On March 2, 2022 Signify Health, Inc. (NYSE: SGFY), a leading healthcare platform that leverages advanced analytics, technology and nationwide healthcare networks to create and power value-based payment programs, reported the Company’s financial results for the fourth quarter and full year 2021, and established 2022 guidance (Press release, Signify Health, MAR 2, 2022, View Source [SID1234609383]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"Successful execution drove immense growth for Signify Health in 2021 as we delivered meaningful value to our clients by facilitating improved health outcomes for their patients or members. Signify’s achievements reflect the dedication and perseverance of our employees and network of over 10,000 clinicians," said Kyle Armbrester, Chief Executive Officer of Signify Health. "Our 2021 results demonstrate the strength of our business model and were driven by Home & Community Services and the value recognized by clients who significantly expanded In-Home Evaluation (IHE) volume in 2021 to 1.9 million unique visits. We also delivered substantial savings to our Episodes of Care partners and the BPCI-A program in 2021 despite the impact of COVID-19 on program size and savings rates, which we expect will lessen over time as cases continue to decline and the situation stabilizes."

Mr. Armbrester continued, "We are excited about closing our acquisition of Caravan Health, which puts Signify at the forefront of integrating value-based care programs together, expanding to broader populations and reaching a diverse array of urban, suburban, and rural communities across the country. By creating more relevancy for providers through multi-payor contracts, combined with our access to and scale within members’ homes, we are confident in our ability to accelerate the transformation of the U.S. healthcare system from fee-for-service to value-based care. We also expect Caravan Health to add to our revenue diversification this year and it is included in our 2022 guidance of 22-25% revenue growth for the combined company."

Fourth Quarter 2021 Financial Results

Total revenue for the fourth quarter was $181.4 million compared to $193.5 million in the same period a year ago, primarily reflecting the decline in ECS revenue, which was largely due to the continued impact from COVID-19.
HCS revenue in the fourth quarter of 2021 grew 5% from a year ago to $156.2 million. IHE volume in the fourth quarter of 2021 was strong at 473 thousand evaluations and reflected a more typical seasonality when compared to the fourth quarter of 2020. Fourth quarter 2020 HCS revenue was unseasonably high, due to the shift in IHE volume to the latter half of the year due to the COVID-19 pandemic shutdowns in the second quarter of 2020.
Fourth quarter 2021 ECS revenue of $25.2 million declined from $44.7 million a year ago primarily as a result of the semi-annual BPCI-A reconciliation we received during the fourth quarter of 2021, which indicated a lower than expected savings rate and program size. The savings rate was impacted primarily by COVID-19, including higher cost next site of care decisions. Program size was impacted by the ongoing COVID-19 pandemic, and the highly contagious Omicron variant in particular, as CMS excludes any episodes that have a COVID-19 diagnosis at any stage of the episode, irrespective of whether COVID-19 had any meaningful impact on the outcome of the episode itself.
Fourth quarter 2021 net income was $32.4 million compared to $0.7 million for the same period a year ago. The improvement was driven primarily by the quarterly revaluation of the customer Equity Appreciation Rights agreements, or EARs. The EARs are marked to market each quarter and this resulted in other income of $36.7 million, reflecting the lower value of Signify stock at year end.
Non-GAAP Adjusted EBITDA1 for the fourth quarter of 2021 increased 3% to $40.2 million, from $38.9 million for the fourth quarter of 2020, reflecting a decrease in operating expenses.
Non-GAAP Adjusted EBITDA margin1 for the fourth quarter of 2021 was 22.2%, a 200-basis point improvement from the comparable year ago period.
Full Year 2021 Financial Results

