On August 9, 2022 Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, reported financial results for the second quarter ended June 30, 2022 (Press release, Beam Therapeutics, AUG 9, 2022, View Source [SID1234617934]).

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"2022 is a critical year for Beam’s transition to becoming a multi-program clinical-stage company, as we prepare for the near-term initiation of patient enrollment in our BEACON Phase 1/2 trial, the first clinical trial evaluating BEAM-101 in patients with sickle cell disease," said John Evans, chief executive officer of Beam. "In June, we submitted our IND for BEAM-201 for CD7-positive T-cell malignancies and recently received notification from the FDA of a clinical hold on the IND. We look forward to receiving more detail from the FDA and working with them in an effort to advance BEAM-201 for these difficult-to-treat cancer indications. We are on track to further expand our portfolio with a steady cadence of clinical and preclinical milestones expected in the quarters ahead, including the IND submission for BEAM-102, our second program in sickle cell disease, and the initiation of IND-enabling studies for BEAM-301, our first liver-directed base editing program in glycogen storage disease, both targeted in the second half of this year."

Mr. Evans added, "As pioneers and leaders in the field of base editing, we’ve continued to extend the potential reach of our base editing technology and applications with the development of new base editors, as well as novel base editing-enabled therapeutic strategies, such as our work on non-genotoxic conditioning to improve transplant regimens. We’ve also continued to enhance our team, and I’m thrilled to welcome John Lo as chief commercial officer. John has a deep science background and an extensive track record in the strategic development and commercialization of novel medicines, including cell therapy products, at leading companies. I can’t wait to work with him to advance our portfolio and our vision of providing a new class of precision genetic medicines to patients."

Pipeline Updates & Anticipated Milestones
Ex Vivo HSC Programs

Beam remains on track to begin patient enrollment in its BEACON trial, an open-label, single-arm, multicenter, Phase 1/2 clinical trial evaluating the safety and efficacy of BEAM-101 in adult patients with severe sickle cell disease (SCD) in the second half of 2022.
BEAM-102 continues to progress, and the company plans to submit an investigational new drug (IND) application for BEAM-102 for the treatment of SCD in the second half of 2022.
Ex Vivo T Cell Programs

Beam submitted its IND for BEAM-201 to the U.S. Food and Drug Administration (FDA) in June 2022, and on July 29, 2022, was notified via e-mail that the IND was placed on clinical hold. The FDA indicated it will provide an official clinical hold letter to Beam within 30 days. Beam plans to provide additional updates pending interaction with the FDA.
Beyond BEAM-201, Beam is focused on identifying the collection of multiplex base edits required to make cells fully allogeneic, with internal and external data suggesting a higher number of edits will be required to meet this goal. As a result, Beam does not expect to nominate a second CAR-T development candidate in 2022 and anticipates providing further updates in 2023.
In Vivo LNP Liver-targeting Programs

Beam presented updated preclinical data from its BEAM-301 program at the American Society of Cell and Gene Therapy (ASGCT) (Free ASGCT Whitepaper) meeting, highlighting that BEAM-301 demonstrated high and durable editing efficiency in a mouse model of glycogen storage disease 1a (GSDIa) out to 35 weeks. BEAM-301, a liver-targeting lipid nanoparticle (LNP) formulation of base editing reagents designed to correct the R83C mutation, the most common disease-causing mutation of GSDIa, is on track for initiation of IND-enabling studies in the second half of 2022.
At ASGCT (Free ASGCT Whitepaper), Beam also presented new preclinical data from its base editing program targeting the treatment of alpha-1 antitrypsin deficiency, highlighting optimizations made to the editor and the guide RNA that have led to two-fold increases in observed editing potency in mice, leading to potentially clinically relevant increases in circulating alpha-1 antitrypsin at doses below 1 mg/kg.
Beam plans to present new in vivo preclinical data from its multiplex base editing program for the potential treatment of hepatitis B virus (HBV) in a poster titled, "Cytosine base editing inhibits Hepatitis B Virus replication and reduces HBsAg expression in vitro and in vivo," at the 2022 International HBV Meeting from Sept. 18-22. The data will build on initial in vitro data presented in September 2021, which showed that base editing can introduce permanent mutations in covalently closed circular DNA (cccDNA) and prevent HBV rebound in relevant models.
Beam continues to anticipate the nomination of a second liver-targeted development candidate in 2022.
Recent Research Highlights

