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Lyell Immunopharma Reports Recent Business Highlights and Third Quarter Financial Results

On November 8, 2022 Lyell Immunopharma, Inc. (Lyell) (Nasdaq: LYEL), a clinical‑stage T-cell reprogramming company dedicated to developing curative cell therapies for patients with solid tumors, reported financial results for the third quarter of 2022 (Press release, Lyell Immunopharma, NOV 8, 2022, View Source [SID1234623404]).

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"In the past year we have advanced two product candidates into clinical development and have added LYL119, a second-generation CAR T-cell product candidate, to our pipeline of wholly owned novel cell therapies," said Liz Homans, CEO of Lyell. "As we continue to progress our pipeline, we are grateful for the support of physicians, clinical site staff, patients and their families and our dedicated and talented employees who enable our mission," said CEO Liz Homans. "Our strong financial position allows us to execute against our long-range plans with a cash runway into 2026, which takes us through important clinical milestones. These expected milestones include initial clinical data from both of our wholly owned product candidates, LYL797 and LYL845."

Recent Business Highlights

Announced FDA clearance of the IND for LYL845, a TIL product candidate enhanced with Lyell’s novel epigenetic reprogramming technology for solid tumors. LYL845 is an autologous TIL therapy enhanced with Lyell’s Epi-R reprogramming technology designed to create polyclonal T cell populations with properties of durable stemness and improved function.
The Phase 1 trial is expected to initially enroll patients with relapsed and/or refractory metastatic or locally advanced melanoma and subsequently expand into non-small cell lung cancer and colorectal cancer.
Initial data presentation for LYL845 is expected in 2024.
Announced the presentation of five abstracts at the 2022 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting highlighting preclinical data on Lyell’s product candidates and new genetic and epigenetic reprogramming technologies. The abstracts showcase compelling preclinical data underlying Lyell’s lead TIL product candidate, LYL845, as well as preclinical data on new stackable genetic and epigenetic reprogramming technologies being incorporated into LYL119, its second-generation investigational ROR1-targeting CAR T-cell product candidate.
Presented the first-in-human Phase 1 trial design for LYL797, Lyell’s ROR1-targeted CAR T-cell therapy enhanced with genetic and epigenetic reprogramming for the treatment of solid tumors, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022 in Paris, France.
Patient screening in the Phase 1 trial of LYL797 was initiated in late March; however, clinical site activation was initially slower than anticipated. Lyell has undertaken several measures to accelerate administrative site activation activities and has also increased the number of sites that will participate in the trial. As a result, although site activations are now progressing well, enrollment has been slower than anticipated.
Despite the accelerated pace of site activations, in order to present a meaningful dataset in terms of both the number of patients and duration of response to therapy, the timing of presentation of initial data is now expected to occur in the first half of 2024.
Announced the appointment of Rahsaan W. Thompson, as Chief Legal Officer. Mr. Thompson is a biopharmaceutical industry veteran, with more than 20 years of experience with development stage and commercial companies.
Announced that GSK informed Lyell that, as part of a number of strategic actions it is taking, it is discontinuing its development of product candidates targeting NY-ESO-1, including the second-generation product candidates incorporating our genetic and epigenetic reprogramming technologies (LYL132 and LYL331). The termination of the collaboration agreement with Lyell will be effective December 24, 2022. Given the early stage of these second-generation programs, the decision is not based on any clinical efficacy or safety data from these programs.
Third Quarter 2022 Financial Results

Revenue

Revenue was approximately zero and $2.8 million for the three months ended September 30, 2022 and 2021, respectively. No additional research and development pursuant to the GSK Agreement was performed in the third quarter of 2022, which drove a decrease in revenue of $2.8 million.
GAAP and Non-GAAP Operating Expenses

