On April 30, 2020 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on developing curative therapeutics using CRISPR/Cas9 technology both in vivo and ex vivo, reported that it will present its first quarter 2020 financial results and operational highlights in a conference call on May 7, 2020 at 8 a.m. ET (Press release, Intellia Therapeutics, APR 30, 2020, View Source [SID1234556849]).

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To join the call:

U.S. callers should dial 1-877-317-6789 and use conference ID# 10141541, approximately five minutes before the call.
International callers should dial 1-412-317-6789 and use conference ID# 10141541, approximately five minutes before the call.
A replay of the call will be available through the Events and Presentations page of the Investors & Media section of the company’s website at www.intelliatx.com, beginning on May 7, 2020 at 12 p.m. ET.

On April 30, 2020 Perrigo Company plc (NYSE; TASE: PRGO) reported financial results for the first quarter ended March 28, 2020 (Press release, Perrigo Company, APR 30, 2020, View Source [SID1234556848]).

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President and CEO Murray S. Kessler commented, "During these unprecedented times, I am honored to be surrounded by our more than 11,000 dedicated employees who are making tremendous sacrifices to help ensure that our essential products remain available to consumers and patients who need them. Our top priorities remain our employees’ well-being and business continuity, while at the same time supporting the communities where we live and work."

Kessler continued, "Thanks to these courageous employees, we were able to report another quarter of strong growth across all business segments with robust sales and profitability above expectations. While we started the year off with similarly strong trends that we experienced in the fourth quarter of 2019, our business surged significantly in March in response to the global demand created by the COVID-19 pandemic. Worth noting, not only did our team keep the business running, they also made significant further progress on our Consumer Self-Care transformation. Perrigo is clearly well-positioned for a ‘New-Normal’ future, which will need Quality, Affordable Self-Care Products more than ever before."

First Quarter Financial Highlights

Consolidated first quarter net sales were $1.3 billion, an increase of 14.2% compared to the prior year quarter. Excluding exited businesses(1) and the impact of currency, net sales increased 17.6%.
Worldwide Consumer first quarter net sales increased 16.2% compared to the prior year quarter. Excluding exited businesses and the impact of currency, Worldwide Consumer net sales were 20.7% higher year-over-year.
Consumer Self-Care Americas ("CSCA") achieved record first quarter net sales of $701 million, or growth of 20.4% versus the prior year quarter highlighted by 15.0% organic(2) growth; Consumer Self-Care International ("CSCI") first quarter net sales grew 9.1% versus the prior year quarter highlighted by 8.1% organic growth.
Reported diluted EPS for the first quarter of 2020 was $0.77 per diluted share as compared to EPS of $0.47 in the prior year quarter.
Adjusted diluted EPS for the first quarter of 2020 increased 6.5% to $1.14 as compared to $1.07 per diluted share in the prior year quarter.
See attached Appendix for reconciliation of adjusted (non-GAAP) to reported (GAAP) financial measures.

(1) Exited businesses excludes $20 million from the divested animal health business in the prior year period, which was previously included in the Consumer Self-Care Americas segment, and $4 million from the divested Canoderm prescription product in the prior year period, which was previously included in the Consumer Self-Care International segment. Full year 2019 net sales of Canoderm were $13 million and adjusted operating income was $8 million.

(2) Organic net sales growth excludes the 2019 acquisition of Ranir, exited businesses and the impact of currency.

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.

First Quarter 2020 Consolidated Results Versus First Quarter 2019

Consolidated net sales for the first quarter of calendar year 2020 increased 14.2% to $1.3 billion. Net sales increased 17.6% compared to the first quarter 2019, excluding exited businesses of $23 million and unfavorable currency movements of $13 million. This was driven by strong consumer demand for Worldwide Consumer products due to higher illnesses and higher allergens, new products including the launch of generic albuterol sulfate, and the addition of Ranir. These drivers were positively impacted by a surge in demand for certain products due to consumer and customer behavior surrounding the COVID-19 pandemic, which added an estimated $90 million to $110 million in net sales to Perrigo in the quarter. These gains were partially offset by pricing pressure, specifically in the Prescription Pharmaceuticals ("RX") segment, and $11 million in discontinued products. Organic net sales were up 11.0%.

