REVEAL1 and REVEAL2). In these trials, the data showed that VGX-3100 could clear both virus and lesions, which INOVIO believes could be supportive evidence for pursuing regulatory approval in other global markets.

For non-U.S. markets, where the access to and options for treatment differs, INOVIO believes that VGX-3100 could be a valuable treatment option for cervical HSIL should current and future trials continue to show potential efficacy and achieve regulatory approvals. For the Chinese market, INOVIO’s partner ApolloBio continues to advance the development of VGX-3100 for cervical HSIL in a Phase 3 trial. This trial is designed to use a similar protocol to that of REVEAL1 and does not utilize the novel biomarker used in INOVIO’s REVEAL2 trial. INOVIO also continues to discuss the clinical development of VGX-3100 with potential partners in other global markets.

Other VGX-3100 Indications and Clinical Pipeline Candidates

Pending discussions with regulators, INOVIO plans to investigate opportunities to advance VGX-3100 as a potential treatment for anal HSIL, an indication that continues to have significant unmet need. Results published in the New England Journal of Medicine in June 2022 from a multi-year study sponsored by the National Cancer Institute, called the ANCHOR study, showed "for the first time that treating anal HSIL is effective at reducing the incidence of anal cancer in a very high-risk group of people – people living with HIV" (NCI press release, June 15, 2022). INOVIO has observed that this study produced results that are moving the medical community away from the historical practice of actively monitoring anal HSIL and toward a more proactive approach in treating lesions that can progress to cancer. The challenge for patients and their healthcare providers in taking a more proactive approach is that there are few effective options available to treat anal HSIL. VGX-3100 has the ability to clear HPV-16/18 lesions and virus, which was not only observed in the cervical HSIL Phase 3 trials, but also in an open-label Phase 2 anal HSIL trial in HIV negative people. VGX-3100 is currently being investigated in an ongoing Phase 2 trial in HIV-positive anal HSIL patients being conducted by the AIDS Malignancy Consortium.

INOVIO is also working to advance its oncology product candidates, specifically INO-5401 and INO-3112, which target glioblastoma (GBM) and HPV-related cancers, respectively, as well as other candidates in its early-stage clinical pipeline targeting infectious diseases, in particular the company’s Ebola vaccine candidate, INO-4201. Progress for these candidates has continued in the areas of manufacturing, regulatory submissions, and partnership discussions. The next stage of clinical development will most likely require additional funding or partnerships.

Corporate Restructuring

As a result of the decision to focus its resources on its late-stage candidates with the greatest likelihood of success, including stopping the development of VGX-3100 in cervical HSIL for the U.S. market, INOVIO has taken steps to further conserve its capital resources. The company recently announced plans to further reduce its workforce by 58 employees, or 30%. The company estimates the cost savings from the headcount reduction will provide annual savings of approximately $9.9 million, which alongside other reductions in spending would allow the company to extend its cash runway into the third quarter of 2025.

Second Quarter 2023 Financial Results

Cash, Cash Equivalents and Short-term Investments: As of June 30, 2023, cash, cash equivalents and short-term investments were $194.9 million compared to $253.0 million as of December 31, 2022.

Revenues: Total revenues for the three months ended June 30, 2023 were $226,000, compared to $784,000 for the same period in 2022.

Research and Development (R&D) Expenses: R&D expenses for the three months ended June 30, 2023 were $23.7 million compared to $56.5 million for the same period in 2022. The decrease in R&D expenses was primarily the result of lower drug manufacturing, clinical trial expenses and outside services related to INO-4800 and other COVID-19 studies and lower employee and consultant compensation, including stock-based compensation, among other variances.

General and Administrative (G&A) Expenses: G&A expenses for the 2023 second quarter were $13.5 million compared to $48.5 million for the same period in 2022. The decrease in G&A expenses was primarily related to significant one-time costs in the second quarter of 2022 related to the settlement of the class action litigation and related legal expenses, as well as severance expenses incurred in 2022 in connection with the separation of the company’s former president and chief executive officer, among other variances.

Total Operating Expenses: Total operating expenses were $37.3 million compared to $104.9 million for the same period in 2022.

Net Loss: INOVIO’s net loss for the quarter ended June 30, 2023 was $35.5 million, or $0.13 per basic and diluted share, compared to net loss of $108.5 million, or $0.46 per basic and diluted share, for the second quarter of 2022.

Shares Outstanding: As of June 30, 2023, INOVIO had 268.1 million common shares outstanding and 290.0 million common shares outstanding on a fully diluted basis, after giving effect to the exercise, vesting and conversion, as applicable, of its outstanding options, restricted stock units, convertible preferred stock, and convertible debt.