At the Federation of American Societies for Experimental Biology (FASEB) Genome Engineering Conference in June, Beam presented the first research highlighting the company’s internal efforts to develop improved transplant conditioning regimens for patients with SCD undergoing hematopoietic stem cell transplantation (HSCT). With a goal of overcoming limitations of today’s conditioning regimens, Beam leveraged its base editing capabilities to develop a potentially non-genotoxic approach that combines antibody-based conditioning with multiplex gene-edited hematopoietic stem cells (HSCs) called ESCAPE, or Engineered Stem Cell Antibody Paired Evasion. These improved conditioning regimens could potentially be paired with BEAM-101 and BEAM-102, as well as other future programs.
At the CRISPR 2.0 conference in June, Beam highlighted research that led to the creation of an improved class of cytosine base editors (CBEs), leveraging a TadA enzyme-based CBE (CBE-T), that are capable of editing at levels comparable to traditional CBEs but with lower off-target editing potential. Further, Beam disclosed an additional editor, CABE-T, that can conduct both C-to-T and A-to-G edits with a single TadA deaminase.
Business Updates

Beam recently appointed John Lo, Ph.D., as chief commercial officer, where he will be responsible for commercial readiness, as well as leading product and portfolio strategy. Dr. Lo joins Beam after serving as an advisor to multiple private- and public-stage biotechnology companies, including Beam. Dr. Lo has held a number of global strategic and operating roles of increasing responsibility within the biopharmaceutical industry, including as senior vice president, worldwide hematology at Bristol Myers Squibb; head of global marketing and market access at Astra Zeneca; corporate vice president, hematology and oncology at Celgene; and multiple P&L roles at Novartis. While at these companies, Dr. Lo successfully helped launch numerous drugs in the U.S. and globally, including Tagrisso in lung cancer and two cell therapies. Dr. Lo has also helped build strategies and grow R&D pipelines as co-chair of the Development Committee at Celgene, leading to multiple pivotal study investments. Dr. Lo also spent several years as an associate principal at McKinsey & Company and holds a Ph.D. in molecular biology from MIT.
In July, Beam and Verve Therapeutics amended their collaboration and license agreement, originally executed in April 2019. The amended agreement returned two targets to Beam, while adding a new, third target toward an additional liver-mediated, cardiovascular disease target. Beam has the right to opt in on this target after Phase 1 to share 35% of worldwide costs and profits from the program. The two lead targets in the collaboration, PCSK9 and ANGPTL3, are unchanged. Verve also granted to Beam licenses and options to certain delivery technologies.
Second Quarter 2022 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $1.2 billion as of June 30, 2022, as compared to $965.6 million as of December 31, 2021.
Research & Development (R&D) Expenses: R&D expenses were $74.6 million for the second quarter of 2022, compared to $45.6 million for the second quarter of 2021.
General & Administrative (G&A) Expenses: G&A expenses were $24.1 million for the second quarter of 2022, compared to $13.4 million for the second quarter of 2021.
Net Loss: Net loss was $72.0 million for the second quarter of 2022, or $1.02 per share, compared to $76.3 million for the second quarter of 2021, or $1.23 per share.

On August 9, 2022 Perrigo Company plc (NYSE: PRGO) ("Perrigo" or the "Company"), a leading provider of Consumer Self-Care Products, reported financial results for the second quarter ended July 2, 2022 (Press release, Perrigo Company, AUG 9, 2022, View Source [SID1234617933]). All comparisons are against the prior year fiscal second quarter, unless otherwise noted.

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President and CEO, Murray S. Kessler commented, "This was a truly remarkable quarter for the Perrigo team. During the quarter: we closed the HRA transaction, closed on $2.6 billion senior secured credit facilities, received FDA approval for and launched the Company’s first led Rx-to-OTC switch of Nasonex 24HR, filed with the FDA for the first ever Rx-to-OTC switch for a daily birth control pill, and worked around the clock at our infant formula facilities to help mitigate the shortage in the United States – all the while delivering a constant currency 20% increase in net sales and a 310 basis points sequential improvement in our consolidated adjusted gross margin. All of this was achieved despite a dynamic external environment, including severe inflationary headwinds. I couldn’t be prouder of the performance of my Perrigo colleagues as our self-care strategy is being executed with excellence."

Kessler continued, "While we remain certain that the self-care strategy is the correct approach and we are executing well against it, we recognize that the macro-economic environment has and will continue to present significant headwinds in the near-term. Based on the strong performance of the business, as evident in continued strong demand, increased organic net sales outlook and sequentially improving margins, we expect to cover incremental headwind costs with the exception of the massive negative impact from foreign currency exchange. We continue to be excited about our future and look forward to delivering double-digit top and bottom line growth over the next few years as we ‘Optimize and Accelerate’ the newly transformed Perrigo Consumer Self-Care Company."

Refer to Tables I – VI 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 Consolidated Statements of Operations, Balance Sheets and Statements of Cash Flows.