Reported net income was $106 million, or $0.77 per diluted share, versus net income of $64 million, or $0.47 per diluted share in the prior year period. Excluding certain charges as outlined in Table I, first quarter 2020 adjusted net income was $157 million, or $1.14 per diluted share, versus $146 million, or $1.07 per diluted share, for the same period last year. The adjusted diluted EPS increase was due primarily to strong growth across the Worldwide Consumer businesses and the addition of Ranir. These were partially offset by RX business price erosion on testosterone gel 1.62%, which launched in the prior year with 180-day market exclusivity, exited businesses and a 200 basis points increase in the adjusted effective tax rate equating to $0.03 per share.

Worldwide Consumer Self-Care First Quarter 2020 Results Versus First Quarter 2019

Worldwide Consumer is comprised of the CSCA segment, CSCI segment and Corporate.

Worldwide Consumer Self-Care delivered record first quarter net sales of $1.1 billion, an increase of 16.2%. Net sales excluding $23 million in exited businesses and $14 million from the impact of currency increased 20.7%. Organic net sales were up 12.3%.

First quarter reported gross profit margin was 36.5%. Adjusted gross profit margin of 38.4%, was 220 basis points lower year-over-year due to 1) higher growth of lower margin store brand products, partially driven by the COVID-19 pandemic, 2) lower operational efficiencies due primarily to a carryover impact from 2019 and Company prioritization of products most needed by society during the COVID-19 pandemic, 3) the addition of Ranir oral self-care products, which have a lower gross margin profile than the existing portfolio, and 4) the impact from exited businesses. These more than offset the margin contribution of new products and positive pricing.

Reported operating margin was 8.7%. Adjusted operating margin was 14.0%, or 100 basis points higher year-over-year due primarily to operating leverage on gross margin flow-through, savings from Project Momentum and the addition of Ranir, which had a relatively higher operating margin profile than the existing portfolio in the quarter. These were partially offset by higher employee compensation costs, including a $4 million special bonus to front-line employees.

CSCA First Quarter 2020 Results Versus First Quarter 2019

Consumer Self-Care Americas achieved record first quarter net sales of $701 million, an increase of 20.4%, and included $55 million in net sales attributable to Ranir. Excluding the exited animal health business, CSCA net sales increased 24.8%. Organic net sales were up 15.0%.

The OTC business delivered solid net sales growth driven by 1) overall OTC category growth and increased demand related to COVID-19, 2) continued robust growth in e-commerce, 3) Perrigo market share gains from store brand competitors due to greater consumer purchases of existing and new products, and 4) increased store brand penetration market-wide versus national brands of 60 basis points according to IRI MULO data, for the 13-weeks ending March 22, 2020.

Growth in the nutrition business was driven by 1) infant formula category growth and increased demand related to COVID-19, 2) the December 2019 store brand infant formula launch at a major retailer, and 3) growth in customer e-commerce activities. These drivers were partially offset by lower contract pack sales, which were due to planned contract production and sales that took place in the fourth quarter 2019.

First quarter reported gross margin was 30.8%. Adjusted gross margin of 31.4% was 110 basis points lower than the prior year due primarily to 1) lower operational efficiencies related to a carryover impact from 2019 and Company prioritization of products most needed by society during the COVID-19 pandemic, and 2) the exited animal health business, which had a relatively higher gross margin. These were partially offset by favorable product mix and the addition of Ranir.

Reported operating margin was 17.8%. Adjusted operating margin increased 130 basis points to 19.6%, driven by operating leverage on gross margin flow-through and lower operating expenses resulting from Project Momentum savings.

CSCI First Quarter 2020 Results Versus First Quarter 2019

Consumer Self-Care International net sales increased 9.1% to $383 million. Excluding unfavorable currency movements of $13 million and exited businesses, net sales were higher by 14.1%. Organic net sales grew 8.1%.

Net sales growth was due primarily to 1) brand OTC sales attributed to COVID-19 in the upper respiratory and vitamins, minerals and supplements (VMS) categories, and growth in the U.K. store brand business, 2) strong new product sales of $30 million driven by new launches including XLS-Medical Forte 5 and in the ACO skincare line, and 3) $21 million in net sales from Ranir. These drivers were partially offset by lower net sales of existing products in weight management, which is within the healthy lifestyle category, and lower net sales in France.

Reported gross margin was 47.0%. Adjusted gross margin of 51.4% declined 250 basis points due primarily to the addition of Ranir oral self-care products, which have a relatively lower gross margin than the overall CSCI portfolio. In addition, lower operational efficiencies were partially offset by favorable brand product mix.

Reported operating margin was 6.5%. Adjusted operating margin of 16.7% improved 130 basis points due primarily to operating leverage on gross margin flow-through and lower advertising and promotion expense.