Total 2021 revenue for the year increased 27% to $773.4 million, compared to $610.6 million a year ago. Overall revenue growth in the year was driven by a 45% increase in HCS revenue to $653.1 million, partially offset by a 25% decrease in ECS revenue.
HCS revenue growth in 2021 was primarily driven by a 34% increase in IHEs performed, which grew to 1.920 million, up from 1.436 million in 2020. Increases in customer demand throughout 2021 drove IHE revenue, in conjunction with a reduction in the mix of virtual evaluations to 17% of total IHEs for 2021, down from 38% in 2020.
The ECS revenue decline in 2021 was driven by the ongoing impacts from COVID-19 and the corresponding decline in the weighted average bundled payment savings rate to 5.7% and the weighted average bundled payment program size to $4.6 billion for the year, compared to 7.3% and $5.2 billion, respectively, for 2020.
Total net income for 2021 improved to $9.9 million, compared to a net loss of $14.5 million in 2020. The improvement was driven by total revenue growth of 27%, partially offset by an increase in operating expenses and income tax expense now that Signify is subject to tax as a corporation.
Non-GAAP Adjusted EBITDA1 for 2021 increased 37% to $171.2 million, compared to $124.9 million for 2020, driven by the aforementioned increase in revenue.
Full year non-GAAP Adjusted EBITDA margin1 was 22.1%, a 160-basis point improvement from a year ago, driven by revenue growth and efficiencies.
"We had a very strong year for Signify Health in 2021 and we have tremendous momentum going into this year as evidenced by our 2022 guidance which includes assumptions for IHE volume in the range of 2.39 to 2.42 million evaluations," said Steven Senneff, President and Chief Financial Officer of Signify Health. "Our 2022 guidance includes growth based on Caravan Health’s anticipated greater than 500,000 lives under management, the ongoing impact of COVID-19 on our weighted average bundled payment program size that we expect to grow between $500 million and $1 billion from 2021 levels, and an improvement in the bundled payment savings rate of 25-50 basis points. As a result, we expect our ECS segment revenue to grow in the mid -20 to low-30 percent range for the full year 2022."

2022 Guidance

Signify Health estimates the following full year 2022 results, which reflect Caravan Health results for ten months of ownership in 2022:

Total GAAP revenue in the range of $948 million to $971 million; and
Total adjusted EBITDA1 in the range of $212 million to $222 million.
1Adjusted EBITDA and Adjusted EBITDA margin are non-GAAP financial measures. Refer to the reconciliation in "Non-GAAP Financial Measures." We have not reconciled guidance for adjusted EBITDA to net income/(loss), the most directly comparable GAAP measure, and have not provided forward-looking guidance for net income/(loss) because of the uncertainty around certain items that may impact net income/loss, including stock-based compensation, that are not within our control or cannot be reasonably predicted.

Conference Call Information

Signify Health will host a conference call to discuss the Company’s fourth quarter and full year 2021 results on March 3, 2021 at 8:30am ET. A live audio webcast of the conference call may be accessed through the investor relations section of Signify Health’s website at investors.signifyhealth.com/events/default.aspx and will be available for replay through May 3, 2021.

On March 2, 2022 Verrica Pharmaceuticals Inc. (Verrica) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, reported financial results for the fourth quarter and year ended December 31, 2021 (Press release, Verrica Pharmaceuticals, MAR 2, 2022, View Source [SID1234609381]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"2022 is poised to be an exciting year for Verrica as we prepare to potentially launch VP-102 this summer for the treatment of molluscum, a disease affecting an estimated six million patients with no approved treatments, representing a significant market opportunity," said Ted White, Verrica’s President and Chief Executive Officer. "In addition, in keeping with our mission to develop treatments for the most significant unmet needs in medical dermatology, we are rapidly advancing LTX-315, a novel immunotherapy for the treatment of non-melanoma skin cancers. The first patient is expected to be dosed in the Phase 2 trial evaluating LTX-315 in basal cell carcinoma in the first quarter of 2022."

Business Highlights and Recent Developments

VP-102

On November 29, 2021, Verrica announced that it resubmitted the New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum (molluscum) to the U.S. Food and Drug Administration (FDA). On December 15, 2021, Verrica announced that the FDA acknowledged that Verrica’s resubmitted NDA was complete and assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 24, 2022.
LTX-315

Verrica expects to dose the first patient in the Phase 2 clinical trial of LTX-315 for the treatment of basal cell carcinoma in the first quarter of 2022. LTX-315 is a potentially first-in-class oncolytic peptide immunotherapy in development as a non-surgical treatment option for non-melanoma skin cancers. The Phase 2 trial is a three-part, open-label, multicenter, dose-escalation, proof-of-concept study with a safety run-in designed to assess the safety, pharmacokinetics, and efficacy of LTX-315 when administered intratumorally to adults with biopsy-proven basal cell carcinoma. The study is expected to enroll approximately 66 adult subjects with a histological diagnosis of basal cell carcinoma in at least one eligible target lesion.
Corporate Highlights

On March 1, 2022, Verrica amended its existing $40 million credit facility led by Silicon Valley Bank. The amendment provides Verrica increased financial flexibility by extending the interest-only payment period and reducing the minimum cash Verrica is required to maintain on its balance sheet.
Financial Results

