On May 5, 2021 Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) reported financial and operational results for the first quarter ended March 31, 2021 (Press release, Vanda Pharmaceuticals, MAY 5, 2021, View Source [SID1234579235]).

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"Despite seasonal and global challenges, we recorded another quarter of strong revenue across our commercial portfolio coupled with the launch of HETLIOZ in the new indication of nighttime sleep disturbances in patients with Smith-Magenis Syndrome," said Mihael H. Polymeropoulos, M.D., President and CEO of Vanda. "In our clinical programs, we have made significant progress, reaching 85% randomization in our Phase III tradipitant study in gastroparesis and initiating a new clinical program for HETLIOZ in delayed sleep phase disorder."

Financial Highlights

Total net product sales from HETLIOZ and Fanapt were $62.7 million in the first quarter of 2021, an 8% increase compared to $58.0 million in the first quarter of 2020.
HETLIOZ net product sales were $39.3 million in the first quarter of 2021, an 11% increase compared to $35.3 million in the first quarter of 2020.
Fanapt net product sales were $23.3 million in the first quarter of 2021, a 3% increase compared to $22.7 million in the first quarter of 2020.
Income before taxes was $10.4 million in the first quarter of 2021 compared to $1.2 million in the first quarter of 2020.
Cash, cash equivalents and marketable securities (Cash) was $378.2 million as of March 31, 2021, representing an increase to Cash of $65.8 million compared to March 31, 2020.
Key Operational Highlights

Tradipitant

The gastroparesis Phase III clinical study (VP-VLY-686-3301) is ongoing. The study has a target enrollment of 200 randomized patients and is expected to complete enrollment in the second quarter of 2021, with a New Drug Application (NDA) filing expected in late 2021 or early 2022.
HETLIOZ (tasimelteon)

In December 2020, the U.S. Food and Drug Administration (FDA) approved HETLIOZ capsule and liquid formulations for the treatment of adults and children, respectively, with nighttime sleep disturbances in Smith-Magenis Syndrome (SMS).1 HETLIOZ capsules, for adults with SMS, were immediately available after approval and the HETLIOZ LQ liquid formulation, for children with SMS, became available in the first quarter of 2021.
A Phase III clinical study of HETLIOZ in delayed sleep phase disorder (DSPD) was initiated in the first quarter of 2021.
Fanapt (iloperidone)

A Phase III clinical study of Fanapt in bipolar disorder resumed during the first quarter of 2021 after pausing in 2020 due to the COVID-19 pandemic.
Development of the long acting injectable (LAI) formulation of Fanapt is ongoing.
A clinical development program of Fanapt in Parkinson’s disease psychosis (PDP) was initiated in the first quarter of 2021.
GAAP Financial Results

Income before taxes was $10.4 million in the first quarter of 2021 compared to $1.2 million in the first quarter of 2020. Net income was $8.7 million in the first quarter of 2021 compared to net income of $0.5 million in the first quarter of 2020. Diluted net income per share was $0.15 in the first quarter of 2021 compared to diluted net income per share of $0.01 in the first quarter of 2020.

2021 Financial Guidance

Vanda expects to achieve the following financial objectives in 2021:

Conference Call

Vanda has scheduled a conference call for today, Wednesday, May 5, 2021, at 4:30 PM ET. During the call, Vanda’s management will discuss the first quarter 2021 financial results and other corporate activities. Investors can call 1-866-688-9426 (domestic) or 1-409-216-0816 (international) and use passcode 5709209. A replay of the call will be available on Wednesday, May 5, 2021, beginning at 7:30 PM ET and will be accessible until Wednesday, May 12, 2021 at 7:30 PM ET. The replay call-in number is 1-855-859-2056 for domestic callers and 1-404-537-3406 for international callers. The passcode number is 5709209.

The conference call will be broadcast simultaneously on Vanda’s website, www.vandapharma.com. Investors should click on the Investors tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary software or presentations. The call will also be archived on Vanda’s website for a period of 30 days.

On May 5, 2021 Ampio Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions for which there are limited treatment options, reported quarterly financial results for the first quarter period ended March 31, 2021, and provided a corporate overview and business update (Press release, Ampio, MAY 5, 2021, View Source [SID1234579234]).

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Mr. Michael Macaluso, President and Chief Executive Officer, commented, "This has been an important quarter for Ampio, with noted progress across our therapeutic platform. For example, the FDA has recently responded to our plans for the AP-013 Phase III trial for the intra-articular injection of Ampion for patients suffering from severe osteoarthritis of the knee (OAK). The response not only provides us with flexibility for maintaining the Special Protocol Assessment (SPA) but, in addition, allows us to consider several alternative paths forward to an optimal solution that may include strategic discussions with potential partners for the commercialization, and expansion of osteoarthritis indications, of Ampion."