RX First Quarter 2020 Results Versus First Quarter 2019

RX net sales increased 6.5% to $258 million due primarily to new product sales of $58 million led by the launch of generic albuterol sulfate inhalation aerosol. This was partially offset by expected pricing pressure associated with testosterone gel 1.62%, which had 180-day market exclusivity in the first quarter of 2019. Discontinued products, consisting of lower margin distribution products, were $5 million.

Reported gross margin was 34.1% and adjusted gross margin was 42.3%. The 630 basis point decline in adjusted gross margin was due primarily to competitive price pressure and lower operational efficiencies compared to last year. These were partially offset by higher gross profit from the incremental sales of generic albuterol sulfate inhalation aerosol.

Reported operating margin was 20.0%. Adjusted operating margin was 28.7%, or 520 basis points lower due primarily to gross margin flow-through, which was partially offset by lower administrative expenses.

Fiscal 2020 Outlook

Due to the volatility and uncertainty associated with the COVID-19 pandemic and its potential impact on demand, the Company’s ability to manufacture and supply product and overall fluidity of the current environment, amongst other factors, the Company is not providing updated fiscal 2020 guidance at this time.

On April 30, 2020 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that Janssen-Cilag International NV (Janssen) received a Committee for Medicinal Products for Human Use (CHMP) Positive Opinion from the European Medicines Agency (EMA) recommending approval of a DARZALEX (daratumumab) subcutaneous (SC) formulation for the treatment of adult patients with multiple myeloma in frontline and relapsed/refractory settings (Press release, Halozyme, APR 30, 2020, View Source [SID1234556847]). The CHMP’s Positive Opinion for daratumumab SC formulation applies to all current daratumumab indications including newly diagnosed and transplant-ineligible patients, as well as relapsed or refractory patients.

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The DARZALEX SC formulation utilizes Halozyme’s ENHANZE drug delivery technology and reduces the treatment time from several hours to approximately five minutes with comparable efficacy to intravenous DARZALEX and lower rates of infusion-related reactions.

"We are excited that a subcutaneous formulation of DARZALEX is one step closer to transforming the treatment experience for multiple myeloma patients and physicians in the European Union," said Dr. Helen Torley, president and chief executive officer. "Once available, multiple myeloma patients may benefit from a shorter infusion time when compared with a multi-hour intravenous infusion."

The CHMP opinion is supported by data from Janssen’s Phase 3 COLUMBA study, which investigated subcutaneously administered DARZALEX in comparison to intravenous DARZALEX in patients with relapsed and refractory multiple myeloma, and the Phase 2 PLEIADES study. In the COLUMBA study, subcutaneous DARZALEX, using ENHANZE drug delivery technology, was found to be non-inferior to intravenous DARZALEX with regard to the co-primary endpoints of overall response rate and maximum Ctrough concentration on day 1 of the third treatment cycle prior to dose.

About ENHANZE Technology
Halozyme’s proprietary ENHANZE drug delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.

On April 30, 2020 Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, reported that it has entered into definitive agreements for a private placement of its securities for gross proceeds of approximately $1.9 million, prior to deducting placement agent commissions and estimated offering expenses (Press release, OncoGenex Pharmaceuticals, APR 30, 2020, View Source [SID1234556846]).

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The private placement will be for up to 5,615,653 units at a price of $0.33 per unit, with each unit consisting of one share of common stock and a warrant to purchase 0.75 shares of common stock. The private placement will close in two tranches based on the execution of definitive documents on April 27, 2020 and April 28, 2020. The warrants for the first closing have an initial per share exercise price of $0.362, and the warrants for the second closing have an initial per share exercise price of $0.366. All warrants will be exercisable beginning on the six-month anniversary of the initial closing of the offering and will have a five-year term. The Company intends to use the proceeds from the private placement to fund clinical research and development, and for general working capital.

Paulson Investment Company, LLC, acted as the exclusive placement agent in connection with this offering.

The Company has additionally agreed to file a registration statement to register the resale of the shares of common stock included in the units and underlying the investor and placement agent warrants within 60 days of the closing of the offering.

The Company offered and sold the securities described above in reliance on Section 4(a)(2) of the Securities Act of 1933, as amended, and Regulation D promulgated thereunder.

About Achieve & Cytisinicline
Tobacco use is currently the leading cause of preventable death and is responsible for more than eight million deaths annually worldwide1. It is estimated that 28.7% of cancer deaths in the U.S. are attributable to cigarette smoking2. Achieve’s focus is to address the global smoking health epidemic through the development and commercialization of cytisinicline.

Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

As an approved, branded product in Central and Eastern Europe for more than two decades, it is estimated that over 20 million people have used cytisinicline to help combat nicotine addiction.

On April 30, 2020 Emergent BioSolutions Inc. (NYSE: EBS) reported financial results for the three months ended March 31, 2020 (Press release, Emergent BioSolutions, APR 30, 2020, View Source [SID1234556845]).

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"Emergent is uniquely positioned to respond to the unprecedented challenges of the COVID-19 pandemic," said Robert G. Kramer Sr., president and chief executive officer of Emergent BioSolutions. "We are deploying our decades of experience in vaccines and therapeutics development and manufacturing, our well-established platform technologies, and our significant development and manufacturing capabilities. Our goal is to create multiple innovative solutions to deliver on our commitments to our customers and patients, while continuing to safeguard our employees."

Signed a contract development and manufacturing (CDMO) agreement, valued at $135 million, to be U.S. manufacturing partner of Johnson & Johnson’s lead vaccine candidate for COVID-19. Negotiations continue on a long-term commercial supply agreement for large-scale drug substance manufacturing, anticipated to begin in 2021.

Initiated development of two investigational plasma-derived therapies. COVID-Human Immune Globulin (COVID-HIG), a human plasma-derived product candidate, for which the Company subsequently received $14.5 million in Health and Human Services (HHS) funding, is being developed as a potential treatment for COVID-19 in severe hospitalized and high-risk patients and will be included in at least one of the studies of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, evaluating potential treatments for COVID-19. COVID-Equine Immune Globulin (COVID-EIG) is also being developed as an equine plasma-derived therapy candidate for potential treatment of severe disease in humans.

Signed a CDMO agreement with Novavax, Inc. to provide development services, drug substance and drug product manufacturing for its experimental vaccine candidate for COVID-19, NVX-CoV2373.

Signed a CDMO agreement with Vaxart, Inc. to provide development services and drug substance manufacturing to produce its experimental oral vaccine candidate for COVID-19.

Q1 2020 AND OTHER RECENT BUSINESS ACCOMPLISHMENTS

Received agreement from the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) on the company’s proposed development plan to use Serum Neutralizing Antibodies (SNA) as surrogate endpoint to predict likely clinical benefit of CHIKV VLP, the company’s chikungunya virus virus-like particle (VLP) vaccine candidate, in a Phase 3 safety and immunogenicity study anticipated in late 2020.

Received positive opinion and subsequent approval from EMA of Vaxchora Cholera Vaccine (recombinant, Live, Oral), making it the only single-dose oral cholera vaccine approved across all European Union member states, the UK, and the European Economic Area countries, indicated for active immunization against disease caused by Vibrio cholerae serogroup 01 in adults and children from 6 years of age. Commercial launch is being planned for late 2020.

Signed a CDMO agreement with Novavax, Inc. to provide drug substance manufacturing of NanoFluTM, its seasonal influenza vaccine candidate.

Announced the appointment of Dr. Karen Smith as chief medical officer with responsibility for leading and further establishing Emergent’s global integrated capability in clinical development, medical affairs, and regulatory affairs.

Submitted a data package to the FDA in support of extending the shelf life of NARCAN (naloxone HCl) Nasal Spray from 24 to 36 months, with an expected review by FDA to take approximately six months.

2020 FINANCIAL PERFORMANCE (unaudited)

(I) Quarter Ended March 31, 2020 (Q1)

Revenues

Total Revenues
For Q1 2020, total revenues were $192.5 million, a slight increase over 2019. Total revenues reflect a decline in product sales revenues partially offset by an increase in CDMO and contracts and grants revenues.
Product Sales
For Q1 2020, product sales were $148.2 million, a decrease of $4.8 million or 3% as compared to 2019. The change primarily reflects increases in sales of Anthrax Vaccines and NARCAN Nasal Spray offset by a decrease in ACAM2000, as previously anticipated.

Contract Development and Manufacturing
For Q1 2020, revenue from the Company’s contract development and manufacturing operations was $21.7 million, an increase of $5.8 million or 36% as compared to 2019. The increase primarily reflects increased demand across development services, drug substance and drug product offerings.