Fourth Quarter 2021 Financial Results

Verrica reported a net loss of $9.5 million for the fourth quarter of 2021, compared to a $13.0 million loss for the same period in 2020.
Research and development expenses were $3.4 million in the fourth quarter of 2021, compared to $2.3 million for the same period in 2020. The increase was primarily attributable to higher Chemistry, Manufacturing, and Controls (CMC).
General and administrative expenses were $5.1 million in the fourth quarter of 2021, compared to $9.8 million for the same period in 2020. The decrease was primarily due to higher stock-based compensation expense recorded in December 2020, which includes $4.8 million of stock-based compensation expense related to the modification of a stock award to a former executive partially offset by an increase in expenses due to increased headcount, an increase in insurance, and other operating costs.
Full Year 2021 Financial Results

Verrica recognized license revenues of $12.0 million for the year ended December 31, 2021 related to the Collaboration and License Agreement (Torii Agreement) with Torii Pharmaceutical Col, Ltd (Torii). There were no license revenues recognized in 2020.
Research and development expenses were $15.9 million for the year ended December 31, 2021, compared to $15.7 million for the same period in 2020. The increase was primarily attributable to a one-time $2.3 million milestone payment to Lytix Biopharma AS upon the achievement of a regulatory milestone for LTX-315 and increased compensation costs related to higher headcount and increased clinical costs related to Verrica’s development of VP-102 for molluscum partially offset by decreased CMC costs related to Verrica’s development of VP-102 for molluscum contagiosum
General and administrative expenses were $27.0 million for the year ended December 31, 2021, compared to $24.5 million for the same period in 2020. The increase was primarily a result of expenses related to increased headcount, an increase in insurance, professional fees and other operating costs, and an increase in expenses related to pre-commercial activities for VP-102. The increase was partially offset by a decrease in stock-based compensation costs, which includes $4.8 million of stock-based compensation expense recorded in December 2020 related to the modification of a stock award to a former executive.
For the year ended December 31, 2021, net loss on a GAAP basis was $35.1 million, or $1.30 per share, compared to a net loss of $42.7 million, or $1.71 per share, for the same period in 2020.
For the year ended December 31, 2021, non-GAAP net loss was $27.6 million, or $1.02 per share, compared to a non-GAAP net loss of $31.9 million, or $1.28 per share, for the same period in 2020.
As of December 31, 2021, Verrica had aggregate cash, cash equivalents, and marketable securities of $70.4 million. Verrica believes that its existing cash, cash equivalents, and marketable securities as of December 31, 2021 will be sufficient to support planned operations into the third quarter of 2022.
Non-GAAP Financial Measures

In evaluating the operating performance of its business, Verrica’s management considers non-GAAP loss from operations, non-GAAP net loss and non-GAAP net loss per share. These non-GAAP financial measures exclude stock-based compensation charges and non-cash interest expense that are required by GAAP. Verrica believes that non-GAAP loss from operations, non-GAAP net loss and non-GAAP net loss per share provides useful information to both management and investors by excluding the effect of certain non-cash expenses and items that Verrica believes may not be indicative of its operating performance, because either they are unusual and Verrica does not expect them to recur in the ordinary course of its business, or they are unrelated to the ongoing operation of the business in the ordinary course. Non-GAAP loss from operations, non-GAAP net loss and non-GAAP net loss per share should be considered in addition to results prepared in accordance with GAAP, but should not be considered a substitute for, or superior to, GAAP results. Non-GAAP loss from operations, non-GAAP net loss and non-GAAP net loss per share have been reconciled to the nearest GAAP measure in the tables following the financial statements in this press release.

About VP-102

Verrica’s lead product candidate, VP-102, is a proprietary drug-device combination product that contains a GMP-controlled formulation of cantharidin (0.7% w/v) delivered via a single-use applicator that allows for precise topical dosing and targeted administration. VP-102 is currently under U.S. Food and Drug Administration (FDA) review and could potentially be the first product approved by the FDA to treat molluscum contagiosum — a common, highly contagious skin disease that affects an estimated six million people in the United States, primarily children. If approved, VP-102 will be marketed in the United States under the conditionally accepted brand name YCANTH. In addition, Verrica has successfully completed a Phase 2 study of VP-102 for the treatment of common warts and a Phase 2 study of VP-102 for the treatment of external genital warts.

