On May 7, 2019 Allergan plc (NYSE: AGN) reported its first quarter 2019 financial results including GAAP net revenues of $3.60 billion, a 2.0 percent decrease from the prior year quarter (Press release, Allergan, MAY 7, 2019, View Source [SID1234535841]).

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Executive Commentary

"Our first quarter results reflected continued growth of our Core Business, which increased 4.4 percent year-over-year across our four key therapeutic areas. Growth of key products such as BOTOX Cosmetic, BOTOX Therapeutic, VRAYLAR, JUVÉDERM and Lo LOESTRIN offset declines in products that lost exclusivity and products which were divested in 2018," said Brent Saunders, Chairman and CEO of Allergan. "Many key R&D programs have made steady progress and we now anticipate five regulatory approvals over the next 18 months. I appreciate the talented Allergan colleagues around the world who are bringing our products to patients who need them and positioning Allergan for a successful 2019 and beyond."

First Quarter 2019 Results

GAAP operating loss in the first quarter of 2019 was $2.31 billion, including the impact of impairments. Non-GAAP operating income in the first quarter of 2019 was $1.63 billion, a decrease of 7.6 percent versus the prior year quarter, impacted by lower operating margin and revenues due to the impact of divestitures, products that lost exclusivity and declines in textured breast implants and RESTASIS. GAAP cash flow from operations for the first quarter of 2019 totaled $1.23 billion.

Operating Expenses

Total GAAP Selling, General and Administrative (SG&A) Expense was $1.11 billion for the first quarter 2019, an increase of 1.5 percent from the prior year quarter. Total non-GAAP SG&A expense was $1.10 billion for the first quarter 2019, an increase of 4.5 percent from the prior year quarter, primarily related to an increase in selling and marketing spending in Medical Aesthetics. GAAP R&D investment for the first quarter of 2019 was $435.0 million, compared to $474.7 million in the first quarter of 2018. Non-GAAP R&D investment for the first quarter 2019 was $397.9 million, an increase of 11.8 percent compared to the prior year quarter, due to increased direct project spend to support pipeline advancement.

Amortization, Tax and Capitalization

Amortization expense for the first quarter 2019 was $1.40 billion, compared to $1.70 billion in the first quarter of 2018. The Company’s GAAP tax rate was 2.8 percent in the first quarter 2019. The Company’s non-GAAP adjusted tax rate was 12.8 percent in the first quarter 2019. As of March 31, 2019, Allergan had cash and marketable securities of $1.78 billion and outstanding indebtedness of $23.53 billion.

Asset Sales & Impairments, Net and In-Process R&D Impairments

Allergan recorded a goodwill impairment of $2.47 billion in the three months ended March 31, 2019, primarily related to the failure of rapastinel in clinical trials for major depressive disorder, which resulted in a lower fair value of the General Medicine reporting unit compared to the fair value as of December 31, 2018. The Company excludes asset sales and impairments, net and in-process research and development impairments from its Non-GAAP performance net income attributable to shareholders as well as Adjusted EBITDA and Non-GAAP Operating Income.

FIRST QUARTER 2019 BUSINESS SEGMENT RESULTS

U.S. Specialized Therapeutics

U.S. Specialized Therapeutics net revenues were $1.54 billion in the first quarter of 2019, a decrease of 2.3 percent versus the prior year quarter. Demand growth in BOTOX Therapeutic, BOTOX Cosmetic and JUVÉDERM Collection was partially offset by a decline in CoolSculpting sales compared to the prior year quarter, lower RESTASIS revenues due to lower net pricing, as well as the divestiture of the Company’s Medical Dermatology business on September 20, 2018. Segment gross margin for the first quarter of 2019 was 92.2 percent. Segment contribution for the first quarter 2019 was $1.01 billion.