Lyell reported a net loss of $70.3 million for the third quarter ended September 30, 2022, compared to a net loss of $48.9 million for the same period in 2021. Non-GAAP net loss, which excludes non-cash stock-based compensation, non-cash expenses related to the change in the estimated fair value of success payment liabilities and non-cash impairment adjustment of other investments, was $43.7 million for the third quarter ended September 30, 2022 compared to $35.7 million for the same period in 2021.
Research and development (R&D) expenses were $41.6 million for the third quarter ended September 30, 2022, compared to $31.4 million for the same period in 2021. The increase in R&D expenses was primarily driven by increases in personnel and infrastructure costs to support the expansion of our R&D and manufacturing capabilities. Non‑GAAP R&D expenses, which exclude non-cash stock-based compensation and non-cash expenses related to the change in the estimated fair value of success payment liabilities for the third quarter ended September 30, 2022, were $34.7 million, compared to $28.7 million for the same period in 2021.
General and administrative (G&A) expenses were $26.1 million for the third quarter ended September 30, 2022, compared to $21.2 million for the same period in 2021. The increase in G&A expenses was primarily due to a $4.3 million increase in stock-based compensation expense, primarily related to award modifications and new awards granted. Non‑GAAP G&A expenses, which exclude non-cash stock-based compensation, for the third quarter ended September 30, 2022 were $11.4 million, compared to $10.9 million for the same period in 2021. The increase in non-GAAP G&A expenses was driven by public company operating costs.
A discussion of non-GAAP financial measures, including reconciliations of the most comparable GAAP measures to non-GAAP financial measures, is presented below under "Non-GAAP Financial Measures."

Cash, cash equivalents and marketable securities

Cash, cash equivalents and marketable securities as of September 30, 2022 were $750.7 million, compared to $898.3 million as of December 31, 2021. Certain clinical trial expenses projected for 2022 are now expected to be incurred in 2023. As a result of expense timing, as well as diligent expense management, Lyell believes that its cash, cash equivalents and marketable securities balances will be sufficient to meet working capital and capital expenditure needs into 2026.

Pliant Therapeutics Provides Corporate Update and Reports Third Quarter 2022 Financial Results

On November 8, 2022 Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical stage biotechnology company focused on discovering and developing novel therapeutics for the treatment of fibrosis, reported third quarter 2022 financial results (Press release, Pliant Therapeutics, NOV 8, 2022, View Source [SID1234623403]).

"Our strong third quarter progress was highlighted by positive data from our lead candidate PLN-74809 in IPF, the further strengthening of our financial position through a successful public offering and the positive DSMB safety review of the ongoing INTEGRIS-IPF trial that added to the growing favorable safety profile of this novel drug candidate," said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant Therapeutics. "This progress sets the stage for several near-term clinical data readouts, including the 12-week and 24-week data from the INTEGRIS-IPF program in early 2023 and the first half of 2023, respectively."

Third Quarter and Recent Highlights

PLN-74809 (bexotegrast) Highlights

The International Nonproprietary Names (INN) Expert Group adopted "bexotegrast" as the unique non-proprietary or generic name for PLN-74809. Going forward, Pliant will use bexotegrast in place of PLN-74809.
Positive safety and efficacy data from Phase 2a INTEGRIS-IPF trial of PLN-74809 (bexotegrast) in patients with idiopathic pulmonary fibrosis (IPF). PLN-74809 (bexotegrast), at once-daily doses of 40 mg, 80 mg, 160 mg, demonstrated a dose-dependent treatment effect on forced vital capacity (FVC) and quantitative lung fibrosis (QLF) and serum biomarkers of PRO-C3 versus placebo over 12 weeks of treatment. A treatment effect was observed at all three doses tested on top of standard of care therapy and as monotherapy. In addition, PLN-74809 (bexotegrast) was well tolerated over 12 weeks of treatment with no drug related serious adverse events (SAEs) and no treatment discontinuations due to adverse events.
Positive independent Data Safety Monitoring Board (DSMB) review of the ongoing INTEGRIS-IPF Phase 2a trial. This regularly scheduled DSMB review was held in August after the completion of enrollment of the 320 mg cohort. The DSMB examined the safety data from all patients enrolled, approximately half of whom had completed at least 12 weeks of treatment, and recommended the INTEGRIS-IPF trial continue without modification.
INTEGRIS-IPF Phase 2a trial of PLN-74809 (bexotegrast) at 320 mg on track for 12-week data readout in early first quarter 2023. This randomized, double-blind, placebo-controlled trial is also evaluating PLN-74809 (bexotegrast) at a once daily dose of 320 mg administered for at least six months and up to 48 weeks in approximately 28 patients with IPF. The trial will evaluate primary and secondary endpoints of safety, tolerability, and pharmacokinetics. Exploratory efficacy endpoints will include effect on FVC and QLF imaging as well as biomarkers. Trial enrollment was completed in the second quarter of 2022 with interim 12-week data expected early in the first quarter of 2023 and 24-week data expected in the first half of 2023.
Positive independent DSMB review of the ongoing INTEGRIS-PSC Phase 2a trial of PLN-74809 (bexotegrast) in patients with primary sclerosing cholangitis (PSC). This regularly scheduled DSMB review was held in October to examine the safety data from all patients enrolled. The DSMB recommended the INTEGRIS-PSC trial continue without modification. Topline data from this trial is expected in the third quarter of 2023.
Early-Stage Development Programs