"We were also encouraged with the results of the AP-014 Phase I clinical trial of inhaled Ampion for COVID-19 patients. The study met its primary endpoint of safety and tolerability, and a 78% reduction in all-cause mortality was observed for patients treated with Ampion compared to Standard of Care (SOC). Approximately 24% of the patients receiving SOC alone died during the study, compared with 5% treated with Ampion."

"Our results from the AP-014 trial are strong and compelling," continued Macaluso, "and we look forward to promptly enrolling patients in a set of double-blind, placebo-controlled Phase II trials utilizing Ampion in COVID-19 patients with inhalation and intravenous routes of drug delivery. We will be looking for confirmation of the efficacy results seen in our Phase I trial in order to move quickly in applying for Emergency Use Authorization."

Mr. Michael Macaluso, President and Chief Executive Officer, Dr. David Bar-Or, Director and Founder, Ms. Holli Cherevka, Chief Operating Officer and Mr. Daniel Stokely, Chief Financial Officer will be hosting a Conference Call for the Investment Community this afternoon beginning at 4:30 PM ET (see details below).

The key areas of focus will be as follows:

COVID-19 Platform / Pipeline Overview and Update

AP-014 (inhaled) Phase I clinical trial of Ampion met its primary endpoint, and demonstrated improvement in all-cause mortality
Double-blind, placebo-controlled Phase II trials utilizing (i) inhaled Ampion for patients impacted from COVID-19 induced respiratory distress and (ii) intravenously delivered Ampion for COVID-19 patients, will begin enrollment in the U.S. during the second quarter of 2021
OAK Clinical Trial 2021 Timeline / Update

Positive FDA response provides guidance on multiple pathways forward on paused AP-013 Phase III trial in osteoarthritis of the knee (OAK)
Long-COVID and Other Clinical Trial 2021 Timeline / Update

Phase I Long-COVID trial is expected to commence enrolling patients in the U.S. during the second quarter of 2021
Update on Other Pre-Clinical Research Programs

Results of pre-clinical study demonstrated that Ampion inhibits pro-inflammatory pathway in types of immune cells implicated in COVID-19 and Lupus Nephritis
Ampion shown to suppress TRL7 signaling, and thereby, reducing the pro-inflammatory chemokine, CXCL10
Financial Results for the First Quarter Period Ended March 31, 2021

Cash and cash equivalents totaled $15.8 million at March 31, 2021, compared to $17.3 million at December 31, 2020. The decrease of $1.5 million is primarily attributable cash used to fund the operating activities for the period of $4.1 million; partially offset by net proceeds received from the utilization of our at-the-market (ATM) equity offering and warrant exercises totaling $2.6 million and $0.1 million, respectively.

Research and development expenditures for the first quarter period ended March 31, 2021 were $2.3 million, compared to $4.3 million for the same period in 2020. The decrease in research and development expenses of $2.0 million, or 46%, for the first quarter period ended March 31, 2021 compared to the amounts for the same period in 2020 was primarily due to the overall decrease in clinical trial and sponsor research related expenses related to the AP-013 study being temporarily paused in April 2020 and continuing through current as a result of the COVID-19 pandemic. The pause of this study resulted in a reduction of expenses totaling $2.4 million which was partially offset by $0.2 million of expenses associated with the AP-014 (inhaled Ampion) and AP-017 (intravenous Ampion) Phase I studies; both of which were initiated in periods subsequent to March 31, 2020.

General and administrative expenses for the first quarter period ended March 31, 2021 were $1.5 million, compared to $1.8 million for the same period in 2020. The decrease in general and administrative expenses for the first quarter period ended March 31, 2021 compared with the same period for 2020 is primarily due to the decrease in professional fees as a result of the decrease in legal costs which is primarily attributable to both the securities class action and derivative cases being closed in the third quarter of 2020.

Other income was $0.2 million for the first quarter period ended March 31, 2021 compared to other income of $0.8 million for the same period in 2020. For the first quarter period ended March 31, 2021 the other income relates directly to the warrant derivative gain recorded for the investor warrants as a result of the warrant exercises during the period which reduced the liability and was partially offset by the increase in stock price of 6.3% during the period. The derivative gain of $0.8 million recorded for the 2020 period related to the reduction of the derivative liability resulting from the 28.2% reduction of stock price during the period.

Net loss for the first quarter period ended March 31, 2021 was $3.7 million, or $0.02 on a fully diluted per share basis, compared to a net loss of $5.2 million, or $0.04 on a fully diluted per share basis, for the same period in 2020. The lower net loss reported for the first quarter period ended March 31, 2021 compared to the same period for 2020 is primarily attributable to a reduction in clinical trial and sponsor related research expenses of $2.4 million as a result of pausing the AP-013 study in early 2020 due to the COVID-19 pandemic; partially offset by the higher reported derivative gain resulting from the reduction of the derivative liability associated with the unexercised investor warrants.

