CBB = CINCINNATI–(BUSINESS WIRE)– Cincinnati Bell Inc. (NYSE:CBB), today announced financial results for the third quarter of 2019.

Commenting on the company’s performance, President and Chief Executive Officer Leigh Fox stated, “Our solid third quarter results demonstrate the superior quality of our fiber assets and ability to capitalize on the expanded scale of our IT services business. Looking ahead, we remain committed to our full year 2019 financial guidance.”

  • Revenue of $383 million and operating income of $23 million— Adjusted EBITDA1 totaled $102 million
  • Entertainment and Communications revenue totaled $249 million, generating Adjusted EBITDA of $93 million, up 2% year-over-year
  • Fiber-to-the-premise (“FTTP”) HSI net activations totaled 3,800 in Cincinnati and 900 in Hawaii during the quarter
  • Hawaiian Telcom generated Adjusted EBITDA of $25 million, an increase of 13% from a year ago
  • IT Services and Hardware revenue totaled $141 million, generating Adjusted EBITDA of $12 million
  • Cash provided by operating activities totaled $189 million year-to-date, and free cash flow2 of $34 million year-to-date

AXGN = Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for damage or transection to peripheral nerves, today reported financial results and business highlights for the third quarter ended September 30, 2019.

Third Quarter 2019 Financial Results:

  • Net sales were $28.6 million during the quarter, an increase of 26.1% compared to third quarter 2018 revenue of $22.7 million.
  • Gross margin was 84.2% for the quarter, compared to 84.7% in the third quarter of 2018.
  • Net loss for the quarter was $5.6 million, or $0.14 per share, compared to net loss of $4.1 million, or $0.11 per share in the third quarter of 2018.
  • Adjusted net loss was $2.6 million for the quarter, or $0.07 per share, compared with adjusted net loss of $1.9 million, or $0.05 per share, in the third quarter of 2018.
  • Adjusted EBITDA loss was $3.0 million for the quarter, compared to adjusted EBITDA loss of $2.4 million in the third quarter of 2018.
  • Ended the quarter with $106.1 million in cash, cash equivalents, and investments, compared to $109.1 million at the end of the second quarter of 2019.

“We delivered solid financial results during the quarter, and I am pleased with the progress we are making to improve our commercial operations,” commented Karen Zaderej, chairman, CEO, and president. “We are rebalancing our efforts toward our largest market opportunity, extremity trauma, which represents the most efficient and effective path to sustainable long-term growth. We will continue to invest in the breast reconstruction neurotization and oral and maxillofacial markets and expect to expand these efforts as these nascent markets continue to develop. Additionally, we are slowing the rate of sales force expansion to enable further productivity gains across our existing commercial footprint. We are encouraged with the early results of these initiatives and will continue to evaluate and build upon them throughout the remainder of the year and into 2020.” 

Additional Third Quarter 2019 Operational and Clinical Updates:

  • Increased active accounts in the third quarter to 791, up 16% from 679 a year ago.
  • Ended the quarter with 105 direct sales representatives and 19 independent agencies.
  • Conducted four national education programs in the third quarter, including one OMF specialty program, and expect to conduct 25 programs in total during 2019.
  • Added five peer reviewed clinical publications to our surgical portfolio for a total of 105.
  • Increased the number of presentations at clinical and scientific conferences related to our surgical portfolio by 14, for a total of 44 year-to-date.
  • The following updates were provided by clinical investigators at the 2019 American Society for Surgery of the Hand (ASSH) meeting:
    • Updated data from the RANGER® registry, including 511 upper extremity nerve repairs, demonstrate a consistent meaningful recovery rate for Avance® Nerve Graft of 84%
    • Findings from the MATCHSM study show Avance Nerve Graft had statistically significant improvements as compared to synthetic conduits in three essential areas: the rate of recovery, the overall degree of recovery, and in average recovery of static two-point discrimination, a key sensory measure in the hand

2019 Financial Guidance
The Company continues to expect 2019 revenue will be between $106 million and $110 million. Management reiterates its expectation for gross margin to remain above 80%. Additionally, the Company now expects to have between 105 and 110 direct sales representatives by year-end, compared to its previous estimate of at least 115.