Oncology program is completing Investigational New Drug (IND) enabling activities. Based on encouraging preclinical data generated to date, the Company is prioritizing the oncology program as the next program to enter clinical development. IND application submission is expected by the end of 2022.
Muscular dystrophy program progressing through IND enabling activities. IND application submission is expected in 2023.
Corporate Highlights

Closing of underwritten public offering of $230 million in common stock. The Company closed a public offering yielding $215.4 million in net proceeds to the Company, which included the underwriter’s exercise in full of their option to purchase additional shares. Pliant intends to use the net proceeds from the offering, together with its existing cash, cash equivalents and investments, to develop its ongoing and future preclinical and clinical programs including PLN-74809 (bexotegrast), further develop its integrin targeting platform, to fund working capital, operating expenses and capital expenditures, and for other general corporate purposes.
Appointment of Dr. Katharine Knobil to the Company’s Board of Directors. Dr. Knobil brings over 20 years of clinical development and medical affairs expertise from strategic leadership roles from across the globe to the Company. Dr. Knobil currently serves as the Chief Medical Officer at Agilent Technologies, Inc.
Third Quarter 2022 Financial Results

Research and development expenses were $24.6 million, as compared to $21.1 million for the prior-year quarter. The increase was due primarily to employee related expenses and higher manufacturing related costs which was partially offset by a decrease in clinical trial expenses given several Phase 1 studies completed prior to the third quarter of 2022.
General and administrative expenses were $8.8 million, as compared to $7.7 million for the prior-year quarter. The increase was due to higher personnel-related and professional services expenses.
Net loss of $30.6 million as compared to $27.0 million for the prior-year quarter due to an increase in operating expenses coupled with a slight decrease in collaboration revenues under the Novartis collaboration during the quarter.
As of September 30, 2022, the Company had cash, cash equivalents and short-term investments of $360.2 million and considering full utilization of the Oxford loan facility, the Company expects to be able to fund operations to mid-2025.

Invitae Reports Third Quarter 2022 Financial Results

On November 8, 2022 Invitae (NYSE: NVTA), a leading medical genetics company, reported financial and operating results for the third quarter ended September 30, 2022 (Press release, Invitae, NOV 8, 2022, View Source [SID1234623402]).

Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

"In the third quarter, we continued to deliver positive results as the organizational realignment and expense controls we put in place resulted in another quarter of improvements in our non-GAAP gross margin and operating expense, as well as our cash burn. There are also early signs demonstrating that the steps we’ve taken to drive higher-quality revenue are taking hold, driven by our portfolio optimization efforts and a focus on operational excellence," said Ken Knight, president and chief executive officer of Invitae. "We continue to be optimistic about the vitality of Invitae’s many strengths, including our great assets, capabilities, and a comprehensive, synergistic set of solutions serving the current and future needs of our patients and partners. I am pleased with the momentum, and our energy is targeting significant market opportunities."