Medical Aesthetics

Facial Aesthetics
BOTOX Cosmetic net revenues in the first quarter of 2019 were $229.5 million, an increase of 16.7 percent from the prior year quarter.
JUVÉDERM Collection (defined as JUVÉDERM, VOLUMA and other fillers) net revenues in the first quarter of 2019 were $129.7 million, an increase of 5.6 percent versus the prior year quarter.
Regenerative Medicine
ALLODERM net revenues in the first quarter of 2019 were $95.0 million, a decrease of 4.5 percent versus the prior year quarter.
Body Contouring
CoolSculpting net revenues (including both CoolSculpting Systems/Applicators and Consumables) in the first quarter of 2019 were $62.9 million, a decrease of 27.8 percent from the prior year quarter.
Neurosciences & Urology

BOTOX Therapeutic net revenues in the first quarter of 2019 were $397.6 million, an increase of 5.8 percent versus the prior year quarter.
Eye Care

RESTASIS net revenues in the first quarter of 2019 were $231.7 million, a decrease of 9.4 percent versus the prior year quarter.
ALPHAGAN/COMBIGAN net revenues in the first quarter of 2019 were $83.0 million, a decrease of 1.4 percent versus the prior year quarter.
OZURDEX net revenues in the first quarter of 2019 were $30.3 million, an increase of 18.8 percent versus the prior year quarter.
U.S. General Medicine

U.S. General Medicine net revenues in the first quarter of 2019 were $1.25 billion, an increase of 2.1 percent versus the prior year quarter, primarily due to growth in VRAYLAR and Lo LOESTRIN, partially offset by lower revenues from products that lost exclusivity. Segment gross margin for the first quarter of 2019 was 84.8 percent. Segment contribution for the first quarter 2019 was $805.1 million.

Central Nervous System

VRAYLAR net revenues were $143.7 million in the first quarter of 2019, an increase of 70.3 percent from the prior year quarter.
VIIBRYD/FETZIMA net revenues in the first quarter of 2019 were $85.0 million, an increase of 18.5 percent from the prior year quarter.
Gastrointestinal, Women’s Health & Diversified Brands

LINZESS net revenues in the first quarter of 2019 were $161.3 million, an increase of 1.3 percent versus the prior year quarter.
Lo LOESTRIN net revenues in the first quarter of 2019 were $125.8 million, an increase of 9.8 percent versus the prior year quarter.
BYSTOLIC/BYVALSON net revenues in the first quarter of 2019 were $128.3 million, a decrease of 3.4 percent from the prior year quarter.
International

International net revenues in the first quarter of 2019 were $801.5 million, an increase of 1.3 percent versus the prior year quarter excluding foreign exchange impact, driven by growth in Facial Aesthetics partially impacted by regulatory changes for textured breast implants in certain international markets as well as lower glaucoma and eye drop revenues due to trade buying patterns. Segment gross margin for the first quarter of 2019 was 86.3 percent. Segment contribution was $428.5 million.

Facial Aesthetics

BOTOX Cosmetic net revenues in the first quarter of 2019 were $147.4 million, an increase of 8.5 percent versus the prior year quarter excluding foreign exchange impact.
JUVÉDERM Collection net revenues in the first quarter of 2019 were $157.8 million, an increase of 18.3 percent versus the prior year quarter excluding foreign exchange impact.
Eye Care

LUMIGAN/GANFORT net revenues in the first quarter of 2019 were $85.1 million, a decrease of 7.8 percent versus the prior year quarter excluding foreign exchange impact.
OZURDEX net revenues in the first quarter of 2019 were $63.1 million, an increase of 6.7 percent versus the prior year quarter excluding foreign exchange impact.
Botox Therapeutic

BOTOX Therapeutic net revenues in the first quarter of 2019 were $93.9 million, an increase of 6.7 percent versus the prior year quarter excluding foreign exchange impact.
PIPELINE UPDATE

Allergan R&D continues to advance its pipeline. During the first quarter of 2019, the Company’s key late-stage clinical developments included (most recent listed first):