The total shares of common stock outstanding were 195,689,128 at March 31, 2021, compared to 193,378,996 at December 31, 2020.

Financial Guidance

Based on its current operating plans and expected access to equity financing, Ampio expects to have cash and cash equivalents along with access to external sources of liquidity sufficient to fund research and development programs and business operations through the second quarter of 2022.

Conference Call and Webcast

Ampio will host a conference call today at 4:30pm EST (1:30 pm PST) to discuss these first quarter 2021 results and provide a corporate business update.

The live call / webcast may be accessed as follows:

A replay of the conference call will also be available from the Investors Relations section of the Company’s website at www.ampiopharma.com and will be archived there shortly after the live event.

On May 5, 2021 Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal (GI) diseases in areas of high unmet need, reported financial results for the quarter ended March 31, 2021 (Press release, Synthetic Biologics, MAY 5, 2021, View Source [SID1234579233]).

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Recent developments:

Announced enrollment has commenced and three out of a total of four cohorts have been dosed in the first Phase 1a clinical trial of SYN-020 intestinal alkaline phosphatase ("IAP") intended to support development of SYN-020 in multiple indications
Announced enrollment has commenced and the first patient was dosed in the Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant ("HCT") recipients
Current cash position of approximately $76.9 million
Received $8.0 million from the exercise of warrants
Current cash runway provides funding into 2023 and ability to fund Phase 1b/2a clinical trial of SYN-004 as well as SYN-020 intestinal alkaline phosphatase ("IAP") through proof-of-concept
Upcoming milestones, pandemic conditions permitting:

Topline data from the Phase 1a single-ascending-dose ("SAD") study of SYN-020 anticipated during Q3 2021
Expect to commence second Phase 1a multiple-ascending-dose ("MAD") study of SYN-020 during Q3 2021; topline data anticipated during Q2 2022
Topline data readout from the first antibiotic cohort of the SYN-004 Phase1b/2a clinical trial is expected during Q4 2021
"During the first quarter of 2021 we remained diligently focused on advancing our portfolio of GI and microbiome-focused clinical programs and were pleased to announce the commencement of clinical trials for our SYN-004 and SYN-020 programs," said Steven A. Shallcross, Chief Executive Officer of Synthetic Biologics. "Enrollment in the SYN-004 Phase 1b/2a clinical trial in allogeneic hematopoietic cell transplant (HCT) recipients is underway at the Washington University School of Medicine in St. Louis ("Washington University") and the first patient of the first antibiotic cohort was dosed earlier this year. We believe SYN-004 has the potential to address an important and underserved patient population, and may significantly improve outcomes for allogeneic HCT recipients by preventing downstream complications often associated with disruption of the gut microbiome by intravenous ("IV") beta-lactam antibiotics. If enrollment proceeds as planned, we anticipate announcing topline data from the first antibiotic cohort during the fourth quarter of 2021, pandemic conditions permitting."

Mr. Shallcross continued, "We were also very excited to announce the initiation of a Phase 1a single-ascending-dose clinical trial of our SYN-020 IAP program during the first quarter of 2021. To date, three out of a total of four cohorts have been dosed and we remain on track to report topline data from this study during the third quarter of 2021, pandemic conditions permitting. A second Phase 1a multiple-ascending-dose study is also expected to begin enrollment during the third quarter of 2021 with topline data expected early next year. Both studies are designed to support the advancement of SYN-020 in multiple potential therapeutic indications, including celiac disease, nonalcoholic fatty liver disease ("NAFLD") and age-related metabolic and inflammatory diseases. We are very excited about the potential for this program to be a long-term value driver for our Company and look forward to sharing important updates."

Mr. Shallcross concluded, "While we remain focused on the execution of our clinical development activities, we were also able raise net proceeds of approximately $66 million as well as $8.0 million in proceeds from the cash exercise of warrants, significantly strengthening our balance sheet and financial position. As a result of these activities, our current cash position is approximately $76.9 million. Importantly, our fortified balance sheet will fully fund our SYN-004 and SYN-020 clinical programs through proof-of-concept clinical studies, and help accelerate our other ongoing activities."