About Molluscum Contagiosum (Molluscum)

There are currently no FDA-approved treatments for molluscum, a highly contagious viral skin disease that affects approximately six million people — primarily children — in the United States. Molluscum is caused by a pox virus that produces distinctive raised, skin-toned-to-pink-colored lesions that can cause pain, inflammation, itching and bacterial infection. It is easily transmitted through direct skin-to-skin contact or through fomites (objects that carry the disease like toys, towels or wet surfaces) and can spread to other parts of the body or to other people, including siblings. The lesions can be found on most areas of the body and may carry substantial social stigma. Without treatment, molluscum can last for an average of 13 months, and in some cases, up to several years.

On March 2, 2022 Amgen (NASDAQ:AMGN) reported that it will virtually present at the 42nd Annual Cowen Healthcare Conference at 11:10 a.m. ET on Tuesday, March 8, 2022 (Press release, Amgen, MAR 2, 2022, View Source [SID1234609380]). Murdo Gordon, executive vice president of Global Commercial Operations and Peter H. Griffith, executive vice president and chief financial officer at Amgen will present at the conference . The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The webcast, as with other selected presentations regarding developments in Amgen’s business given at certain investor and medical conferences, can be accessed on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On March 2, 2022 Ascendis Pharma A/S (Nasdaq: ASND) reported financial results for the full year ended December 31, 2021 and provided a business update (Press release, Ascendis Pharma, MAR 2, 2022, View Source [SID1234609379]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"2021 was an extraordinary year for Ascendis, and we expect that 2022 will be even stronger. The regulatory approvals of TransCon hGH in the U.S. and Europe were key milestones in achieving our Vision 3×3," said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer.

"By progressing towards our Vision 3×3, we believe we are moving towards becoming a viable, sustainable, and profitable biopharmaceutical company. We estimate that our first therapeutic area of endocrinology rare disease alone represents a combined US$10 billion global market potential. On top of that, we have a highly differentiated oncology pipeline, and we plan to add a third therapeutic area," continued Mr. Mikkelsen.

Corporate 2021 Highlights & Anticipated 2022 Milestones

TransCon hGH:

In fall-2021, the Company commercially launched in the U.S., TransCon hGH under the brand name of SKYTROFA (lonapegsomatropin-tcgd), the only FDA-approved once-weekly treatment for pediatric patients one year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone. As of February 28, 2022, 708 SKYTROFA prescriptions were written by approximately 263 prescribers, including 44% writing prescriptions for multiple patients.

In January 2022, the Company received marketing authorization for Lonapegsomatropin Ascendis Pharma (developed under the brand name of TransCon hGH) in the European Union as a once-weekly subcutaneous injection for the treatment of children and adolescents ages 3 to 18 years with growth failure due to insufficient secretion of endogenous growth hormone.

Plan to submit a protocol to the FDA to evaluate TransCon hGH for Turner Syndrome in the second quarter of 2022. The Company expects to evaluate higher doses of TransCon hGH and daily growth hormone for Turner Syndrome compared to those doses for pediatric or adult GHD.

The ongoing conflict in the region surrounding Ukraine and Russia has impacted our ability to continue clinical trial activities in those countries. While this may affect our timelines for the foresiGHt Trial, our Phase 3 trial in adult growth hormone deficiency, there is currently no material impact to our business from this situation.

TransCon PTH:

In November 2021, the Company announced top-line results from Week-84 of the Company’s Phase 2 PaTH Forward Trial evaluating the safety, tolerability, and efficacy of TransCon PTH in adults with HP. The week 84 data showed that subjects treated with TransCon PTH had both mean serum calcium levels and urinary calcium excretion that remained stable and in the normal range and that all subjects continued to be free from taking active vitamin D and 93% were taking less than 600 mg/day of calcium supplements.

After two years of treatment in the open label extension portion of the PaTH Forward Trial, as of February 22, 2022, 57 out of 59 original subjects continued in the trial.

Top-line results from PaTHway, a Phase 3 randomized, double-blind placebo-controlled clinical trial in North America and Europe, evaluating the safety, tolerability, and efficacy of TransCon PTH in adults with HP, are expected in the first quarter of 2022.

If the Phase 3 Trial results are positive, the Company plans to submit a New Drug Application to the FDA during the third quarter of 2022 and expects to submit a Marketing Authorisation Application to the European Medicines Agency during the fourth quarter of 2022.

