Nuvalent Reports Pipeline Progress and Third Quarter 2021 Financial Results

On November 10, 2021 Nuvalent, Inc., (Nasdaq: NUVL), a biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported recent pipeline progress and third quarter 2021 financial results (Press release, Nuvalent, NOV 10, 2021, View Source [SID1234595048]).

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"Throughout the third quarter of 2021, we continued to progress our novel portfolio of precisely targeted therapies for patients with cancer. Notably, our first clinical trial of NVL-520, the ‘ARROS-1’ study, is now open for enrollment of patients with advanced ROS1-positive NSCLC and other solid tumors," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "We anticipate a robust set of upcoming operational milestones, including the dosing of the first patient in our ARROS-1 study in 2021, the advancement of our parallel lead program NVL-655 into clinical development for ALK-positive cancers, and the expansion of our portfolio with additional internally developed product candidates. With a dedicated, expert team and a strong balance sheet in place, we believe we are well-positioned to achieve the milestones ahead."

Recent Program Highlights

ARROS-1 Phase 1/2 Clinical Trial of NVL-520 Open for Enrollment:
Nuvalent has activated multiple U.S. sites to begin enrollment in its ARROS-1 clinical trial, a Phase 1/2, multicenter, open-label, dose-escalation and expansion study evaluating NVL-520 as an oral monotherapy in patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) and other solid tumors. NVL-520 is a novel ROS1-selective inhibitor designed to address the clinical challenges of emergent treatment resistance, central nervous system (CNS)-related adverse events, and brain metastases that may limit the use of currently available ROS1 tyrosine kinase inhibitors (TKIs). The Phase 2 portion of the ARROS-1 study is designed to support potential registration of NVL-520 in both ROS1-positive patients with NSCLC who are kinase inhibitor-naïve and who have been previously treated with ROS1 kinase inhibitors. Clinical site expansion in the US and EU is ongoing.
Preclinical Data Supporting Lead Programs for ROS1-Positive and ALK-Positive NSCLC Presented at 2021 AACR (Free AACR Whitepaper)-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference: Nuvalent presented new preclinical data at the 2021 AACR (Free AACR Whitepaper)-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference further demonstrating that NVL-520 and NVL-655, its parallel lead product candidates, were active against both wild-type and various known resistance variants of ROS1 or ALK, respectively; were brain-penetrant with the potential to address brain metastases; and selectively inhibited their respective targets compared to the structurally related tropomyosin receptor kinase B (TRKB), thereby minimizing the potential for off-target TRKB-related CNS adverse events. The ARROS-1 Phase 1/2 clinical trial of NVL-520 is open for enrollment, and Nuvalent plans to initiate a Phase 1/2 clinical trial of NVL-655 in advanced ALK-positive NSCLC and other cancers during the first half of 2022.
Upcoming Investor Conference Presentations

33rd Annual Virtual Piper Healthcare Conference: Dr. Porter will participate in a pre-recorded fireside chat during the 33rd Annual Virtual Piper Healthcare Conference, being held November 30 – December 2, 2021. The fireside chat will be available to registered participants beginning on November 22, 2021, and the webcast will be available in the investor section of the company’s website at www.nuvalent.com for 30 days following the presentation.
Third Quarter 2021 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $302.4 million as of September 30, 2021, including net proceeds from the initial public offering completed on August 2, 2021, compared to $10.3 million as of December 31, 2020.
Research & Development (R&D) expenses: R&D expenses were $9.1 million for the third quarter of 2021, compared to $3.7 million for the third quarter of 2020.
General & Administrative (G&A) expenses: G&A expenses were $3.4 million for the third quarter of 2021, compared to $0.3 million for the third quarter of 2020.
Net Loss: Net loss for the third quarter of 2021 was $12.4 million, or $0.39 per share, compared to $4.8 million, or $1.57 for the third quarter of 2020.

HOOKIPA Pharma Reports Third Quarter 2021 Financial Results and Recent Highlights

On November 10, 2021 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported financial results and business highlights for the third quarter of 2021 (Press release, Hookipa Pharma, NOV 10, 2021, View Source [SID1234595047]).