Global Reporting Category Updates
As a result of the completed acquisition of HRA, the Company has updated its global reporting categories beginning in the second quarter of 2022 as follows:

The creation of a new "Women’s Health" reporting category, comprised of the women’s health portfolio of HRA, including ellaOne and Hana, in addition to legacy Perrigo women’s health products, including feminine hygiene and pregnancy products.
The creation of a new "Skin Care" reporting category, comprised of Compeed, Mederma, and all of the products in the legacy Perrigo "Skincare and Personal Hygiene" category except for legacy Perrigo women’s health products.
The "Other" category now includes the HRA Rare Diseases business.
These product category updates have been adjusted retrospectively to reflect this change. These updates have no impact on the Company’s historical consolidated financial position, results of operations, or cash flows.

Second Quarter 2022 Perrigo Results from Continuing Operations
Perrigo net sales for the second quarter were $1.1 billion, an increase of $141 million or 14.3%, including a positive impact of 6.8 percentage points from acquisitions, and negative impacts of 5.9 percentage points and 3.8 percentage points from adverse currency translation and divested businesses, respectively. Organic net sales increased 17.2%.

Net sales were driven by 1) $65 million in constant currency net sales from the April 29, 2022 closing of the acquisition of HRA, 2) higher global incidences of cough/cold and flu-like illnesses, including COVID-19, leading to an increase of $72 million in cough/cold-related sales that benefited the Upper Respiratory and Pain and Sleep Aids categories, 3) contract manufacturing sales to the divested RX business of $38 million, and 4) strong growth of $29 million in the Nutrition category stemming from store brand infant formula share gains amid a national brand recall. These drivers also benefited from increased pricing across both Consumer Self-Care segments, strong e-commerce growth and new product sales. These increases were partially offset by 1) the impact of adverse currency translation of $58 million, and 2) $30 million from divested businesses.

Second quarter reported operating loss was $7 million, compared to an operating loss of $126 million in the prior year period, due primarily to the absence of $159 million of prior year impairment charges related to the divested Latin American businesses. Adjusted operating income decreased $1 million, or 0.9%, to $116 million. Constant currency adjusted operating income increased 7.9% driven by 1) higher gross profit flow-through resulting from higher volumes and increased pricing, 2) the addition of HRA, and 3) cost savings from Project Momentum. These factors were partially offset by 1) $39 million in cost headwinds, including cost of goods sold inflation, increased freight expenses and lower plant productivity stemming from a tight labor market, and 2) higher operating expenses, driven primarily by the inclusion of HRA, in addition to higher employee and distribution costs compared to the prior year.

Reported net loss was $65 million, or $0.48 per diluted share, compared to reported net loss of $112 million, or $0.84 per diluted share, in the prior year period. Excluding certain charges as outlined in Table I, second quarter 2022 adjusted net income was $59 million, or $0.43 per diluted share, compared to $68 million, or $0.50 per diluted share, in the prior year. Constant currency EPS for the quarter was $0.49.

Cough/cold-related net sales includes the cough/cold sub-category within Upper Respiratory and the adult and children’s analgesics sub-categories within the Pain and Sleep Aids category.

Second Quarter 2022 Business Segment Results from Continuing Operations
Consumer Self-Care Americas Segment

CSCA second quarter net sales of $728 million increased $106 million, or 17.0%, including a positive impact of 1.6 percentage points from acquisitions, and a negative impact of 5.8 percentage points from divested businesses. Organic net sales growth was 21.2%. Primary category drivers are provided below.

Upper Respiratory
Net sales of $146 million increased 38.6% due primarily to higher incidences of cough/cold and flu-like illnesses, including COVID-19, that led to strong demand, online and in-store, for cough/cold-related products. Sales of allergy products were higher, despite lower levels of incidence compared to the year ago period, due primarily to increased promotions at a particular customer.

Digestive Health
Net sales of $125 million increased 8.8% due primarily to growth in store brand proton pump inhibitor products, including the store brand versions of Esomeprazole and Omeprazole, driven by share gains, in addition to growth in store brand versions of Famotidine.

Nutrition
Net sales of $125 million increased 30.6% due primarily to strong growth in infant formula stemming from store brand share gains, due in part to new product launches and a national brand recall, as well as third-party contract sales. Continued growth in the oral electrolytes business also contributed to the quarter.

Pain & Sleep-Aids
Net sales of $103 million increased 14.8% due primarily to strong demand, online and in-store, for analgesics products stemming from higher incidences of cough/cold and flu-like illnesses, including COVID-19.

Oral Care
Net sales of $77 million increased 1.2% due primarily to sales of store brand products, particularly non-power toothbrushes, mostly offset by a decline in branded offerings stemming from delayed receipt of products manufactured outside the U.S., leading to unfulfilled customer orders.