Third Quarter 2022 Highlights

Generated revenue of $133.5 million, a 16.7% increase compared to $114.4 million in the third quarter of 2021.
GAAP gross profit was $16.6 million, and non-GAAP gross profit was $61.2 million.
GAAP gross margin was 12.4%. Non-GAAP gross margin was 45.9% as compared with 40.1% in the second quarter of 2022 and 35.6% in the third quarter of 2021.
Cash, cash equivalents, restricted cash and marketable securities were $596.0 million as of September 30, 2022, compared to $736.8 million as of June 30, 2022. Cash burn was $151.5 million, which excludes a $9.7 million inflow from sales under our ATM facility. Our cash burn was $108.3 million after adjustments for outflows of $29.1 million related to realignment and $14.1 million related to contingent consideration held for past M&A transactions.
Total active healthcare provider accounts totaled 20,831 as of September 30, an increase of approximately 20% year-over-year.
Active pharmaceutical and commercial partnerships grew to 234, an increase of approximately 38% year-over-year, due to revenue growth from lab services, data services to pharmaceutical, health systems and other partners.
Revenue per patient was $505, an increase of approximately 8% from $468 in the third quarter of 2021.
Total patient population as of September 30 is more than 3.3 million with over 62% available for data sharing.
Total operating expense, which excludes cost of revenue, for the third quarter of 2022 was $306.5 million, which includes items related to the strategic realignment. As a result, GAAP operating expense as a percentage of revenue was 230%. Non-GAAP operating expense was $150.0 million for the third quarter of 2022. Non-GAAP operating expense as a percentage of revenue was 112%, which consistently improved as compared with 146% in the second quarter of 2022 and 176% in the third quarter of 2021.

Net loss for this year’s third quarter was $301.2 million, or a $1.27 net loss per share, compared to net loss of $198.2 million, or net loss per share of $0.91, for the third quarter of 2021. Non-GAAP net loss for the third quarter of 2022 was $100.8 million, or a $0.42 non-GAAP net loss per share, compared to a net loss of $175.9 million, or an $0.81 non-GAAP net loss per share, for the third quarter of 2021.

Financial Guidance

Invitae is reiterating its revenue and non-GAAP gross margin financial guidance. The company expects a low double-digit growth rate for its full year 2022 revenue over 2021. Non-GAAP gross margins are expected to be in the range of 42-43% for full year 2022.

Invitae is reducing its full year 2022 cash burn guidance to $585-625 million, an improvement from its previous guidance of $600-650 million. This guidance includes cash to be used for realignment activities and severance of up to $75 million in 2022, which remained unchanged from the previous estimate.

Webcast and Conference Call Details

Management will host a conference call and webcast today at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time to discuss financial results and recent developments. To access the conference call, please register at the link below:

View Source;confId=43070

Upon registering, each participant will be provided with call details and a conference ID.

The live webcast of the call and slide deck may be accessed here or by visiting the investors section of the company’s website at ir.invitae.com. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the company’s website.

Heron Therapeutics Announces Financial Results for the Three and Nine Months Ended September 30, 2022 and Highlights Recent Corporate Updates

On November 8, 2022 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care, reported financial results for the three and nine months ended September 30, 2022 and highlighted recent corporate updates (Press release, Heron Therapeutics, NOV 8, 2022, View Source [SID1234623401]).

Recent Corporate Updates

Acute Care Franchise

ZYNRELEF:
Net product sales of ZYNRELEF (bupivacaine and meloxicam) extended-release solution for the three and nine months ended September 30, 2022 were $2.7 million and $6.3 million, respectively. Net product sales of ZYNRELEF for both the three and nine months ended September 30, 2021 were $2.1 million (ZYNRELEF was launched July 1, 2021). ZYNRELEF end-user (ambulatory surgical centers (ASCs) and hospitals) demand unit sales were 15,077 in the third quarter of 2022, representing an increase of 18% over the prior quarter. Growth has substantially increased in October with weekly average ZYNRELEF demand unit sales increasing 27% over the weekly average in the third quarter. We currently expect fourth quarter 2022 ZYNRELEF net product sales to increase in the range of 30% to 40% over the prior quarter.
Since launch on July 1, 2021 through September 30, 2022, 704 unique accounts purchased ZYNRELEF with 84% of those accounts reordering the product.
All clinical studies planned for inclusion in the supplemental New Drug Application (NDA) to further expand the ZYNRELEF indication to soft tissue and orthopedic procedures are complete, with submission planned for late 2022.
APONVIE:
The APONVIE (aprepitant) injectable emulsion NDA was approved by the U.S. Food and Drug Administration (FDA) on September 16, 2022. We expect to make APONVIE commercially available in the U.S. in the first quarter of 2023.
APONVIE is the only intravenous (IV) substance P/neurokinin-1 (NK1) receptor antagonist (RA) indicated for the prevention of postoperative nausea and vomiting (PONV) in adults.
PONV represents a significant opportunity that leverages our existing sales organization in the acute care setting. There are approximately 36 million surgical procedures annually in patients at moderate to high risk for PONV, where guidelines recommend using multiple agents for prophylaxis.
Oncology Care Franchise