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"Our team remains focused on optimizing the potential of our versatile arenaviral platform to redefine success in cancer immunotherapy by driving strong tumor-specific T cell responses. Third quarter highlights include our clinical collaboration with Merck & Co., Inc., Kenilworth, NJ, USA, on our HB-200 program in head and neck cancer and the publication of our pre-clinical data in melanoma in Nature Communications, both of which offered external validation of the promise of our technology," said Joern Aldag, Chief Executive Officer at HOOKIPA. "Given our recent HB-200 data update, we’re even more energized about the start of our Phase 2 combination study of HB-201 with pembrolizumab as a 1st- or 2nd-line treatment in head and neck cancers, as well as progressing and expanding our oncology pipeline with candidates for prostate and KRAS-mutated cancers."

Quarter Highlights

In August, pre-clinical data on HOOKIPA’s arenaviral immunotherapeutic in melanoma was published in the peer-reviewed journal, Nature Communications. The data showed that HOOKIPA’s replicating Lymphocytic choriomeningitis (LCMV)-based vector, designed to target melanoma, modulated the tumor micro-environment and induced potent, antigen-specific T cell responses, resulting in tumor regression and tumor eradication in the pre-clinical setting. The data reinforce the potential of HOOKIPA’s arenaviral immunotherapeutic technology to activate and mobilize anti-tumor T cells for effective control and eradication of established tumors.

In September, HOOKIPA announced a clinical collaboration and supply agreement with Merck & Co, Inc., Kenilworth, NJ, USA (known as MSD outside of the United States and Canada) to evaluate the combination of HB-200, a novel arenaviral immunotherapeutic, and KEYTRUDA (pembrolizumab) as 1st-line treatment for patients with advanced head and neck cancer.
Business updates

On November 9, 2021 HOOKIPA provided a data update across its clinical development program. HOOKIPA announced it is advancing HB-201 to Phase 2, to be evaluated in combination with pembrolizumab as 1st- or 2nd-line treatment for Human Papillomavirus 16 Positive (HPV16+) squamous cell head and neck cancers (HNSCC). Interim Phase 1 data in heavily pre-treated patients continue to show HB-200 monotherapy (both HB-201 alone and HB-202/HB-201) is highly effective at expanding T cells, has a favorable tolerability profile and promising, early anti-tumor activity. As of November 1, 2021, among 28 patients dosed intravenously, HB-200 resulted in a 75 percent disease control rate and shrinkage of target lesions in 53 percent of patients. In these patients, HOOKIPA has observed three partial responses (including one confirmed and one unconfirmed in an ongoing patient) and one ongoing patient with a near partial response (29 percent tumor shrinkage). Based on the strength of the HB-200 data, HOOKIPA has prioritized its oncology portfolio, including HB-300 for prostate cancer and HB-700 for KRAS-mutated cancers, and plans further development of its infectious disease programs to be done in partnership with other companies.

Upcoming Milestones

Phase 1 HB-200 HPV16+ HNSCC additional data: mid-year 2022
Phase 2 HB-201 + pembrolizumab HPV16+ HNSCC 1st-line initial data: second half of 2022
Phase 2 HB-201 + pembrolizumab HPV16+ HNSCC 2nd-line initial data: second half of 2022
Randomized Phase 2 HB-200 + pembrolizumab HPV16+ HNSCC 1st-line trial initiation: first half of 2023
Investigational New Drug application for HB-300 in metastatic prostate cancer: third quarter 2022
Third Quarter 2021 Financial Results

Cash Position: HOOKIPA’s cash, cash equivalents and restricted cash as of September 30, 2021 was $82.7 million compared to $143.2 million as of December 31, 2020. The decrease was primarily attributable to cash used in operating activities.

Revenue was $3.9 million for the three months ended September 30, 2021, and $4.0 million for the three months ended September 30, 2020. Revenues did not materially change compared to the three months ended September 30, 2020 though they included lower deferred revenues from upfront and milestone payments which were partially offset by higher cost reimbursements.