Clinical Development and Operational Update

Announced Washington University has begun enrollment and the first patient was dosed in the first antibiotic cohort of the Company’s Phase 1b/2a clinical trial of SYN-004 in allogeneic HCT recipients for the prevention of acute graft-versus-host-disease (aGVHD)
The Phase 1b/2a clinical trial comprises a single center, randomized, double-blind, placebo-controlled clinical trial of oral SYN-004 in up to 36 evaluable adult allogeneic HCT recipients
The goal of this clinical trial is to evaluate the safety, tolerability and potential absorption into the systemic circulation (if any) of oral SYN-004 administered to allogeneic HCT recipients who receive an IV beta-lactam antibiotic to treat fever,
Study participants will be enrolled into three sequential cohorts and administered a different study-assigned IV beta-lactam antibiotic. Eight participants in each cohort will receive SYN-004 and four will receive placebo
Safety and pharmacokinetic data for each cohort will be reviewed by an independent Data and Safety Monitoring Committee ("DSMC"), which will make a recommendation on whether to proceed to the next IV beta-lactam antibiotic
A topline data readout for the first antibiotic cohort is anticipated during the fourth quarter of 2021, pandemic conditions permitting;
Announced enrollment has commenced and three out of a total of four cohorts have been dosed in a Phase 1a SAD clinical trial of SYN-020 in healthy adult volunteers
The Phase 1a SAD study is designed to evaluate safety, tolerability and pharmacokinetics of four single-ascending doses of oral SYN-020 in healthy adult volunteers
In all, up to 24 study participants will be enrolled into four cohorts that will run sequentially, all of which will receive oral SYN-020. A topline data readout is anticipated during the third quarter of 2021, pandemic conditions permitting
A second Phase 1a clinical trial evaluating multiple-ascending doses of SYN-020 in healthy volunteers is expected to commence during the third quarter of 2021. Topline data is anticipated during the second quarter of 2022, pandemic conditions permitting
Both studies are intended to support the development of SYN-020 in multiple potential clinical indications including celiac disease, NAFLD, and indications supported by the Company’s collaboration with Massachusetts General Hospital;
Strengthened balance sheet by raising net proceeds of $66 million from the sale of common stock via the Company’s At-The-Market ("ATM") facility and $8.0 million resulting from the cash exercise of a portion of Company’s 2018 warrants during Q1 2021
As a result of these activities, the Company has extended its cash runway into 2023 and has the ability to fully fund its Phase 1b/2a clinical trial of SYN-004 and planned Phase 1 SAD and MAD clinical trials of SYN-020.
Quarter Ended March 31, 2020 Financial Results

General and administrative expenses increased by 2% to approximately $1.42 million for the three months ended March 31, 2021, from approximately $1.39 million for the three months ended March 31, 2020. This increase is primarily due to higher insurance costs, audit fees, and legal costs offset by a reduction in patent related legal fees, consulting fees and travel expense. The charge related to stock-based compensation expense was $82,000 for the three months ended March 31, 2021, compared to $65,000 the three months ended March 31, 2020.

Research and development expenses decreased by 32% to approximately $1.1 million for the three months ended March 31, 2021, from approximately $1.6 million for the three months ended March 31, 2020. This decrease is primarily the result of lower indirect program costs for the three months ended March 31, 2021, including salary and related expense reductions, a decrease in manufacturing costs for SYN-020 and market research. In addition, as a result of the global COVID-19 pandemic, the Company’s development partner (Washington University) reduced their operating capacity during 2021 to include only essential activities as part of their pandemic response, which delayed the start of the Company’s clinical trial, resulting in lower clinical trial expenses for the quarter. The research and development costs incurred during the quarter were primarily related to the Company’s Phase 1a clinical trial of SYN-020 and the Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients. The Company anticipates research and development expense to increase as ongoing clinical trials continue to enroll patients. The charge related to stock-based compensation expense was $19,000 for the three months ended March 31, 2021, compared to $18,000 related to stock-based compensation expense for the three months ended March 31, 2020.

Other income was $347 for the three months ended March 31, 2021, compared to other income of $38,000 for the three months ended March 31, 2020. Other income for the three months ended March 31, 2021 and 2020 is primarily comprised of interest income.

Cash and cash equivalents as of March 31, 2021 totaled $76.9 million, an increase of $70.7 million from December 31, 2020.

Conference Call

Synthetic Biologics will hold a conference call today, Wednesday, May 5, 2021, at 4:30 p.m. (EST). The dial-in information for the call is as follows, U.S. toll free: 1-888-347-5280 or International: +1 412-902-4280. Participants are asked to dial in 15 minutes before the start of the call to register. The call will also be webcast over the Internet at View Source." target="_blank" title="View Source." rel="nofollow">View Source An archive of the call will be available for replay at the same URL, View Source, for 90 days after the call.

On May 5, 2021 Unum Group (NYSE: UNM) reported net income of $153.0 million ($0.75 per diluted common share) for the first quarter of 2021, compared to net income of $161.0 million ($0.79 per diluted common share) for the first quarter of 2020 (Press release, Unum Therapeutics, MAY 5, 2021, View Source [SID1234579232]).