Allergan and Molecular Partners announced topline safety results from the MAPLE study of abicipar for the treatment of neovascular age-related macular degeneration. The study used a modified manufacturing process and demonstrated decreased intraocular inflammation of 8.9 percent compared to greater than 15 percent in previous Phase 3 clinical trials. Allergan expects to submit a Biologics License Application (BLA) for abicipar with the U.S. Food and Drug Administration (FDA) in the first half of 2019.
Allergan announced the FDA approved the company’s supplemental New Drug Application (sNDA) for AVYCAZ (ceftazidime and avibactam), expanding the label to include children and infants (patients three months and older) for the treatment of complicated intra-abdominal infections in combination with metronidazole and of complicated urinary tract infections.
The FDA accepted Allergan’s New Drug Application (NDA) for ubrogepant for the acute treatment of migraine. The NDA filing is based on positive results from two Phase 3 clinical trials demonstrating the efficacy, safety and tolerability of ubrogepant, an oral CGRP receptor antagonist, as well as two additional positive safety studies. A 10-month review period has been assigned with a Prescription Drug User Fee Act (PDUFA) date in the fourth quarter of 2019.
The FDA accepted Allergan’s supplemental biologics license applications (sBLAs) to expand the BOTOX (onabotulinumtoxinA) label for the treatment of pediatric patients ages two years and older with upper and lower limb spasticity. The pediatric upper limb spasticity indication has been designated a 6-month Priority Review with a PDUFA date expected in the second quarter of 2019. The pediatric lower limb spasticity indication will undergo a standard 10-month review with a PDUFA date expected in the fourth quarter of 2019.
Allergan announced topline results from three Phase 3 studies of rapastinel as an adjunctive treatment of Major Depressive Disorder. In all three pivotal acute studies, rapastinel did not meet primary and key secondary endpoints. Additionally, an interim analysis of a relapse prevention study of rapastinel suggested the primary and key secondary endpoints would not be met.
Allergan reported positive topline results from two Phase 3 clinical trials of Bimatoprost SR, a first-in-class sustained-release, biodegradable implant for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Allergan anticipates submitting an NDA to the FDA in the first half of 2019.
In addition to first quarter 2019 pipeline developments, Allergan anticipates a regulatory decision from the FDA in May 2019 for the Company’s sNDA for VRAYLAR (cariprazine) seeking to expand the indication to include the treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults.

1) GAAP represents EPS for ordinary shareholders. GAAP income per share includes the impact of amortization of approximately $5.6 billion. Non-GAAP represents performance net income per share.

(2) GAAP EPS shares do not include dilution of shares when earnings are a net loss. As such, the dilution impact of outstanding equity awards is not included in the forecasted shares.

FIRST QUARTER 2019 CONFERENCE CALL AND WEBCAST DETAILS

Allergan will host a conference call and webcast today, Tuesday, May 7, at 8:30 a.m. Eastern Time to discuss its first quarter 2019 results. The dial-in number to access the call is U.S./Canada (877) 251-7980, International (706) 643-1573, and the conference ID is 7466378. A replay of the conference call will also be available beginning approximately two hours after the call’s conclusion and will remain available through 11:30 p.m. Eastern Time on June 7, 2019. The replay may be accessed by dialing (855) 859-2056 or (404) 537-3406 and entering the conference ID 7466378.

To access the webcast, please visit Allergan’s Investor Relations website at View Source;. A replay of the webcast will also be available on Allergan’s Investor Relations website.

Allergan Contacts:

Investors:

Manisha Narasimhan, PhD

(862) 261-7162

Christine Chiou

(862) 261-7396

Media:

Amy Rose

(862) 289-3072

Lisa Brown

(862) 261-7320

On May 7, 2019 Vericel Corporation (NASDAQ:VCEL), a leader in advanced cell therapies for the sports medicine and severe burn care markets, reported financial results for the first quarter ended March 31, 2019, and recent business highlights (Press release, Vericel, MAY 7, 2019, View Source [SID1234535836]).

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First Quarter 2019 Financial Highlights

Total net product revenues increased 21% to $21.8 million compared to $18.0 million in the first quarter of 2018;

Gross margins of 60% compared to gross margins of 57% in the first quarter of 2018;

Net loss of $2.8 million, or $0.07 per share, compared to $7.7 million, or $0.21 per share, in the first quarter of 2018;

Non-GAAP adjusted EBITDA loss of $0.4 million compared to a loss of $2.6 million in the first quarter of 2018;

As of March 31, 2019, the company had $84.1 million in cash and short-term investments compared to $82.9 million as of December 31, 2018; and

Full year 2019 revenue guidance for MACI and Epicel raised to $110 to $114 million compared to previous full year revenue guidance of $108 million to $112 million.

Recent Business Highlights
During and since the first quarter of 2019, the company:

Announced an exclusive license agreement with MediWound Ltd. for North American rights to NexoBrid, a biological orphan product for debridement of thermal burns;

Deployed the expanded MACI sales force, which increased from 40 to 48 territories; and

Reported publication of outcomes data from 954 burn patients treated with Epicel in the Journal of Burn Care and Research.