Research and Development Expenses: HOOKIPA’s research and development expenses were $20.7 million for the three months ended September 30, 2021, compared to $16.0 million for the three months ended September 30, 2020.

The primary drivers of the increase in direct research and development expenses were an increase in manufacturing and quality control expenses of $2.1 million, along with a general increase in other direct research and development expenses and laboratory expenses of $1.6 million, partially offset by a decrease in expenses for clinical studies of $0.6 million. The increase in manufacturing and quality control expenses as well as other direct research and development expenses was mainly due to the progress in HOOKIPA’s HB-201 and HB-202 clinical trial, in particular for monitoring and testing activities, and manufacturing and quality control work in preparation of a further extension of the trial. Clinical study expenses decreased primarily due to the completion of patient enrollment of the Phase 2 study for our CMV vaccine candidate HB-101.

Internal research and development expenses increased by $1.6 million, mainly due to HOOKIPA’s increased research and development headcount.

General and Administrative Expenses: General and administrative expenses for the three months ended September 30, 2021 were $4.3 million, compared to $4.4 million for the three months ended September 30, 2020. The decrease was primarily due to a decrease in personnel-related expenses and a decrease in professional and consulting fees. The decrease in personnel-related expenses resulted from decreased stock compensation expenses, partially offset by a growth in headcount along with increased salaries in our general and administrative functions.

Net Loss: HOOKIPA’s net loss was $20.0 million for the three months ended September 30, 2021, compared to a net loss of $13.6 million for the three months ended September 30, 2020. The increase was primarily due to an increase in HOOKIPA’s research and development activities.

Perrigo Reports Third Quarter 2021 Financial Results From Continuing Operations

On November 10, 2021 Perrigo Company plc (NYSE: PRGO; TASE) ("Perrigo" or the "Company"), a leading provider of Consumer Self-Care Products, reported financial results for the third quarter of fiscal year 2021 ended October 2, 2021 (Press release, Perrigo Company, NOV 10, 2021, View Source [SID1234595046]). All comparisons are against the prior year fiscal third quarter, unless otherwise noted.

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President and CEO, Murray S. Kessler commented, "Major initiatives were completed in the third quarter that will secure Perrigo a bright future. The RX generic prescription business divestiture was completed, the acquisition of the highly successful HRA Pharma business was announced, and a major overhang on the business was removed through a favorable settlement of the Irish tax dispute paid for with proceeds from the successful arbitration in Belgium. Perrigo is now a solely focused consumer self-care company, poised for strong growth, unencumbered by the major overhangs of the past. Our team is intently focused on driving long-term profitable growth."

Kessler continued, "Our disappointing third quarter results reflect the continuing impacts of the challenging operating environment caused by the global COVID-19 pandemic that began in 2020, have continued in 2021 and are not indicative of our future growth potential. These challenges fall into three categories for Perrigo: a historically weak cough/cold season affecting first quarter sales and manufacturing efficiencies, higher input costs and the sudden supply chain disruption, primarily in the form of a shortage of truck drivers, which began in the third quarter. In combination, these factors are forecasted to negatively impact total year adjusted diluted EPS by $0.79, which could only be partially offset, leading us to lower our earnings guidance."

Kessler also noted, "Importantly, third quarter consumer off-take was very strong, as were factory orders on almost all of our businesses. This included a strong rebound in cough/cold sales. Unfortunately, we exited the quarter with record unshipped orders as there were not enough trucks or drivers to fulfill those orders in the U.S. Supply chain disruptions impacted CSCA net sales growth in the quarter by 5.7 percentage points."

Kessler concluded: "Our cough/cold business is rebounding, which will positively impact sales and manufacturing efficiencies. We have taken multiple steps to adjust our supply chain during this unusual period, which has already resulted in a significant improvement in October. And, we are taking action to mitigate higher input costs, including price increases on approximately 75% of the Company’s portfolio and delivering on project momentum cost savings. Through the combination of these actions, along with the anticipated closing and successful integration of HRA expected in the first half of next year, we still believe we will deliver on our original 2023 EPS transformation plan targets."