INOVIO’s balance sheet and statement of operations are provided below. Additional information is included in INOVIO’s quarterly report on Form 10-Q for the quarter ended June 30, 2023, which can be accessed at: View Source

Cash Guidance
INOVIO estimates that the cost savings announced today will enable it to fund its operations into the third quarter of 2025. This projection includes a cash burn estimate of approximately $34.0 million for the third quarter of 2023 and the expectation that cash burn will decrease incrementally throughout the remainder of 2023 and 2024. These cash projections do not include any funds that may be raised through the Company’s existing at-the-market program or other capital-raising activities.

Conference Call / Webcast Information
INOVIO’s management will host its quarterly conference call and webcast at 4:30 p.m. ET today. A replay of the conference call will be available following the conclusion of the call. The live webcast and replay may be accessed by visiting INOVIO’s website at View Source

On August 9, 2023 Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics to improve patient care, reported financial results for the second quarter ended June 30, 2023 and provided a corporate update (Press release, Immunome, AUG 9, 2023, View Source [SID1234634077]).

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"We believe combining Immunome and Morphimmune’s technologies represents a major step in our long-term strategy of creating a preeminent oncology therapeutics company," stated Purnanand Sarma, PhD, President and CEO of Immunome. "Targeted cancer therapies have made great strides in recent years, and the possible synergy between Morphimmune’s Targeted Effector Platform and Immunome’s proprietary Discovery Engine presents an opportunity to discover and develop truly novel therapies that can help cancer patients. We look forward to completing the merger by the end the year."

Highlights

· Immunome and Morphimmune Announce Definitive Merger Agreement and Simultaneous Private Placement Investment of $125 Million to Develop Targeted Cancer Therapies. In June 2023, Immunome and Morphimmune, a private biotechnology company focused on developing targeted oncology therapeutics, announced that the two companies entered into a definitive merger agreement. The closing of the transaction is subject to customary closing conditions, including the effectiveness of the registration statement on Form S-4 to be filed by Immunome, and the receipt of required stockholder approvals from Immunome and Morphimmune stockholders.

o The combined company, which will operate as Immunome, will feature a synergistic platform expected to enable the development of best-in-class targeted cancer therapies across multiple modalities
o Clay B. Siegall, Ph.D., current Morphimmune President & CEO and former co-founder & CEO of Seagen, Inc., to serve as Chairman and CEO of combined company
o A concurrent $125 million private placement investment with leading institutional investors will support development of a combined pipeline expected to submit three investigational new drug applications (INDs) within 18 months of closing

· Immunome Published Preclinical Research Demonstrating that Inhibition of IL-38 Using an Antibody Leads to Anti-Tumor Activity. In May 2023, Immunome announced the publication of data highlighting efficacy of its preclinical IL-38 blocking antibody, titled "IL-38 blockade induces anti-tumor immunity by abrogating tumor-mediated suppression of early immune activation," in the peer-reviewed journal mAbs. The data in the article demonstrates that antibody-based targeting of IL-38 leads to activation of the immunostimulatory anti-tumor mechanisms within the tumor microenvironment in preclinical testing.

Financial Highlights

· Collaboration Revenue: Collaboration Revenue from the Collaboration Agreement with AbbVie for the three months ended June 30, 2023 was $4.3 million.
· Research and development (R&D) expenses: R&D expenses for the three months ended June 30, 2023 were $5.7 million.
· General and administrative (G&A) expenses: G&A expenses for the three months ended June 30, 2023 were $4.2 million.
· Net loss: Net loss for the three months ended June 30, 2023 was $5.6 million, or $0.46 per share.
· Cash and cash equivalents: As of June 30, 2023, cash and cash equivalents totaled $38.4 million.

On August 9, 2023 Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immuno-oncology company developing novel T cell engagers, reported financial results for the second quarter ended June 30, 2023 and provided a corporate update (Press release, Harpoon Therapeutics, AUG 9, 2023, View Source [SID1234634076]).

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"Following successful completion of the planned Phase 1 enrollment in the HPN217 trial, we are eager to reach additional important milestones in 2023," said Julie Eastland, President and CEO of Harpoon Therapeutics. "We are on track to present data from our two TriTAC clinical programs later this year at leading medical conferences and select the Phase 2 monotherapy regimens for both HPN217 and HPN328. Harpoon’s financial resources are expected to fund current operations into the second half of 2024 and we remain focused on advancing our key programs."

Corporate Update / Recent Highlights and Upcoming Milestones

Tri-specific T cell Activating Construct (TriTAC) Platform

HPN217 (BCMA) Phase 1 trial for relapsed, refractory multiple myeloma

•
Completed planned patient enrollment in the Phase 1 trial in June 2023 with 97 patients.

•
Recommended Phase 2 regimen(s) expected to be identified by the end of 2023.