Healthy Lifestyle
Net sales of $67 million increased 4.0% due primarily to increased distribution of store brand smoking cessation products, partially offset by the discontinuation of diabetes products.

Skin Care
Net sales of $49 million increased 3.2% due primarily to the addition of HRA brands, including Mederma and Compeed, partially offset by the divested ScarAway brand asset and discontinued product in non-strategic category segments.

Women’s Health
Net sales of $12 million increased 48.1% due primarily to the addition of HRA brands, including ella.

Vitamins, Minerals, and Supplements ("VMS") and Other
Net sales of $25 million increased 17.0% due primarily to contract manufacturing sales to the divested RX business in the Other category.

Reported operating income was $86 million in the quarter compared to an operating loss of $72 million in the prior year period, due primarily to the absence of $159 million of prior year impairment charges related to the divested Latin American businesses. Adjusted operating income decreased $2 million to $105 million due primarily to 1) cost headwinds, including cost of goods sold inflation and increased freight expenses, 2) lower plant productivity, including reduced volumes due to a tight labor market, 3) the impact of divestitures, and 4) higher operating expenses to support net sales growth. These factors were mostly offset by higher gross profit flow-through resulting from higher net sales growth and the addition of HRA.

Consumer Self-Care International Segment

CSCI net sales of $394 million increased $35 million, or 9.7%, including a positive impact of 15.2 percentage points from acquisitions, partially offset by negative impacts of 16.1 percentage points and 0.9 percentage points from currency translation and lower sales in Ukraine and Russia, respectively. Organic net sales growth was 10.6%. Primary category drivers are provided below.

Skin Care
Net sales of $120 million increased 21.9%, or an increase of 43.0% excluding the impact from currency translation, driven primarily by the addition of HRA brands, including Compeed, strong performance in the Sebamed and ACO skincare lines, and increased net sales of anti-parasite offerings, due to the easing of COVID-19-related restrictions. These benefits were partially offset by lower sales in Ukraine and Russia.

Upper Respiratory
Net sales of $60 million increased 41.0%, or 59.0% excluding the impact of currency, as the higher incidences of cough/cold and flu-like illnesses, including COVID-19, led to strong demand for cough/cold products, including Bronchonolo, Bronchostop and Coldrex and U.K. store brands. In addition, a relatively stronger hayfever season drove net sales performance of allergy products, particularly the Beconase brand in the U.K.

VMS
Net sales of $48 million decreased 11.9%, or 0.4% excluding the impact of currency, due primarily to lower overall category consumption and lower sales of the probiotic brand Probify in certain geographies, partially offset by the restocking of the Abtei brand in Germany following the third quarter 2021 recall of certain batches.

Pain & Sleep-Aids
Net sales of $49 million increased 0.4%, or 12.8% excluding the impact of currency, due primarily to higher demand for Solpadeine, a paracetamol-based analgesics product, as well as an increase in U.K. store brand consumption within the category. These increases were driven primarily by strong demand for analgesics products stemming from higher incidences of cough/cold and flu-like illnesses, including COVID-19.

Healthy Lifestyle
Net sales of $39 million decreased 17.6%, or 7.7% excluding the impact of currency, due primarily to lower net sales in the XLS Medical weight management franchise stemming from lower category consumption, partially offset by stronger performance of NiQuitin smoking cessation products, due to customer restocking following supply constraints earlier in the year.

Women’s Health
Net sales of $24 million increased 69.4%, or an increase of 93.3% excluding the impact of currency, due primarily to the addition of HRA brands, including ellaOne and NorLevo.

Digestive Health, Oral Care and Other
Net sales of $54 million increased 0.6%, or an increase of 17.1% excluding the impact of currency, due primarily to the addition of the HRA Rare Diseases portfolio in the Other category.

Reported operating income was $2 million in the quarter compared to $1 million in the prior year quarter. Adjusted operating income increased $7 million, or 15.1%, to $54 million. Constant currency adjusted operating income grew 36.3%, driven by higher gross profit flow-through resulting from higher volumes, increased pricing and the addition of HRA. These factors were partially offset by 1) cost headwinds, including cost of goods sold inflation and increased freight expenses, and 2) higher operating expenses, driven primarily by the inclusion of HRA, in addition to higher employee and distribution costs compared to the prior year.

Fiscal 2022 Outlook
The Company is increasing its fiscal 2022 organic net sales growth range outlook to 9.0%-10.0%, from 8.0%-9.0%, versus the prior year, due to continued strong global consumer demand. The Company is reaffirming its fiscal 2022 total net sales growth range outlook of 8.5%-9.5%, as the organic net sales growth outlook increase is expected to be offset by the worsening impact of currency translation.