Refer to Tables I – IV at the end of this press release for a reconciliation of non-GAAP adjustments to the current year and prior year periods and additional non-GAAP information. The Company’s reported results are included in the attached Condensed Consolidated Statements of Operations, Balance Sheets and Statements of Cash Flows.

Third Quarter 2021 Financial Highlights from Continuing Operations

Perrigo third quarter net sales were $1.04 billion, an increase of 4.0%. Organic(1) net sales growth was 2.6%, despite an increase in unfulfilled orders of 4.3 percentage points as a result of supply chain disruptions.

CSCA third quarter net sales of $694 million increased 4.6%, with organic growth of 4.2%; CSCI third quarter net sales of $349 million increased 2.8%, with organic net sales down by 0.6%.

Reported diluted loss per share was $0.40, compared to reported diluted earnings per share ("EPS") of $0.19 in the prior year quarter.

Adjusted diluted EPS, which excludes certain charges as outlined in Table I, decreased 25.0% to $0.45 per diluted share. Adjusted diluted EPS was negatively impacted by approximately $0.22 per diluted share from lower operating efficiencies, higher materials and freight costs, and two product recalls, as compared to the prior year quarter. The increase in unfulfilled orders depressed adjusted EPS by $0.08 per diluted share.
Year-to-Date 2021 Financial Highlights from Continuing Operations(2)

Perrigo year-to-date net sales were $3.03 billion, or flat, compared to the prior year period, including a negative impact of 3.4 percentage points from lower cough/cold-related net sales due to the historically weak 2020/2021 cough/cold season. Unfulfilled orders due to supply chain disruptions depressed growth by 1.4 percentage points.

CSCA year-to-date net sales of $1.96 billion were 1.8% lower compared to the prior year period; organic net sales were down 3.2%, including a negative 3.2 percentage points impact from lower cough/cold-related net sales. Unfulfilled orders due to supply chain disruptions depressed growth by 1.9 percentage points.

CSCI year-to-date net sales of $1.08 billion grew 3.3% compared to the prior year period; organic net sales were down 2.2%, including a negative 3.9 percentage points impact from lower cough/cold-related net sales. Unfulfilled orders due to supply chain disruptions depressed growth by 0.5 percentage points.

Reported diluted loss per share year-to-date was $1.22 per diluted share as compared to EPS of $0.70 in the prior year period.

Adjusted diluted EPS year-to-date decreased 22.5% to $1.45 per diluted share as compared to $1.87 per diluted share in the prior year period. Adjusted diluted EPS was negatively impacted by lower cough/cold-related net sales, lower operating efficiencies and higher materials and freight expenses.

See attached Appendix for details. Organic net sales growth excludes the effects of acquisitions and divestitures and the impact of currency.

In addition to other non-GAAP adjustments as described in the attached appendix, adjusted profit measures, including adjusted EPS and adjusted operating income, exclude from both periods certain costs, which are reported in GAAP continuing operations but were previously allocated to the RX business. On a go-forward basis, such costs are either covered by the transition services agreement or have been eliminated following closing. We do not believe such operational costs are representative of the future expenses of our continuing operations. See attached appendix for additional details.

Third Quarter 2021 Perrigo Results from Continuing Operations

Perrigo net sales for the third quarter were $1.04 billion, an increase of $40 million, or 4.0%. Favorable currency movements and acquisitions contributed 0.9 and 0.5 percentage points, respectively. Organic net sales growth was 2.6%, despite an increase in unfulfilled orders as a result of supply chain disruptions, including a lack of truck drivers in the U.S. and record backups at global shipping ports, which held back growth by 4.3 percentage points.

Net sales in the quarter were driven by 1) strong growth in e-commerce, primarily in CSCA, 2) contract manufacturing sales to the now-divested RX business, 3) increased pricing, 4) a rebound in cough/cold in the U.S., 5) the November 2020 acquisition of Eastern European dermatology brands in CSCI, and 6) $9 million in net favorable currency movements. These increases were partially offset by 1) discontinued products of $11 million, 2) lost distribution within the Healthy Lifestyle category in CSCA, 3) lower net sales in the CSCI contract manufacturing business, and 4) $4 million from a product recall.