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Unum Group Reports First Quarter 2021 Results
Included in net income for the first quarter of 2021 are the net after-tax loss from the second phase of the Closed Block individual disability reinsurance transaction of $56.7 million ($0.27 per diluted common share), the after-tax amortization of the cost of reinsurance of $15.8 million ($0.08 per diluted common share), and a net after-tax realized investment gain on the Company’s investment portfolio, excluding the net realized investment gain associated with the completion of the second phase of the Closed Block individual disability reinsurance transaction, of $13.5 million ($0.06 per diluted common share). Included in net income for the first quarter of 2020 is a net after-tax realized investment loss on the Company’s investment portfolio of $113.1 million ($0.56 per diluted common share). Excluding the items above, after-tax adjusted operating income was $212.0 million ($1.04 per diluted common share) in the first quarter of 2021, compared to $274.1 million ($1.35 per diluted common share) in the first quarter of 2020.

"Our first quarter results reflect the dynamics of the world around us with good growth results, pressured by high, yet improving, levels of mortality," said Richard P. McKenney, president and chief executive officer. "With vaccines rolling out and a better economy, the current trends show continued improvement. Looking forward, our market leadership and financial underpinnings position us well to drive growth as the recovery builds in the second half of the year."

RESULTS BY SEGMENT

We measure and analyze our segment performance on the basis of "adjusted operating income" or "adjusted operating loss", which differ from income before income tax as presented in our consolidated statements of income due to the exclusion of net realized investment gains and losses, amortization of cost of reinsurance, and certain other items. These performance measures are in accordance with GAAP guidance for segment reporting, but they should not be viewed as a substitute for income before income tax or net income.

Unum US Segment

Unum US reported adjusted operating income of $115.7 million in the first quarter of 2021, a decrease of 55.8 percent from $261.8 million in the first quarter of 2020. Premium income for the segment was $1,525.8 million in the first quarter of 2021, which was generally consistent with the $1,527.7 million in the first quarter of 2020. Net investment income for the segment was $179.7 million in the first quarter of 2021, which was consistent with the $179.6 million in the first quarter of 2020.

Within the Unum US operating segment, the group disability line of business reported a 16.0 percent decrease in adjusted operating income to $64.1 million in the first quarter of 2021, compared to $76.3 million in the first quarter of 2020. Premium income for the group disability line of business increased 1.0 percent to $672.9 million in the first quarter of 2021, compared to $666.2 million in the first quarter of 2020 due to higher sales in our short-term disability product line. Net investment income increased 4.3 percent to $97.4 million in the first quarter of 2021, compared to $93.4 million in the first quarter of 2020, driven by higher miscellaneous investment income, partially offset by a decline in the yield on invested assets and a lower level of invested assets. The benefit ratio for the first quarter of 2021 was 74.8 percent, compared to 73.2 percent in the first quarter of 2020, due to higher claims incidence in the short-term disability product line, resulting from the impacts of COVID-19, partially offset by favorable claim recoveries in our group long-term disability product line. Group long-term disability sales were $31.1 million in the first quarter of 2021, which was generally consistent with the $31.4 million in the first quarter of 2020. Group short-term disability sales were $24.1 million in the first quarter of 2021, an increase of 69.7 percent from $14.2 million in the first quarter of 2020. Persistency in the group long-term disability product line was 90.7 percent for the first quarter of 2021, compared to 90.6 percent for the first quarter of 2020. Persistency in the group short-term disability product line was 86.1 percent for the first quarter of 2021, compared to 86.1 percent for the first quarter of 2020.

The group life and accidental death and dismemberment line of business reported an adjusted operating loss of $58.3 million in the first quarter of 2021, compared to adjusted operating income of $70.4 million in the first quarter of 2020. Premium income for this line of business decreased 1.1 percent to $451.4 million in the first quarter of 2021, compared to $456.2 million in the first quarter of 2020, driven primarily by lower prior period sales, partially offset by higher persistency. Net investment income decreased 3.1 percent to $24.9 million in the first quarter of 2021, compared to $25.7 million in the first quarter of 2020, due to decline in the yield on invested assets. The benefit ratio in the first quarter of 2021 was 98.8 percent, compared to 70.6 percent in the first quarter of 2020, due primarily to higher claims incidence in the group life product line resulting from the impacts of COVID-19. Sales of group life and accidental death and dismemberment products increased 7.5 percent in the first quarter of 2021 to $30.2 million, compared to $28.1 million in the first quarter of 2020. Persistency in the group life product line was 90.1 percent for the first quarter of 2021, compared to 88.4 percent for the first quarter of 2020. Persistency in the accidental death and dismemberment product line was 89.7 percent for the first quarter of 2021, compared to 87.9 percent for the first quarter of 2020.