"We delivered another solid quarter of performance and the MACI sales force continues to increase its productivity even as we add new representatives, which speaks to the quality of our sales representatives as well as the demand for MACI," said Nick Colangelo, president and CEO of Vericel. "Based on the strong underlying indicators of growth for the rest of the year we have raised our full year 2019 revenue guidance. Moreover, we believe that the addition of NexoBrid significantly expands our burn care target addressable market and will enable us to build a second significant commercial franchise to go along with our cartilage repair franchise, thereby enhancing the long-term growth profile of the company."

First Quarter 2019 Results
Total net product revenues for the quarter ended March 31, 2019 increased 21% to $21.8 million compared to $18.0 million in the first quarter of 2018. Total net product revenues for the quarter included $16.6 million of MACI (autologous cultured chondrocytes on porcine collagen membrane) net revenue and $5.2 million of Epicel (cultured epidermal autografts) net revenue, compared to $12.1 million of MACI net revenue and $6.0 million of Epicel net revenue, respectively, in the first quarter of 2018.
Gross profit for the quarter ended March 31, 2019 was $13.2 million, or 60% of net revenues, compared to $10.4 million, or 57% of net revenues, for the first quarter of 2018.
Total operating expenses for the quarter ended March 31, 2019 were $16.5 million compared to $14.7 million for the same period in 2018. The increase in operating expenses was primarily due to a $1.2 million increase in stock-based compensation, an incremental $0.6 million in MACI sales force expenses as a result of the sales force expansion in the second quarter of 2018, and a $0.6 million increase in selling expenses and patient reimbursement support services.
Vericel’s net loss for the quarter ended March 31, 2019 was $2.8 million, or $0.07 per share, compared to $7.7 million, or $0.21 per share, for the first quarter of 2018.
Non-GAAP adjusted EBITDA loss was $0.4 million for the quarter ended March 31, 2019 compared to a loss of $2.6 million in the first quarter of 2018. See table reconciling non-GAAP measures for more details.
As of March 31, 2019, the company had $84.1 million in cash and short-term investments compared to $82.9 million as of December 31, 2018.
Full Year 2019 Financial Guidance
The company now expects total MACI and Epicel net product revenues for the full year 2019 to be in the range of $110 to $114 million, compared to the previous full year revenue guidance of $108 to $112 million.

Conference Call Information
Today’s conference call will be available live at 8:00am Eastern time in the Investor Relations section of the Vericel website at View Source." target="_blank" title="View Source." rel="nofollow">View Source A presentation supporting today’s conference call will be available on the webcast and in the Investor Relations section of the Vericel website. Please access the site at least 15 minutes prior to the scheduled

start time in order to download the required audio software if necessary. To participate in the live call by telephone, please call (877) 312-5881 and reference Vericel Corporation’s first-quarter 2019 investor conference call. If calling from outside the U.S., please use the international phone number (253) 237-1173.
If you are unable to participate in the live call, the webcast will be available at View Source until May 7, 2020. A replay of the call will also be available until 11:00am (EDT) on May 12, 2019 by calling (855) 859-2056, or from outside the U.S. (404) 537-3406. The conference ID is 1775796.

On May 7, 2019 Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, reported financial results and business highlights for the first quarter ended March 31, 2019 (Press release, Tocagen, MAY 7, 2019, View Source [SID1234535835]).

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"We had a strong start to the year with excellent progress on multiple fronts related to our Phase 3 Toca 5 trial of Toca 511 & Toca FC in patients with recurrent high grade glioma and potential commercial launch," said Marty Duvall, chief executive officer of Tocagen. "We ended the quarter well capitalized to fund operations into 2020 and look forward to the pending interim analysis of the Toca 5 trial this quarter and the final analysis by the end of the year."

First Quarter 2019 and Recent Highlights

Expanded leadership team: Fairooz Kabbinavar, M.D., FACP, was appointed senior vice president, clinical development, to oversee the advancement of Tocagen’s platform and lead product candidate, Toca 511 & Toca FC. Prior to joining Tocagen, Dr. Kabbinavar was principal medical director at Genentech where he led the development of cancer immunotherapy TECENTRIQ (atezolizumab) in small cell lung cancer as well as serving as the clinical lead for the head and neck cancer program. With this addition, Tocagen further adds to its leadership team’s deep biopharmaceutical R&D and commercialization experience, positioning the company for potential BLA filing and commercialization. Acting chief medical officer Lori A. Kunkel, M.D. has returned to the company’s board of directors.