Third quarter reported operating income was $438 million in 2021 compared to $79 million in 2020. Adjusted operating income was $112 million in 2021 and $141 million in 2020, a decrease of $29 million, or 20.6%. This decrease was driven by 1) $29 million from lower operating efficiencies resulting from the weak 2020/2021 cough/cold season, and higher materials and freight expenses, and 2) $9 million of costs from two product recalls. These results were partially offset by lower operating expenses, including project momentum cost savings.

Reported net loss was $54 million, or $0.40 per diluted share, compared to net income of $26 million, or $0.19 per diluted share in the prior year period. Excluding certain charges as outlined in Table I, third quarter 2021 adjusted net income was $61 million, or $0.45 per diluted share, compared to $83 million, or $0.60 per diluted share, last year due to the factors described above.

Third Quarter 2021 Business Segment Results from Continuing Operations

Consumer Self-Care Americas Segment

CSCA third quarter net sales of $694 million grew 4.6%, including a 0.4 percentage point positive impact from favorable currency movements. Organic net sales increased 4.2%, despite an increase in unfulfilled orders slowing growth by 5.7 percentage points as a result of supply chain disruptions, including a lack of truck drivers in the U.S. and record backups at global shipping ports.

OTC net sales were driven by 1) strong growth in e-commerce, 2) contract manufacturing sales to the now divested RX business, 3) higher incidences of cough/cold illness as society returns to in-person activities, benefiting the Cough/Cold and Pain categories, 4) a double-digit percentage increase in the branded OTC business, and 5) increased pricing stemming from management actions taken earlier in the year. These gains were partially offset by 1) lost distribution within the Healthy Lifestyle category, 2) $10 million in discontinued products, primarily from the discontinuation of diabetes care products in the Healthy Lifestyle category, and 3) lower net sales in the Allergy category due primarily to the recall of third-party manufactured product.

Net sales in the Oral Self-Care category declined mid-single digits due primarily to delayed receipt of ex-U.S. manufactured product, leading to record unfulfilled customer orders.

Net sales in the Nutrition category grew mid-single digits driven by new product launches within infant formula as well as strong growth in the oral electrolytes business.

Reported operating income was $90 million in 2021 compared to $122 million in 2020. Adjusted operating income decreased $28 million to $106 million driven by 1) lower operating efficiencies due primarily to the weak 2020/2021 cough/cold season and higher materials and freight expenses, and 2) a product recall during the quarter. These factors were partially offset by lower operating expenses, including project momentum cost savings.

Consumer Self-Care International Segment

CSCI net sales of $349 million increased $10 million, or 2.8%, including a 1.9 percentage point positive impact from favorable currency movements and a 1.5 percentage point positive impact from acquisitions. Organic net sales decreased 0.6%. Unfulfilled orders increased 1.5 percentage points as a result of supply chain disruptions, due primarily to record backups at global shipping ports.

Net sales in the quarter were driven by 1) the November 2020 acquisition of three Eastern European OTC Dermatology Brands, 2) higher net sales in the U.K. store brand business, 3) greater demand for NiQuitin smoking cessation products in the Healthy Lifestyle category, 4) increased pricing, and 5) $6 million in favorable currency movements. These drivers were more than offset by 1) lower than normal buy-in for cough/cold products by pharmacies, 2) a decline in net sales in the contract manufacturing category, 3) lower demand for weight loss products across Europe, which led to lower net sales for XLS Medical within the Healthy Lifestyle category, and 4) a product recall that negatively impacted the Vitamins, Minerals & Supplements (VMS) category.

Reported operating income was $4 million in 2021 compared to $10 million in 2020. Adjusted operating income decreased $6 million to $46 million due to a $6 million negative impact related to the VMS product recall and less favorable product mix, which were partially offset by lower operating expenses.