The Company expects to achieve a fiscal 2022 constant currency adjusted EPS range outlook of $2.40-$2.50 per diluted share and is updating its fiscal 2022 adjusted EPS range outlook to $2.25-$2.35 from $2.30-$2.40, due entirely to the worsening impact of currency translation.

The Company continues to expect an adjusted effective tax rate of approximately 23% and cash flow from operations as a percentage of adjusted net income above its long-term range outlook of 95%-105%.

The Company cannot reconcile its organic net sales growth to reported net sales or its expected adjusted diluted EPS or constant currency adjusted EPS to diluted EPS under "Fiscal 2022 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. These items include taxes, interest costs that would occur if the Company issued debt, and costs to acquire and or sell a business if the Company executed such transactions, which could significantly affect our financial results. These items depend on highly variable factors and any such reconciliations would imply a degree of precision that would be confusing or misleading to investors.

On August 9, 2022 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology," Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, reported second quarter financial results for the period ended June 30, 2022, and provided a business update (Press release, Olema Oncology, AUG 9, 2022, View Source [SID1234617932]).

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"Our objective is for OP-1250 to become the endocrine therapy of choice for ER+ breast cancer and, based on the progress we are making across the program and receipt of Fast Track designation from FDA, we believe we are well on our way toward achieving that goal. Our enrollment continues to be robust and the emerging data show a favorable tolerability profile, encouraging early anti-tumor activity, and combinability with palbociclib," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "As we continue to generate more data, OP-1250 is revealing its potential, validating our confidence to move ahead our next set of trials and preparing for a pivotal monotherapy study next year. We are well capitalized into the second half of 2024, and we look forward to presenting more data as the year progresses."

Recent Corporate Highlights

Received Fast Track designation from the U.S. Food and Drug Administration (FDA) for OP-1250 for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor. A drug candidate that receives Fast Track designation is eligible for more frequent communication with the FDA throughout the drug development process for the purpose of expediting the drug’s development, review and potential approval.
Announced interim data from Phase 1b monotherapy expansion of OP-1250 for ER+/HER2- breast cancer.
Based on pharmacokinetics, safety and tolerability, and encouraging early anti-tumor activity in Phase 1b monotherapy expansion, 120 mg once-daily dosing of OP-1250 was selected as the recommended Phase 2 dose (RP2D).
Following the selection of RP2D, Phase 2 enrollment continues and will include three cohorts: patients with measurable disease (N=50), patients with non-measurable disease (N=15) and patients with CNS metastasis (N=15).
Dose escalation in the Phase 1b combination study with the CDK4/6 inhibitor palbociclib continues, with evaluation at 120 mg OP-1250 ongoing. Combinability has been demonstrated across the completed dose escalation cohorts (30 mg, 60 mg and 90 mg OP-1250), including no dose limiting toxicities, no induced metabolism of palbociclib, and overall tolerability consistent with expected profile of palbociclib plus an endocrine therapy.
Announced an exclusive global license agreement with Aurigene Discovery Technologies Limited (Aurigene) to research, develop and commercialize novel small molecule inhibitors of an undisclosed oncology target.
Anticipated Milestones

Initiate a Phase 1b combination study with each of ribociclib, a CDK4/6 inhibitor, and alpelisib, a PI3Kɑ inhibitor, in the third quarter of 2022.
Present updated monotherapy and initial combination data with palbociclib at medical meetings in the fourth quarter of 2022, pending abstract acceptance.
Initiate a pivotal monotherapy study in second-line or later settings in mid-2023.
Present additional monotherapy and combination data in 2023.
Financial Results

Cash, cash equivalents and marketable securities as of June 30, 2022, were $240.7 million. Olema anticipates that this balance will be sufficient to fund operations into the second half of 2024.
Net loss for the quarter ended June 30, 2022, was $32.9 million, compared to $16.4 million for the same period of the prior year. The increase in net loss related primarily to Olema’s continued investment in OP-1250, increased spending on research and development activities, including the $8.0 million upfront payment to Aurigene, and an increase in general and administrative (G&A) costs.
GAAP research and development (R&D) expenses were $27.1 million for the quarter ended June 30, 2022, compared to $11.9 million for the same period of the prior year. The increase in R&D expenses was primarily related to the advancement of the development program for OP-1250 and an increase in nonclinical research and discovery program activities, including the $8.0 million upfront payment to Aurigene. Non-GAAP R&D expenses were $23.9 million for the quarter ended June 30, 2022, excluding $3.2 million of non-cash stock-based compensation expense. Non-GAAP R&D expenses were $9.6 million for the quarter ended June 30, 2021, excluding $2.3 million of non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this news release.
GAAP G&A expenses were $6.2 million for the quarter ended June 30, 2022, as compared to $4.6 million for the same period of the prior year. The increase in G&A expenses was primarily related to higher personnel-related expenses and other corporate costs. Non-GAAP G&A expenses were $4.7 million for the quarter ended June 30, 2022, excluding $1.5 million of non-cash stock-based compensation expense. Non-GAAP G&A expenses were $3.0 million for the quarter ended June 30, 2021, excluding $1.6 million of non-cash stock-based compensation expense.