Contracts and Grants
For Q1 2020, revenue from the Company’s development-based contracts and grants was $22.6 million, an increase of $0.9 million as compared to 2019. The increase primarily reflects revenues associated with a grant received related to our PC2A (diazepam) auto-injector drug-device product candidate.
Operating Expenses

Cost of Product Sales and Contract Development and Manufacturing
For Q1 2020, cost of product sales and contract manufacturing was $76.9 million, a decrease of $14.9 million or 16% as compared to 2019. The decrease primarily reflects a decrease in sales of ACAM2000 and raxibacumab.
Research and Development (Gross and Net)

For Q1 2020, gross R&D expenses were $42.7 million, a decrease of $3.4 million or 7% as compared to 2019. The decrease primarily reflects a decline of costs associated with the Company’s FLU-IGIV product candidate. During 2019, the Company was incurring costs associated with phase 2 clinical trials for FLU-IGIV.
For Q1 2020, net R&D expense, which reflects investments made in development programs that are not currently funded in whole or in part by third-party partners and is calculated as gross research and development expenses minus contracts and grants revenue, was 20.1 million, a decrease of $4.3 million or 18% as compared to 2019. The decrease is also attributable to a decline of costs associated with the Company’s FLU-IGIV product candidate. The Q1
2020 and Q1 2019 net R&D expense was 12% of adjusted revenue (total revenue less contracts & grants).

Selling, General and Administrative

For Q1 2020, selling, general and administrative expenses were $69.7 million, an increase of $4.3 million or 7% as compared to 2019. The increase primarily reflects additional expenses related to staffing to support the Company’s growth.

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Amortization of Intangible Assets

For Q1 2020, amortization of intangible assets was $14.8 million was consistent with amortization of intangible assets of $14.5 million in Q1 2019.
Income Taxes

For Q1 2020, the income tax benefit in the amount of $8.8 million was consistent with the benefit during the Q1 2019 as a percentage of net loss during the periods.

Net Loss & Adjusted Net Income (Loss)

For Q1 2020, the Company recorded net loss of $12.5 million, or $0.24 per diluted share, versus net loss of $26.0 million, or $0.51 per diluted share, in 2019.

For Q1 2020, the Company recorded adjusted net income of $0.3 million, or $.01 per diluted share, versus adjusted net loss of $5.2 million, or $.10 per diluted share, in 2019. (1)

Adjusted EBITDA

For Q1 2020, the Company recorded adjusted EBITDA of $15.3 million versus $8.4 million in 2019. (1)

2020 FINANCIAL FORECAST

The Company’s financial forecast for 2020 includes the anticipated impact of the following items:

A full year of product sales, including the following ranges for key components of the product portfolio:

NARCAN Nasal Spray: $285 million – $315 million;

Anthrax Vaccines: $270 million – $300 million;

ACAM2000: $180 million – $200 million;

Contract development and manufacturing revenue of $125 million – $145 million;

Deliveries of raxibacumab to the Strategic National Stockpile (SNS) under the anticipated follow-on procurement contract with HHS;

Domestic and international sales of the other medical countermeasures that comprise Other Product sales;

Continued improvement of gross margin (a combination of product sales and CDMO services) in a range of 200 – 400 basis points annually, driven by improved product mix;

Continued investment in internally funded development projects most notably the anticipated Phase 3 studies for the CHIKV VLP and FLU-IGIV product candidates as well as the Phase 1/2 study for COVID-EIG, among other R&D projects.

Emergent has assessed the risks to its business associated with the COVID-19 pandemic and has adopted measures to mitigate those risks as they are understood today, and accordingly is providing this outlook for 2020. Despite the lack of expected material disruption to the company’s business, the management team continues to assess the business and operational implications associated with the pandemic and market conditions on its employees, patients and customers.

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The outlook for 2020 does not include estimates for potential new corporate development or other M&A transactions.

Q2 2020 REVENUE FORECAST

For Q2 2020, the Company forecast for total revenues is $270 million – $300 million.

FOOTNOTES

(1) See "Reconciliation of Net Loss to Adjusted Net Loss and Adjusted EBITDA" for a definition of terms and the reconciliation tables.

CONFERENCE CALL, PRESENTATION SUPPLEMENT, AND WEBCAST INFORMATION
Company management will host a conference call at 5:00 pm (Eastern Time) today, April 30, 2020, to discuss these financial results. The conference call and presentation supplement can be accessed from the Company’s website or through the following:

Live Teleconference Information:
Dial in: [US] (855) 766-6521; [International] (262) 912-6157
Conference ID: 3784302

Live Webcast Information:
Visit View Source for the live webcast feed.

A replay of the call can be accessed at www.emergentbiosolutions.com under "Investors."