Top-line results from PaTHway Japan, a single-arm Phase 3 trial of TransCon PTH in a minimum of 12 Japanese subjects with HP are expected in the third quarter of 2022.

Initiation of a pediatric HP program is planned for the fourth quarter of 2022.

TransCon CNP:

In December 2021, the Company announced completed enrollment in the ACcomplisH Trial, a Phase 2 randomized, double-blind, placebo-controlled clinical trial in North America, Europe, and Oceania in subjects with achondroplasia (ages 2–10). Forty-two percent of subjects enrolled in the ACcomplisH Trial are between the ages of 2 and 5 years old.

Top-line data from the ACcomplisH Trial are expected in the fourth quarter of 2022.

The Company plans to file an Investigational New Drug (IND) application or similar for the ACcomplisH Infants Trial in subjects with achondroplasia (ages 0–2) during the second quarter of 2022.

TransCon TLR7/8 Agonist:

In December 2021, the Company announced initial first-in-human results from transcendIT-101, a Phase 1/2 study of TransCon TLR7/8 Agonist with or without pembrolizumab in patients with advanced or metastatic solid tumors, which demonstrated early signs of clinical activity in three out of three efficacy-evaluable cancer patients treated with TransCon TLR7/8 Agonist as monotherapy or in combination with pembrolizumab.

transcendIT-101 top-line data from monotherapy and combo-therapy dose escalation expected in the third quarter of 2022.

TransCon IL-2 ß/g:

In the third quarter of 2021, the Company submitted an investigational new drug application and initiated IL-ßeliege ("I’ll Believe") Trial, a Phase 1/2 clinical trial to evaluate TransCon IL-2 ß/g in patients with advanced cancer.

Top-line monotherapy data from the IL-ßeliege Trial are expected in the fourth quarter of 2022.

TransCon TLR7/8 Agonist and TransCon IL-2 ß/g Combination:

The Company plans to submit an IND or similar for Phase 2 cohort expansion for TransCon TLR7/8 Agonist and TransCon IL-2 ß/g during the fourth quarter of 2022.

In November 2021, the Company’s shareholders elected Rafaèle Tordjman, Founder & CEO of Jeito Capital, to the board.

Ended 2021 with cash, cash equivalents, and marketable securities totaling €789.6 million.

Full Year 2021 Financial Results

Total revenue for 2021 was €7.8 million compared to €7.0 million in 2020. Revenues for 2021 include U.S. SKYTROFA sales, and license, clinical supply and services provided to third parties, primarily VISEN Pharmaceuticals.

Research and development (R&D) costs for 2021 were €295.9 million compared to €260.9 million in 2020. Higher R&D costs in 2021 reflect continued advancement of development programs and an increase in personnel-related costs to support them.

Selling, general, and administrative (SG&A) expenses for 2021 were €160.2 million compared to €76.7 million in 2020. Higher SG&A expenses were primarily due to an increase in commercial and administrative personnel as well as an increase in commercial and IT costs.

Net profit of associate was €12.0 million for 2021, compared to a net loss of €9.5 million for 2020. For 2021, the net profit of associate included a non-cash gain of €42.3 million as a result of a financing round in VISEN.

Net finance income was €55.8 million in 2021 compared to a net expense of €79.0 million in 2020.

For the full year 2021, Ascendis Pharma reported a net loss of €383.6 million, or €7.00 per share (basic and diluted) compared to a net loss of €419.0 million, or €8.28 per share (basic and diluted) for the same period in 2020.

As of December 31, 2021, Ascendis Pharma had cash, cash equivalents, and marketable securities totaling €789.6 million compared to €834.1 million as of December 31, 2020. As of December 31, 2021, Ascendis Pharma had 56,937,682 ordinary shares outstanding.

Conference Call and Webcast Information

Ascendis Pharma will host a conference call and webcast today at 4:30 pm Eastern Time (ET) to discuss its full year 2021 financial results. Details include:

A live webcast of the conference call will be accessible from the Investors and News section of the Ascendis Pharma website at www.ascendispharma.com. A replay of the webcast will be available on this website shortly after conclusion of the event for 30 days.

On March 2, 2022 Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, reported that it will report the company’s fourth quarter and full year 2021 financial results on Thursday, March 10, 2022 after the close of U.S. financial markets (Press release, Aligos Therapeutics, MAR 2, 2022, View Source [SID1234609378]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!