The supplemental and voluntary line of business reported a decrease of 4.5 percent in adjusted operating income to $109.9 million in the first quarter of 2021, compared to $115.1 million in the first quarter of 2020. Premium income for the supplemental and voluntary line of business decreased to $401.5 million in the first quarter of 2021, compared to $405.3 million in the first quarter of 2020, with a decline in the voluntary benefits product line, mostly offset by growth in the individual disability and dental and vision product lines. Net investment income decreased 5.1 percent to $57.4 million in the first quarter of 2021, compared to $60.5 million in the first quarter of 2020, due to a decline in the yield on invested assets, partially offset by an increase in the level of invested assets. The benefit ratio for the individual disability product line was 42.4 percent for the first quarter of 2021, compared to 52.1 percent for the first quarter of 2020, due to lower claims incidence and higher mortality. The benefit ratio for the voluntary benefits product line was 39.3 percent in the first quarter of 2021, compared to 32.7 percent for the first quarter of 2020, due to higher claims incidence in the life product line, resulting from the impacts of COVID-19. The benefit ratio for the dental and vision product line was 73.2 percent for the first quarter of 2021, compared to 65.1 percent for the first quarter of 2020, due primarily to higher claims incidence. Relative to the first quarter of 2020, sales in the individual disability product line declined 25.1 percent in the first quarter of 2021 to $17.0 million. Sales in the voluntary benefits product line declined 21.5 percent in the first quarter of 2021 to $101.0 million. Sales in the dental and vision product line totaled $8.0 million for the first quarter of 2021, a decrease of 25.9 percent compared to the first quarter of 2020. Persistency in the individual disability product line was 90.2 percent for the first quarter of 2021, compared to 88.9 percent for the first quarter of 2020. Persistency in the voluntary benefits product line was 74.3 percent for the first quarter of 2021, compared to 72.4 percent for the first quarter of 2020. Persistency in the dental and vision product line was 87.4 percent for the first quarter of 2021, compared to 81.9 percent for the first quarter of 2020.

Unum International

The Unum International segment reported adjusted operating income of $26.4 million in the first quarter of 2021, an increase of 36.1 percent from $19.4 million in the first quarter of 2020. Premium income increased 6.0 percent to $174.4 million in the first quarter of 2021, compared to $164.6 million in the first quarter of 2020. Net investment income was $26.0 million in the first quarter of 2021, compared to $26.5 million in the first quarter of 2020. Sales decreased 2.9 percent to $23.2 million in the first quarter of 2021, compared to $23.9 million in the first quarter of 2020.

The Unum UK line of business reported adjusted operating income, in local currency, of £18.6 million in the first quarter of 2021, an increase of 35.8 percent from £13.7 million in the first quarter of 2020. Premium income was £110.5 million in the first quarter of 2021, a decrease of 2.9 percent from £113.8 million in the first quarter of 2020, driven by an increase in ceded premiums in the group life product line, partially offset by both higher sales and persistency in the group life product line and rate increases in the group long-term disability product line. Net investment income was £17.4 million in the first quarter of 2021, a decrease of 9.8 percent from £19.3 million in the first quarter of 2020, due to lower miscellaneous investment income and a lower yield on fixed-rate bonds, partially offset by higher investment income from inflation index-linked bonds. The benefit ratio in the first quarter of 2021 was 75.3 percent, compared to 80.5 percent in the first quarter of 2020, due primarily to favorable mortality experience and lower claims incidence in both the group long-term disability and group critical illness product lines, partially offset by higher claims incidence in the group life product line, resulting from the impacts of COVID-19. Sales decreased 13.3 percent to £14.3 million in the first quarter of 2021, compared to £16.5 million in the first quarter of 2020. Persistency in the group long-term disability product line was 87.0 percent for the first quarter of 2021, compared to 90.1 percent for the first quarter of 2020, resulting from pricing discipline. Persistency in the group life product line was 87.2 percent for the first quarter of 2021, compared to 86.3 percent for the first quarter of 2020. Persistency in the supplemental product line was 88.2 percent for the first quarter of 2021, compared to 91.2 percent for the first quarter of 2020.

Colonial Life Segment

Colonial Life reported a 9.6 percent decrease in adjusted operating income to $73.3 million in the first quarter of 2021, compared to $81.1 million in the first quarter of 2020. Premium income decreased 1.9 percent to $426.4 million in the first quarter of 2021, compared to $434.7 million in the first quarter of 2020, due to a decline in sales, partially offset by higher persistency. Net investment income was $37.7 million in the first quarter of 2021, which was consistent with the first quarter of 2020. The benefit ratio was 55.4 percent in the first quarter of 2021, compared to 52.4 percent in the first quarter of 2020, with unfavorable experience in the life product line, resulting from the impacts of COVID-19, partially offset by favorable experience in the accident, sickness, and disability line of business.