COMM = HICKORY, N.C.–(BUSINESS WIRE)– CommScope Holding Company, Inc. (NASDAQ: COMM), a global leader in infrastructure solutions for communications networks, reported results for the quarter ended September 30, 2019.

The company reported third quarter net sales of $2.38 billion, an increase of 106.9% compared to $1.15 billion during the same period in the prior year. The third quarter of 2019 included sales of $1.34 billion from ARRIS, which was acquired in April 2019. ARRIS sales in the third quarter include a $14 million reduction of revenue related to deferred revenue purchase accounting adjustments. CommScope generated a net loss of $(156.5) million, or $(0.88) per basic share, a decrease from the prior year period’s net income of $63.8 million, or $0.33 per diluted share. Non-GAAP adjusted net income for the third quarter of 2019 was $126.9 million, or $0.55 per diluted share, versus $114.5 million, or $0.59 per diluted share, in the third quarter of 2018. A reconciliation of reported GAAP results to non-GAAP results is included below.

“We are pleased to deliver third quarter adjusted EBITDA at the high end, and adjusted earnings per share above the high end, of our guidance,” said President and Chief Executive Officer Eddie Edwards. “Despite a challenging customer environment, our results reflect the company’s ability to manage near-term headwinds while maximizing profitability. In the third quarter, we generated over $500 million of adjusted free cash flow, enabling $400 million of early debt repayment in the third quarter and beginning of the fourth quarter. These results illustrate our ability to act with agility and meet our short-term and long-term financial obligations despite broader industry headwinds.

“We remain enthusiastic about the unique opportunity to generate significant cash flow while playing an important role in shaping the future of communications connectivity. We’ve taken significant strides throughout the year to execute on our plan, reposition the company to achieve accelerated returns, and improve financial and operational results. With our portfolio of industry-leading products, strong customer relationships, and talented team, our confidence in achieving our full potential remains as strong as ever.”

Third Quarter 2019 Highlights (all comparisons highlighted below are year-over-year)

  • Net sales of $2.38 billion
  • GAAP operating loss of $(50.8) million
  • GAAP net loss of $(0.88) per basic share compared to net income of $0.33 per diluted share
  • Non-GAAP adjusted EBITDA (excluding special items) increased 55.5% to $369.8 million
  • Non-GAAP adjusted net income (excluding special items) of $0.55 per diluted share decreased 6.8%
  • GAAP cash flow from operations of $522.1 million
  • Non-GAAP adjusted free cash flow of $535 million
  • $200 million of notes due 2021 redeemed in August and an additional $200 million of 2021 notes redeemed in the fourth quarter

COLL = STOUGHTON, Mass., Nov. 06, 2019 (GLOBE NEWSWIRE) — Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a specialty pharmaceutical company committed to being the leader in responsible pain management, today reported its financial results for the quarter ended September 30, 2019 and provided a corporate update.

“Driven by strong Xtampza ER revenue growth and a commitment to leveraging our existing cost structure, we are on track to make 2019 a breakthrough year for Collegium,” said Joe Ciaffoni, President and Chief Executive Officer of Collegium. “Effective January 1, 2020, Xtampza ER will become the exclusive extended-release oxycodone for more than 35 million additional lives. These payer wins will drive the next stage of growth for Xtampza ER.”

Recent Business Highlights

  • Xtampza ER formulary access continues to strengthen: As of January 1, 2020, Xtampza ER will move into an exclusive formulary position across 15 plans covering more than 35 million lives. With the addition of these new exclusive ER oxycodone formulary positions, Xtampza ER will be the exclusive branded ER oxycodone for more than 85 million lives.
  • Xtampza ER total prescriptions grew to 120,409 in the third quarter of 2019. Through the first three quarters of 2019, prescriptions grew 44% over the prior year period, and 3% compared to the second quarter of 2019.
  • Strengthened management team with the appointment of Bart Dunn to the role of Executive Vice President, Strategy and Corporate Development.
  • Leading with the Science

Collegium had a strong presence at the 13th Annual PAINWeek National Conference which took place in Las Vegas in September 2019. Four poster presentations that span Collegium’s product portfolio were presented during the conference.