2022 Oncology Care Franchise Net Product Sales: For the three and nine months ended September 30, 2022, oncology care franchise net product sales were $23.9 million and $71.3 million, respectively, compared to $21.1 million and $63.6 million, respectively, for the same periods in 2021.
CINVANTI Net Product Sales: Net product sales of CINVANTI (aprepitant) injectable emulsion for the three and nine months ended September 30, 2022 were $21.2 million and $64.2 million, respectively, compared to $18.0 million and $56.2 million, respectively, for the same periods in 2021.
Validation of large-scale manufacturing of CINVANTI was completed, which will result in a significant reduction in cost of product sales in the fourth quarter of 2022 and beyond.
SUSTOL Net Product Sales: Net product sales of SUSTOL (granisetron) extended-release injection for the three and nine months ended September 30, 2022 were $2.7 million and $7.1 million, respectively, compared to $3.1 million and $7.4 million, respectively, for the same periods in 2021.
2022 Oncology Care Franchise Net Product Sales Guidance: Heron currently expects full-year 2022 net product sales for the oncology care franchise of $93 million to $95 million.
"Approval of APONVIE expands our acute care franchise to cover the two most common concerns of patients and clinicians after surgery, pain and PONV. We are gratified to see improved growth of ZYNRELEF in October following the slower than anticipated growth in the third quarter, which coincided with a greater than 10% decline in indicated surgical procedures," said Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron. "Our oncology care franchise reported solid net product sales of $23.9 million for the third quarter of 2022 and we remain on track to achieve our full-year 2022 guidance of $93 million to $95 million. In addition, we strengthened our balance sheet with a $75 million private placement to advance our commercial franchises and extend our runway against a challenging external backdrop."

Financial Results

Net product sales for the three and nine months ended September 30, 2022 were $26.6 million and $77.6 million, respectively, compared to $23.2 million and $65.7 million, respectively, for the same periods in 2021.

Heron’s net loss for the three and nine months ended September 30, 2022 was $41.9 million, or $0.38 per share, and $162.2 million, or $1.54 per share, respectively, compared to $52.4 million, or $0.51 per share, and $166.0 million, or $1.71 per share, respectively, for the same periods in 2021. Net loss for the three and nine months ended September 30, 2022 included non-cash, stock-based compensation expense of $11.2 million and $32.5 million, respectively, compared to $11.2 million and $34.0 million, respectively, for the same periods in 2021.

As of September 30, 2022, Heron had cash, cash equivalents and short-term investments of $121.7 million, compared to $157.6 million as of December 31, 2021. Net cash used for operating activities for the three and nine months ended September 30, 2022 was $37.1 million and $109.4 million, respectively, compared to $53.2 million and $158.1 million, respectively, for the same periods in 2021. The decrease in our net cash used for operating activities was primarily due to changes in working capital related to the launch of ZYNRELEF, including manufacturing of commercial inventory, as well as a decrease in net loss.

Conference Call and Webcast

Heron will host a conference call and webcast on November 8, 2022 at 4:30 p.m. ET. The conference call can be accessed by dialing (646) 307-1963 for domestic callers and (800) 715-9871 for international callers. Please provide the operator with the passcode 4433557 to join the conference call. The conference call will also be available via webcast under the Investor Relations section of Heron’s website at www.herontx.com. An archive of the teleconference and webcast will also be made available on Heron’s website for 60 days following the call.

About ZYNRELEF for Postoperative Pain

ZYNRELEF is the first and only dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. ZYNRELEF was initially approved by the FDA in May 2021 for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. In December 2021, the FDA approved an expansion of ZYNRELEF’s indication. ZYNRELEF is now indicated in the U.S. in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures. In September 2020, the European Commission granted a marketing authorization for ZYNRELEF for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. As of January 1, 2021, ZYNRELEF is approved in 31 European countries including the countries of the European Union and European Economic Area and the United Kingdom. In March 2022, Health Canada issued a Notice of Compliance for ZYNRELEF for instillation into the surgical wound for postoperative analgesia after bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty surgical procedures.

Please see full prescribing information, including Boxed Warning, at www.ZYNRELEF.com.