On August 9, 2022 Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company, reported that its product portfolio of FDA-approved brands delivered combined revenues of $10.3 million during the second quarter of 2022 – a 14% increase over the prior year period (Press release, Cumberland Pharmaceuticals, AUG 9, 2022, View Source [SID1234617931]). Cumberland also reports a 10% increase in net revenues for the first half of the year compared to the same period in 2021.

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Year-to-date cash flow from operations were $2.2 million. The Company’s financial position included $93 million in total assets, $53 million in total liabilities and $40 million of shareholders’ equity at the end of the quarter.

"We have had a strong first half of the year, especially following our exciting and significant acquisition of the oncology-supportive care medicine Sancuso," said A.J. Kazimi, CEO of Cumberland Pharmaceuticals. "We look forward to building on this success throughout the remainder of the year, as we continue to fulfill our mission of providing innovative products to improve the quality of care for patients."

Cumberland will report its full second quarter 2022 financial results and provide a company update via a conference call today at 4:30 p.m. Eastern Time.

Earnings Call Participation
To join, please register at https://register.vevent.com/register/BIcc5e9791aa7343d9927dca16dc4cf493. Once registered, participants can dial in from their phone using a dial-in and PIN number that will be provided. Alternatively, there is a "Call Me" option to have the system automatically call them at the start of the conference. A replay of the call will be available for one year and can be accessed via Cumberland’s website or by visiting View Source

Among the updates the company will share during today’s conference call are:
Sancuso Promotion
Following its January 2022 acquisition of oncology-supportive care medicine Sancuso, Cumberland entered into an agreement with Verity Pharmaceuticals International Limited for the national co-promotion of the product. A specialty pharmaceutical company, Verity will utilize its established oncology commercial organization and customer network to co-promote Sancuso throughout the United States. Verity launched its national co-promotion efforts in July 2022.

2021 Sustainability Report
In early August 2022, Cumberland announced the results of its 2021 Sustainability Report, outlining the company’s activities pertaining to environmental, social and governance matters.

Highlights from the report include:

• Cumberland provided 2.43 million doses of its products for patients in 2021.
• Cumberland also safely disposed of over 6,200 pounds of expired or damaged products in 2021.
• During 2021, Cumberland had:
* no products recalled,
* no company brands listed on FDA’s MedWatch Safety Alerts for Human Medical Products,
* no company product issues identified by FDA from their Adverse Event Reporting System,
* no clinical trials terminated due to failure to practice good clinical standards.

The 2021 Sustainability Report also highlights Cumberland’s investment in its employees through its continuing education programs, employee development initiatives and employee recognition awards. Cumberland’s workforce is 44% women, and 15% of its employees are minorities.

New Board Member
In July 2022, Cumberland welcomed Martin Brown Jr. to its board of directors. Brown’s experience includes 10 years on the board of directors of Brown-Forman Corporation, a large American spirits and wine company whose shares are listed on the New York Stock Exchange. Additionally, he has served since 2018 on the board of directors of the parent company of Aegis Sciences Corporation, a federally certified health care laboratory headquartered in Nashville.

Brown is an attorney at Adams and Reese LLP. He has nearly 30 years of legal experience representing privately held businesses, counseling owners in complex business transactions, intellectual property licensing, international commerce, mergers and acquisitions, and estate planning. He has been listed since 2009 in the corporate law category of Best Lawyers.

Additionally, Brown has been an active board member for many community organizations, including the Land Trust for Tennessee, Nashville Public Radio, Montgomery Bell Academy, Nashville Public Television, Centerstone Mental Health Center, Cheekwood Estate and Gardens, and Tennessee chapter of the Nature Conservancy.

RediTrex Arrangements with Nordic Pharma
On July 12, 2022, Cumberland and Nordic Pharma entered into an amendment to their agreement, addressing the responsibilities and financial arrangements regarding Cumberland’s license to Nordic’s methotrexate line of products for the U.S., which is marketed under the brand name RediTrex.

Based on the amendment, Cumberland has provided Nordic the opportunity to assume responsibility for commercializing the methotrexate products in the U.S. after March 31, 2023. Until then, Cumberland will continue to distribute and support the RediTrex product line. Following the return of the license, Nordic will provide Cumberland with a royalty on their future sales of the product through April 2035. The two companies will continue to collaborate on any transition and ongoing commercialization of the product line.