•
An abstract detailing the 12mg cohort from the Phase 1 trial has been accepted for poster presentation at the 30th International Myeloma Society (IMS) Annual Meeting, being held September 27-30, 2023 in Athens.

•
Presentation of full Phase 1 data set, including 24mg cohorts, expected by the end of 2023.

•
Harpoon expects to deliver the Phase 1 data package to AbbVie by the end of 2023.

HPN328 (DLL3) Phase 1/2 trial in small cell lung cancer (SCLC) and other neuroendocrine cancers

•
Phase 1/2 dose and schedule optimization ongoing with monotherapy cohorts enrolling at 12mg and 24mg target doses. Early observations in the monotherapy cohorts included encouraging signs of anti-tumor activity, with two confirmed partial responses per RECIST in patients with SCLC and in patients with other neuroendocrine tumor types.

•
Abstract with interim data accepted for poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) being held October 20-24, 2023 in Madrid.

•
Enrollment in combination therapy of HPN328 with atezolizumab (Tecentriq) in patients with SCLC, as part of the Phase 1/2 dose escalation trial, is anticipated to initiate in the third quarter of 2023.

•
Completion of the Phase 1 monotherapy regimen exploration is expected in the second half of 2023, including the identification of the recommended Phase 2 regimen(s) in the monotherapy setting by the end of 2023.

ProTriTAC

HPN601 (EpCAM)

•
HPN601 is the first conditionally active T cell engager based on the ProTriTAC platform. EpCAM is expressed in a broad range of solid tumors, potentially enabling HPN601 to address multiple indications with high unmet medical need.

TriTAC-XR

•
The proprietary TriTAC-XR extended-release T cell engager platform is designed to minimize on-target CRS, a characteristic of many T cell engagers that can lead to dose limiting toxicities and can reduce the efficacy of these potent anti-tumor drugs.

Corporate Update

•
Haibo Wang joined Harpoon in August 2023 as Senior Vice President of Business Development, with 15 years of biopharma business development, finance, and M&A transaction experience, including a focus in both BCMA and DLL3 targeted bi-specific T cell engagers. He most recently served as Vice President of Business Development at Hummingbird Bioscience. Prior to Hummingbird, Mr. Wang was Director of Business Development at Amgen, where he played a major role in the Teneobio and Five Prime Therapeutics acquisitions, the oncology collaboration with BeiGene, and many clinical collaborations to advance Amgen’s oncology pipeline.

Second Quarter 2023 Financial Results

•
Harpoon ended the second quarter of 2023 with $45.6 million in cash, cash equivalents, short-term marketable securities, compared to $53.1 million as of December 31, 2022. Current cash, cash equivalents, short-term marketable securities are expected to fund planned operations into the second half of 2024.

•
Revenue for the second quarter ended June 30, 2023 was $20.2 million, compared to $8.3 million for the second quarter ended June 30, 2022. For the six months ended June 30, 2023, revenue was $28.8 million compared to $14.2 million for the six months ended June 30, 2022. The increase for both periods was primarily due to an increase in revenue recognized related to Harpoon’s Development Option Agreement with AbbVie and the remaining deferred revenue recognized under the AbbVie Restated Research and Discovery Collaboration Agreement, due to the delivery of the remaining targets in the second quarter of 2023 that fulfilled the performance obligation.

•
Research and development (R&D) expense for the second quarter ended June 30, 2023 was $12.2 million, compared to $20.7 million for the second quarter ended June 30, 2022. For the six months ended June 30, 2023, R&D expense was $27.4 million compared to $41.5 million for the six months ended June 30, 2022. The decrease for both periods was primarily due to a decrease in personnel and research activities associated with the corporate restructuring and winddown of HPN424 and HPN536 studies.

•
General and administrative (G&A) expense for the second quarter ended June 30, 2023 was $3.8 million, compared to $5.1 million for the second quarter ended June 30, 2022. For the six months ended June 30, 2023, G&A expense was $8.0 million compared to $10.5 million for the six months ended June 30, 2022. The decrease for both periods was primarily due to lower personnel-related expenses, primarily attributable to a decrease in stock-based compensation and a decrease in other professional services.

•
Impairment of long-lived assets charge for the three and six months ended June 30, 2023 was $1.7 million, compared to zero for the three and six months ended June 30, 2022. The charge is due to subleasing all office and lab space at the Cove facility as part of Harpoon’s previously announced restructuring plan which required reducing the carrying values of long-lived assets to their fair values.

•
Net income attributable to common stockholders for the second quarter ended June 30, 2023 was $1.1 million compared to a net loss attributable to common stockholders of $17.4 million for the second quarter ended June 30, 2022. Net loss attributable to common stockholders for the six months ended June 30, 2023 was $10.3 million compared to $37.7 million for the six months ended June 30, 2022.