About APONVIE for PONV

APONVIE (aprepitant) injectable emulsion is a substance NK1 RA, indicated for the prevention of postoperative nausea and vomiting in adults. Delivered via a 30-second intravenous (IV) injection, APONVIE 32 mg was demonstrated to be bioequivalent to oral aprepitant 40 mg with rapid achievement of therapeutic drug levels. APONVIE is the same formulation as Heron’s approved CINVANTI. APONVIE is supplied in a single-dose vial that delivers the full 32 mg dose for PONV. APONVIE was approved by the FDA in September 2022.

Please see full prescribing information at www.APONVIE.com.

About CINVANTI for Chemotherapy Induced Nausea and Vomiting (CINV) Prevention

CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen, delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen, and nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen. CINVANTI is an IV formulation of aprepitant, an NK1 RA. CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND capsules. Aprepitant (including its prodrug, fosaprepitant) is the only single-agent NK1 RA to significantly reduce nausea and vomiting in both the acute phase (0–24 hours after chemotherapy) and the delayed phase (24–120 hours after chemotherapy). The FDA-approved dosing administration included in the U.S. prescribing information for CINVANTI include 100 mg or 130 mg administered as a 30-minute IV infusion or a 2-minute IV injection.

Please see full prescribing information at www.CINVANTI.com.

About SUSTOL for CINV Prevention

SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-hydroxytryptamine type 3 RA that utilizes Heron’s Biochronomer drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL’s efficacy and safety in more than 2,000 patients with cancer. SUSTOL’s efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0–24 hours after chemotherapy) and delayed phase (24–120 hours after chemotherapy).

Supernus Announces Third Quarter 2022 Financial Results

On November 8, 2022 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported financial results for the third quarter of 2022, and associated Company developments (Press release, Supernus, NOV 8, 2022, View Source [SID1234623400]).

Qelbree Launch Update

Total IQVIA prescriptions were 94,328 in the third quarter of 2022, an increase of 50% compared to total prescriptions of 62,938 in the second quarter of 2022. In September 2022, the most recent month available, total prescriptions reached 34,633.
Qelbree continues to expand its base of prescribers, with approximately 14,265 prescribers in the third quarter of 2022, up from 9,276 prescribers from the second quarter of 2022.
Product Pipeline Update

SPN-830 (apomorphine infusion device) – Continuous treatment of motor fluctuations ("off" episodes) in Parkinson’s disease (PD)

In October 2022, the Company announced the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the SPN-830 New Drug Application (NDA). The CRL does not request additional efficacy and safety clinical studies, but rather requires additional information and analysis related to the infusion device and drug product across several areas of the NDA, including labeling, product quality and manufacturing, device performance and risk analysis. In addition, the FDA mentions that approval of the NDA requires inspections that could not be completed in a timely manner due to COVID-19 travel restrictions. Supernus will continue to work closely with its partners and the FDA to address all questions, and when possible, provide clarity regarding the potential timing of a resubmission of the NDA. The FDA has made an initial determination that the amendment to the Company’s application in response to the CRL will be subject to a Class 2, or six-month, review timeline.
SPN-820 – Novel first-in-class activator of mTORC1

The Phase II multi-center, randomized double-blind placebo-controlled parallel design study of SPN-820 in adults with treatment-resistant depression is ongoing. The study will examine the efficacy and safety of SPN-820 over a course of five weeks of treatment in approximately 270 patients. The primary outcome measure is the change from baseline to end of treatment period on the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score, a standard depression rating scale.
SPN-817 – A novel product candidate for the treatment of epilepsy

An open-label Phase II clinical study of SPN-817 in patients with treatment-resistant seizures is expected to start in the fourth quarter of 2022.
Financial Highlights

Net Product Sales

For the three months ended September 30, 2022, net product sales were $172.7 million, a 19% increase over net product sales of $145.5 million for the same period in 2021. For the nine months ended September 30, 2022, net product sales were $485.6 million, an 18% increase over net product sales of $412.5 million for the same period in 2021. The increases in both periods were primarily due to net product sales of GOCOVRI and growth in net product sales of Qelbree and Oxtellar XR.