Ifetroban Clinical Studies
Cumberland is currently sponsoring three Phase II clinical programs to evaluate its ifetroban product candidate in 1) Aspirin-Exacerbated Respiratory Disease (AERD), a severe form of asthma; 2) Systemic Sclerosis or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs; and 3) patients with cardiomyopathy associated with Duchenne Muscular Dystrophy, a genetic neuromuscular disease that results in deterioration of the skeletal, heart and lung muscles. Cumberland is awaiting results from the studies underway before deciding on the best development path for the registration of ifetroban.

The company is also designing a fourth Phase II program to evaluate the use of ifetroban to treat patients with Progressive Fibrosing Interstitial Lung Diseases and is currently preparing an application to the FDA to support the new program.

In addition to these Cumberland-sponsored studies, Harvard clinical investigators have led a Phase II trial in patients with AERD. Their study is designed to understand the mechanism of ifetroban in those patients and therefore complements the work Cumberland has underway. Their work has been supported by a $5 million grant from the NIH. Patient enrollment in the study is now closed, and the data analysis is underway.

New Ifetroban Publication
In June 2022, the American Journal of Respiratory and Critical Care Medicine published preclinical studies that support the use of ifetroban as a promising therapeutic for patients with pulmonary fibrosis associated with lung disease.

Specifically, the researchers reported that ifetroban was used to block thromboxane receptor signaling in three preclinical models of lung fibrosis: bleomycin-induced lung fibrosis, Hermansky-Pudlak Syndrome mice and radiation-induced lung fibrosis. Ifetroban reduced pro-fibrotic signaling in the lungs and prevented lung fibrosis due to multiple causes (bleomycin, genetic and radiation).

FINANCIAL RESULTS:
Net Revenue: For the three months ended June 30, 2022, net revenues from continuing operations were $10.3 million.

Net revenue by product for the second quarter of 2022, included $3.6 million for Kristalose, $3.4 million for Sancuso, $1.6 million for Vibativ and $1.2 million for Caldolor.

Year-to-date 2022 net revenues were $21.5 million, compared to $19.6 million for the prior year period.

Year-to-date net revenues by product were $7.5 million for Kristalose, $6.8 million for Sancuso, $4.1 million for Vibativ and $2.2 million for Caldolor.

Operating Expenses: Total operating expenses for the second quarter were $12.1 million, compared to $10.5 million for the prior year period.

Year-to-date 2022 operating expenses were $24.6 million, compared to $21.4 million for 2021.

Adjusted Earnings: Adjusted earnings for the second quarter of 2022 were $(0.3) million, or $(0.01) per share.

The adjusted earnings calculation does not include the benefit of the $0.3 million of Vibativ cost of goods, which were received with the product acquisition. It also does not include the benefit of the $0.4 million of Sancuso cost of goods, which were received with that product’s acquisition.

Cash Flow: Year-to-date cash flow from operations was $2.2 million.

Balance Sheet: At June 30, 2022, Cumberland had $93 million in total assets including $18 million in cash and cash equivalents. Total liabilities were $53 million, including $19 million outstanding on the Company’s revolving line of credit. Total shareholders’ equity was $40 million.

ABOUT CUMBERLAND PHARMACEUTICALS:
Cumberland Pharmaceuticals Inc. is the largest biopharmaceutical company founded and headquartered in the Mid-South and is focused on the delivery of high-quality, prescription brands designed to improve patient care. The company develops, acquires, and commercializes products for the hospital acute care, gastroenterology, rheumatology and oncology market segments.

The Company’s portfolio of FDA-approved brands includes:

• Acetadote (acetylcysteine) injection, for the treatment of acetaminophen poisoning;
• Caldolor (ibuprofen) injection, for the treatment of pain and fever;
• Kristalose (lactulose) oral, a prescription laxative, for the treatment of constipation;
• Omeclamox-Pak, (omeprazole, clarithromycin, amoxicillin) oral, for the treatment of Helicobacter pylori (H. pylori) infection and related duodenal ulcer disease;
• RediTrex (methotrexate) injection, for the treatment of active rheumatoid, juvenile idiopathic and severe psoriatic arthritis, as well as disabling psoriasis;
• Sancuso (granisetron) transdermal, for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment;
• Vaprisol (conivaptan) injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia; and
• Vibativ (telavancin) injection, for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections;

The Company also has a series of Phase II clinical programs underway evaluating its ifetroban product candidate in patients with cardiomyopathy associated with Duchenne Muscular Dystrophy, Systemic Sclerosis and Aspirin-Exacerbated Respiratory Disease.