Presented Toca 511 & Toca FC data: In April, Tocagen presented clinical and preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 and the 2019 American Association of Neurological Surgeons (AANS) Annual Meeting. New preclinical data demonstrated increased survival from the combination of Toca 511 & Toca FC with either temozolomide or cyclophosphamide. These results support the planned Phase 2/3 trial (NRG-BN006) evaluating Toca 511 & Toca FC in combination with standard of care, including temozolomide, in patients with newly diagnosed glioblastoma (GBM) to be conducted by NRG Oncology under its NCI-funded grant.

First Quarter 2019 Financial Results

Research and Development (R&D) Expenses: R&D expenses were $12.4 million for the quarter ended March 31, 2019, compared to $10.4 million for the quarter ended March 31, 2018. The R&D expenses in both periods were primarily driven by costs to support the Toca 5 trial and to support the manufacturing of drug product. The increase in 2019 reflects primarily higher manufacturing spend as compared to the same period in 2018.

General and Administrative (G&A) Expenses: G&A expenses were $4.4 million for the quarter ended March 31, 2019, compared to $2.4 million for the quarter ended March 31, 2018. The increase in G&A expenses was primarily due to higher personnel costs and contracted services to support the increased activity.

Net Loss: Net loss was $17.1 million, or $0.74 per common share (basic and diluted), for the quarter ended March 31, 2019, compared to a net loss of $12.9 million, or $0.65 per common share (basic and diluted), for the quarter ended March 31, 2018. The 2019 calculation is based on 23.0 million average common shares outstanding for the first quarter of 2019, compared to 19.9 million average common shares outstanding for the first quarter of 2018. Our average shares outstanding increased primarily as a result of selling 3.0 million shares in a public offering in December 2018.

Cash Position

Cash, cash equivalents and marketable securities were $80.1 million at March 31, 2019 compared to $96.1 million at December 31, 2018.

About Toca 511 & Toca FC

Tocagen’s lead product candidate is a two-part cancer-selective immunotherapy comprising an investigational biologic, Toca 511 (vocimagene amiretrorepvec), and an investigational small molecule, Toca FC (flucytosine, extended-release). Toca 511 is a retroviral replicating vector (RRV) that selectively infects cancer cells and delivers a gene for the enzyme, cytosine deaminase (CD). Through this targeted delivery, infected cancer cells carry the CD gene and produce CD. Toca FC is an orally administered prodrug, 5-fluorocytosine (5-FC), which is converted into an anti-cancer drug, 5-fluorouracil (5-FU), when it encounters CD. 5-FU kills cancer cells and immune-suppressive myeloid cells resulting in anti-cancer immune activation and subsequent tumor killing.

On May 7, 2019 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported that Marc N. Casper, president and chief executive officer, will present at the Bank of America Merrill Lynch 2019 Health Care Conference on Tuesday, May 14, 2019, at 8:40 a.m. (PT) at the Encore at the Wynn Las Vegas, Las Vegas, Nevada (Press release, Thermo Fisher Scientific, MAY 7, 2019, View Source [SID1234535834]).

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You can access the live webcast of the presentation via the Investors section of our website, www.thermofisher.com.

On May 7, 2019 Novelion Therapeutics Inc. (NASDAQ: NVLN), a biopharmaceutical company dedicated to developing and commercializing therapies for individuals living with rare diseases ("Novelion" or the "Company"), reported financial results for the first quarter ended March 31, 2019 (Press release, QLT, MAY 7, 2019, View Source [SID1234535833]).

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Novelion’s Interim Chief Executive Officer Ben Harshbarger commented, "We continue to execute on our goals of achieving target revenues, maximizing the impact of the operating cost reductions that we implemented in late 2018, working with the FDA on the development program for the potential expansion of the metreleptin label in the U.S. to include the partial lipodystrophy (PL) indication, and pursuing a comprehensive capital restructuring."