Settlement of the Irish Revenue Notice of Amended Assessment ("NoA")

The Company announced on September 29, 2021 that it had reached a settlement with the Irish Office of the Revenue Commissioners for the Notice of Amended Assessment ("NoA") dated November 29, 2018. As part of the settlement terms, Perrigo made a total cash payment to Irish Revenue of €266.1 million in the fourth quarter of 2021. This payment has resolved the entire €1.6 billion NoA against the Company.

Receipt in Cash of €355 million from the Belgian Arbitration Decision

Perrigo announced on September 29, 2021 that it received the entire €355 million in cash on behalf of Alychlo NV and Holdco I BE NV ("Sellers") in payment of the previously announced arbitration award issued in favor of Perrigo Ireland 2 ("Perrigo Ireland"). The award was issued August 27, 2021, by a tribunal sitting under the rules of the Belgian Centre for Arbitration and Mediation and related to claims arising under the Stock Purchase Agreement between Sellers and Perrigo Ireland dated November 6, 2014. Under Belgian law, Sellers have the right to challenge the tribunal’s award for up to three months following the date of the award. However, Perrigo does not believe that Sellers have any legal grounds for any such challenge.

Fiscal 2021 Outlook from Continuing Operations

The Company is updating its fiscal 2021 outlook to reflect third quarter results and management expectations for the remainder of the year. The Company now expects calendar year 2021 adjusted diluted EPS of between $2.00 to $2.10.

The Company cannot reconcile its expected adjusted diluted earnings per share to diluted earnings per share under "Fiscal 2021 Outlook" without unreasonable effort because certain items that impact net income and other reconciling metrics are out of the Company’s control and/or cannot be reasonably predicted at this time.

Alligator Bioscience to Participate in Upcoming Investor Conferences

On November 10, 2021 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that Søren Bregenholt, Chief Executive Officer, will participate and host one-on-one investor meetings at the following upcoming investor conferences (Press release, Alligator Bioscience, NOV 10, 2021, View Source [SID1234595045]):

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Redeye Life Science Day 2021
Location: Hybrid Event
Date: Thursday, November 11, 2021
Type: Live Presentation

Time: 16:30 – 16:50 CET

Live presentations can be viewed via the following link: View Source

H.C. Wainwright 7th Annual Israel Conference
Location: Virtual

Date: Monday, November 15, 2021
Type: Live Presentation & 1×1’s

Time: 14:00 – 14:30 CET

Inv€$tival Showcase 2021
Location: London and Virtual

Dates: November 8 – 15, 2021
Type: In Person 1×1’s, Nov 15, 2021

Jefferies HealthCare Conference
Location: London and Virtual
Date: November 16, 2021

Type: In Person 1×1’s

ØU Life Science Life Science Investor Konference Summit
Location: Copenhagen
Date: Wednesday, November 24, 2021
Type: Live Presentation & 1×1’s

Time: 15:50 – 16:20 CET

Presentation can be viewed via the following link: View Source

All presentations will be available via a digital library, which is accessible to event participants only. Please contact the organizers to if you wish to attend or Julie Silber if you wish to schedule a meeting with Alligator.

PureTech Receives Approximately $100 Million from Sale of a Portion of Founded Entity Shares

On November 10, 2021 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company, reported that it has sold 750,000 shares of its Founded Entity, Karuna Therapeutics ("Karuna," Nasdaq: KRTX), through a block trade executed by Morgan Stanley & Co. LLC for cash consideration of approximately $100 million (the "Transaction") (Press release, PureTech Health, NOV 10, 2021, View Source [SID1234595044]). PureTech intends to use the proceeds from the Transaction to further the advancement and growth of the Company and will update its cash runway guidance in due course.

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Following the Transaction, PureTech continues to hold 1,656,564 of Karuna common stock, which is equal to approximately 5.6% of Karuna’s outstanding shares as of September 30, 2021. PureTech is eligible to receive certain payments from Karuna under its license agreement, including sublicense payments and royalties on any sales of KarXT.

The Transaction constitutes a class 2 transaction for the purposes of the UK Financial Conduct Authority’s Listing Rules.