A manuscript about Nucynta ER titled, “Evaluation of Abuse and Route of Administration of Extended-Release Tapentadol Among Treatment-Seeking Individuals, as Captured by the Addiction Severity Index–Multimedia Version (ASI-MV)” was recently published in the online journal Pain Medicine.

Financial Results for Quarter Ended September 30, 2019

  • Xtampza ER net product revenues were $26.5 million for the quarter ended September 30, 2019 (the “2019 Quarter”), compared to $17.0 million for the quarter ended September 30, 2018 (the “2018 Quarter”) and $26.0 million for the quarter ended June 30, 2019, representing an increase of 56% and 2%, respectively.
  • Nucynta franchise net product revenues were $46.4 million in the 2019 Quarter, compared to $53.1 million for the 2018 Quarter and $49.0 million for the quarter ended June 30, 2019, representing a decrease of 13% and 5%, respectively.
  • Selling, general and administrative expenses were $30.1 million for the 2019 Quarter, compared to $33.4 million for the 2018 Quarter.
  • Net loss for the 2019 Quarter was $6.1 million, or $0.18 per share (basic and diluted), compared to net loss of $16.5 million, or $0.50 per share (basic and diluted), for the 2018 Quarter. Net loss included stock-based compensation expense of $4.1 million and $3.9 million for the 2019 Quarter and 2018 Quarter, respectively.
  • Non-GAAP adjusted income for the 2019 Quarter was $1.7 million, compared to a non-GAAP adjusted loss of $8.3 million for the 2018 Quarter.
  • Collegium had cash and cash equivalents of $153.8 million as of September 30, 2019, an increase of $5.1 million compared to the second quarter of 2019. The increase in cash and cash equivalents was primarily the result of cash provided by operating activities, partially offset by capital expenditures related to the buildout of additional manufacturing capacity.

VSTO = ANOKA, Minn., Nov. 7, 2019 /PRNewswire/ — Vista Outdoor Inc. (NYSE: VSTO) today reported operating results for the second quarter of its Fiscal Year 2020 (FY20), which ended on September 29, 2019.

“We have had a good start to the first half of the year, and have delivered a solid second quarter of results,” said Vista Outdoor Chief Executive Officer Chris Metz. “While we were presented with several significant new challenges in the second quarter, particularly within our Ammunition business unit, we have continued to make progress on our profitability and de-leveraging goals. The decisive actions we have taken to strengthen performance are yielding results. I am confident in the plans we have in place, and in our team’s ability to successfully deliver on our financial guidance for Fiscal Year 2020.”

For the second quarter ended September 29, 2019:

  • Sales were $445 million, down 19 percent from the prior-year quarter, down 7 percent on an organic basis, excluding results from the sale of our Eyewear brands, which were sold in the second quarter of Fiscal Year 2019, and our Firearms business which was sold in the second quarter of Fiscal Year 2020.
  • Gross profit was $90 million, down 17 percent from the prior year quarter, down 3 percent on an adjusted organic basis, excluding results from the sale of our Eyewear brands and Firearms business.
  • Operating expenses were $89 million. This compares to $128 million of operating expenses in the prior-year quarter. Adjusted operating expenses were $81 million compared to $94 million in the prior year quarter.
  • Fully diluted earnings per share (EPS) was $(0.21), compared to $(0.57) in the prior year quarter. Adjusted EPS was $0.00, compared to $0.05 in the prior year quarter.
  • Cash flow used in operating activities year-to-date was $8 million, compared to $58 million provided by operations in the prior year period. Year-to-date free cash flow was negative $23 million, compared to free cash flow of positive $55 million in the prior year period. Free cash flow generated in the quarter was positive $21 million.
  • For the second quarter ended September 29, 2019 Operating Segment Results:

Outdoor Products

The Outdoor Products segment generated $234 million in sales during the second quarter, down 14 percent from the prior-year quarter, down 7 percent on an organic basis, excluding our Eyewear brands.