Sales decreased 9.2 percent to $90.2 million in the first quarter of 2021, compared to $99.3 million in the first quarter of 2020. Persistency in Colonial Life was 78.4 percent for the first quarter of 2021, compared to 76.8 percent for the first quarter of 2020.

Closed Block Segment

The Closed Block segment reported adjusted operating income of $97.0 million in the first quarter of 2021, which excludes the impacts from the second phase of the Closed Block individual disability reinsurance transaction of $139.3 million and the amortization of cost of reinsurance related to the Closed Block individual disability reinsurance transaction of $20.0 million, compared to $29.7 million in the first quarter of 2020. Premium income for this segment increased 3.0 percent to $251.7 million in the first quarter of 2021, compared to $244.4 million in the first quarter of 2020, due to premium rate increases on certain in-force business in the long-term care line of business, partially offset by continued policy terminations and maturities in the individual disability line of business. Net investment income decreased 11.6 percent to $297.2 million in the first quarter of 2021, compared to $336.1 million in the first quarter of 2020, due to a decrease in the level of invested assets supporting individual disability resulting from the reinsurance transaction, partially offset by higher miscellaneous investment income, primarily related to increases in the net asset values on our private equity partnerships, and an increase in the level of invested assets supporting long-term care. In connection with the completion of the second phase of the Closed Block individual disability reinsurance transaction, we recognized a net realized investment gain of $67.6 million.

The interest adjusted loss ratio for the long-term care line of business was 77.7 percent in the first quarter of 2021, compared to an interest adjusted loss ratio of 81.0 percent in the first quarter of 2020, driven primarily by higher claimant mortality, partially offset by higher submitted claims. The interest adjusted loss ratio for long-term care for the rolling twelve months ended March 31, 2021, excluding the update of assumptions during the fourth quarter of 2020, was 68.1 percent which is significantly below our long-term expected range. The interest adjusted loss ratio for the individual disability line of business, excluding the impacts from the reinsurance transaction, was 68.9 percent in the first quarter of 2021, compared to 84.5 percent in the first quarter of 2020, driven primarily by lower submitted claims.

Corporate Segment

The Corporate segment reported an adjusted operating loss of $38.9 million in the first quarter of 2021 compared to an adjusted operating loss of $45.9 million in the first quarter of 2020, resulting primarily from an increase in the level of invested assets and lower operating expenses.

OTHER INFORMATION

Shares Outstanding

The Company’s weighted average number of shares outstanding, assuming dilution, was 204.7 million for the first quarter of 2021, compared to 203.4 million for the first quarter of 2020. Shares outstanding totaled 204.2 million at March 31, 2021. The Company did not repurchase shares during the first quarter of 2021.

Capital Management

At March 31, 2021, the weighted average risk-based capital ratio for the Company’s traditional U.S. insurance companies was approximately 370 percent, and cash and marketable securities in the holding companies equaled $1,664 million.

Book Value

Book value per common share as of March 31, 2021 was $51.77, compared to $48.21 at March 31, 2020.

Outlook

As previously announced, the Company expects a modest decline in after-tax adjusted operating income per share for full-year 2021 compared to full-year 2020. The Company also anticipates a strong recovery in after-tax adjusted operating income per share in the second half of 2021 as the expected impacts of the COVID-19 pandemic subside.

NON-GAAP FINANCIAL MEASURES

We analyze our performance using non-GAAP financial measures. A non-GAAP financial measure is a numerical measure of a company’s performance, financial position, or cash flows that excludes or includes amounts that are not normally excluded or included in the most directly comparable measure calculated and presented in accordance with GAAP. The non-GAAP financial measure of "after-tax adjusted operating income" differs from net income as presented in our consolidated operating results and income statements prepared in accordance with GAAP due to the exclusion of net realized investment gains and losses and amortization of cost of reinsurance as well as certain other items as specified in the reconciliations in the Financial Highlights section below. We believe after-tax adjusted operating income is a better performance measure and better indicator of the profitability and underlying trends in our business.

Realized investment gains or losses depend on market conditions and do not necessarily relate to decisions regarding the underlying business of our segments. Our investment focus is on investment income to support our insurance liabilities as opposed to the generation of realized investment gains or losses. Although we may experience realized investment gains or losses which will affect future earnings levels, a long-term focus is necessary to maintain profitability over the life of the business since our underlying business is long-term in nature, and we need to earn the interest rates assumed in calculating our liabilities.

As previously discussed, we have exited a substantial portion of our Closed Block individual disability product line through the two phases of the reinsurance transaction that were executed in December 2020 and March 2021, respectively. As a result, we exclude the amortization of the cost of reinsurance that was recognized upon the exit of the business related to the ceded reserves for the cohort of policies on claim status. We believe that the exclusion of the amortization of the cost of reinsurance provides a better view of our results from our ongoing businesses.