The following table provides information regarding net product sales during the three and nine months ended September 30, 2022 and 2021 (dollars in millions):

Operating earnings (GAAP and non-GAAP)

For the three months ended September 30, 2022, operating loss (GAAP) was $1.5 million, as compared to operating earnings (GAAP) of $32.6 million for the same period in 2021. For the nine months ended September 30, 2022 operating earnings (GAAP) were $11.8 million, as compared to $79.9 million for the same period in 2021. The decreases in both periods were primarily due to activities to support the launch of Qelbree to the adult population, the Qelbree direct-to-consumer campaign, which substantially occurred in the third quarter of 2022, and amortization of acquired intangible assets from the Adamas Acquisition.

For the three months ended September 30, 2022, adjusted operating earnings (non-GAAP) were $25.4 million, compared to $43.3 million in the third quarter of 2021. For the nine months ended September 30, 2022, adjusted operating earnings (non-GAAP) were $91.1 million, compared to $106.0 million for the same period of 2021.

Reconciliation of GAAP to Non-GAAP Adjustments

An itemized reconciliation between operating earnings on a GAAP basis and operating earnings on a non-GAAP basis is as follows (dollars in millions):

Non-GAAP operating earnings adjusts for non-cash items including amortization of intangible assets, share-based compensation expense, change in fair value of contingent consideration, and depreciation. The increase in amortization of intangible assets for the three and nine months period ended September 30, 2022 was due to the amortization of acquired intangible assets from the Adamas Acquisition in November 2021.

Net earnings (GAAP)

For the three months ended September 30, 2022, net earnings (GAAP) and diluted earnings per share (GAAP) were $1.7 million and $0.03, respectively, as compared to $21.6 million, or $0.40 per diluted share, in the same period in 2021.

For the nine months ended September 30, 2022, net earnings (GAAP) and diluted earnings per share (GAAP) were $35.2 million and $0.62, respectively, as compared to $51.0 million, or $0.94 per diluted share, in the same period in 2021.

Cash, cash equivalents and marketable securities

At September 30, 2022, the Company’s cash, cash equivalents, current and long-term marketable securities are approximately $523.7 million, compared to $458.8 million as of December 31, 2021. This increase was primarily due to cash generated from operations.

Full Year 2022 Financial Guidance (GAAP)

For full year 2022, the Company is raising the midpoint and narrowing the expected ranges of full year 2022 financial guidance for total revenues and operating earnings (GAAP). The Company’s revised full-year 2022 financial guidance is set forth below (dollars in millions):

Full Year 2022 Financial Guidance – GAAP to Non-GAAP Adjustments

An itemized reconciliation between projected operating earnings on a GAAP basis and projected operating earnings on a non-GAAP basis is as follows (dollars in millions):

Non-GAAP Financial Information

This press release contains a financial measure, non-GAAP operating earnings, which does not comply with United States generally accepted accounting principles (GAAP). The non-GAAP financial measure should be considered in addition to, not as a substitute for or in isolation from, or superior to measures prepared in accordance with GAAP. Non-GAAP operating earnings adjusts for non-cash share-based compensation expense, depreciation and amortization, and accretion of contingent consideration, and for factors that are unusual, non-recurring or unpredictable, and excludes those costs, expenses, and other specified items presented in the reconciliation tables in this press release. We believe the use of non-GAAP operating earnings is useful supplemental information to investors regarding the Company’s results of operations and assist management, analysts, and investors in evaluating the performance of the business. There are limitations associated with the use of non-GAAP financial measures. Including such measures may not be entirely comparable to similarly titled measures used by other companies, may not reflect all items of income and expense, as applicable, that affect our operations, potential differences among calculation methodologies, may differ from the non-GAAP information used by other companies, including peer companies, and therefore comparability may be limited. We mitigate these limitations by reconciling the non-GAAP financial measure to the most comparable GAAP financial measure. Investors are encouraged to review the reconciliation. The Company’s 2022 financial guidance is also being provided on both a reported and a non-GAAP basis.

Conference Call Details

Supernus will host a conference call and webcast today, November 8, 2022, at 4:30 p.m. Eastern Time to discuss these results. A live webcast will be available in the Events & Presentations section of the Company’s Investor Relations website www.supernus.com/investors.

Participants may also pre-register any time before the call here. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.

Following the live call, a replay will be available on the Company’s Investor Relations website www.supernus.com/investors. The webcast will be available on the Company’s website for 60 days following the live call.