Gross profit was $61 million, down 0.3 percent from the prior year quarter, and up 9 percent on an adjusted organic basis. The gross profit margin was 26 percent, up 361 bps from the prior year quarter, and was 26 percent on an adjusted organic basis, up 397 bps from the prior year quarter.
Shooting Sports

The Shooting Sports segment generated $211 million in sales during the second quarter, down 23 percent from the prior-year quarter, down 6 percent on an organic basis, excluding our Firearms business.
Gross profit was $29 million, down 39 percent from the prior year quarter, down 22 percent on an adjusted organic basis. The gross profit margin was 14 percent, down 353 bps from the prior year quarter, and was 14 percent on an adjusted organic basis, down 277 bps from the prior year quarter.
Please see the tables in this press release for a reconciliation of non-GAAP adjusted gross profit, operating expenses, operating profit, tax rate, fully diluted earnings per share, and free cash flow to the comparable GAAP measures.

Outlook for Fiscal Year 2020

“We have continued to deliver on our debt reduction and de-leveraging goals, paying off the balance of our higher interest Junior Term loan in October. We have now reduced our debt by approximately $600 million, which is a 51 percent reduction from our peak long-term debt balance of approximately $1.176 billion. Our transformation initiatives continue to deliver positive impacts in our financial results, and our more efficient, profitable brand platforms are now better positioned to seize growth opportunities going forward,” said Mick Lopez, Vista Outdoor Chief Financial Officer.

Vista Outdoor’s guidance for FY20 is as follows:

  • Sales in a range of $1.75 billion to $1.85 billion.
  • Interest expense reported of approximately $40 million and adjusted of approximately $37 million.
  • GAAP Earnings per share in a range of $(0.23) to $(0.08), as compared to previous range of $(0.03) and $0.12 to reflect restructuring and asset impairments. We maintain our adjusted earnings per share of $0.10 to $0.25 from previous guidance.
  • Capital expenditures of approximately $40 million.
  • Free cash flow in a range of $30 million to $40 million.
  • The company also expects FY20 EBITDA margins of approximately 6 percent. FY20 guidance does not include the impact of any additional future strategic acquisitions, divestitures, investments, business combinations or other significant transactions.

IQ = BEIJING, Nov. 7, 2019 /PRNewswire/ — Japanese virtual idol Hatsune Miku’s 2019 China Concert Tour, which is jointly sponsored by iQIYI, Inc (“iQIYI” or the “Company”), an innovative market-leading online entertainment service in China, officially launched recently. The Japanese virtual idol will hold concerts in Shanghai, Chengdu, Beijing and Guangzhou from November 2 to 24. This is the first time that iQIYI is involved in an offline concert tour for Hatsune Miku, marking another milestone in iQIYI’s attempt to develop the two-dimensional pan-entertainment industry following its collaboration with iQIYI’s original virtual band RiCH BOOM and band member PRODUCER C at the iQIYI Scream Night concert.

With 600 million fans worldwide, Hatsune Miku was the opening act for Lady Gaga’s world tour and has expanded her commercial footprint in many areas including music, fashion, advertising and gaming. iQIYI’s collaboration with Hatsune Miku once again highlights its strategic planning and business capabilities in the two-dimensional pan-entertainment industry.

iQIYI maximizes commercial value of two-dimensional content through its diversified business model. 