We may at other times exclude certain other items from our discussion of financial ratios and metrics in order to enhance the understanding and comparability of our operational performance and the underlying fundamentals, but this exclusion is not an indication that similar items may not recur and does not replace net income or net loss as a measure of our overall profitability.

CONFERENCE CALL INFORMATION

Members of Unum Group senior management will host a conference call on Thursday, May 6, at 8:00 a.m. (Eastern Time) to discuss the results of operations for the first quarter. Topics may include forward-looking information, such as the Company’s outlook on future results, trends in operations, and other material information.

The dial-in number for the conference call is (866) 652-5200 for U.S. and Canada (Please ask to be joined to the Unum Group call). For international, the dial-in number is (412) 317-6060 (Please ask to be joined to the Unum Group call). A live webcast of the call will also be available at www.investors.unum.com in a listen-only mode. It is recommended that webcast viewers access the "Investors" section of the Company’s website and opt-in to the webcast approximately 5-10 minutes prior to the start of the call. A replay of the webcast will be available on the Company’s website. A replay of the call will also be available through Thursday, May 13 by dialing (877) 344-7529 (U.S.), (855) 669-9658 (Canada), or (412) 317-0088 (International) – pass code 10154518.

In conjunction with today’s earnings announcement, the Company’s Statistical Supplement for the first quarter of 2021 is available on the "Investors" section of the Company’s website.

On May 5, 2021 Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products in Greater China and other parts of Asia, reported that the Ministry of Food and Drug Safety (MFDS) in South Korea has granted Orphan Drug Designation (ODD) for sacituzumab govitecan-hziy (SG), an investigational treatment for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease (Press release, Everest Medicines, MAY 5, 2021, View Source [SID1234579231]).

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"We are very pleased that the Ministry of Food and Drug Safety in South Korea has granted Orphan Drug Designation for SG, which we believe has the potential to become a transformative treatment for patients around the world living with metastatic triple-negative breast cancer – a highly aggressive disease with limited treatment options," said Kerry Blanchard, MD, PhD, CEO of Everest Medicines. "Breast cancer is the leading cause of cancer death in women in South Korea, and the incidence for this disease continues to climb rapidly in the region. As we work closely with local regulatory bodies to bring this innovative treatment to patients in South Korea as quickly as possible, we look forward to continuing to expand our international footprint outside of China and adding to our recent New Drug Application submission for SG in Singapore earlier this year."

Orphan Drug Designation is granted by the MFDS to pharmaceuticals used to treat diseases with a prevalence of 20,000 patients or less in the Korean population, pharmaceuticals used to treat diseases for which appropriate therapy and pharmaceuticals have not been developed, or pharmaceuticals that have been significantly improved in terms of safety and/or efficacy, compared to existing alternative therapies.

About Triple-Negative Breast Cancer

Triple-Negative Breast Cancer (TNBC) is a highly aggressive disease and accounts for approximately 15% of all breast cancer types worldwide. The median age of breast cancer diagnoses tends to be younger in Asian than western countries, and the percentage of the TNBC molecular subtype has been increasing in the past 10 years. TNBC cells lack sufficient estrogen, progesterone or HER2 receptor expression to benefit from the use of hormonal or HER2-directed therapy. Overall survival among patients with this form of breast cancer has not changed in the past 20 years, which highlights the need for advances in therapeutic options for these patients.

In South Korea, the growth in breast cancer incidence in recent decades has been one of the fastest in the world.[1] It is the leading cause of cancer death in South Korean women. Statistics from the International Agency for Cancer Research indicate that breast cancer was the leading cause of cancer diagnoses in South Korea in 2020, accounting for 23.7% of total cases.[2]

About Sacituzumab Govitecan-Hziy

Sacituzumab govitecan-hziy (SG) is a first-in-class, antibody-drug conjugate (ADC) directed at TROP-2, a membrane antigen that is over-expressed in many common epithelial cancers. SG is approved in the United States under the trade name Trodelvy.

Under a licensing agreement with Gilead Sciences, Inc., Everest Medicines has exclusive rights to develop, register, and commercialize SG for all cancer indications in Greater China, South Korea, and certain Southeast Asian countries. In October 2020, SG was included in the updated 2020 China Guidelines for the Standardized Diagnosis and Treatment of Advanced Breast Cancer, compiled by the Breast Cancer Expert Committee of the National Cancer Control Center, the Breast Cancer Professional Committee of the Chinese Anti-Cancer Association, and the Cancer Drug Clinical Research Professional Committee of the Chinese Anti-Cancer Association.