Business Update

Sales growth was supported by the launch of MYALEPTA (metreleptin) in Germany in the fourth quarter of 2018. Following marketing authorization of MYALEPTA for generalized lipodystrophy (GL) and PL by the EMA, Novelion’s subsidiary Aegerion Pharmaceuticals commenced the pricing and reimbursement processes in key EU markets. Reimbursement decisions in many of the key EU markets are anticipated throughout 2019.

In January 2019, Aegerion held a meeting with the U.S. Food and Drug Administration (FDA) to obtain feedback on the design of the placebo-controlled study for the PL indication for MYALEPT in the U.S. Aegerion is assessing feedback on the study design and integrating it into the Phase 3 study protocol.

Aegerion plans to file for regulatory approvals for metreleptin in GL and PL in certain key markets outside the U.S. and EU, including Brazil, in 2019.

As previously announced, Novelion and Aegerion have each engaged advisors to independently explore and advise them on all available strategic alternatives regarding the Company’s capital structure, such as a restructuring of Aegerion’s Convertible Notes due August 2019 (including a restructuring that would likely involve a debt for equity exchange), a sale or merger of Novelion or Aegerion, or the sale or other disposition of certain businesses or assets. The implementation of one or more of such transactions (or the failure to complete any such transaction or transactions) will likely require Aegerion, and could require Novelion, to seek the protections of applicable bankruptcy laws allowing for corporations to seek to restructure their debts and other affairs under a court supervised reorganization process.

First Quarter 2019 Financial Results

JUXTAPID: The Company reported net revenues of JUXTAPID of $14.2 million in the first quarter of 2019, compared to $13.4 million for the same period in 2018, $9.1 million, or 64.1%, of which was from prescriptions written in the U.S. and $0.8 million of which was royalty revenue from sales in the EMEA region. Growth in JUXTAPID revenue in the first quarter of 2019 compared to the same period in 2018 was due to an increase in revenues in the U.S., primarily resulting from a price increase, and a greater number of patients on therapy in Japan.

MYALEPT/MYALEPTA: The Company reported net revenues of MYALEPT/MYALEPTA of $18.0 million in the first quarter of 2019, compared to $14.1 million for the same period in 2018, $11.4 million, or 63.3%, of which was from prescriptions written in the U.S. MYALEPT/MYALEPTA revenue growth in the first quarter was driven by increased sales in Germany, as a result of the recent launch, and the U.S., as a result of a greater number of shipments to patients as well as a price increase, partially offset by a decline in sales in Brazil.

GAAP total net revenues for the first quarter of 2019 were $32.2 million compared to $27.5 million for the same period in 2018.

Cost of product sales for the first quarter of 2019 was $15.2 million compared to $13.5 million for the same period in 2018. The increase is primarily attributed to higher stability testing costs and higher supply chain costs as well as a higher royalty rate on U.S. sales of metreleptin, partially offset by a lower inventory cost basis in the first quarter of 2019. Despite the increase, gross margin improved from 50.9% to 52.7% as a result of higher revenues in comparison to certain fixed costs.

GAAP total operating expenses for the first quarter of 2019 were $33.0 million compared to total operating expenses of $35.5 million, a 7.0% reduction compared to the same period in 2018. GAAP selling, general and administrative (SG&A) expenses were $26.0 million in the first quarter of 2019, including approximately $13.8 million of costs related to the Company’s ongoing debt restructuring and strategic review processes, compared to $23.7 million for the same period in 2018. GAAP R&D expenses were $6.9 million in the first quarter of 2019 compared to $11.8 million for the same period in 2018.

On a non-GAAP basis, during the first quarter of 2019, SG&A expenses were $11.7 million compared to $21.6 million for the same period in 2018. In the first quarter of 2019, we incurred $12.3 million of non-ordinary course expenses, which primarily consist of legal, financial/restructuring advisory, and consulting fees, in connection with our ongoing strategic alternatives review, as well as a $1.5 million payment to extend the maturity date of Aegerion’s bridge loans. The 45.8% decrease in non-GAAP SG&A expenses in the first quarter of 2019 compared with the same period in 2018 is primarily the result of cost reduction initiatives implemented in late 2018 as well as the delay of certain ordinary course projects and initiatives to later in the year.