Capitalizing on its large membership base and comprehensive library of high-quality animation IP, iQIYI has developed several monetization approaches in the two-dimensional pan-entertainment industry to unleash the commercial value of high-quality content. In 2015, iQIYI provided an exclusive live broadcast of Hatsune Miku’s first concert in mainland China. The concert’s livestream page reached over 1.5 million in traffic. At the same time, iQIYI was also exploring online content monetization strategy for this world-renowned virtual animation IP. This year, iQIYI was directly involved in the preparation of Hatsune Miku’s offline concert, as well as its ticket revenue sharing, providing fans with a one-stop pan-entertainment experience.

iQIYI carries out cross-industry chain investment and teams up with renowned national and international content creators.

Committed to growing business in the entertainment industry in recent years, iQIYI has continuously been exploring and developing influential quality contents in the field of drama, variety show, film and animation. Leveraging on the business model covering the entirety of the company’s entertainment offerings, iQIYI has established an IP-focused entertainment ecosystem through its “Apple Orchard” business model. Having access to extensive resources including comics, animation and literature, iQIYI is also actively building a two-dimensional pan-entertainment ecosystem that covers animation, film, gaming and location-based entertainment, tapping into the market of animation adaption, game development and offline entertainment offering.

In addition, iQIYI has also partnered with renowned national and international names in the area of film, game and live broadcast to improve its content ecosystem. For example, iQIYI and Viacom International Media Networks jointly produced the 3D animated series Deer Run, targeting an international audience. The Croods, a mobile game produced and released by iQIYI, topped the free games chart of Apple’s Chinese App Store on the day of its release in 2019 and at one stage reached 500,000 in daily downloads for its Android version. Meanwhile, iQIYI has forged long-term and stable cooperation with companies including DeNA, Shueisha, Toei Animation and TV Tokyo.

Drawing on the successful experience accumulated through the live broadcasts of Hatsune Miku concerts, iQIYI officially experimented with an offline cooperation this year in an effort to push for synergy between online and offline quality two-dimensional content and boost creation of content ecology. This in turn would help create more possibilities for monetization of the two-dimensional industry and give rise to more new directions to navigate regarding the development of the entire animation industry.                              

iQIYI, Inc. is an innovative market-leading online entertainment service in China. Its corporate DNA combines creative talent with technology, fostering an environment for continuous innovation and the production of blockbuster content. iQIYI’s platform features highly popular original content, as well as a comprehensive library of other professionally-produced content, partner-generated content and user-generated content. The Company distinguishes itself in the online entertainment industry by its leading technology platform powered by advanced AI, big data analytics and other core proprietary technologies. iQIYI attracts a massive user base with tremendous user engagement, and has developed a diversified monetization model including membership services, online advertising services, content distribution, live broadcasting, online games, IP licensing, online literature and e-commerce.

AIMT = BRISBANE, Calif.–(BUSINESS WIRE)– Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing treatments for potentially life-threatening food allergies, today announced financial results for the quarter and nine months ended September 30, 2019 and provided operational highlights.

“This is a transformative time for the company as we prepare to launch PALFORZIATM, our first drug candidate and potentially the first FDA-approved treatment for any food allergy. We were encouraged by the positive vote from the FDA APAC to support the use of PALFORZIA as a treatment for peanut allergy in children and teens, and we look forward to the FDA’s completed review of our BLA in January,” said Jayson Dallas, M.D., President and CEO of Aimmune Therapeutics. “We have continued to make important progress in preparation for PALFORZIA’s commercial launch, if approved, in the first quarter of 2020 – we have completed hiring for our commercial field leadership team, have had further conversations with payors, and have conducted additional physician and patient research to improve our understanding of the market. Finally, we have been working with the FDA to finalize the REMS program which will support the safe and appropriate use of PALFORZIA.”