For more information on Cumberland’s approved products, including full prescribing information, please visit links to the individual product websites, which can be found on the Company’s website www.cumberlandpharma.com.

About Acetadote (acetylcysteine) Injection
Acetadote, administered intravenously within 8 to 10 hours after ingestion of a potentially hepatotoxic quantity of acetaminophen, is indicated to prevent or lessen hepatic injury. Used in the emergency department, Acetadote is approved in the United States to treat overdose of acetaminophen, a common ingredient in many over-the-counter medications. Acetadote is contraindicated in patients with hypersensitivity or previous anaphylactoid reactions to acetylcysteine or any components of the preparation. For full prescribing and safety information, visit www.acetadote.com.

About Caldolor (ibuprofen) Injection
Caldolor is indicated in adults and pediatric patients for the management of mild to moderate pain and management of moderate to severe pain as an adjunct to opioid analgesics, as well as the reduction of fever. It was the first FDA-approved intravenous therapy for fever. Caldolor is contraindicated in patients with known hypersensitivity to ibuprofen or other NSAIDs, patients with a history of asthma or other allergic type reactions after taking aspirin or other NSAIDs. Caldolor is contraindicated for use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery. For full prescribing and safety information, including boxed warning, visit www.caldolor.com.

About Kristalose (lactulose) Oral Solution
Kristalose is indicated for the treatment of acute and chronic constipation. It is a unique, proprietary, crystalline form of lactulose, with no restrictions on length of therapy or patient age. Kristalose is contraindicated in patients who require a low-galactose diet. Elderly, debilitated patients who receive lactulose for more than six months should have serum electrolytes (potassium, chloride, carbon dioxide) measured periodically. For full prescribing and safety information, visit www.kristalose.com

About Omeclamox-Pak (omeprazole, clarithromycin, amoxicillin)
Omeprazole is an antisecretory drug, which works by decreasing the amount of acid the stomach produces. Clarithromycin and amoxicillin are antibacterial drugs, which inhibit the growth of bacteria allowing the stomach lining to heal. Omeclamox-Pak is contraindicated in patients with a history of hypersensitivity to omeprazole, any macrolide antibiotic or penicillin. For full prescribing and safety information, visit www.omeclamox.com.

About RediTrex (methotrexate) Injection
RediTrex is a single-dose prefilled syringe containing prescription methotrexate. RediTrex is used to treat adults with severe, active rheumatoid arthritis and children with active polyarticular juvenile idiopathic arthritis, after treatment with other medicines including non-steroidal anti-inflammatory drugs (NSAIDS) have been used and did not work well. Methotrexate can control the symptoms of severe, resistant, disabling psoriasis in adults when other types of treatment have failed. For full prescribing and safety information, visit www.reditrex.com

About Sancuso (granisetron) Transdermal System
Sancuso is the only skin patch approved by the U.S. Food and Drug Administration for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately and/or highly emetogenic chemotherapy. When applied 24 to 48 hours before receiving chemotherapy, the SANCUSO patch slowly and continuously releases the medicine contained in the adhesive through clean and intact skin areas into the patient’s bloodstream. It can be worn for up to seven days in a row for chemotherapy regimens of up to five consecutive days. For full prescribing and safety information, visit www.sancuso.com.

About Vaprisol (conivaptan hydrochloride) Injection
Vaprisol is an intravenous treatment for hyponatremia used in the critical care setting. Hyponatremia is an electrolyte disturbance in which sodium ion concentration in blood plasma is lower than normal. This can be associated with a variety of critical care conditions including congestive heart failure, liver failure, kidney failure and pneumonia. The product is a vasopressin receptor antagonist that raises serum sodium levels and promotes free water secretion. Vaprisol is contraindicated in patients with hypovolemic hyponatremia. The coadministration of Vaprisol with potent CYP3A inhibitors, such as ketoconazole, itraconazole, clarithromycin, ritonavir, and indinavir, is contraindicated. For full prescribing and safety information, including boxed warning, visit www.vaprisol.com.

About Vibativ (telavancin) for Injection
Vibativ is a patented, FDA approved injectable anti-infective for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia and complicated skin and skin structure infections. It addresses a range of Gram-positive bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant. Intravenous unfractionated heparin sodium is contraindicated with Vibativ administration due to artificially prolonged activated partial thromboplastin time (aPTT) test results for up to 18 hours after Vibativ administration. Vibativ is contraindicated in patients with a known hypersensitivity to telavancin. For more information please visit www.vibativ.com.

On August 9, 2022 AVEO presented the Corporate Presentation (Presentation, AVEO, AUG 9, 2022, View Source [SID1234617930]).

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