On a non-GAAP basis, during the first quarter of 2019, R&D expenses decreased 41.4% to $6.8 million compared to $11.6 million for the same period in 2018, reflecting cost reduction initiatives, as well as the delay of certain ordinary course projects and initiatives to later in the year, partially offset by higher spending related to pharmacovigilance activities.

On a non-GAAP basis, during the first quarter of 2019, total operating expenses were $18.6 million compared to $33.3 million for the same period in 2018, reflecting a decrease in expenses for the reasons set forth above.

GAAP net loss in the first quarter of 2019 was $31.8 million, an improvement of approximately 3.0% compared to GAAP net loss of $32.8 million during the same period in 2018.

On a non-GAAP basis, net income was $1.9 million in the first quarter of 2019 compared to a net loss of $13.5 million for the same period in 2018.

A full reconciliation of the GAAP financial results to non-GAAP financial results is included in the financial information tables below.

Debt and Government Settlement Payments

As of March 31, 2019, Aegerion’s debt liabilities and government settlement payments included $302.5 million in outstanding principal under Aegerion’s Convertible Notes due August 15, 2019, $74.4 million in outstanding principal (including paid in kind fees and interest) under Aegerion’s secured term loans having a maturity date of June 30, 2019, $35.7 million outstanding under Aegerion’s secured intercompany term loan with Novelion, as lender, which has a maturity date of July 1, 2019, as well as $29.3 million owed under Aegerion’s settlements with the Department of Justice and the U.S. Securities and Exchange Commission (the "Commission"), payable in prescribed installments until the first quarter of 2021.

Financial Guidance

Novelion expects total net revenues in 2019 to be between $160.0 and $175.0 million, including approximately $30.0 million of licensing revenues, in the form of the $25.0 million upfront licensing payment and $5.0 million payment upon transfer of the marketing authorization to Recordati Rare Diseases Inc. ("Recordati"), resulting from the licensing agreement entered into between Aegerion and Recordati for the commercialization of JUXTAPID in Japan in February 2019.

About Novelion Therapeutics

Novelion Therapeutics is a global biopharmaceutical company dedicated to developing and commercializing therapies that deliver new standards of care for people living with rare and underserved diseases. With a global footprint and an established commercial portfolio, including MYALEPT (metreleptin) and JUXTAPID (lomitapide), our business is supported by differentiated treatments that treat severe and rare diseases.

Cautionary Note

Novelion is the parent company of Aegerion, our operating subsidiary and the source of the consolidated company’s revenues. References to "we," "our" and the "Company" refer to the entire enterprise, whose assets and operations reside primarily at Aegerion. As described above, Aegerion has a substantial amount of debt, including a secured term loan entered into in November 2018, which matures on June 30, 2019, its 2% Convertible Notes, which mature on August 15, 2019, and a secured intercompany term loan from Novelion, which matures on July 1, 2019. In light of these arrangements and their provisions, which prohibit Aegerion from making certain payments,

including payments in cash, to Novelion (including for out-of-pocket costs incurred, and services rendered, by or on behalf of Novelion, for the benefit of Aegerion), investors are cautioned that Aegerion’s interests may not always be aligned, and may in certain circumstances be in conflict, with those of Novelion or its shareholders. The risks attendant to these conflicts of interest are described below under the caption "Forward Looking Statements and Risk Factors," which section you should read carefully and in its entirety.

Non-GAAP Results

The non-GAAP results in this press release, including, without limitation, non-GAAP R&D expenses, non-GAAP SG&A expenses, non-GAAP total operating expenses and non-GAAP net income (loss), are provided as a complement to results provided in accordance with GAAP because management believes, when considered together with the GAAP information, these non-GAAP financial measures help indicate underlying trends in the Company’s business, are important in comparing current results with prior period results and provide additional information regarding the Company’s financial performance. Management also uses these non-GAAP financial measures to establish budgets and operational goals that are communicated internally and externally, and to manage the Company’s business and evaluate its performance. The non-GAAP financial measures have no standardized meaning under GAAP and therefore may not be comparable to similar measures presented by other companies. The non-GAAP financial measures are not intended to be considered in isolation or as a substitute for, or superior to, the financial measures prepared and presented in accordance with GAAP and should be reviewed in conjunction with the relevant GAAP financial measures. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the attached financial information.