Third Quarter 2019 Clinical and Operational Highlights

  • The U.S. Food and Drug Administration (FDA) Allergenic Products Advisory Committee (APAC) voted to support the use of PALFORZIA in children and teens with peanut allergy on September 13, 2019. The APAC voted 7 to 2 that the efficacy data, and 8 to 1 that the safety data, in conjunction with additional safeguards, are adequate to support the use of PALFORZIA. As part of Aimmune’s original Biologics License Application (BLA) submission, the Company proposed risk management measures in line with the Advisory Committee’s discussion and recommendation for a Risk Evaluation and Mitigation Strategy (REMS).
  • PALFORZIA U.S. launch preparations in final stages. Commercial field leadership positions have been filled and offers have been accepted for almost all of the 80 Practice Account Manager positions. The market access team has already met with payers representing nearly 90% of covered lives. Finally, in ongoing consultation with the FDA, the Company continues to finalize the REMS program that will help support the safe and appropriate use of PALFORZIA, if approved.
  • The European Medicines Agency (EMA) continues its review of the Marketing Authorization Application (MAA) for PALFORZIA. In June 2019, the Company submitted a MAA to the EMA for PALFORZIA. The Company expects to receive the Day 120 questions in November 2019 at which time there will be a pause while the Company prepares to answer the questions. A standard overall review period of 12- to 15-months is expected.
  • Ongoing clinical trials to expand pipeline and support CODIT™ platform.
  • In December 2018, Aimmune initiated its POSEIDON phase 3 clinical trial to explore the efficacy and safety of PALFORZIA in young peanut-allergic children ages 1 to <4 years.
  • In October 2018, Regeneron initiated a phase 2 clinical trial of PALFORZIA with adjunctive dupilumab in peanut-allergic patients.
  • In August 2019, Aimmune enrolled the first patient in a phase 2 clinical trial of AR201 in patients with egg allergy.
  • Strong balance sheet. $200.5 million in cash, cash equivalents and investments as of September 30, 2019, and access to up to an additional $130 million from our loan agreement with KKR upon satisfaction of borrowing conditions.
  • Upcoming Milestones

January 2020

Expected FDA review action date for PALFORZIA BLA

Q1 2020

Potential U.S. commercial launch of PALFORZIA, if approved

H2 2020

Expected completion of enrollment of AR201 phase 2 trial

H2 2020

Expected EMA action date for MAA of PALFORZIA for peanut allergy in children and adolescents ages 4 to 17 years

H2 2020

Potential EU commercial launch of PALFORZIA, if approved

Third Quarter 2019 Financial Results

For the quarter and nine months ended September 30, 2019, net loss was $64.5 million and $181.6 million, respectively, compared to net loss of $51.7 million and $153.8 million, respectively, for the comparable periods in 2018. On a per share basis, net loss for the quarter and nine months ended September 30, 2019, was $1.03 and $2.91, respectively, compared to net loss per share of $0.89 and $2.72, respectively, for the comparable periods in 2018. The weighted average shares outstanding for the quarter and nine months ended September 30, 2019, were 62.6 million and 62.3 million shares, respectively, compared to 58.3 million and 56.6 million shares, respectively, for the comparable periods in 2018.

Research and development expenses for the quarter and nine months ended September 30, 2019 were $30.6 million and $93.9 million, respectively, compared to $31.7 million and $100.4 million, respectively, for the comparable periods in 2018. The decrease was primarily due to lower costs related to the completion of certain PALFORZIA clinical trials, partially offset by higher costs related to regulatory activities and increased contract manufacturing costs to support potential commercialization of PALFORZIA as well as costs related to the phase 2 clinical trial of AR201 for egg allergy.

General and administrative expenses for the quarter and nine months ended September 30, 2019 were $34.0 million and $89.0 million, respectively, compared to $21.3 million and $56.5 million, respectively, for the comparable periods in 2018. The increase was primarily due to additional employee-related costs and external professional services as Aimmune continued to build its infrastructure to support the development and potential commercialization of PALFORZIA.

Cash, cash equivalents, and investments totaled $200.5 million on September 30, 2019, compared to $303.9 million on December 31, 2018. The decrease primarily reflects net cash used in operating activities, partially offset by cash provided by financing activities, including net borrowings from our debt issuance in January 2019 of $36.1 million.